| Primary | Mean Change in Functional Interference From Pain From Baseline to 4 Weeks (Blinded Phase) | Pain will be assessed with a validated questionnaire called Brief Pain Inventory interference composite score (BPI-I). The maximum score is 10, meaning pain completely interferes, while the minimum score is zero, meaning pain does not interfere. | Blinded phase of the study at 4 weeks. | Posted | | Mean | Standard Error | score on a scale | | baseline to 4 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks. | | OG001 | Placebo Group | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000.454± 0.503
- OG0010.198± 0.503
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| Secondary | Mean Change in Pain Severity From Baseline to 4 Weeks (Blinded Phase) | Pain severity will be assessed using the Brief Pain Inventory questionnaire composite score for severity. The maximum score is 10, meaning pain as bad as one can imagine, while the minimum score is zero, meaning no pain. | | Posted | | Mean | Standard Error | score on a scale | | Baseline to 4 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 4 Weeks (Blinded Phase) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 4 Weeks (Blinded Phase) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). TENS - low-dose: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day. |
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| Secondary | Mean Change in Functional Interference From Fatigue From Baseline to 4 Weeks (Blinded Phase) | Functional interference from fatigue will be assessed calculating the Global Fatigue Index (GFI) obtained from a validated questionnaire called Multidimensional Assessment Fatigue, which has a minimum score of 0 (no fatigue) and a maximum sore of 100 (severe fatigue). | Blinded phase of the study. | Posted | | Mean | Standard Error | score on a scale | | Baseline to 4 weeks | | | | ID | Title | Description |
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| OG000 | Active Group (AG) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. | | OG001 | Placebo Group (PG) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
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| Secondary | Stride Time at 4 Weeks During a Simple Walking Task (Blinded Phase) | Stride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds. | | Posted | | Mean | Standard Deviation | seconds | | at 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Active Group (AG) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. | | OG001 | Placebo Group (PG) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
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| Secondary | Cadence at 4 Weeks During a Simple Walking Task (Blinded Phase) | Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute. | | Posted | | Mean | Standard Deviation | steps/min | | at 4 weeks | | | | ID | Title | Description |
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| OG000 | Active Group (AG) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. | | OG001 | Placebo Group (PG) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
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| Secondary | Double Support Phase at 4 Weeks During a Simple Walking Task (Blinded Phase) | Double Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride. | | Posted | | Mean | Standard Deviation | percentage of time | | at 4 weeks | | | | ID | Title | Description |
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| OG000 | Active Group (AG) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. | | OG001 | Placebo Group (PG) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
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| Secondary | Cadence at 4 Weeks During a Dual Walking Task (Blinded Phase) | Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute. | | Posted | | Mean | Standard Deviation | steps/min | | at 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Active Group (AG) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. | | OG001 | Placebo Group (PG) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
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| Secondary | Cadence at 4 Weeks During a Fast Walking Task (Blinded Phase) | Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Cadence is defined as rate of number of steps per minute. | | Posted | | Mean | Standard Deviation | steps/min | | at 4 weeks | | | | ID | Title | Description |
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| OG000 | Active Group (AG) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. | | OG001 | Placebo Group (PG) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
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| Other Pre-specified | Stride Time at 4 Weeks During a Dual Walking Task (Blinded Phase) | Stride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds. | | Posted | | Mean | Standard Deviation | seconds | | at 4 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 4 Weeks (Blinded Phase) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 4 Weeks (Blinded Phase) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). TENS - low-dose: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Stride Time at 4 Weeks During a Fast Walking Task (Blinded Phase) | Stride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds. | | Posted | | Mean | Standard Deviation | seconds | | at 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention Group at 4 Weeks (Blinded Phase) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 4 Weeks (Blinded Phase) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). TENS - low-dose: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation at 4 Weeks (Blinded Phase) | Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US). | | Posted | | Mean | Standard Deviation | Hertz | | at 4 weeks | lower extremities | lower extremities | | ID | Title | Description |
