Combined Effect of CIMT and Brunnstrom Therapy on UE in Stroke Patients

Not Applicable

• Conditions: Stroke Patients

• Registration Number: NCT06762249
• Lead Sponsor: Riphah International University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-10-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-02-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Upper Extremity Motor Evaluation Scale (FM-UE)	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)	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	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	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.

Trial Locations

Locations (2)

Azeem Electroneurophysiology diognostic and Physiotherapy center Multan; 🇵🇰 Multan, Punjab, Pakistan

Qaisrani Hospital Multan; 🇵🇰 Multan, Punjab, Pakistan