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

January 1, 2025 updated by: Riphah International University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan
        • Azeem Electroneurophysiology diognostic and Physiotherapy center Multan
      • Multan, Punjab, Pakistan
        • Qaisrani Hospital Multan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CIMT+ Brunnstrom therapy + routine physical therapy.
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.
Other: CIMT + Brunnstrom therapy + routine physical therapy
this therapy will be given for 5 days per week for 4 weeks.
Active Comparator: CIMT + routine physical therapy
Group B participants will receive Constraint Induced movement therapy along with routine physical therapy exercises. This therapy will be given for 4 weeks.
Other: CIMT + routine physical therapy
this therapy will be given for 5 days per week for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Upper Extremity Motor Evaluation Scale (FM-UE)
Time Frame: 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"
4 weeks
Functional Independence Measure (FIM)
Time Frame: 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
4 weeks
Modified Ashworth scale
Time Frame: 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.
4 weeks
Mini Mental state examination
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sabiha Arshad, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 1, 2025

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 1, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/24/0250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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