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| Name | Class |
|---|---|
| TIRR Memorial Hermann | OTHER |
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The purpose of the study is to determine whether transcutaneous spinal direct current stimulation (tsDCS) is safe for individuals with spinal cord injury (SCI). tsDCS is an electrical current applied to the skin. The plan is to also study the potential neurophysiological changes (changes in speed and excitability of the nerves) and functional improvements in gait (for example, gait quality, speed and walking distance) for individuals with SCI after combined application of tsDCS and exoskeleton assisted gait training.
Subjects will participate in two baseline visits, 4 days apart. Each baseline visit will last 1 hour and will include assessment of soleus H-Reflex and 10 meter walk test on arrival and 40 minutes after the initial assessment. Subjects will be asked to minimize their activity between assessments by either sitting in a chair or lying on a mat.
Each training visit will involve either an exoskeleton intervention or a combined exoskeleton and tsDCS intervention. Each training visit will include assessment of soleus H-Reflex and 10 meter walk test before and after the exoskeleton intervention or before and after the combined exoskeleton and tsDCS intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no intervention; then no intervention; then cathode tsDCS + Ekso; then Ekso; then cathode tsDCS+Ekso | Experimental | Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS. |
|
| no intervention; then no intervention; then Ekso; then cathode tsDCS + Ekso; then Ekso | Experimental | Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS. |
|
| no intervention; then no intervention; then anode tsDCS + Ekso; then Ekso; then anode tsDCS + Ekso | Experimental | Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cathode tsDCS | Device | Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg. | beginning and end of first no-intervention visit (7 days before any intervention) |
| Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg. | beginning and end of second no-intervention visit (3 days before any intervention) |
| Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | Soleus H-Reflex is assessed on arrival and then after the intervention is applied--change between these two readings is reported. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Speed as Assessed by 10 Meter Walk Test | The 10 Meter Walk Test (10MWT) will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | first no-intervention visit (7 days before any intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcie Kern, PT, MSPT | TIRR Memorial Hermann | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeuroRecovery Research Center at TIRR Memorial Hermann | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | no Intervention; Then no Intervention; Then Cathode tsDCS + Ekso; Then Ekso; Then Cathode tsDCS+Ekso | Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS. cathode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin. Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. |
| FG001 | no Intervention; Then no Intervention; Then Ekso; Then Cathode tsDCS + Ekso; Then Ekso | Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS. cathode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin. Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. |
| FG002 | no Intervention; Then no Intervention; Then Anode tsDCS + Ekso; Then Ekso; Then Anode tsDCS + Ekso | Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS. Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. anode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin. |
| FG003 | no Intervention; Then no Intervention; Then Ekso; Then Anode tsDCS + Ekso; Then Ekso | Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS. Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. anode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7 Days Before Any Intervention |
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| 3 Days Before Any Intervention |
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| Intervention 1 (1 Week) |
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| Washout (1 Week) |
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| Intervention 2 (1 Week) |
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| Washout (1 Week) |
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| Intervention 1 Again (1 Week) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ekso Alone, and Ekso + Cathode tsDCS | Participants received Ekso alone and also Ekso combined with cathode non-invasive transcutaneous spinal direct current stimulation (tsDCS). Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso alone will consist of a walking session in Ekso with no tsDCS. Cathode tsDCS plus Ekso involves cathode tsDCS application followed by a walking session in Ekso. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg. | All participants were assessed for the H-Reflex at this visit. | Posted | Mean | Standard Deviation | percent change in H-Reflex | beginning and end of first no-intervention visit (7 days before any intervention) |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cathode tsDCS + Ekso | Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin. Cathode tsDCS plus Ekso involves cathode tsDCS application followed by a walking session in Ekso. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcie Kern, PT, MSPT | The University of Texas Health Science Center at Houston | 713-799-6995 | neurorecoveryresearch@memorialhermann.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2016 | Nov 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
| no intervention; then no intervention; then Ekso; then anode tsDCS + Ekso; then Ekso | Experimental | Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS. |
|
| Ekso | Device | Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. |
|
| anode tsDCS | Device | Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin. |
|
| before and after intervention on day 1 |
| Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | Soleus H-Reflex is assessed on arrival and then after the intervention is applied--change between these two readings is reported. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg. | before and after intervention on day 5 |
| Gait Speed as Assessed by 10 Meter Walk Test | The 10 Meter Walk Test (10MWT) will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | second no-intervention visit (3 days before any intervention) |
| Gait Speed as Assessed by 10 Meter Walk Test | Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | Day 1 of intervention |
| Gait Speed as Assessed by 10 Meter Walk Test | Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | Day 2 of intervention |
| Gait Speed as Assessed by 10 Meter Walk Test | Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | Day 3 of intervention |
