Gait Modification Treatments for Knee Pathology

Analysis of Pain, Function, and Joint Mechanics in Response to Two Treatments for Knee Pathology

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 Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Knee Injuries
• Intervention / Treatment: Device: Cutaneous Stimulation; Device: Knee Sleeve

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Device: Knee Sleeve; Commercially-available knee sleeve.
Experimental: 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.	Device: 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.; Device: Knee Sleeve; Commercially-available knee sleeve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Thomas Andriacchi, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): January 22, 2019
• Study Completion (Actual): January 22, 2019

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: July 24, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Knee pathology
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Knee Injuries
• Other Study ID Numbers: 40688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No