The Effect of Two Models of an Early Intervention Program on Functional Recovery at Three Months to Acute Stroke Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Postural Assessment Scale for Stroke Patient (PASS)
研究概览
简要总结
To investigate the difference between two models of an early intervention program (focused on mobility function) in the functional recovery 3 months post stroke in a group of patients with acute ischemic stroke while in acute inpatient ward hospitalization.
详细描述
Patients with acute stroke admit into an acute inpatient ward who meet study criteria and provide institutional-reviewed consent form will be randomly assigned into either model 1 or model 2 of an early functional training program. Participants in model 1 group will receive 2 sessions of functional training per day whereas those in model 2 group will receive 1 session of functional training and 1 session of friendly visit and education per day. The following outcomes will be measured at admission, at discharge and at 3 months post stroke: Barthel index (BI), Postural Assessment Scale for Stroke (PASS), Mobility Scale for Acute Stroke (MASA), and usual gait speed (UGS). The rater is blinded to participants' group membership.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with acute ischemic stroke / ICH
- •referred for early rehabilitation,
- •aged 20 years or more,
排除标准
- •able to walk independently and safely at admission,
- •unable to understand three simple comments,
- •unable to recovery even with appropriate medical management,
- •serious condition require ICU care,
- •terminal illness for hospice care,
- •waiting to transfer to long term care facilities
研究组 & 干预措施
Model 1
Participants will receive 2 sessions of functional training per day, 15-min per session.
干预措施: Early intervention (Mobility functional training) (Other)
Model 2
Participants will receive 1 session of functional training and 1 session of sham intervention (therapist visiting and education) per day, 15-min per session.
干预措施: Sham intervention (Other)
Model 2
Participants will receive 1 session of functional training and 1 session of sham intervention (therapist visiting and education) per day, 15-min per session.
干预措施: Early intervention (Mobility functional training) (Other)
结局指标
主要结局
Postural Assessment Scale for Stroke Patient (PASS)
时间窗: at 3 months post stroke
The total score range is 0 to 36 points. Higher score indicate better performance.
Barthel index (BI)
时间窗: at 3 months post stroke
The total score range is 0 to 100 points. Higher score indicate better performance.
Postural Assessment Scale for Stroke Patient (PASS)
时间窗: Baseline
The total score range is 0 to 36 points. Higher score indicate better performance.
Postural Assessment Scale for Stroke Patient (PASS)
时间窗: up to 2 weeks
The total score range is 0 to 36 points. Higher score indicate better performance.
Barthel index (BI)
时间窗: Baseline
The total score range is 0 to 100 points. Higher score indicate better performance.
Barthel index (BI)
时间窗: up to 2 weeks
The total score range is 0 to 100 points. Higher score indicate better performance.
次要结局
- Usual gait speed(at 3 months post stroke)
- Mobility Scale for Acute Stroke (MSAS)(at 3 months post stroke)
- Usual gait speed(Baseline)
- Usual gait speed(up to 2 weeks)
- Mobility Scale for Acute Stroke (MSAS)(Baseline)
- Mobility Scale for Acute Stroke (MSAS)(up to 2 weeks)
研究者
Ching-Yi Wang
Professor
Chung Shan Medical University