Preoperative Perturbation Training to Prevent Falls After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Post-training trunk angle
研究概览
简要总结
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.
详细描述
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
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Number of falls in the past 12 months
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Self-reported activity level (UCLA activity score)
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Habitual walking speed (8-meter walk test)
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Functional Limitations
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PROMIS (Patient-Reported Outcomes Measurement Information Systems) Physical Function computerized adaptive test (CAT)
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Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living Subscale
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Pain - KOOS pain subscale; Intermittent and Constant Osteoarthritis Pain Scale; Pain Catastrophizing Scale; Tampa Scale of Kinesiophobia
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Balance and mobility impairment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Training Group
The intervention consists of disturbances delivered on a treadmill that simulates tripping over an obstacle or being perturbed to the side.
干预措施: Treadmill-based perturbation training (Behavioral)
Education Group
This group will receive educational materials related to fall prevention in older adults.
干预措施: Education Control (Behavioral)
结局指标
主要结局
Post-training trunk angle
时间窗: Immediately after completion of training program
post-training trunk angle at recovery step completion
Post-training trunk angular velocity
时间窗: Immediately after completion of training program
post-training trunk angular at recovery step completion
Fall rate
时间窗: 1 year
Number of falls during the first year after surgery
次要结局
- Fall status(Immediately after completion of training program)
研究者
Kharma C Foucher
Professor
University of Illinois at Chicago