Targeting Balance Confidence as a Strategy to Increase Integration and Improve Outcomes in Users of Lower-Limb Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Community integration
研究概览
简要总结
Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living. It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation. Balance confidence is not necessarily related to functional abilities. It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence. Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities. The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.
详细描述
Lower limb prosthesis users, with self-reported low balance confidence complete baseline gait analysis and balance testing, as well as a series of validated self-reported outcome scales addressing balance confidence, quality of life, and community integration. Participants are then provided a step activity monitor (SAM) and a global position sensing (GPS) tracker to be worn for one week, the data from which is linked and used to objectively quantify baseline community participation. At the conclusion of the one week, participants are randomized to one of two groups, each of which will last for 8 weeks. At the conclusion of the eight weeks, participants repeat baseline assessments and are again provided a SAM and GPS tracker to wear for one week. Baseline measures and activity monitoring occur again 8 and 16 weeks thereafter.
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
- None
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
- •age ≥18 years
- •unilateral lower limb amputation without serious complications
- •at least 6 months experience using a definitive lower limb prosthesis
- •Activity Specific Balance Confidence (ABC) scale score≤80
- •self-reported concern about balance that limit activities
排除标准
- •active wounds on weight bearing surfaces
- •inability to perform the protocol without an assistive device
- •currently seeing a physical therapist for any reason
- •history of neurodegenerative disease
- •history of stroke
- •ill-fitting or ill-functioning prosthesis (to be verified by research prosthetist during screening)
- •prohibited by primary care physician or research physician to participate in mild exercise
结局指标
主要结局
Community integration
时间窗: 24 weeks
number of steps taken outside of the home
次要结局
- Social Functioning scale from the 36-item Short Form Health Survey(24 weeks)
- Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers(24 weeks)
- Change from baseline in Activity-specific balance confidence scale following the intervention(8 weeks)
- Role Limitation due to Emotional Problems scale from the Short Form Health Survey (SF36)(24 weeks)
- Extent of Participation scale from the Measure of Community Reintegration of Servicemembers(24 weeks)
- Frenchay Activity Index(24 weeks)
- Activity-specific balance confidence scale(24 weeks)
研究者
Noah Rosenblatt
Assistant Professor
Rosalind Franklin University of Medicine and Science