Gait Modification Treatments for Knee Pathology

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116230
• Other study ID #: 40688
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: January 22, 2019

Study information

• Verified date: July 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries
• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• Knee Sleeve
Commercially-available knee sleeve.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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