Movement Pattern Biofeedback Training After Total Knee Arthroplasty (MOVE)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Older Adults; Total Knee Arthroplasty

Treatments: Behavioral: Control; Behavioral: Experimental: MOVE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03325062

R01AG056585 (U.S. NIH Grant/Contract)

17-1701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups

Experimental: MOVE

Experimental group

Description:

Movement pattern training in addition to contemporary progressive rehabilitation

Treatment:

Behavioral: Experimental: MOVE

CONTROL

Active Comparator group

Description:

Contemporary progressive rehabilitation

Treatment:

Behavioral: Control