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Behavioral Intervention

Movement Pattern Biofeedback Training for Total Knee Replacement Recovery (MOVE Trial)

N/A
Waitlist Available
Led By Jennifer E Stevens-Lapsley, PT, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Underwent primary, unilateral knee arthroplasty for end-stage osteoarthritis
50-85 years old
Must not have
Moderate to severe contralateral knee osteoarthritis (pain >4/10 on verbal pain rating or Kellgren-Lawrence grade >3)
Unstable orthopedic conditions limiting function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks after surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing a new movement pattern training program to regular rehabilitation after knee surgery, to see if the new program leads to better movement quality and function.

Who is the study for?
Adults aged 50-85 who have had a knee replacement due to severe osteoarthritis can join this study. It's not for those discharged elsewhere than home, with previous opposite knee surgery, uncontrolled diabetes, unable to walk 30m without help, other limiting conditions, certain knee pain levels or smokers.
What is being tested?
The trial is testing a new training program called MOVE that uses biofeedback insoles during rehabilitation after knee replacement surgery. It aims to see if MOVE improves movement and function more than the usual rehab exercises alone.
What are the potential side effects?
Since this trial involves physical therapy and exercise rather than medication, side effects may include muscle soreness or discomfort from the exercises. The biofeedback insoles are non-invasive but might cause skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had knee replacement surgery for severe arthritis in one knee.
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I am between 50 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe pain (more than 4/10) or high-grade arthritis in my other knee.
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I have bone problems that limit my movement.
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I had surgery complications that changed my rehab plan.
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I cannot walk 30 meters by myself without help.
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I have had a total knee replacement on the opposite knee.
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I will be discharged to a place that is not my home after surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Knee
Secondary study objectives
Adherence to the intervention
Change in 30-Second Sit-to-Stand Test (30-STS)
Change in Accelerometer-based Physical Activity
+9 more
Other study objectives
Change in contralateral knee whole-organ MRI scoring method (WORMS) total sum score
Incidence of contralateral TKA

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: MOVEExperimental Treatment1 Intervention
Movement pattern training in addition to contemporary progressive rehabilitation
Group II: CONTROLActive Control1 Intervention
Contemporary progressive rehabilitation

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,800 Previous Clinical Trials
2,821,794 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,782 Previous Clinical Trials
28,183,955 Total Patients Enrolled
University of California, San FranciscoOTHER
2,580 Previous Clinical Trials
15,177,362 Total Patients Enrolled

Media Library

MOVE (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03325062 — N/A
Total Knee Replacement Research Study Groups: Experimental: MOVE, CONTROL
Total Knee Replacement Clinical Trial 2023: MOVE Highlights & Side Effects. Trial Name: NCT03325062 — N/A
MOVE (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03325062 — N/A
~0 spots leftby Dec 2024
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