Skip to main content
Clinical Trials/NCT06762249
NCT06762249
Enrolling By Invitation
Not Applicable

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 sites in 1 country56 target enrollmentOctober 1, 2024
ConditionsStroke Patients

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke Patients
Sponsor
Riphah International University
Enrollment
56
Locations
2
Primary Endpoint
Fugl-Meyer Upper Extremity Motor Evaluation Scale (FM-UE)
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
May 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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"

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

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.

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.

Study Sites (2)

Loading locations...

Similar Trials