| Gait Speed as Assessed by 10 Meter Walk Test | Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | Day 4 of intervention |
| Gait Speed as Assessed by 10 Meter Walk Test | Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | Day 5 of intervention |
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| COMPLETED |
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| COMPLETED |
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| COMPLETED |
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| BG001 | Ekso Alone, and Ekso + Anode tsDCS | Participants received Ekso alone and also Ekso combined with anode non-invasive transcutaneous spinal direct current stimulation (tsDCS). Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso alone will consist of a walking session in Ekso with no tsDCS. Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Level of Spinal Cord Injury (SCI) | The level of injury is based on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The level reported is the lowest (most caudal) segment of the spinal cord that remains fully intact for sensory and motor function. C is cervical (the region of the neck), with C1 being the highest level closest to the skull and C7 being the bottom of the neck. T is the thoracic/chest region (all the levels with ribs attached), with T1 being the top closest to the neck and T12 the bottom close to low back. | Count of Participants | Participants |
|
| Time since injury | Mean | Standard Deviation | years |
|
| Title |
|---|
| Description |
|---|
| OG000 | No Intervention | Neither Ekso nor tsDCS are applied. |
|
|
| Primary | Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg. | All participants were assessed for the H-Reflex at this visit. | Posted | Mean | Standard Deviation | percent change in H-Reflex | beginning and end of second no-intervention visit (3 days before any intervention) |
|
|
|
| Primary | Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | Soleus H-Reflex is assessed on arrival and then after the intervention is applied--change between these two readings is reported. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg. | All participants received all interventions as assigned during all 3 intervention periods and were assessed for H-reflex. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total). | Posted | Mean | Standard Deviation | percent change in H-Reflex | before and after intervention on day 1 | data points | data points |
|
|
|
| Primary | Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | Soleus H-Reflex is assessed on arrival and then after the intervention is applied--change between these two readings is reported. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg. | All participants received all interventions as assigned during all 3 intervention periods and were assessed for H-reflex. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total). | Posted | Mean | Standard Deviation | percent change in H-Reflex | before and after intervention on day 5 | data points | data points |
|
|
|
| Secondary | Gait Speed as Assessed by 10 Meter Walk Test | The 10 Meter Walk Test (10MWT) will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | All participants were assessed for the 10MWT at this visit. | Posted | Mean | Standard Deviation | seconds | first no-intervention visit (7 days before any intervention) |
|
|
|
| Secondary | Gait Speed as Assessed by 10 Meter Walk Test | The 10 Meter Walk Test (10MWT) will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | One participant was not assessed for gait speed at this visit. | Posted | Mean | Standard Deviation | seconds | second no-intervention visit (3 days before any intervention) |
|
|
|
| Secondary | Gait Speed as Assessed by 10 Meter Walk Test | Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | All participants received all interventions as assigned during all 3 intervention periods and were assessed for gait speed. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total). | Posted | Mean | Standard Deviation | seconds | Day 1 of intervention | data points | data points |
|
|
|
| Secondary | Gait Speed as Assessed by 10 Meter Walk Test | Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | One participant was not assessed for gait speed for two intervention periods of the cathode tsDCS + Ekso arm and one intervention period of the the Ekso alone arm. For the cathode tsDCS + Ekso arm, 1 received the intervention once (1 data point total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 1 received the intervention once, and 2 received the intervention twice (5 data points total). | Posted | Mean | Standard Deviation | seconds | Day 2 of intervention | data points | data points |
|
|
|
| Secondary | Gait Speed as Assessed by 10 Meter Walk Test | Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | One participant was not assessed for gait speed for two intervention periods of the cathode tsDCS + Ekso arm and one period of the the Ekso alone arm. Another participant was not assessed for gait speed for one period of the the anode tsDCS+Ekso arm. For the cathode tsDCS+Ekso arm, 1 received intervention once (1 data point). For the anode tsDCS+Ekso arm, 2 received intervention once (2 data points). For the Ekso alone arm, 1 received intervention once, and 2 received it twice (5 data points). | Posted | Mean | Standard Deviation | seconds | Day 3 of intervention | data points | data points |
|
|
|
| Secondary | Gait Speed as Assessed by 10 Meter Walk Test | Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | One participant was not assessed for gait speed for two intervention periods of the cathode tsDCS + Ekso arm and one intervention period of the the Ekso alone arm. For the cathode tsDCS + Ekso arm, 1 received the intervention once (1 data point total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 1 received the intervention once, and 2 received the intervention twice (5 data points total). | Posted | Mean | Standard Deviation | seconds | Day 4 of intervention | data points | data points |
|
|
|
| Secondary | Gait Speed as Assessed by 10 Meter Walk Test | Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. | All participants received all interventions as assigned during all 3 intervention periods and were assessed for Gait speed. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total). | Posted | Mean | Standard Deviation | seconds | Day 5 of intervention | data points | data points |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Anode tsDCS + Ekso | Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin. Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Ekso Alone | Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Ekso alone will consist of a walking session in Ekso with no tsDCS. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | No Intervention | Neither Ekso nor tsDCS are applied. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D014947 | Wounds and Injuries |