Effectiveness of a Walking Intervention on Impact Loading and Pain
1 other identifier
interventional
40
1 country
1
Brief Summary
This study investigates the feasibility of a gait-retraining program for older adults with knee osteoarthritis. The study will enroll 40 participants, with 20 receiving a gait retraining intervention and 20 receiving a graded walking program without gait retraining.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
November 4, 2019
CompletedStudy Start
First participant enrolled
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedSeptember 29, 2022
September 1, 2022
3.4 years
October 29, 2019
September 27, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Recruitment rate
\# of participants screened per month
through study completion, an average of 2 years
Enrollment rate
\# of participants enrolled per month
through study completion, an average of 2 years
Retention
% participants that complete all study visits
through study completion, an average of 2 years
Secondary Outcomes (7)
Withdrawals/Terminated
through study completion, an average of 2 years
Adverse events (AE)/Unanticipated problems (UP)
through study completion, an average of 2 years
Vertical average loading rate
Change from baseline to conclusion of intervention, an average of 1-month
Vertical instantaneous loading rate
Change from baseline to conclusion of intervention, an average of 1-month
Knee Pain with Activities
Change from baseline to conclusion of intervention, an average of 1-month
- +2 more secondary outcomes
Study Arms (2)
Progressive walking program with gait retraining
EXPERIMENTALParticipant will receive 8 gait-retraining intervention sessions.
Progressive walking program
ACTIVE COMPARATORParticipant receives 8 sessions of a graded walking program.
Interventions
A progressive walking program with gait retraining will be performed on a treadmill at self-selected comfortable walking speed wearing an inertial measurement unit (IMU) on the medial aspect of the distal tibia. The (vertical) peak positive acceleration (PPA) of the tibia is a measure of tibial shock. Subjects will be provided real-time audio feedback to reduce PPA by 20% of their average peak PPA. During retraining sessions, a faded feedback approach will be used. Feedback will be provided continuously during the first four sessions and will be faded over the last 4 sessions. Walking time will increase over the 8 sessions.
A progressive walking program will also be performed on a treadmill where subjects will walk at a self-selected comfortable speed with the same walking times per session as the retraining group without any feedback or retraining cues.
Eligibility Criteria
You may qualify if:
- Subjects with a clinical definition of knee OA using NICE guidelines:
- Age ≥ 45
- Walking related joint pain in the last week that averages ≥ 4 on 11-point numeric rating scale, where 0 = no pain and 10 = worst pain possible
- History of knee pain for at least 3 months
- Morning stiffness in the morning lasting less than 30 minutes
You may not qualify if:
- Walk with an assistive device
- Current use of oral opiates or centrally acting pain medications
- History of lower extremity surgery
- Underwent an intra-articular knee joint injection in the past 3 months
- Suffer from inflammatory arthritis or other conditions that affect lower extremity functions
- Currently receiving treatment for their knee and unwilling to stop this treatment for the duration of the study
- Currently pregnant
- Skin allergies to adhesives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northeastern University
Boston, Massachusetts, 02115, United States
Related Publications (1)
Corrigan P, Davis IS, James KA, Crossley KM, Stefanik JJ. Reducing knee pain and loading with a gait retraining program for individuals with knee osteoarthritis: Protocol for a randomized feasibility trial. Osteoarthr Cartil Open. 2020 Sep 3;2(4):100097. doi: 10.1016/j.ocarto.2020.100097. eCollection 2020 Dec.
PMID: 36474880DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2019
First Posted
November 4, 2019
Study Start
November 5, 2019
Primary Completion
March 30, 2023
Study Completion
March 30, 2023
Last Updated
September 29, 2022
Record last verified: 2022-09