Back to resultsGait Modification and Knee Joint Load
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gait modification
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- people with radiographic TF OA fulfilling American College of Rheumatology classification criteria
- reporting average knee pain on walking > 3 on an 11-point scale (0-10) in at least one knee
- pain or tenderness predominantly located on the medial knee.
Exclusion Criteria:
- medial TF joint space width greater than lateral
- Kellgren/Lawrence (K/L) grade 4
- knee surgery or intra-articular corticosteroid injection in the past 6 months
- uncomfortable walking on treadmill for 20 minutes
- unable to walk without a walking aide
- inflammatory arthritis
- other musculoskeletal or neurological disorders that affect gait patterns
- currently receiving physical therapy
Sites / Locations
- Northwestern UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gait modification
Arm Description
In this pilot study, participants modify their gait patterns guided by real-time visual feedback on their medial knee load while walking on an instrumented treadmill.
Outcomes
Primary Outcome Measures
External knee adduction moment during walking
The external knee adduction moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee adduction moment during walking.
WOMAC (Western Ontario and McMaster Universities) score
WOMAC questionnaire contains 24 questions in three domains of pain (score range 0-20), stiffness (score range 0-8) and physical function (score range 0-68). Higher score indicates worse symptom/function.
Secondary Outcome Measures
External knee flexion moment during walking
The external knee flexion moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee flexion moment during walking.
KOOS (Knee Injury and Osteoarthritis Outcome Score)
KOOS questionnaire contains 42 items in 5 domains of pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores are transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.
Full Information
NCT ID
NCT04946136
First Posted
June 15, 2021
Last Updated
September 26, 2022
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT04946136
Brief Title
Gait Modification and Knee Joint Load
Official Title
The Effect of Gait Modification on Knee Joint Load in Persons With Medial Tibiofemoral Osteoarthritis - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This pilot study aims to assess the effect of a 6-week individualized gait retraining program on knee load and symptoms in persons with knee osteoarthritis (OA).
Detailed Description
This study aims to pilot-test an individualized gait retraining intervention to reduce knee load, guided by real-time visual feedback of the external knee adduction moment (KAM), a commonly used determinant for medial tibiofemoral (TF) joint load, during walking. Our central hypothesis is that individuals with predominantly medial TF OA can adapt their gait patterns to lower KAM during walking; consequently, reduce knee load and pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
This is a pilot single-arm study examining the effect of an intervention on biomechanical and symptomatic outcomes. There is no control group, therefore no masking employed.
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gait modification
Arm Type
Experimental
Arm Description
In this pilot study, participants modify their gait patterns guided by real-time visual feedback on their medial knee load while walking on an instrumented treadmill.
Intervention Type
Other
Intervention Name(s)
Gait modification
Intervention Description
Individualized gait modifications guided by real-time visual feedback of knee load
Primary Outcome Measure Information:
Title
External knee adduction moment during walking
Description
The external knee adduction moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee adduction moment during walking.
Time Frame
Baseline-to-6-week change
Title
WOMAC (Western Ontario and McMaster Universities) score
Description
WOMAC questionnaire contains 24 questions in three domains of pain (score range 0-20), stiffness (score range 0-8) and physical function (score range 0-68). Higher score indicates worse symptom/function.
Time Frame
Baseline-to-6-week change
Secondary Outcome Measure Information:
Title
External knee flexion moment during walking
Description
The external knee flexion moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee flexion moment during walking.
Time Frame
Baseline-to-6-week change
Title
KOOS (Knee Injury and Osteoarthritis Outcome Score)
Description
KOOS questionnaire contains 42 items in 5 domains of pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores are transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.
Time Frame
Baseline-to-6-week change
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
people with radiographic TF OA fulfilling American College of Rheumatology classification criteria
reporting average knee pain on walking > 3 on an 11-point scale (0-10) in at least one knee
pain or tenderness predominantly located on the medial knee.
Exclusion Criteria:
medial TF joint space width greater than lateral
Kellgren/Lawrence (K/L) grade 4
knee surgery or intra-articular corticosteroid injection in the past 6 months
uncomfortable walking on treadmill for 20 minutes
unable to walk without a walking aide
inflammatory arthritis
other musculoskeletal or neurological disorders that affect gait patterns
currently receiving physical therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison H Chang
Phone
312-908-8273
Email
hsini@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison H Chang
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison H Chang
Phone
312-908-8273
Email
hsini@northwestern.edu
12. IPD Sharing Statement
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Gait Modification and Knee Joint Load
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