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The objective of this study is complete a longitudinal cross-over clinical study to investigate the effect of treatments for knee pathology, including cutaneous stimulation (skin vibration and soft knee brace), on locomotion tasks (i.e. walking, jogging, stair ascending and descending), muscle function, and pain/function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment A then B | Experimental | Subjects will receive two treatments: (1) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject and (2) a commercially-available knee sleeve, separated by a washout period. |
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| Experimental Treatment B then A | Experimental | Subjects will receive two treatments: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject, separated by a washout period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutaneous Stimulation | Device | A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Knee Flexion Moment (%Bw*Ht) | Within-subject change (follow-up - baseline) in peak knee flexion moment (%Bodyweight*Height) with the intervention at 4-week follow-up versus control (without the intervention) at baseline. | Baseline and 4 week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | Within-subject change (follow-up - baseline) in pain (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Baseline and 4 week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Andriacchi, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Treatment A Then B | Subjects will receive two treatments: (1) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject and (2) a commercially-available knee sleeve, separated by a washout period. Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject. Knee Sleeve: Commercially-available Passive Knee Bands. |
| FG001 | Experimental Treatment B Then A | Subjects will receive two treatments: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject, separated by a washout period. Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject. Knee Sleeve: Commercially-available knee sleeve. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants entered into the study (all participants received both Treatments A and B in this cross-over study design)
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Subjects received two treatments assigned in random order: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject, separated by a washout period. Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject. Knee Sleeve: Commercially-available knee sleeve. |
| Units | Counts |
|---|---|
| Participants |
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| 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 Peak Knee Flexion Moment (%Bw*Ht) | Within-subject change (follow-up - baseline) in peak knee flexion moment (%Bodyweight*Height) with the intervention at 4-week follow-up versus control (without the intervention) at baseline. | Participants completing the study protocol. | Posted | Mean | Standard Deviation | %Bw*Ht | Baseline and 4 week follow-up |
|
During active study participation, up to 4 weeks for each treatment
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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 | Treatment A (Cutaneous Stimulation) | Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Skin irritation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Andriacchi | Stanford University | 650- | tandriac@stanford.edu |
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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 | Sep 7, 2017 | Jul 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Participants will be told only that we are comparing two types of treatment for their knee pain.
|
| Knee Sleeve | Device | Commercially-available knee sleeve. |
|
| Change in Function |
Within-subject change (follow-up - baseline) in function (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. |
| Baseline and 4 week follow-up |
| Change in Symptoms | Within-subject change (follow-up - baseline) in symptoms (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Baseline and 4-week follow-up |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Peak Knee Flexion Moment (%Bw*Ht) | The peak knee flexion moment during stance phase of gait, collected during motion capture analysis at a self-selected normal walking speed. The peak knee flexion moment is normalized to percentage body weight and height (%Bw*Ht). | Mean | Standard Deviation | %Bw*Ht |
|
| KOOS Pain | Pain subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Mean | Standard Deviation | units on a scale |
|
| KOOS Symptoms | Symptom subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Mean | Standard Deviation | units on a scale |
|
| KOOS Function | Function subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Mean | Standard Deviation | units on a scale |
|
Knee Sleeve: Commercially-available Passive Knee Bands. |
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| Secondary | Change in Pain | Within-subject change (follow-up - baseline) in pain (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Participants completing the study protocol. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 week follow-up |
|
|
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| Secondary | Change in Function | Within-subject change (follow-up - baseline) in function (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Participants completing the study protocol. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 week follow-up |
|
|
|
| Secondary | Change in Symptoms | Within-subject change (follow-up - baseline) in symptoms (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Participants completing the study protocol. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4-week follow-up |
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| 0 |
| 32 |
| 0 |
| 32 |
| 2 |
| 32 |
| EG001 | Treatment B (Knee Sleeve) | Knee Sleeve: Commercially-available Passive Knee Bands. | 0 | 32 | 0 | 32 | 0 | 32 |
|
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| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |