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临床试验/NCT05916885
NCT05916885已完成不适用

Effects of Short-intensity Modified Constraint-induced Movement Therapy on Hand Function in Stroke Patients.

Riphah International University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
The motor activity log

研究概览

简要总结

To determine effects of short-intensity modified constraint-induced movement therapy on hand function in stroke patients.

详细描述

The aim of the study is to determine the effects of a short-intensity modified CIMT (mCIMT) program on hand function in stroke patients. This study will be a randomized controlled trial comprising two groups, an experimental group in which patients will be given short-intensity mCIMT along with conventional therapy. A control group, in which participants will be given conventional therapy alone. Patients will be assessed with the Wolf Motor Function Test, the Motor Activity Log, and the Ashworth Scale before and after treatment. The data will be analyzed by using SPSS for windows software version 25. Statistical significance will be set at p=0.05.

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
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having the First stroke either ischemic or hemorrhagic (3-24 months after stroke)
  • Patients having Mini-mental status examination score (MMSE) ≤23/30
  • Patients having Passive range of motion (PROM) includes at least 90 degrees shoulder flexion and abduction, 45degrees shoulder external rotation,- 30 degrees elbow extension, and 45 degrees forearm supination and pronation (from a neutral position). At least 10 degrees active wrist extension, 10 degrees abduction/thumb extension, and 10-degree extension at the level of the metacarpophalangeal and interphalangeal joints between the two toes among the II-III-IV-V fingers (these movements will be repeated starting from a resting position 3 times in 1 minute).

排除标准

  • Patients having Subarachnoid hemorrhage.
  • Patients having Motor activity log - the amount of use score ≥2.5
  • Patients having treatment of upper limb spasticity (e.g., botulinum toxin) in the 3 months prior to the start of the study and/or during its execution.

研究组 & 干预措施

experimental group

Experimental

an experimental group receiving short-intensity modified CIMT and conventional therapy

干预措施: short-intensity modified CIMT and conventional therapy (Other)

control group

Active Comparator

a control group receiving conventional therapy alone.

干预措施: conventional therapy alone (Other)

结局指标

主要结局

The motor activity log

时间窗: 9 months

The motor activity log is a structured interview, designed to explore how and how well subjects are using the more affected arm outside of a laboratory setting. Participants are asked standardized questions about their high-impact arm usage (amount scale or AS) and quality of movement (how good scale or HW) during a specified functional activity. The scale is printed on a separate sheet and placed in front of the participant during test administration. Participants should be told that they can give half marks (i.e. 0.5, 1.5, 2.5, 3.5, 4.5) if this reflects their assessment.

Wolf motor function test (WMF)

时间窗: 9 months

Wolf motor function test (WMF) is a new time-based method for evaluating upper extremity performance that provides insight into joint-specific and whole limb movements. To investigates the effects of mandatory exercise therapy in patients with mild to moderate stroke and traumatic brain injury. The original version of the WMFT consisted of 21 items. The widely used WMFT consists of 17 items. The first 6 items consist of timed functional tasks, items 7 and 14 measure muscle strength, and the remaining 9 items consist of analyses of the quality of movement in accomplishing various tasks.

The Ashworth scale,

时间窗: 9 months

The Ashworth scale, which rates each passive movement between 1 (normal) and 5 (immobility), was used in a recent study and is easier to use than other methods and applicable to wide-range movements.

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 (1)

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