Assessing the Outcome of Rehabilitation After Hip Fracture With a Wearable Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in postural sway
研究概览
简要总结
A randomized control trial, including two intervention arms with different methods for rehabilitation after hip fracture, conducted among persons with the need of rehabilitation in their own home.
详细描述
The increase of the aging population challenges health care providers. Fragility, oste-oporosis, and impaired balance are some major risk factors for hip fracture, an injury causing morbidity, mortality, and loss of independent life. This study aims to study if adding continuous measures of body positions and movements 24 hours a day with an Inertial Measurement Unit (IMU) can, compared to standard rehabilitation alone, optimize rehabilitation after hip fracture. The study is designed as a randomized controlled trial. Patients with hip fracture that require rehabilitation at home, will be invited to participate in the study. Those who accept to participate will randomly be assigned to intervention- or control group. The intervention comprises standard rehabilitation and continuous measures of body positions and movements 24 hours a day with an IMU. Standard rehabilitation comprises of home-visits by a PT, where an individualized rehabilitation plan is outlined together with the patient. The plan includes individually tailored functional exercises. The plan also includes individually tailored walking exercises, indoor and outdoor when possible. At each home visit, the PT provides feedback to the participant based on the data from the IMU, i.e. body positions (time spent in sitting, standing, lying down) and body movements (steps per day, step length, walking speed, sideway deviation during walking). The control group receives standard rehabilitation only. The primary outcome is balance, in terms of postural sway measured with the IMU, and functional balance measured with the Functional Balance test for Geriatric patients, secondary outcomes are health-related quality of life, measured with the EQ5D, functional independence in everyday activities, measured with the Barthel Index, fear of falling, measured with the Falls Efficacy Scale International, satisfaction with rehabilitation, measured with a single question, and compliance to the intervention .
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 (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a hip fracture, living in Malmö, and who are unable to visit a rehabilitation facility and therefore request treatment at home. Another inclusion criterion is the ability to read and understand the Swedish language or the ability to understand information through an interpreter.
排除标准
- •the presence of major neurological diseases that have an impact on balance and walk-ing ability; a diagnosed cognitive disease, or moderate to severe cognitive impairment as assessed by a physiotherapist
结局指标
主要结局
Change in postural sway
时间窗: Baseline, through study completion, on average 3 months
Medio-lateral and anterior-posterior sway measured with the IMU in mm/sec
次要结局
- Change in functional balance(Baseline and after study completion, on average 3 months)
- Satisfaction with rehabilitation(After study completion, on average 3 months)
- Compliance to the intervention(Through study completion, on average 3 months)
- Change in functional independence i everyday activities(Baseline and after study completion, on average 3 months)
- Change in function(Baseline and after study completion, on average 3 months)
- Change in health-related quality of life(Baseline and after study completion, on average 3 months)
- Change in fear of falling(Baseline and after study completion, on average 3 months)
研究者
Eva Ekvall-Hansson
Professor
Lund University