Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Balance
研究概览
简要总结
The goal of this clinical trial is to assess the effect of S-HRAT to improve patients' motor function and activities of daily living.
详细描述
Limb dysfunction is the primary disability factor among stroke patients. However, due to various factors, most stroke survivors do not receive sufficient rehabilitation training after discharge. Home-based rehabilitation appropriate technology (S-HRAT） training could be a strategy to meet the patients' requirements for rehabilitation after hospital discharge. This study aims to assess the effect of a nursing intervention based on Cox's Interaction Model of Client Health Behavior (IMCHB) with the application of S-HRAT to improve patients' motor function and activities of daily living.
In this pilot trial, 36 stroke survivors with limb dysfunction will be screened for inclusion before hospital discharge and randomly assigned to the experimental or control group with their informed consent. The control group(n=18) will receive the usual care provided by the hospital. The experimental group(n=18) will receive usual care and an 8-week S-HRAT training program. This nursing interventions use Cox's IMCHB as a theoretical framework that consists of rehabilitation exercises and the provision of health information. Baseline assessments will be conducted on the day before hospital discharge, and outcomes will be assessed at 8 weeks and 12 weeks after discharge. The primary outcome is change in motor function 8 weeks after discharge, and the secondary outcomes include the activities of daily living, anxiety, depression, exercise adherence, and patient satisfaction.
This study is the first of its kind conducted in China to use Cox's IMCHB as a framework to guide the development of the S-HRAT training program. Our pilot will determine if such an approach is feasible and effective in enhancing motor function and improving the activities of daily living post-stroke after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Due to the nature of the intervention, it is impossible to blind the researcher of the intervention who will deliver the intervention. Therefore, the participants and the outcome assessor will be blinded. The outcome assessor will be blinded to the allocation throughout the study and will independently assess all outcomes at T0, T1, and T2 for both groups.
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
- •Patients diagnosed with cerebrovascular disease who have cerebral infarction or cerebral hemorrhage based on cranial CT or MRI and meet the diagnostic criteria;
- •Patients are in the non-acute phase, meaning between two weeks and six months after the onset of the disease;
- •Patients with limb dysfunction.
排除标准
- •Return to a hospital or rehabilitation facility after discharge;
- •The patient has a history of mental illness and dyslexia;
- •Patients have a combination of serious, life-threatening conditions.
结局指标
主要结局
Balance
时间窗: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
Balance was measured using the Berg Balance Scale (BBS). The scale consists of 14 items, including sitting to standing, standing independently, walking independently, and standing to sit, and each item is scored on five functional levels: 0, 1, 2, 3, and 4. A score of 4 indicates that the action under examination can be performed normally. In contrast, a score of 0 indicates that it cannot be performed or requires significant assistance. The total possible score is 56, with higher scores indicating better balance.
Motor Function
时间窗: baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).
The motor function of the patients is measured using the Motor Assessment Scale (MAS) for stroke. MAS is methodologically simple, targeted, and easily generalizable for motor function assessment in stroke patients, as well as reliable and valid. The scale consists of nine items, each of which is scored from 0 to 6 out of 48, with the ninth item not scoring. Higher scores indicate better motor function.
次要结局
- Activity of Daily Living(baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).)
- Anxiety and Depression(baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).)
- Exercise Adherence(baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).)
- Patient Satisfaction(baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).)
研究者
Xi Chen
researcher
Harbin Medical University