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| OG000 | Intervention Group at 4 Weeks (Blinded Phase) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 4 Weeks (Blinded Phase) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). TENS - low-dose: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Frailty at 4 Weeks (Blinded Phase) | Frailty will be measured with a upper-extremity wearable sensor (Frailty meter, BioSensics, MA) which enables a frailty index score based on a validated algorithm. Patients with frailty index >0.27 is considered are considered as frail. Patients with a frailty index <0.27 are considered as non-frail. The higher the frailty index, the higher the level of frailty. The frailty index ranges from 0-1. | | Posted | | Mean | Standard Deviation | frailty index | | up to 4 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 4 Weeks (Blinded Phase) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 4 Weeks (Blinded Phase) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). TENS - low-dose: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Sural Nerve Conduction Velocity at 4 Weeks (Blinded Phase) | Sural nerve conduction will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 20 m/s to a maximum of 60m/s. Measurements will be obtained at 4 weeks and value will be compared between groups. | Sural nerve conduction velocity from both right and left lower extremities were measured in each participant | Posted | | Mean | Standard Deviation | m/s | | 4 weeks | lower extremities | lower extremities | | ID | Title | Description |
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| OG000 | Active Group (AG) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. | | OG001 | Placebo Group (PG) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
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| Other Pre-specified | Ankle Strength at 4 Weeks (Blinded Phase) | Ankle strength will be assessed with an ankle dynamometer. Participants will be asked to perform 3 maximum voluntary contractions (MVC) sustaining ankle dorsiflexion for 5 seconds with 30 seconds of resting in between MVCs. The average of the 3 MVCs will then be calculated per lower extremity. | bilateral ankle strength was measured in each participant | Posted | | Mean | Standard Deviation | kg | | up to 4 weeks | lower extremities | lower extremities | | ID | Title | Description |
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| OG000 | Active Group (AG) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. | | OG001 | Placebo Group (PG) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
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| Other Pre-specified | Plantar Tissue Oxygen Saturation at 4 Weeks (Blinded Phase) | Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced. | | Posted | | Mean | Standard Deviation | percentage of oxygen saturation | | up to 4 weeks | lower extremities | lower extremities | | ID | Title | Description |
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| OG000 | Active Group (AG) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. | | OG001 | Placebo Group (PG) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
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| Other Pre-specified | Mean Daily Step Count at 4 Weeks (Blinded Phase) | Step count obtained with the mean 90 percentile will be will be measured over the course of the 4 weeks using a smart watch (Vivosmart 4, Garmin, US) | | Posted | | Mean | Standard Deviation | steps/day | | up to 4 weeks | | | | ID | Title | Description |
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| OG000 | Active Group (AG) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. | | OG001 | Placebo Group (PG) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
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| Other Pre-specified | Sleep Duration at 4 Weeks (Blinded Phase) | Daily sleep duration in hours obtained with the mean 90 percentile will be measured over the course of the 4 weeks using a smart watch (Vivosmart 4, Garmin, US) | | Posted | | Mean | Standard Deviation | hours/day | | up to 4 weeks | | | | ID | Title | Description |
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| OG000 | Active Group (AG) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. | | OG001 | Placebo Group (PG) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
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| Other Pre-specified | Sural Nerve Amplitude at 4 Weeks (Blinded Phase) | Sural nerve amplitude will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 0 microVolts to a maximum of 32 microVolts. Measurements will be obtained at 4 weeks. | Sural nerve amplitude will be measured in each of the participant's legs | Posted | | Mean | Standard Deviation | microVolts | | at 4 weeks | lower extremities | lower extremities | | ID | Title | Description |
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| OG000 | Intervention Group at 4 Weeks (Blinded Phase) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 4 Weeks (Blinded Phase) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). TENS - low-dose: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Mean Change in Functional Interference From Pain at 8 Weeks (Unblinded Phase) | Pain will be assessed with a validated questionnaire called Brief Pain Inventory interference composite score (BPI-I). The maximum score is 10, meaning pain completely interferes, while the minimum score is zero, meaning pain does not interfere. This outcome assesses the difference between the mean BPI interference composite score at week 8 and week 4. | | Posted | | Mean | Standard Deviation | score on a scale | | from week 4 to week 8 | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Mean Change in Pain Severity From 4 Weeks to 8 Weeks (Unblinded Phase) | Pain severity will be assessed using the Brief Pain Inventory questionnaire composite score for severity. The maximum score is 10, meaning pain as bad as one can imagine, while the minimum score is zero, meaning no pain. This outcome assesses the difference between the mean BPI severity composite score at week 8 and week 4. | | Posted | | Mean | Standard Deviation | score on a scale | | 4 weeks to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Mean Change in Functional Interference From Fatigue From 4 Weeks to 8 Weeks (Unblinded Phase) | Functional interference from fatigue will be assessed calculating the Global Fatigue Index (GFI) obtained from a validated questionnaire called Multidimensional Assessment Fatigue, which has a minimum score of 0 (no fatigue) and a maximum sore of 100 (severe fatigue). This outcome assesses the difference between the mean global fatigue index at week 8 and week 4. | | Posted | | Mean | Standard Deviation | score on a scale | | 4 weeks to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Stride Time at 8 Weeks During a Simple Walking Task (Unblinded Phase) | Stride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds. | | Posted | | Mean | Standard Deviation | seconds | | at 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation at 8 Weeks (Unblinded Phase) | Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US). | | Posted | | Mean | Standard Deviation | Hertz | | at 8 weeks | lower extremities | lower extremities | | ID | Title | Description |
