Gait Modification Treatments for Knee Pathology

Stanford University38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Knee Injuries Knee Osteoarthritis

Interventions

Cutaneous StimulationDEVICE

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 SleeveDEVICE

Commercially-available knee sleeve.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 4 week follow-up

Secondary Outcomes

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.

Time frame: Baseline and 4 week follow-up

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.

Time frame: 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.

Time frame: Baseline and 4-week follow-up

Data from ClinicalTrials.gov

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