Back to resultsGait Modifications and Cutaneous Stimulation
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cutaneous stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee Pathology
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cutaneous Stimulation
Arm Description
Cutaneous stimulation and/or feedback. This stimulation and/or feedback may be visual, auditory, tactile (e.g. vibratory, temperature), or haptic and is completely external.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02884414
Brief Title
Gait Modifications and Cutaneous Stimulation
Official Title
Analysis of Joint Mechanics in Response to Gait Modifications and Cutaneous Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Knee Pathology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cutaneous Stimulation
Arm Type
Experimental
Arm Description
Cutaneous stimulation and/or feedback. This stimulation and/or feedback may be visual, auditory, tactile (e.g. vibratory, temperature), or haptic and is completely external.
Intervention Type
Device
Intervention Name(s)
Cutaneous stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Peak Knee Flexion Moment (%Bw*Ht)
Description
Within-subject change in peak knee flexion moment (%Bodyweight*Height) with the intervention versus control (without the intervention).
Time Frame
Immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Andriacchi, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gait Modifications and Cutaneous Stimulation
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