|---|
| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Frailty at 8 Weeks (Unblinded Phase) | Frailty will be measured with an upper-extremity wearable sensor (Frailty meter, BioSensics, MA) which enables a frailty index score based on a validated algorithm. Patients with frailty index >0.27 is considered are considered as frail. Patients with a frailty index <0.27 are considered as non-frail. The higher the frailty index, the higher the level of frailty. The frailty index ranges from 0-1. | | Posted | | Mean | Standard Deviation | frailty index | | at 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Sural Nerve Conduction Velocity at 8 Weeks (Unblinded Phase) | Sural nerve conduction will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 20 m/s to a maximum of 60m/s. Measurements will be obtained at 8 weeks and value will be compared between groups. | | Posted | | Mean | Standard Deviation | m/s | | at 8 weeks | lower extremities | lower extremities | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Ankle Strength at 8 Weeks (Unblinded Phase) | Ankle strength will be assessed with an ankle dynamometer. Participants will be asked to perform 3 maximum voluntary contractions (MVC) sustaining ankle dorsiflexion for 5 seconds with 30 seconds of resting in between MVCs. The average of the 3 MVCs will then be calculated per lower extremity. | | Posted | | Mean | Standard Deviation | kg | | at 8 weeks | lower extremities | lower extremities | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Plantar Tissue Oxygen Saturation at 8 Weeks (Unblinded Phase) | Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced. | | Posted | | Mean | Standard Deviation | percentage of oxygen saturation | | at 8 weeks | lower extremities | lower extremities | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Mean Daily Step Count at 8 Weeks (Unblinded Phase) | Step count obtained with the mean 90 percentile will be will be measured starting from 4 weeks up to 8 weeks using a smart watch (Vivosmart 4, Garmin, US) | | Posted | | Mean | Standard Deviation | steps/day | | Starting at 4 weeks up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Sleep Duration at 8 Weeks (Unblinded Phase) | Daily sleep duration in hours obtained with the mean 90 percentile will be measured starting from 4 weeks up to 8 weeks using a smart watch (Vivosmart 4, Garmin, US) | | Posted | | Mean | Standard Deviation | hours/day | | Starting at 4 weeks up to 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Sural Nerve Amplitude at 8 Weeks (Unblinded Phase) | Sural nerve amplitude will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 0 microVolts to a maximum of 32 microVolts. Measurements will be obtained at 8 weeks. | | Posted | | Mean | Standard Deviation | microVolts | | up to 8 weeks | lower extremities | lower extremities | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Double Support Phase at 4 Weeks During a Dual Walking Task (Blinded Phase) | Double Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride. | | Posted | | Mean | Standard Deviation | percentage time | | at 4 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 4 Weeks (Blinded Phase) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 4 Weeks (Blinded Phase) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). TENS - low-dose: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Double Support Phase at 4 Weeks During a Fast Walking Task (Blinded Phase) | Double Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride. | | Posted | | Mean | Standard Deviation | percentage time | | at 4 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 4 Weeks (Blinded Phase) | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 4 Weeks (Blinded Phase) | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). TENS - low-dose: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Double Support Phase at 8 Weeks During a Simple Walking Task (Unblinded Phase) | Double Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride. | | Posted | | Mean | Standard Deviation | percentage time | | at 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Double Support Phase at 8 Weeks During a Dual Task (Unblinded Phase) | Double Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride. | | Posted | | Mean | Standard Deviation | percentage | | at 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Stride Time at 8 Weeks During a Dual Task (Unblinded Phase) | Stride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds. | | Posted | | Mean | Standard Deviation | seconds | | at 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Stride Time at 8 Weeks During a Fast Walk Task (Unblinded Phase) | Stride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds. | | Posted | | Mean | Standard Deviation | seconds | | at 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Cadence at 8 Weeks During a Simple Walking Task (Unblinded Phase) | Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute. | | Posted | | Mean | Standard Deviation | steps/min | | at 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Cadence at 8 Weeks During a Dual Task (Unblinded Phase) | Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute. | | Posted | | Mean | Standard Deviation | steps/min | | at 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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| Other Pre-specified | Cadence at 8 Weeks During a Fast Walking Task (Unblinded Phase) | Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Cadence is defined as rate of number of steps per minute. | | Posted | | Mean | Standard Deviation | steps/min | | at 8 weeks | | | | ID | Title | Description |
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| OG000 | Intervention Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | | OG001 | Placebo Group at 8 Weeks (Unblinded Phase) | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. |
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