NCT01574599终止不适用
A Randomized Controlled Evaluation of a Repetitive Facilitative Exercise Program for Adults With an Established Stroke and Upper Extremity Impairment
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Arm score
研究概览
简要总结
The purpose of this study is to assess whether a novel therapy approach (repetitive facilitative exercise (RFE)) is more effective than conventional rehabilitation in facilitating the recovery of upper extremity function following stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than 18 years
- •Having a single ischemic or hemorrhagic hemispheric stroke of more than 6 months duration
- •The ability to selectively demonstrate active extension of at least 10 degrees at the metacarpo-phalangeal joint and the interphalangeal joints and 20 degrees at the wrist
- •Capable of effectively participating in the study
排除标准
- •Upper extremity contracture/pain that interfere with study technique
- •Pre-existing upper extremity neurologic or orthopedic disorders
- •Unstable medical condition
- •BMI > 35
- •Active treatment of condition during 3 months prior to enrollment in study (botulinum toxin, therapy, tendon release, etc.)
- •Language or cognitive/perceptual deficits or scheduling problems that would limit participation
- •Inability to provide informed consent
研究组 & 干预措施
Repetitive Facilitative Exercise
Experimental
Occupational therapy program - Repetitive facilitative exercise therapy protocol including 40 min of RFE and 20 minutes of task-specific activity. 3 treatment sessions weekly for a total of 4 weeks.
干预措施: Occupational therapy- Repetitive Facilitative Exercise (Other)
Conventional Therapy Program
No Intervention
Typical therapy excluding robotics, RFE
结局指标
主要结局
Fugl-Meyer Arm score
时间窗: baseline, immediate post-intervention and 3 month post-intervention
次要结局
- Box and Block test(baseline, immediate post-intervention and 3 month post-intervention)
- Grasp strength(baseline, immediate post-intervention and 3 month post-intervention)
- 9-Hole Peg Test(baseline, immediate post-intervention and 3 month post-intervention)
- Active Range of motion of shoulder flexion, wrist extension, and index finger extension(baseline, immediate post-intervention and 3 month post-intervention)
- Motor Activity Log(baseline, immediate post-intervention and 3 month post-intervention)
- Overall patient satisfaction(baseline, immediate post-intervention and 3 month post-intervention)
研究者
Billie A. Schultz
MD; Consultant in Department of Physical Medicine and Rehabilitation
Mayo Clinic
研究点 (1)
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