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临床试验/NCT06459336
NCT06459336招募中不适用

Comparative Effects of Intensive and Distributed Constraint-induced Movement Therapy on Upper Extremity Function in Stroke Patients

Riphah International University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Fugl-Meyer Assessment-Upper Extremity

研究概览

简要总结

The main question this clinical trial is aims to answer is whether intensive and distributed constraint-induced movement therapy has similar effects on upper extremity function in participants with stroke. Participants will receive intensive protocol of CIMT for 6 hours for 6 days to make total of 36 hours while distributed protocol participants will receive 2.25 hours of training two times a week for 8 weeks making total of 36 hours.

详细描述

Many studies have examined the effects of constraint-induced movement therapy (CIMT) in upper extremity function in stroke patients. Literature has shown effectiveness of different CIMT protocols for stroke patients. Emerging research have demonstrated comparative efficacy of constraint-induced movement therapy with different physical therapy approaches i.e. bimanual intensive training, motor relearning programme for improving upper extremity function. But according to researcher's knowledge, the gap of current knowledge is that no study has directly investigated the comparative effectiveness of intensive and distributed CIMT in stroke patients and if intensive and distributed CIMT had similar motor outcomes in upper limb function after stroke

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
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40-70 years
  • ischemic or hemorrhagic stroke
  • Both genders eligible
  • Gcs score ≥ 13
  • Able to extend at least 10° at the fingers
  • Able to extend at least 20° at the wrist
  • Patients diagnosed with one side more affected(hemiplegia)
  • Modified Ashworth scale score ≤2

排除标准

  • severe, chronic systemic illness
  • History of fall past 6 months
  • Injections of botulinum toxin type A or operations on the UE within 6 months

结局指标

主要结局

Fugl-Meyer Assessment-Upper Extremity

时间窗: 8th week

It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).

Wolf motor function test

时间窗: 8th week

This test was designed to assess the motor ability of patients with moderate to severe upper extremity motor deficits in the laboratory and clinic. The original version of this test was developed by Dr. Steven L. Wolf, Emory University School of Medicine. The original version consisted of 21 items; the widely used version of the wolf motor function test consists of 17 items. it uses a Uses a 6-point ordinal scale i.e."0" means "does not attempt with the involved arm" to "5" means "arm does participate; movement appears to be normal."

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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