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Knee OsteoarthritisNCT05736666

Treadmill Perturbation Training for Fall Prevention After Total Knee Replacement

A study testing Treadmill-based perturbation training in people with Knee Osteoarthritis and Arthroplasty Complications, run by University of Illinois at Chicago at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The goal of this clinical trial is to learn about preventing falls in people who have total knee replacement surgery using treadmill perturbation training. Perturbation training involves adjusting to rapid speed changes on a treadmill. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Treadmill-based perturbation training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
31 Jul 2025to 30 Apr 2026
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of endstage knee osteoarthritis requiring total knee arthroplasty (TKA). TKA scheduled within two months and able to schedule the required training visits prior to surgery.
  • Exclusion Criteria: Potential participants will be excluded if they have dizziness or self-reported medical conditions that would be expected to affect walking and balance. These specifically include history of stroke, multiple sclerosis, Parkinson's disease, and balance disorders including positional vertigo and Meniere's disease. Other exclusion criteria include plans to undergo a contralateral TKA within 12 months or history of other lower extremity joint replacement within 5 years. Finally, people who report idiopathic low back pain, history of heart disease, uncorrected vision impairment, or institutionalization will be excluded.
  • -

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Biomechanics and Clinical Outcomes Laboratory, University of Illinois Chicago

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Preoperative Perturbation Training to Prevent Falls After Total Knee Arthroplasty

The goal of this clinical trial is to learn about preventing falls in people who have total knee replacement surgery using treadmill perturbation training. Perturbation training involves adjusting to rapid speed changes on a treadmill. The main questions it aims to answer are:

  • Does perturbation training improve the way that people who are planning to have total knee replacement surgery recover after treadmill test that reproduces a trip to the front or side?
  • Does perturbation training reduce the incidence of preventable gait-related falls during the first year after total knee replacement?
Read more

Participants will:

  • complete surveys about their condition and fall history and take part in testing of walking ability and balance.
  • have a baseline gait analysis test to measure the motion of their body during normal walking.
  • Be randomized into two groups. One will receive fall-prevention literature. The other will receive the same literature and then take part in a two-week treadmill perturbation training program.
  • be contacted every two weeks for one year, and asked questions about whether they have fallen during that time.
  • wear a Fitbit activity monitor on their wrist for one year. Researchers will compare the number of falls from the group that only received literature to the treatment group to see if the training group has fewer falls during the year after surgery.
Read the detailed description

Participants:

We will recruit 196 participants who are scheduled for primary unilateral total knee arthroplasty (TKA) and can commit to 5 additional study visits.

Baseline assessment: At enrollment, all participants will be assessed for a set of demographic and functional risk factors listed below

  1. Age
  2. Sex
  3. Body mass index
  4. Number of painful joints - Patient Reported Arthralgia Inventory
  5. Medications that increase fall risk
  6. Number of falls in the past 12 months
  7. Self-reported activity level (UCLA activity score)
  8. Habitual walking speed (8-meter walk test)
  9. Functional Limitations
  10. PROMIS (Patient-Reported Outcomes Measurement Information Systems) Physical Function computerized adaptive test (CAT)
  11. Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living Subscale
  12. Pain - KOOS pain subscale; Intermittent and Constant Osteoarthritis Pain Scale; Pain Catastrophizing Scale; Tampa Scale of Kinesiophobia
  13. Balance and mobility impairment
  14. Timed up and go test
  15. 30 second chair stand test
  16. 4 stage balance test
  17. 8 m walk test
  18. Functional reach test
  19. 6-minute walk test
  20. 4 square step test
  21. Comorbidities - SCQ comorbidity questionnaire
  22. Depression - PROMIS depression (CAT)

Participants will also undergo a standard gait analysis assessment consisting of approximately 5 nonconsecutive minutes of walking at comfortable and fast speeds on an instrumented treadmill with reflective markers will be placed on bony landmarks of the trunk, arms, and lower extremities.

After this assessment, participants will be provided with a Fitbit that they will wear daily except during bathing or swimming. Physical activity level will be measured for the duration of the follow-up period (1 year).

