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Gait Modification Treatment for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Progressive walking program with toe-out gait modification
Progressive walking program
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring osteoarthritis, knee, walking, toeout, gait modification

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged 50 years and older
  • radiographically confirmed medial compartment tibia-femoral knee osteoarthritis
  • available for weekly training sessions in the Vancouver British Columbia Canada region
  • able to safely perform treadmill walking under therapist supervision

Exclusion Criteria:

  • articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
  • inflammatory arthritic condition
  • history of knee replacement or arthroscopic knee surgery
  • recent use of corticosteroids (oral or via injection)
  • inability to ambulate without a gait aid
  • non-English speaking
  • planning to commence a new treatment approach within the next 4 months

Sites / Locations

  • Motion Analysis and Biofeedback Laboratory, The University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gait Modification Group

Walking Only Group

Arm Description

Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait, with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well.

Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale
Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = maximum pain). Higher scores mean a worse outcome. Change was calculated as the value at 17 weeks and at 21 weeks minus the value at baseline.
Change From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.
Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. Minimum value of the WOMAC pain subscale is 0 and maximum value is 20. Higher scores mean a worse outcome.
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment
Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment
Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse
Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.
Change From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA)
FPA indicates orientation of the foot with respect to the forward progression of the body. Positive values correspond to a toe-in orientation, whereas negative values correspond to a toe-out orientation. Therefore, a positive change value indicates more toe-in versus a negative change value indicates more toe-out.

Secondary Outcome Measures

Change From Baseline to Week 17 and From Baseline to Week 21 in Self-reported Physical Function as Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale.
Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. The WOMAC physical function subscale minimum value is 0 and maximum value is 68. Higher scores mean a worse outcome.
Change From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb.
Participants were instructed to ascend 12 stairs "as quickly as possible", and the fastest time from two attempts was recorded.
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment
Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.

Full Information

First Posted
December 5, 2013
Last Updated
April 15, 2019
Sponsor
University of British Columbia
Collaborators
University of Melbourne, Arthritis Research Centre of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02019108
Brief Title
Gait Modification Treatment for Knee Osteoarthritis
Official Title
Effects of Toe-out Gait Modification on Clinical and Biomechanical Measures in People With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
University of Melbourne, Arthritis Research Centre of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Knee osteoarthritis (OA) is a costly health condition affecting more than 10% of Canadian adults. Excessive and unbalanced loads passing through the knee joint have been implicated in the progression of OA. Typical conservative treatment of OA has focused on increasing daily activity, without consideration for the underlying joint loading. This study aims to compare a 4-month walking program that aims to increase the angle of the foot (toe-out angle) during walking - a measure shown to reduce joint loading and OA disease progression - while increasing walking time/distance, with a standard walking program that aims to increase walking time/distance. It is predicted that the walking program focusing on increasing toe-out will provide greater reductions in self-reported knee pain and a greater reduction in unfavorable knee joint loading.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
osteoarthritis, knee, walking, toeout, gait modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gait Modification Group
Arm Type
Experimental
Arm Description
Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait, with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well.
Arm Title
Walking Only Group
Arm Type
Active Comparator
Arm Description
Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well.
Intervention Type
Other
Intervention Name(s)
Progressive walking program with toe-out gait modification
Intervention Description
Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group.
Intervention Type
Other
Intervention Name(s)
Progressive walking program
Intervention Description
At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale
Description
Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = maximum pain). Higher scores mean a worse outcome. Change was calculated as the value at 17 weeks and at 21 weeks minus the value at baseline.
Time Frame
Weeks 0, 17, 21
Title
Change From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.
Description
Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. Minimum value of the WOMAC pain subscale is 0 and maximum value is 20. Higher scores mean a worse outcome.
Time Frame
Weeks 0, 17, 21
Title
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment
Description
Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.
Time Frame
Weeks 0, 17, 21
Title
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment
Description
Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.
Time Frame
Weeks 0, 17, 21
Title
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse
Description
Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.
Time Frame
Weeks 0, 17, 21
Title
Change From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA)
Description
FPA indicates orientation of the foot with respect to the forward progression of the body. Positive values correspond to a toe-in orientation, whereas negative values correspond to a toe-out orientation. Therefore, a positive change value indicates more toe-in versus a negative change value indicates more toe-out.
Time Frame
Weeks 0, 17, 21
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 17 and From Baseline to Week 21 in Self-reported Physical Function as Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale.
Description
Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. The WOMAC physical function subscale minimum value is 0 and maximum value is 68. Higher scores mean a worse outcome.
Time Frame
Weeks 0, 17, 21
Title
Change From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb.
Description
Participants were instructed to ascend 12 stairs "as quickly as possible", and the fastest time from two attempts was recorded.
Time Frame
Weeks 0, 17, 21
Title
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment
Description
Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.
Time Frame
Weeks 0, 17, 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 50 years and older radiographically confirmed medial compartment tibia-femoral knee osteoarthritis available for weekly training sessions in the Vancouver British Columbia Canada region able to safely perform treadmill walking under therapist supervision Exclusion Criteria: articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial inflammatory arthritic condition history of knee replacement or arthroscopic knee surgery recent use of corticosteroids (oral or via injection) inability to ambulate without a gait aid non-English speaking planning to commence a new treatment approach within the next 4 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Hunt, PT, PhD
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motion Analysis and Biofeedback Laboratory, The University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29709498
Citation
Hunt MA, Charlton JM, Krowchuk NM, Tse CTF, Hatfield GL. Clinical and biomechanical changes following a 4-month toe-out gait modification program for people with medial knee osteoarthritis: a randomized controlled trial. Osteoarthritis Cartilage. 2018 Jul;26(7):903-911. doi: 10.1016/j.joca.2018.04.010. Epub 2018 Apr 27.
Results Reference
derived

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Gait Modification Treatment for Knee Osteoarthritis

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