Gait Modification Treatments for Knee Pathology

Not Applicable

Completed

Conditions: Knee Osteoarthritis
Knee Injuries

Interventions: Device: Cutaneous Stimulation
Device: Knee Sleeve

Registration Number: NCT03116230

Lead Sponsor: Stanford University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental Treatment A then B	Knee Sleeve	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.
Experimental Treatment B then A	Knee Sleeve	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.
Experimental Treatment B then A	Cutaneous Stimulation	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.
Experimental Treatment A then B	Cutaneous Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Change in Peak Knee Flexion Moment (%Bw*Ht)	Baseline and 4 week follow-up	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

Name	Time	Method
Change in Pain	Baseline and 4 week follow-up	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	Baseline and 4 week follow-up	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	Baseline and 4-week follow-up	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.