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NCT02884414 Clinical Trial

Gait Modifications and Cutaneous Stimulation

Osteoarthritis, Knee Clinical Trial

Official title:
Analysis of Joint Mechanics in Response to Gait Modifications and Cutaneous Stimulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02884414
Other study ID # 37562
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date February 2019

Study information
Verified date January 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to quantify differences in joint mechanics between different types of walking in healthy individuals and individuals with knee pathology. The investigators will determine how modifying gait through feedback and/or cutaneous stimulation changes joint loading.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date February 2019
Est. primary completion date February 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - BMI < 35 kg/m^2 - For knee pathology subjects: Diagnosis of knee pathology (e.g. knee osteoarthritis, ACL injury, etc) and/or knee pain - Full weight-bearing status Exclusion Criteria: - Non-ambulatory - Use of walking aid - For healthy volunteers - history of surgical intervention at any joint of the lower extremity - Inability to cooperate with study protocol due to medical or psychiatric reasons - Inability to provide informed consent - For healthy subjects: Any diagnosis of knee osteoarthritis or knee pain

Study Design

Related Conditions & MeSH terms

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.

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 in peak knee flexion moment (%Bodyweight*Height) with the intervention versus control (without the intervention). Immediate
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