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Gait Modification for Knee Osteoarthritis (SENSMOD)

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ClinicalTrials.gov Identifier: NCT04323969
Recruitment Status : Terminated (COVID-related laboratory shutdown.)
First Posted : March 27, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Hunt, University of British Columbia

Brief Summary:
This randomized clinical trial will compare the changes in performance, biomechanical and clinical outcomes before and after a six-week gait modification intervention. Participants with knee osteoarthritis will attend in-lab assessments and practice, while also performing daily, at-home walking tracked using a custom sensorized shoe.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Behavioral: Specific Modification Target Behavioral: Self-directed Modification Not Applicable

Detailed Description:
Greater toe-in or toe-out angles during walking are potential biomechanical management strategies for medial compartment knee osteoarthritis (OA). Multi-week clinical trials demonstrate the biomechanical efficacy and potential clinical efficacy. However, walking biomechanics have only been assessed within laboratory environments and performance of the modifications during daily at-home walking is currently unknown. Furthermore, the modifications have largely been instructed using a specific target, requiring motor learning. No study has examined whether a self-directed strategy is feasible and will produce significant improvements in biomechanical and clinical outcomes. Moreover, objective real-world performance of these modifications is unknown and may explain the previous inconsistent clinical results. This study will address these gaps. The investigators hypothesize that real-world performance of the modifications will improve over the intervention and that both groups will exhibit improvements in biomechanical and clinical outcomes at follow up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Foot Progression Angle Modification: an Exploratory Six-week Intervention in People With Knee Osteoarthritis
Actual Study Start Date : February 20, 2020
Actual Primary Completion Date : March 12, 2020
Actual Study Completion Date : March 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Specific Modification Target
A 15 degree relative increase to foot progression angle
Behavioral: Specific Modification Target
Participants will be instructed to increase their baseline foot progression angle by 15 degrees. Visual feedback during practice will be delivered using a mirror and guideline (tape placed on mirror). Verbal feedback will be incorporated to encourage participants to perform the modified foot progression angle as accurately as possible.

Experimental: Self-directed Modification
A self-directed increase to foot progression angle that is "as much as is comfortable".
Behavioral: Self-directed Modification
Participants will be instructed to modify their foot progression angle as much as is comfortable. A mirror will be used during practice for visual feedback, but no specific target or guide will be provided.




Primary Outcome Measures :
  1. Change in baseline to week 7 foot rotation angle error during stance - in lab walking [ Time Frame: Baseline, Week 7 ]
    Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot (heel to toe) and the walking direction. Foot rotation will be measured via standard marker-based motion capture and sensor-based motion capture during baseline, follow up, and each practice session.

  2. Weekly change in baseline foot rotation angle error during stance - at home walking and during practice sessions [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7 ]
    Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot and the walking direction. Foot rotation will be measured via sensor-based motion capture over each week of the intervention. Median and inter-quartile ranges will be taken as the primary summary statistic.


Secondary Outcome Measures :
  1. Change in baseline to week 7 knee joint moment impulse [ Time Frame: Baseline, Week 7 ]
    Knee flexion and adduction moment impulses will be calculated. Participants will walk on an instrumented walkway (2 force platforms) while 14 high speed cameras track the trajectories of markers placed on boney landmarks. Moments will be calculated using an inverse dynamics approach.

  2. Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, Week 7 ]
    Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis. The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.

  3. Change in baseline to week 7 knee pain on a numerical rating scale [ Time Frame: Baseline, Week 7 ]
    Knee pain rated on a 0 to 10 scale. 0 = "no pain at all" and 10 = "worst pain imaginable".

  4. Change in week 1 to week 7 difficulty performing the modification on a numerical rating scale [ Time Frame: Week 1, 7 ]
    Difficulty will be rated on a 0 to 10 scale. 0 = "no difficulty at all" and 10 = "most difficulty imaginable".



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 50 years of age or greater
  • Exhibit signs of tibiofemoral OA (a score of ≥ 2 on the Kellgren and Lawrence (KL) grading scale) predominantly in the medial compartment,
  • Self-reported knee pain ≥ 3 / 10 on a numerical rating scale of pain (NRS; 0 = "no pain" and 10 = "worst pain imaginable") during most days of the previous month
  • Are comfortable walking intermittently for 30 minutes
  • Fit into the available sizes of sensorized shoes (sizes spanning US women's 5 to men's 13)
  • Exhibit at least a 5% reduction in knee adduction moment impulse for 10 degrees of change to foot rotation measured during a screening appointment.

Exclusion Criteria:

  • Any knee surgery or intraarticular injections within the past 6 months
  • A history of joint replacement surgery or high tibial osteotomy
  • Current or recent (within 6 weeks) corticosteroid injections
  • Use of a gait aid
  • Currently on a wait list for joint replacement surgery or high tibial osteotomy
  • Any inflammatory arthritic condition
  • Any other conditions that may affect normal gait or participation in an aerobic exercise program
  • Cannot attend all required appointments.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323969


Locations
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Canada, British Columbia
Motion Analysis and Biofeedback Laboratory
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Michael Hunt, PT, PhD University of British Columbia
  Study Documents (Full-Text)

Documents provided by Michael Hunt, University of British Columbia:
Study Protocol  [PDF] March 24, 2020
Statistical Analysis Plan  [PDF] March 24, 2020

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Responsible Party: Michael Hunt, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04323969    
Other Study ID Numbers: H19-02621
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Hunt, University of British Columbia:
Gait Modification
Wearable Sensors
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases