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Treadmill Perturbation Training for Fall Prevention After Total Knee Replacement

Primary Purpose

Knee Osteoarthritis, Arthroplasty Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treadmill-based perturbation training
Education Control
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Knee Osteoarthritis focused on measuring Falls, Knee Replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Training Group

    Education Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Post-training trunk angle
    post-training trunk angle at recovery step completion
    Post-training trunk angular velocity
    post-training trunk angular at recovery step completion
    Fall rate
    Number of falls during the first year after surgery

    Secondary Outcome Measures

    Fall status
    Did participant fall during the post-training test

    Full Information

    First Posted
    February 10, 2023
    Last Updated
    June 16, 2023
    Sponsor
    University of Illinois at Chicago
    Collaborators
    National Institute on Aging (NIA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05736666
    Brief Title
    Treadmill Perturbation Training for Fall Prevention After Total Knee Replacement
    Official Title
    Preoperative Perturbation Training to Prevent Falls After Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    January 2027 (Anticipated)
    Study Completion Date
    June 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Chicago
    Collaborators
    National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 an activity monitor on their wrist for one week periods, every three months. Researchers will compare the number of falls from the group that 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 4 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 Use of opiate pain medication 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 Balance and mobility impairment Timed up and go test 30 second chair stand test 4 stage balance test 40 m fast paced walk test Stair climb test 6-minute walk test Comorbidities - Charlson comorbidity index Depression - PROMIS depression (CAT) In addition, physical activity level will be measured for 7 days following the baseline test using accelerometers. Participants will wear the monitor for 7 days and then will return it in a postage-paid express mail envelope that we will provide. After assessment, randomization assignments will be provided, written education materials will be provided (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): 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 21 disturbances of larger magnitude. 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 sagittal plane training perturbation will consist of the treadmill accelerating to 1.25 m/s in 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 first disturbance constitutes the baseline test. The tester will then administer 20 more disturbances of the same magnitude. This constitutes the training protocol. 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 At the end of the baseline visit, participants will coordinate their preferred contact method with the study coordinator (i.e. phone, email, text). Beginning one week after surgery and then every two weeks for one year, participants will be contacted by a research assistant, who will be blinded to the participant's group assignment, and asked whether they had fallen during the previous two weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Arthroplasty Complications
    Keywords
    Falls, Knee Replacement

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    378 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Training Group
    Arm Type
    Experimental
    Arm Description
    The intervention consists of disturbances delivered on a treadmill that simulates tripping over an obstacle or being perturbed to the side.
    Arm Title
    Education Group
    Arm Type
    Active Comparator
    Arm Description
    This group will receive educational materials related to fall prevention in older adults.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treadmill-based perturbation training
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Education Control
    Intervention Description
    Fall prevention educational material
    Primary Outcome Measure Information:
    Title
    Post-training trunk angle
    Description
    post-training trunk angle at recovery step completion
    Time Frame
    Immediately after completion of training program
    Title
    Post-training trunk angular velocity
    Description
    post-training trunk angular at recovery step completion
    Time Frame
    Immediately after completion of training program
    Title
    Fall rate
    Description
    Number of falls during the first year after surgery
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Fall status
    Description
    Did participant fall during the post-training test
    Time Frame
    Immediately after completion of training program

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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. -

    12. IPD Sharing Statement

    Learn more about this trial

    Treadmill Perturbation Training for Fall Prevention After Total Knee Replacement

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