Gait Modification for Knee Osteoarthritis

NCT04323969 | Terminated

• 1 other identifier: H19-02621
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Gait Modification; Wearable Sensors

Outcome Measures

Primary Outcomes (2)

• Change in baseline to week 7 foot rotation angle error during stance - in lab walking

  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.

  Baseline, Week 7

• Weekly change in baseline foot rotation angle error during stance - at home walking and during practice sessions

  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.

  Baseline, Weeks 1, 2, 3, 4, 5, 6, 7

Secondary Outcomes (4)

• Change in baseline to week 7 knee joint moment impulse

  Baseline, Week 7

• Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Baseline, Week 7

• Change in baseline to week 7 knee pain on a numerical rating scale

  Baseline, Week 7

• Change in week 1 to week 7 difficulty performing the modification on a numerical rating scale

  Week 1, 7

Study Arms (2)

Specific Modification Target

EXPERIMENTAL

A 15 degree relative increase to foot progression angle

Behavioral: Specific Modification Target

Self-directed Modification

EXPERIMENTAL

A self-directed increase to foot progression angle that is "as much as is comfortable".

Behavioral: Self-directed Modification

Interventions

Specific Modification Target BEHAVIORAL

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.

Specific Modification Target

Self-directed Modification BEHAVIORAL

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.

Self-directed Modification

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Motion Analysis and Biofeedback Laboratory

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael Hunt, PT, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: March 27, 2020
• Study Start: February 20, 2020
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)