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临床试验/CTRI/2025/05/087452
CTRI/2025/05/087452尚未招募2 期

Effect of modified Constraint induced movement therapy on hemineglect in acute stroke: A randomized controlled trial

Nitte Deemed to be University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年2月6日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
Catherine Bergego Scale

研究概览

简要总结

This study investigates the impact of Modified Constraint Induced Movement Therapy (mCIMT) on patients suffering from hemineglect following an acute stroke. Hemineglect, typically resulting from right hemispheric strokes, is a neuropsychological condition where the patient fails to attend to the side of space opposite the brain lesion. It significantly hampers functional recovery and quality of life.The intervention group will receive Modified Constraint Induced Movement Therapy (mCIMT) in addition to conventional physiotherapy. mCIMT involves restricting the unaffected upper limb using a mitt or padded glove for 3 to 4 hours daily during waking hours. This is combined with structured, task-specific training sessions where the patient performs repetitive, functional activities using the affected arm. Tasks may include reaching, grasping, feeding, and writing—chosen to simulate daily life activities and promote awareness of the neglected side.The therapy is delivered in daily 30-minute sessions of mCIMT plus 45 minutes of conventional therapy over 7–8 consecutive days. The control group will receive only conventional therapy, including positioning, ROM exercises, strengthening, ADL training, and gait activities.The study uses two primary outcome measures to evaluate the effectiveness of the intervention. The **Catherine Bergego Scale (CBS)** assesses the severity of hemineglect by observing patients during daily activities, with scores ranging from 0 (no neglect) to 30 (severe neglect), and also captures the patient’s awareness of their condition (anosognosia). The **Fugl-Meyer Assessment for Upper Extremity (FMA-UE)** evaluates motor function, reflexes, and coordination of the affected upper limb through 33 items scored from 0 to 2, categorizing motor ability from poor to full capacity. Together, these tools provide a detailed picture of both functional and motor recovery in stroke patients.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Post stroke patients who are willing to participate in the study Acute stroke of non-dominant hemisphere confirmed by MRI or CT scan Patients with Hemineglect Hemiparesis with upper limb having at least 20 degree of wrist extension and 10 degree of finger extension.
  • Score greater than10 on Catherine Bergego scale Able to follow and respond to visual and verbal instruction.

排除标准

  • Not willing to give consent Recurrent stroke with residual disability Unconscious patients Uncontrolled Diabetes Mellitus and Hypertension Other neurological conditions Aphasia Cognitive impairment Pre morbid or co-morbid impairment.

结局指标

主要结局

Catherine Bergego Scale

时间窗: Outcomes will be assessed at 2 time points that is at baseline and after 7 to 8 days of intervention.

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

时间窗: Outcomes will be assessed at 2 time points that is at baseline and after 7 to 8 days of intervention.

次要结局

未报告次要终点

研究者

发起方
Nitte Deemed to be University
申办方类型
Research institution and hospital

研究点 (1)

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