Finally, randomization assignments will be provided along with written education materials (fall prevention brochures from the Centers for Disease Control and Prevention), and the following activities will be undertaken according to grouping:

Group 1 - Perturbation training (4 sessions over 2 weeks with a post-test session 1 week later):

  1. 30 reflective markers will be placed on bony landmarks of the trunk, arms, and lower extremities with one marker indicating the proximal and distal end of each segment and one marker placed out of line with the other two so that the motion capture software can define the 3D motion of each segment.
  2. Participants will be stand comfortably with feet at approximately hip width, on a split belt treadmill. They will be fitted with a safety harness. They will be instructed that the treadmill will move and that they should do whatever they can to maintain or regain their balance.
  3. During the next one minute, a tester will activate the treadmill. Two small surface translations (0.02 cm at roughly 0.22 m/s) will then be administered which will require several small forward directed steps to regain stability. These two small disturbances will provide a familiarization of how the treadmill works.
  4. Participants will be informed that they will receive up to 30 disturbances of larger magnitude while facing forward, then again while facing to each side. They will be instructed to "do whatever [they] can to recovery [their] balance".
  5. On the next perturbation, the participant will receive a larger disturbance. Each training perturbation will consist of the treadmill accelerating for 300 ms, maintaining a constant velocity for 170 ms, then decelerating to 0 m/s in 100 ms. Prior to the disturbance participants will be informed to recover their balance and continue walking for 5 seconds after the perturbation.
  6. The tester will then administer no more than 30 disturbances of increasing difficulty as tolerated by the participant.
  7. A final perturbation will be administered. This constitutes the post-test assessment.
  8. Steps 2-7 will be repeated with the participant turned 90 degrees such that a step to the side will be required. The magnitude of the perturbations will be scaled to 2 foot widths.
  9. Step 8 will be repeated with the participant turned by 180 degrees such that both sides receive lateral training.

Group 2 - Education Control: this group will not undergo additional training but will only receive the written materials

Beginning one week after surgery and then every two weeks for one year, participants will be contacted by text message and asked whether they had fallen during the previous two weeks. People who report falls will be contacted for a detailed interview about the circumstances and consequences of the event.

Being tested
Treadmill-based perturbation training, Education Control
Keywords
Falls, Knee Replacement
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treadmill-based perturbation trainingBehavioural

    The intervention consists of disturbances delivered on a treadmill that simulates tripping over an obstacle or being perturbed to the side. These disturbances require a compensatory step to respond. Through this task-specific training, participants should learn to control their trunk motion in a way that will cause them to avoid a trip or fall to the side.

  • Education ControlBehavioural

    Fall prevention educational material

Study groups in NCT05736666
Study groupRoleWhat they receive
Training GroupExperimentalThe intervention consists of disturbances delivered on a treadmill that simulates tripping over an obstacle or being perturbed to the side.
Receives: Behavioral: Treadmill-based perturbation training
Education GroupActive comparatorThis group will receive educational materials related to fall prevention in older adults.
Receives: Behavioral: Education Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-training trunk angle

    post-training trunk angle at recovery step completion

    Measured: Immediately after completion of training program

  2. Post-training trunk angular velocity

    post-training trunk angular at recovery step completion

    Measured: Immediately after completion of training program

  3. Fall rate

    Number of falls during the first year after surgery

    Measured: 1 year

Secondary outcomes (1)
  1. Fall status

    Did participant fall during the post-training test

    Measured: Immediately after completion of training program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start31 Jul 2025
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Why it stopped: Insufficient Enrollment

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05736666
Sponsor's protocol ID
2022-0366
Other IDs
R01AG075098
Status last verified
Jun 2026
First submitted
10 Feb 2023
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Treadmill-based perturbation training in people with Knee Osteoarthritis and Arthroplasty Complications, run by University of Illinois at Chicago 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 3 inclusion and 0 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: stopped early, as of the sponsor's last update on 8 Jun 2026. 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 was stopped early (reason given: Insufficient Enrollment). Results are not available in the source record.

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?

Post-training trunk angle (time frame: Immediately after completion of training program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Jun 2026.

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Clinical Trial NCT05736666 | AzTrials