Recruiting

Walking Intervention

Sponsor:

Northeastern University

Code:

NCT04148807

Conditions

Osteoarthritis, Knee

Knee Pain Chronic

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Progressive Walking with Gait Retraining

Progressive Walking Program

Study Details

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.

Conditions

Osteoarthritis, Knee

Knee Pain Chronic

Study ID

NCT04148807

Start date

Nov 5, 2019

Status verified date

Sep, 2022

Completion date

Mar 30, 2023

Anticipated

Primary completion date

Mar 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Progressive walking program with gait retraining

Participant will receive 8 gait-retraining intervention sessions.

active comparator: Progressive walking program

Participant receives 8 sessions of a graded walking program.

Interventions

Progressive Walking with Gait Retraining

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.

Progressive Walking Program

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.

Primary outcome measure

  • Recruitment rate [ Time Frame: through study completion, an average of 2 years ]
  • Enrollment rate [ Time Frame: through study completion, an average of 2 years ]
  • Retention [ Time Frame: through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Joshua Stefanik, MSPT, PhD

6173738934j.stefanik@northeastern.edu

Locations

Northeastern University

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Northeastern University

Last update posted

Sep 29, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northeastern University on 2022-09-29.