Effectiveness of a Walking Intervention on Impact Loading and Pain

NCT ID: NCT04148807

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2023-03-30

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.

Detailed Description

Knee osteoarthritis (OA) is a chronic condition affecting ~12% of older adults in the United States and is a leading cause of disability. Knee pain is a common clinical manifestation that leads individuals with OA to seek medical care. Current rehabilitation approaches (e.g., bracing, taping, foot orthoses, strengthening, etc.) aim to reduce knee joint loading, a well-accepted risk factor for knee OA and pain, but are not always effective. Altering gait mechanics to reduce knee loading has also been suggested. Gait retraining studies for individuals with knee OA have focused on increasing trunk lean and toe out angle to reduce the knee adduction moment (a surrogate measure of joint loading). However, these strategies create an abnormal gait pattern and may not be the best long-term solutions due to the potential injury to other joints which may limit their overall effectiveness and applicability to clinical practice. Impact loading, another mechanical factor related to knee OA, has been reduced using gait retraining strategies in runners with knee pain. It is unknown if gait retraining strategies to decrease impact loading can reduce symptoms of knee OA. Thus, the purpose of this study is to determine the feasibility of a gait retraining program focusing on decreasing impact loading in individuals with knee OA.

At baseline, following 8 intervention sessions, and at 1-month follow-up, participants will complete questionnaires, undergo three-dimensional gait analysis, and assessment of pressure pain threshold.

Note: For participants enrolled during COVID-19 outbreak, only questionnaires will be collected at follow-up assessments.

Conditions

Osteoarthritis, Knee; Knee Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Progressive walking program with gait retraining

Participant will receive 8 gait-retraining intervention sessions.

Group Type: EXPERIMENTAL

Progressive Walking with Gait Retraining

Intervention Type: BEHAVIORAL

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

Participant receives 8 sessions of a graded walking program.

Group Type: ACTIVE_COMPARATOR

Progressive Walking Program

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northeastern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northeastern University

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joshua Stefanik, MSPT, PhD

Role: CONTACT

j.stefanik@northeastern.edu

6173738934

Facility Contacts

Joshua Stefanik, MSPT, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 36474880 (View on PubMed)

Other Identifiers

18-11-15

Identifier Type: -

Identifier Source: org_study_id