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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG075098 | U.S. NIH Grant/Contract | View source |
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Insufficient Enrollment
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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:
Participants will:
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
Pain - KOOS pain subscale; Intermittent and Constant Osteoarthritis Pain Scale; Pain Catastrophizing Scale; Tampa Scale of Kinesiophobia
Balance and mobility impairment
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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training Group | Experimental | The intervention consists of disturbances delivered on a treadmill that simulates tripping over an obstacle or being perturbed to the side. |
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| Education Group | Active Comparator | This group will receive educational materials related to fall prevention in older adults. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treadmill-based perturbation training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-training trunk angle | post-training trunk angle at recovery step completion | Immediately after completion of training program |
| Post-training trunk angular velocity | post-training trunk angular at recovery step completion | Immediately after completion of training program |
| Fall rate | Number of falls during the first year after surgery | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Fall status | Did participant fall during the post-training test | Immediately after completion of training program |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kharma Foucher, MD, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomechanics and Clinical Outcomes Laboratory, University of Illinois Chicago | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Education Control | Behavioral | Fall prevention educational material |
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| D012216 |
| Rheumatic Diseases |