Movement Pattern Biofeedback Training After Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

— MOVE  

Official title:

Movement Pattern Biofeedback Training After Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03325062
• Other study ID #: 17-1701
• Secondary ID: R01AG056585
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 19, 2018
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Currently in the United States, more than 700,000 total knee arthroplasty (TKA) surgeries are performed annually, with projections of 3.5 million performed annually by 2030. The increasing incidence of TKA comes with an immediate need for establishing optimal rehabilitation guidelines to remediate common post-TKA physical impairments and improve functional outcomes. Over the past decade, a primary focus of the investigators' TKA rehabilitation research has been on progressive strengthening, which improves muscle strength and physical function, and is now the contemporary approach to TKA rehabilitation. However, a major issue remaining for patients rehabilitating from unilateral TKA is the persistence of atypical movement patterns. These atypical movement patterns, observed during walking and other functional tasks, are characterized by disuse of the surgical limb, resulting in smaller knee extension moments on the surgical limb compared to the non-surgical limb. As a result, atypical movement patterns following unilateral TKA are associated with persistent quadriceps weakness and poor physical function.

The investigators will conduct a randomized controlled trial of 150 participants undergoing unilateral TKA to determine if the addition of a novel movement pattern training program (MOVE) to contemporary, progressive rehabilitation improves movement pattern quality more than contemporary progressive rehabilitation alone (CONTROL). The secondary goal is to determine if movement pattern training improves long-term physical function. Testing will occur pre-operatively and after TKA at 10 weeks (end of intervention), 6 months (primary endpoint), and 24 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 50-85 years old

2. primary, unilateral knee arthroplasty for end-stage osteoarthritis

Exclusion Criteria:

1. Moderate to severe contralateral knee OA (>4/10 on verbal pain rating (VPR) or KL grade >3)

2. Current smoker

3. Drug abuse

4. 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)

5. Discharge to location other than home after surgery

6. Unstable orthopedic conditions that limit function

7. Uncontrolled diabetes (hemoglobin A1c level >8.0)

8. Body mass index >40 kg/m2

9. Surgical complication necessitating an altered course of rehabilitation

10. Previous contralateral TKA

11. Unable to safely walk 30m without an assistive device

Exclusion criteria for MRI

1. Ferromagnetic metal implants or pacemakers

2. Other contraindications to MRI

Related Conditions & MeSH terms

• Older Adults
• Total Knee Arthroplasty

Intervention

Behavioral:
• MOVE
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.
• Control
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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Aging (NIA), University of California, San Francisco, University of Delaware

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in contralateral knee whole-organ MRI scoring method (WORMS) total sum score	Whole-organ MRI scoring method (WORMS) is a semi-quantitative, MRI-based scoring system that evaluates the integrity of articular cartilage, ligaments/tendons, menisci, bone marrow lesions, effusion, subchondral cysts, loose bodies, and popliteal cysts. The Total sum score ranges from 0-129 and is computed by summing the following subscales: Cartilage (0-36), Ligaments/tendons (0-24), Meniscus (0-24), Bone marrow Lesions (0-18), Joint Effusion (0-3), Subchondral Cysts (0-18), Loose Bodies (0-3), and Popliteal Cyst (0-3). Higher scores indicate greater amounts of joint degeneration.	10 weeks and 2 years after surgery
Other	Incidence of contralateral TKA	Number of participants who have a contralateral TKA	2 years after surgery
Primary	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	Change in PKEM during activities	PKEM during walking at self-selected gait speed, rising and lowering from a chair, and stepping up and down a step	Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary	Change in Six-minute Walk (6MW) Test	Developed and used extensively to measure endurance, measures the distance walked in six minutes.	Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary	Change in Stair Climbing Test (SCT)	Measures a higher level of function that minimizes the possibility of a ceiling effect	Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary	Change in 30-Second Sit-to-Stand Test (30-STS)	Assesses lower body strength and the fatigue effect caused by the number of sit-to-stand repetitions.	Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary	Change in Accelerometer-based Physical Activity	Assesses daily physical activity levels and number of steps.	Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary	Change in Quadriceps Strength	Assesses the maximal voluntary isometric contraction strength of the quadriceps muscle	Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary	Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Assesses self-reported physical function. Scale assess pain, stiffness, and physical function in patients with hip and / or knee osteoarthritis. Total score range is 0-96. Total score is computed by summing three subscales: pain (range 0-20), stiffness (range 0-8), and functional limitations (range 0-68), then dividing by total points possible. Higher scores indicate worse pain, stiffness, and functional limitations.	Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary	Change in Veterans RAND 12 item health survey (VR-12)	A generic instrument to measure health related quality of life. The VR-12 has two subscales, the Physical Component Score (PCS) and the Mental Component Score (MCS). The PCS and MCS summary scores are standardized using a t-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10.	Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary	Change in Timed Up and Go (TUG)	The TUG evaluates mobility through the time required to rise from an arm chair, walk 3 meters, turn and walk back to the arm chair, and return to a seated position.	Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary	Change in knee range of motion (ROM)	Assesses the mobility of the knee joint.	Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary	Adherence to the intervention	Assesses the adherence of subjects as measured by home exercise program logs and number of clinical sessions attended.	10 weeks after surgery
Secondary	Satisfaction with rehabilitation program	Assesses the satisfaction of subjects with their assigned rehabilitation program using a 5-point Likert scale ranging from "very unsatisfied" to "very satisfied".	10 weeks after surgery