Does Self-initiated Sit-to-stand Training With Assistive Device Regain the Independence of Sit-to-stand in Stroke Patient? A Single-blinded Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Five-Repetition Sit-to-Stand Test
研究概览
简要总结
Background: It is unknown whether the self-initiated sit-to-stand training with assistive device is effective to regain the independence of sit-to-stand in stroke patients.
Objective: To compare the effectiveness of self-initiated sit-to-stand training by assistive device, with manual sit-to-stand training.
Design: Parallel randomised controlled and assessor blinded trial between Jan 2015 and May 2018. Randomisation was performed by drawing lots to allocate treatment to patient.
Setting: A rehabilitation hospital in Hong Kong
Participants: 69 patients in medical wards with unilateral hemiparetic stroke. 52 patients fulfilled the study requirements.
Intervention: Ten sessions of intervention with conventional physiotherapy program followed, by self-initiated sit-to-stand training with assistive device, or by manual sit-to-stand training.
Main outcome measure: Number of patients regained the independence of sit-to-stand, Sit-to-stand test from the balance master® and Five-repetitions sit-to-stand test.
Results: 69 patients (intervention n=36; control n=33) were randomized (mean age 69.8 (SD, 10.6), mean post stroke days 18.6 (SD 16.0)) for intention to treat analysis. 17 patients were excluded because of dropout before 10 sessions of training, leaving 52 (n=26; n=26) patients for per protocol analysis. 18 patients in intervention group and 10 patients in control group had regained the independence of sit-to-stand (Phil and Cramer's V: -0.31 and 0.31). The patients in intervention group were faster to complete the Five-repetition sit-to-stand test than the control group (32.7 secs (SD, 1.93) v 48.4 secs (SD, 6.8); 95% confidence interval, -30.8 to -0.7; p<0.05). No adverse side effects occurred during and after the training across groups.
Conclusions: Self-initiated sit-to-stand training by assistive device can help more stroke patients regain the independence of sit-to-stand.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first episode of unilateral stroke with hemiparesis,
- •able to understand and follow simple verbal instructions,
- •able to sit unsupported for at least two minutes
- •require lifting assistance to stand up from a 18 inches high plinth
排除标准
- •severe pain in the lower extremities when weight bearing or performing movement
- •any other acute comorbid diseases such as unstable angina, recent myocardial infarction
- •unstable medical / psychological condition
研究组 & 干预措施
Control group
The sit-to-stand training is assisted by manual device
干预措施: Manual assisted sit-to-stand training group (Other)
Intervention group
The sit-to-stand training is assisted by mechanical device
干预措施: Mechanical assisted sit-to-stand training group (Device)
结局指标
主要结局
Five-Repetition Sit-to-Stand Test
时间窗: After 10 sessions of training
To assess the functional strength of lower limb, balance and transition move of patient
Number of patients regained the independence of sit-to-stand
时间窗: After 10 sessions of training
To compare how many patients can regain the independence of sit-to-stand between groups
Sit-to-Stand Test (SST) from the Balance Master®
时间窗: After 10 sessions of training
To assess the quality of sit-to-stand of patient
次要结局
未报告次要终点
研究者
Ng Chee Man, Joey
Principal investigator
Tai Po Hospital