Movement Pattern Biofeedback Training After Total Knee Arthroplasty

NCT03325062 | Completed DMC

• 2 other identifiers: 17-1701R01AG056585
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

This research study explores the effects of movement pattern training using real-time biofeedback insoles after total knee arthroplasty. The purpose of this research study is to determine if the addition of a novel movement pattern training program (MOVE) to contemporary progressive rehabilitation leads to improved movement quality and physical function compared to contemporary progressive rehabilitation (CONTROL) alone.

Conditions

Total Knee Arthroplasty; Older Adults

Outcome Measures

Primary Outcomes (1)

• Change in Peak Knee Extension Moment (PKEM) during walking at fixed speed

  Peak Knee Extension Moment (PKEM) during walking at a fixed speed of 1.0 m/s

  Baseline, 10 weeks, 6 months, and 2 years after surgery

Secondary Outcomes (12)

• Change in PKEM during activities

  Baseline, 10 weeks, 6 months, and 2 years after surgery

• Change in Six-minute Walk (6MW) Test

  Baseline, 10 weeks, 6 months, and 2 years after surgery

• Change in Stair Climbing Test (SCT)

  Baseline, 10 weeks, 6 months, and 2 years after surgery

• Change in 30-Second Sit-to-Stand Test (30-STS)

  Baseline, 10 weeks, 6 months, and 2 years after surgery

• Change in Accelerometer-based Physical Activity

  Baseline, 10 weeks, 6 months, and 2 years after surgery

Other Outcomes (2)

• Change in contralateral knee whole-organ MRI scoring method (WORMS) total sum score

  10 weeks and 2 years after surgery

• Incidence of contralateral TKA

  2 years after surgery

Study Arms (2)

Experimental: MOVE

EXPERIMENTAL

Movement pattern training in addition to contemporary progressive rehabilitation

Behavioral: Experimental: MOVE

CONTROL

ACTIVE COMPARATOR

Contemporary progressive rehabilitation

Behavioral: Control

Interventions

Control BEHAVIORAL

The contemporary progressive rehabilitation program consists of progressive resistive exercise to key lower extremity muscle groups, knee range of motion exercise, weight-bearing exercise, as well as education on symptom management strategies.

CONTROL

Experimental: MOVE BEHAVIORAL

The MOVE program emphasizes movement pattern retraining in conjunction with contemporary rehabilitation. More specifically, the MOVE program promotes symmetry in functional knee motion and loading without postural compensation. Intervention uses pressure-sensing shoe insoles to deliver real-time visual biofeedback during activity performance.

Experimental: MOVE

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• primary, unilateral knee arthroplasty for end-stage osteoarthritis

You may not qualify if:

• Moderate to severe contralateral knee OA (\>4/10 on verbal pain rating (VPR) or KL grade \>3)
• Current smoker
• Drug abuse
• Comorbid conditions that substantially limit physical function or would interfere with the participant's ability to successfully complete rehabilitation (e.g. neurologic, vascular, cardiac problems, or ongoing medical treatments)
• Discharge to location other than home after surgery
• Unstable orthopedic conditions that limit function
• Uncontrolled diabetes (hemoglobin A1c level \>8.0)
• Body mass index \>40 kg/m2
• Surgical complication necessitating an altered course of rehabilitation
• Previous contralateral TKA
• Unable to safely walk 30m without an assistive device
• Ferromagnetic metal implants or pacemakers
• Other contraindications to MRI

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of California, San Francisco: collaborator
• University of Delaware: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

• Christiansen CL, Bade MJ, Davidson BS, Dayton MR, Stevens-Lapsley JE. Effects of Weight-Bearing Biofeedback Training on Functional Movement Patterns Following Total Knee Arthroplasty: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2015 Sep;45(9):647-55. doi: 10.2519/jospt.2015.5593. Epub 2015 Jul 24.

  PMID: 26207975 BACKGROUND

• Zeni J Jr, Abujaber S, Flowers P, Pozzi F, Snyder-Mackler L. Biofeedback to promote movement symmetry after total knee arthroplasty: a feasibility study. J Orthop Sports Phys Ther. 2013 Oct;43(10):715-26. doi: 10.2519/jospt.2013.4657. Epub 2013 Aug 30.

  PMID: 23892267 BACKGROUND

• McClelland J, Zeni J, Haley RM, Snyder-Mackler L. Functional and biomechanical outcomes after using biofeedback for retraining symmetrical movement patterns after total knee arthroplasty: a case report. J Orthop Sports Phys Ther. 2012 Feb;42(2):135-44. doi: 10.2519/jospt.2012.3773. Epub 2012 Feb 1.

  PMID: 22333656 BACKGROUND

Study Officials

• Jennifer E Stevens-Lapsley, PT, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are only informed that they will participate in one of two post-operative rehabilitation programs (without specific details). Outcome assessors are also blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 30, 2017
• Study Start: January 19, 2018
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: Publications will be made available to the public through PubMed Central within one year after the date of publication.

Locations

US (1)