Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke? A Multicenter Randomized Controlled Study (TIARAS Trial)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment (upper extremity subscale)
研究概览
简要总结
Study purpose This study will explore whether an additional rehabilitation program that focus on either upper or lower extremity training facilitate the recovery in upper or lower extremity.
The recovery in both neurological status and motor functions will be explored.
详细描述
Design A single-blinded (assessor-blinded) randomized controlled trial. Interventions The participants will be randomly assigned into two experiment groups (enhanced upper extremity program; and enhanced lower-extremity program).
Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy.
The enhanced upper extremity program group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity, while the enhanced lower-extremity program group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity. The participants receive 20-day training over a 4-week period. The additional program is designed to be specific to either upper-extremity or lower-extremity. Accordingly, one group can be used as the control group of the other one.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever stroke with the onset 10-90 days prior to the enrollment
- •Age: 20-80y
- •With a hemiplegic upper extremity with Brunnstrom stage in I~IV
- •Able to understand simple orders (1-step orders, such as "raise your hand, touch your head....)
- •Totally independent in activity of daily life before the onset of stroke
排除标准
- •Incompliance to the assessments or interventions due to unstable medical condition, abnormal cognition, or other conditions.
- •Stroke of brainstem or cerebellum
- •Had received craniotomy or ventriculoperitoneal shunting
- •Needs of orthoses in walking before the onset of stroke
- •Had had motor dysfunctions (eg, amputation, cerebral palsy, poliomyelitis or other neuromuscular diseases) before the stroke.
- •Intracranial hemorrhage caused by artereovenous malformation, aneurysm, or tumor
- •Able to walk independently for more than 50 meters.
结局指标
主要结局
Fugl-Meyer Assessment (upper extremity subscale)
时间窗: 0-, 4- week
The primary outcome is the change from baseline upper extremity subscale of Fugl-Meyer assessment at the end to 4-wk (post-intervention).
次要结局
- Stroke Impact Scale(0-, 4-, 8-, 12-, 24 week)
- Action Research Arm Test (ARAT)(0-, 4-, 8-, 12-, 24 week)
- Fugl-Meyer Assessment (lower extremity subscale)(0-, 4-, 8-, 12-, 24 week)
- Time required for 10 meter walking(0-, 4-, 8-, 12-, 24 week)
- Berg Balance Test(0-, 4-, 8-, 12-, 24 week)
- Barthel Index(0-, 4-, 8-, 12-, 24 week)
- Fugl-Meyer Assessment (upper extremity subscale)(0-, 4-, 8-, 12-, 24 week)
研究者
Yen-Nung Lin
Director of Rehabilitation Department of Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital