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.
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
- Conditions the study is for
- Knee Osteoarthritis, Arthroplasty Complications
- What is being tested?
- Treadmill-based perturbation training
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- Age
- Sex
- Body mass index
- Number of painful joints - Patient Reported Arthralgia Inventory
- Medications that increase fall risk
- Number of falls in the past 12 months
- Self-reported activity level (UCLA activity score)
- Habitual walking speed (8-meter walk test)
- Functional Limitations
- PROMIS (Patient-Reported Outcomes Measurement Information Systems) Physical Function computerized adaptive test (CAT)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living Subscale
- Pain - KOOS pain subscale; Intermittent and Constant Osteoarthritis Pain Scale; Pain Catastrophizing Scale; Tampa Scale of Kinesiophobia
- Balance and mobility impairment
- Timed up and go test
- 30 second chair stand test
- 4 stage balance test
- 8 m walk test
- Functional reach test
- 6-minute walk test
- 4 square step test
- Comorbidities - SCQ comorbidity questionnaire
- 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):
- 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.
- 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.
- 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.
- 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".
- 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.
- The tester will then administer no more than 30 disturbances of increasing difficulty as tolerated by the participant.
- A final perturbation will be administered. This constitutes the post-test assessment.
- 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.
- 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.
- Conditions
- Knee Osteoarthritis, Arthroplasty Complications
- 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 group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | The 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 Group | Active comparator | This 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.
Post-training trunk angle
post-training trunk angle at recovery step completion
Measured: Immediately after completion of training program
Post-training trunk angular velocity
post-training trunk angular at recovery step completion
Measured: Immediately after completion of training program
Fall rate
Number of falls during the first year after surgery
Measured: 1 year
Secondary outcomes (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.
- First posted21 Feb 2023
- Study start31 Jul 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Why it stopped: Insufficient Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kharma C Foucher, University of Illinois at Chicago
- Investigators
- Kharma Foucher, MD, PhD, Principal investigator, University of Illinois at Chicago
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Perturbation Training to Prevent Falls After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05736666
- Acronym / sponsor ID
- 2022-0366
- Conditions
- Knee Osteoarthritis, Arthroplasty Complications
- Keywords
- Falls, Knee Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 21 Feb 2023 (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.
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?
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.
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
- Age
- Sex
- Body mass index
- Number of painful joints - Patient Reported Arthralgia Inventory
- Medications that increase fall risk
- Number of falls in the past 12 months
- Self-reported activity level (UCLA activity score)
- Habitual walking speed (8-meter walk test)
- Functional Limitations
- PROMIS (Patient-Reported Outcomes Measurement Information Systems) Physical Function computerized adaptive test (CAT)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living Subscale
- Pain - KOOS pain subscale; Intermittent and Constant Osteoarthritis Pain Scale; Pain Catastrophizing Scale; Tampa Scale of Kinesiophobia
- Balance and mobility impairment
- Timed up and go test
- 30 second chair stand test
- 4 stage balance test
- 8 m walk test
- Functional reach test
- 6-minute walk test
- 4 square step test
- Comorbidities - SCQ comorbidity questionnaire
- 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):
- 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.
- 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.
- 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.
- 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".
- 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.
- The tester will then administer no more than 30 disturbances of increasing difficulty as tolerated by the participant.
- A final perturbation will be administered. This constitutes the post-test assessment.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Behavioral: Treadmill-based perturbation trainingThe intervention consists of disturbances delivered on a treadmill that simulates tripping over an obstacle or being perturbed to the side. |
| Education Group | Active comparator | Behavioral: Education ControlThis group will receive educational materials related to fall prevention in older adults. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Treadmill-based perturbation trainingThe 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. | Behavioural | Training Group |
| Education ControlFall prevention educational material | Behavioural | Education Group |
Primary outcome
Post-training trunk angle
Time frame: Immediately after completion of training program
post-training trunk angle at recovery step completion
Post-training trunk angular velocity
Time frame: Immediately after completion of training program
post-training trunk angular at recovery step completion
Fall rate
Time frame: 1 year
Number of falls during the first year after surgery
1 secondary outcome
Fall status
Time frame: Immediately after completion of training program
Results and safety
The study was stopped early (reason given: Insufficient Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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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.
Kharma Foucher, MD, PhD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
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.