Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Timed Up-and-Go Test
研究概览
简要总结
The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. The primary hypothesis is that the rehabilitation program will result in greater improvements in performance-based and participant-reported measures of physical function, compared to standard of care after outpatient rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes and/or Peripheral Artery Disease
- •Unilateral transtibial amputation < 6 months prior to screening
- •Household ambulation using definitive prosthesis prior to baseline testing
- •Participation in physical rehabilitation at time of baseline testing
- •Live within 45 minutes of a participating clinic
排除标准
- •Require wheelchair for mobility (use prosthesis for transfers only)
- •Ankle-level or above amputation on contralateral limb
- •Traumatic or cancer-related amputation
- •Uncontrolled heart condition
- •Acute systemic infection
- •Decisionally challenged
研究组 & 干预措施
Exercise, activity, and self-management
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
干预措施: Exercise (Behavioral)
Exercise, activity, and self-management
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
干预措施: Walking Program (Behavioral)
Exercise, activity, and self-management
Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.
干预措施: Health Self-Management Support (Behavioral)
Home and phone visit
No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.
结局指标
主要结局
Timed Up-and-Go Test
时间窗: Baseline, 12-weeks, and 24 weeks
Performance-based physical function test able to predict falls for people with lower limb amputation. The TUG test time is taken from rising from a chair, walking 3 meters, turning, walking back and sitting down. Continuous scale; higher time indicates lower physical function, higher likelihood of falls.
次要结局
- Five Meter Walk Test(Baseline, 12 weeks, and 24 weeks)
- Prosthesis Evaluation Questionnaire - Mobility Section(Baseline, 12 weeks, and 24 weeks)
- Physical Activity Step Counts(Baseline, 12 weeks, and 24 weeks)
- World Health Organization Disability Assessment Scale(Baseline, 12 weeks, and 24 weeks)
- Two-Minute Walk Test(Baseline, 12 weeks, and 24 weeks)
- Patient-Specific Function Scale(Baseline, 12 weeks, and 24 weeks)
- Self-Efficacy in Managing Chronic Disease Questionnaire(Baseline, 12 weeks, and 24 weeks)
- Houghton Scale(Baseline, 12 weeks, and 24 weeks)