Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-27 @ 12:31 AM
Study NCT ID:
NCT05736666
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2023-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treadmill Perturbation Training for Fall Prevention After Total Knee Replacement
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
Preoperative Perturbation Training to Prevent Falls After Total Knee Arthroplasty
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
* 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 378 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
1. PROMIS (Patient-Reported Outcomes Measurement Information Systems) Physical Function computerized adaptive test (CAT)
2. Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living Subscale
10. Pain - KOOS pain subscale; Intermittent and Constant Osteoarthritis Pain Scale; Pain Catastrophizing Scale; Tampa Scale of Kinesiophobia
11. Balance and mobility impairment
1. Timed up and go test
2. 30 second chair stand test
3. 4 stage balance test
4. 8 m walk test
5. Functional reach test
6. 6-minute walk test
7. 4 square step test
12. Comorbidities - SCQ comorbidity questionnaire
13. 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.
We will recruit 378 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
1. PROMIS (Patient-Reported Outcomes Measurement Information Systems) Physical Function computerized adaptive test (CAT)
2. Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living Subscale
10. Pain - KOOS pain subscale; Intermittent and Constant Osteoarthritis Pain Scale; Pain Catastrophizing Scale; Tampa Scale of Kinesiophobia
11. Balance and mobility impairment
1. Timed up and go test
2. 30 second chair stand test
3. 4 stage balance test
4. 8 m walk test
5. Functional reach test
6. 6-minute walk test
7. 4 square step test
12. Comorbidities - SCQ comorbidity questionnaire
13. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AG075098 | NIH | None | https://reporter.nih.gov/quic… | View |