Gait Modification Treatments for Knee Pathology

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Knee Injuries

• 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

Study Timeline

• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-17
• Study Start: 2018-01-15
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Results First Submitted: 2021-06-30
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-24
• Last Update Submitted: 2021-07-24
• Results First Posted: 2021-08-17
• Last Update Posted: 2021-08-17

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

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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States