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临床试验/NCT06883357
NCT06883357招募中不适用

The Effects of Home-based Graded Repetitive Arm Supplementary Program Group on Stroke: the Randomized Controlled Trial.

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年3月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
Jamar Hydraulic Hand Dynamometer (Jamar Dynamometer)

研究概览

简要总结

Graded repetitive arm supplementary program (GRASP) is a self administrated, home-based rehabilitation program and has been incorporated in Canadian Stroke Best Practice Recommendations. Past studies indicated that the home-based GRASP program could facilitate the motor function and motor recovery and prevent learned nonuse of affected upper limb of stroke patients. There is lacking of research and application of the home-based GRASP program in Taiwan. Therefore, this study aims to explore the effects of the home-based GRASP program, which is mainly executed in the form of group intervention, on the affected upper limb of stroke patients.

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

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

  • •Age is above 20 years old.
  • •Onset of first stroke complicated with hemiplegia or hemiparesis.
  • •The affected upper limb remains partially voluntary movements including lifting to chest level and holding for five seconds; slight flexion and extension of wrist and hand.
  • •Understanding and complying with two-steps commands.
  • •Understanding the content of trial and willing to sign informed consent.

排除标准

  • •Complicating with other neurological disease.
  • •Having Orthopedic diseases affecting the movements of upper limbs.
  • •Having symptoms of pain to affect the movements of upper limbs.
  • •Unstable vital sign or medical condition.
  • •Participating another rehabilitative or drug research meanwhile.
  • •Receiving botulinum toxin injection within three months.

研究组 & 干预措施

Control group

No Intervention

GRASP group

Experimental

干预措施: Graded repetitive arm supplementary program (GRASP) (Behavioral)

结局指标

主要结局

Jamar Hydraulic Hand Dynamometer (Jamar Dynamometer)

时间窗: From enrollment to the end of treatment at 6 weeks

The Jamar Hydraulic Hand Dynamometer (Jamar Dynamometer) is a tool used for assessing the strength of grip, lateral pinch, and palmar pinch. The muscle strength is recorded in kilograms or pounds.

Fugl-Meyer Assessment for upper extremity (FMA-UE)

时间窗: From enrollment to the end of treatment at 6 weeks

The Fugl-Meyer Assessment for upper extremity (FMA-UE) includes 33 items for the motor recovery of upper limb. Each item is a 3 point ordinal scale. The total score ranges from 0 to 66, higher score means better motor recovery.

Action Research Arm Test (ARAT)

时间窗: From enrollment to the end of treatment at 6 weeks

The Action Research Arm Test (ARAT) is developed for measuring the motor function of affected upper limb after stroke. ARAT includes subscales of grasp, grip, pinch, and gross movement. The total score ranges from 0 to 57, higher score means better motor function.

次要结局

  • Chedoke Arm and Hand Activity Inventory (CAHAI)(From enrollment to the end of treatment at 6 weeks)
  • Rating of Everyday Arm-use in the Community and Home Scale (REACH-Scale)(From enrollment to the end of treatment at 6 weeks)
  • Stroke Impact Scale Version 3.0 (SIS 3.0)(From enrollment to the end of treatment at 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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