Treadmill Perturbation Training for Fall Prevention After Total Knee Replacement

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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. -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05736666
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Illinois at Chicago
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kharma Foucher, MD, PhD
Principal Investigator Affiliation University of Illinois Chicago
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis, Arthroplasty Complications
Additional Details

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.

Arms & Interventions

Arms

Experimental: Training Group

The intervention consists of disturbances delivered on a treadmill that simulates tripping over an obstacle or being perturbed to the side.

Active Comparator: Education Group

This group will receive educational materials related to fall prevention in older adults.

Interventions

Behavioral: - Treadmill-based perturbation training

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.

Behavioral: - Education Control

Fall prevention educational material

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chicago, Illinois

Status

Recruiting

Address

Biomechanics and Clinical Outcomes Laboratory, University of Illinois Chicago

Chicago, Illinois, 60612

Site Contact

Steven Garcia, PhD

[email protected]

312-413-9432