Older Adults, Total Knee Arthroplasty
Conditions
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.
Detailed 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.
Interventions
BEHAVIORALControl
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.
BEHAVIORALExperimental: 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.
Sponsors
University of California, San Francisco
University of Delaware
National Institute on Aging (NIA)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Knee Extension Moment (PKEM) during walking at fixed speed | Baseline, 10 weeks, 6 months, and 2 years after surgery | Peak Knee Extension Moment (PKEM) during walking at a fixed speed of 1.0 m/s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the intervention | 10 weeks after surgery | Assesses the adherence of subjects as measured by home exercise program logs and number of clinical sessions attended. |
| Satisfaction with rehabilitation program | 10 weeks after surgery | Assesses the satisfaction of subjects with their assigned rehabilitation program using a 5-point Likert scale ranging from very unsatisfied to very satisfied. |
| Change in PKEM during activities | Baseline, 10 weeks, 6 months, and 2 years after surgery | PKEM during walking at self-selected gait speed, rising and lowering from a chair, and stepping up and down a step |
| Change in Six-minute Walk (6MW) Test | Baseline, 10 weeks, 6 months, and 2 years after surgery | Developed and used extensively to measure endurance, measures the distance walked in six minutes. |
| Change in Stair Climbing Test (SCT) | Baseline, 10 weeks, 6 months, and 2 years after surgery | Measures a higher level of function that minimizes the possibility of a ceiling effect |
| Change in 30-Second Sit-to-Stand Test (30-STS) | Baseline, 10 weeks, 6 months, and 2 years after surgery | Assesses lower body strength and the fatigue effect caused by the number of sit-to-stand repetitions. |
| Change in Timed Up and Go (TUG) | Baseline, 10 weeks, 6 months, and 2 years after surgery | 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. |
| Change in knee range of motion (ROM) | Baseline, 10 weeks, 6 months, and 2 years after surgery | Assesses the mobility of the knee joint. |
| Change in Accelerometer-based Physical Activity | Baseline, 10 weeks, 6 months, and 2 years after surgery | Assesses daily physical activity levels and number of steps. |
| Change in Quadriceps Strength | Baseline, 10 weeks, 6 months, and 2 years after surgery | Assesses the maximal voluntary isometric contraction strength of the quadriceps muscle |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline, 10 weeks, 6 months, and 2 years after surgery | 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. |
| Change in Veterans RAND 12 item health survey (VR-12) | Baseline, 10 weeks, 6 months, and 2 years after surgery | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in contralateral knee whole-organ MRI scoring method (WORMS) total sum score | 10 weeks and 2 years after surgery | 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. |
| Incidence of contralateral TKA | 2 years after surgery | Number of participants who have a contralateral TKA |
Countries
United States
Outcome results
None listed