Back to resultsGait Modification Treatments for Knee Pathology
Primary Purpose
Knee Injuries, Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cutaneous Stimulation
Knee Sleeve
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries focused on measuring Knee pathology
Eligibility Criteria
Inclusion Criteria:
- Age 18-80
- Ambulatory
- Symptomatic knee pain ≥ 3/10 on most of the past 30 days
- Prior ACL injury/surgery, meniscus injury/surgery, and/or physician-diagnosed medial compartment knee osteoarthritis (KL grade 1-3)
- Agreement and ability to use provided interventions during the study period (suggested cumulative wear time during walking of 1-2 hr/day)
- Committed to not starting any new therapies for knee condition during the trial, other than rescue pain medication.
Exclusion Criteria:
- Use of walking aid (e.g. cane, crutch, walker, or wheelchair)
- BMI ≥ 35 kg/m2
- Injection in the affected knee during the previous three months
- Known neuropathy due to diabetes or other causes
- Inability to provide informed consent
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental Treatment A then B
Experimental Treatment B then A
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03116230
Brief Title
Gait Modification Treatments for Knee Pathology
Official Title
Analysis of Pain, Function, and Joint Mechanics in Response to Two Treatments for Knee Pathology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
January 22, 2019 (Actual)
Study Completion Date
January 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries, Knee Osteoarthritis
Keywords
Knee pathology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Participants will be told only that we are comparing two types of treatment for their knee pain.
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Treatment A then B
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental Treatment B then A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cutaneous Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Knee Sleeve
Intervention Description
Commercially-available knee sleeve.
Primary Outcome Measure Information:
Title
Change in Peak Knee Flexion Moment (%Bw*Ht)
Description
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.
Time Frame
Baseline and 4 week follow-up
Secondary Outcome Measure Information:
Title
Change in Pain
Description
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.
Time Frame
Baseline and 4 week follow-up
Title
Change in Function
Description
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.
Time Frame
Baseline and 4 week follow-up
Title
Change in Symptoms
Description
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.
Time Frame
Baseline and 4-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-80
Ambulatory
Symptomatic knee pain ≥ 3/10 on most of the past 30 days
Prior ACL injury/surgery, meniscus injury/surgery, and/or physician-diagnosed medial compartment knee osteoarthritis (KL grade 1-3)
Agreement and ability to use provided interventions during the study period (suggested cumulative wear time during walking of 1-2 hr/day)
Committed to not starting any new therapies for knee condition during the trial, other than rescue pain medication.
Exclusion Criteria:
Use of walking aid (e.g. cane, crutch, walker, or wheelchair)
BMI ≥ 35 kg/m2
Injection in the affected knee during the previous three months
Known neuropathy due to diabetes or other causes
Inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Andriacchi, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Gait Modification Treatments for Knee Pathology
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