跳至主要内容
临床试验/NCT06762249
NCT06762249Enrolling By Invitation不适用

Combined Effect of Constraint Induced Movement Therapy and Brunnstrom Movement Therapy on Upper Extremity Spasticity, Motor Activity and Quality of Life in Stroke Patients

Riphah International University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年10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
Enrolling By Invitation
入组人数
56
试验地点
2
主要终点
Fugl-Meyer Upper Extremity Motor Evaluation Scale (FM-UE)

研究概览

简要总结

Stroke is a leading cause of disability characterized by inadequate blood supply to the brain, leading to cell death and neurological deficits. Motor impairment of the upper extremity is a common consequence among stroke patients, resulting in paralysis of the upper limb. Both Constraint Induced Movement Therapy and Brunnstrom therapy have shown promise in improving motor activity and overall quality of life in stroke patients.This randomized controlled trial will be carried out at in Multan over 10 months. Total number of 56 participants meeting the inclusion criteria will be included in this study. Participants will be randomly assigned into 2 groups . Both groups will receive interventions for five days a week for 4 weeks.

详细描述

Stroke is the leading cause of death and disability worldwide. Remarkably, approximately 90 percent of strokes have modifiable risk factors, indicating that stroke prevention is largely possible. UE impairments are the common consequence among stroke patients, resulting in a higher likelihood of residual paralysis in the upper limb. These impairments significantly affect the performance of daily activities and diminish patients' quality of life.This study aims to determine the combined effects of constraint induced movement therapy and brunnstrom movement therapy on upper limb spasticity, motor activity and quality of life in stroke patients. This randomized controlled trial will be carried out at in Multan over 10 months after approval of synopsis. Total number of 56 participants meeting the inclusion criteria will be included in this study through a non-probability convenience sampling technique. Participants will be randomly assigned into 2 groups using computer generated method. Group A participants will receive both CIMT and brunnstrom movement therapy with routine physical therapy while Group B participants will receive only CIMT with routine physical therapy. Both groups will receive interventions for five days a week for 4 weeks. The outcome measuring sacales used will be FMUE scale to assess motor activity, FIM scale to assess spasticity and Modified Ashworth scale to assess spasticity. For within group analysis paired t-test will be applied for parametric data. For between group analysis independent t-test will be applied for parametric data. Data analysis will be performed by using SPSS 28 version.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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
否

入选标准

  • •Age group between 40 and 70 years
  • •Both male and female
  • •Patient being diagnosed with hemiplegic stroke
  • •Patient having hemorrhagic stroke or ischemic stroke
  • •Patient able to give their consent for rehabilitation program
  • •Patient having 24 or higher score from Standardized Mini-Mental Test
  • •Patient being able to stand for 2 min without assistance from a person

排除标准

  • •Patient with cognitive impairment or dementia
  • •Patient having any other disease that prevents participation in the rehabilitation program
  • •Patient that participated in any ongoing rehabilitation program
  • •Patient having pain in UE 4 or higher according to the Visual Analog Scale which is scored 0-10
  • •Patient had spasticity in any joint of the UE and scored 2 or higher according to the Modified Ashworth Scale

研究组 & 干预措施

CIMT+ Brunnstrom therapy + routine physical therapy.

Experimental

Group A participants will receive Constraints innduced movement therapy and Brunnstrom movement therapy along with routine physical therapy This therapy will be given as 5 days session for 4 weeks.

干预措施: CIMT + Brunnstrom therapy + routine physical therapy (Other)

CIMT + routine physical therapy

Active Comparator

Group B participants will receive Constraint Induced movement therapy along with routine physical therapy exercises. This therapy will be given for 4 weeks.

干预措施: CIMT + routine physical therapy (Other)

结局指标

主要结局

Fugl-Meyer Upper Extremity Motor Evaluation Scale (FM-UE)

时间窗: 4 weeks

The FMA-UE 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"

Functional Independence Measure (FIM)

时间窗: 4 weeks

The scale consists of six sub-headings and a total of 18 items. Scores that can be obtained from the scale range from 18-126, and higher scores indicate that the individual is more independent in daily life

Modified Ashworth scale

时间窗: 4 weeks

The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform.

Mini Mental state examination

时间窗: 4 weeks

The MMSE is a widely used cognition screening test. It has a maximum score of 30 points. It assesses aspects of orientation, recall, language and visual construction.

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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