Total Knee ArthroplastyMOVENCT03325062
Movement Pattern Biofeedback Training After Total Knee Arthroplasty
A study testing Experimental: MOVE in people with Total Knee Arthroplasty and Older Adults, run by University of Colorado, Denver at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty, Older Adults
- What is being tested?
- Experimental: MOVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2018to 5 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-85 years old
- primary, unilateral knee arthroplasty for end-stage osteoarthritis
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Total Knee Arthroplasty, Older Adults
- Being tested
- Control, Experimental: MOVE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
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.
Experimental: MOVEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: MOVE | Experimental | Movement pattern training in addition to contemporary progressive rehabilitation Receives: Behavioral: Experimental: MOVE |
| CONTROL | Active comparator | Contemporary progressive rehabilitation Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 10 weeks, 6 months, and 2 years after surgery
Secondary outcomes (12)
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
Measured: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Six-minute Walk (6MW) Test
Developed and used extensively to measure endurance, measures the distance walked in six minutes.
Measured: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Stair Climbing Test (SCT)
Measures a higher level of function that minimizes the possibility of a ceiling effect
Measured: Baseline, 10 weeks, 6 months, and 2 years after surgery
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.
Measured: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Accelerometer-based Physical Activity
Assesses daily physical activity levels and number of steps.
Measured: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Quadriceps Strength
Assesses the maximal voluntary isometric contraction strength of the quadriceps muscle
Measured: Baseline, 10 weeks, 6 months, and 2 years after surgery
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.
Measured: Baseline, 10 weeks, 6 months, and 2 years after surgery
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.
Measured: Baseline, 10 weeks, 6 months, and 2 years after surgery
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.
Measured: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in knee range of motion (ROM)
Assesses the mobility of the knee joint.
Measured: Baseline, 10 weeks, 6 months, and 2 years after surgery
Adherence to the intervention
Assesses the adherence of subjects as measured by home exercise program logs and number of clinical sessions attended.
Measured: 10 weeks after surgery
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".
Measured: 10 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start19 Jan 2018
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, University of Delaware, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jennifer E Stevens-Lapsley, PT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325062
- Sponsor's protocol ID
- 17-1701
- Other IDs
- R01AG056585
- Acronym
- MOVE
- Status last verified
- Apr 2025
- First submitted
- 18 Oct 2017
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be shared in a publication, which will be available through pubmed within a year of publication.
Publications
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.
PubMed 26207975Zeni 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.
PubMed 23892267McClelland 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.
PubMed 22333656Capin JJ, Zeni JA Jr, Forster JE, Cheuy VA, Peters A, Hogan C, Yang C, Christiansen CL, Stevens-Lapsley JE, Bade MJ. Preoperative and Post-Rehabilitation Predictors of Gait Biomechanics Six Months After Total Knee Arthroplasty. J Orthop Res. 2025 Nov;43(11):1964-1972. doi: 10.1002/jor.70052. Epub 2025 Sep 9.
PubMed 40923522
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Pattern Biofeedback Training After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03325062
- Acronym / sponsor ID
- MOVE / 17-1701
- Conditions
- Total Knee Arthroplasty, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of Delaware, National Institute on Aging (NIA)
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: MOVE | Experimental | Behavioral: Experimental: MOVEMovement pattern training in addition to contemporary progressive rehabilitation |
| CONTROL | Active comparator | Behavioral: ControlContemporary progressive rehabilitation |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50-85 years old
- primary, unilateral knee arthroplasty for end-stage osteoarthritis
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlThe 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. | Behavioural | CONTROL |
| Experimental: MOVEThe 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. | Behavioural | Experimental: MOVE |
Primary outcome
Change in Peak Knee Extension Moment (PKEM) during walking at fixed speed
Time frame: 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
12 secondary outcomes
Change in PKEM during activities
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Six-minute Walk (6MW) Test
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Stair Climbing Test (SCT)
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in 30-Second Sit-to-Stand Test (30-STS)
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Accelerometer-based Physical Activity
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Quadriceps Strength
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Veterans RAND 12 item health survey (VR-12)
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in Timed Up and Go (TUG)
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Change in knee range of motion (ROM)
Time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery
Adherence to the intervention
Time frame: 10 weeks after surgery
Satisfaction with rehabilitation program
Time frame: 10 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Background: PubMed 26207975Christiansen 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.
- Background: PubMed 23892267Zeni 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.
- Background: PubMed 22333656McClelland 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.
- Derived from this study: PubMed 40923522Capin JJ, Zeni JA Jr, Forster JE, Cheuy VA, Peters A, Hogan C, Yang C, Christiansen CL, Stevens-Lapsley JE, Bade MJ. Preoperative and Post-Rehabilitation Predictors of Gait Biomechanics Six Months After Total Knee Arthroplasty. J Orthop Res. 2025 Nov;43(11):1964-1972. doi: 10.1002/jor.70052. Epub 2025 Sep 9.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be shared in a publication, which will be available through pubmed within a year of publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer E Stevens-Lapsley, PT, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: MOVE in people with Total Knee Arthroplasty and Older Adults, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Knee Extension Moment (PKEM) during walking at fixed speed (time frame: Baseline, 10 weeks, 6 months, and 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03325062, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.