The Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Function in Stroke Rehabilitation

NCT06692569 | Recruiting

• 1 other identifier: MUREC-May.22/COM-2022/6-1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the effect of Modified Constraint-Induced Movement Therapy and trunk restraint contrasted with conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.

• To find out the effectiveness of conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.
• To find out the effectiveness of modified constraint induced movement therapy (mCIMT) and trunk restraint along with conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.
• To find out the effectiveness of modified constraint induced movement therapy (mCIMT) and trunk restraint combined with conventional physical therapy treatment versus conventional physical therapy treatment alone on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.

Conditions

Stroke; Hemiplegia; Chronic Stroke Patients

Keywords

stroke; hemiplegia; constraint induced movement therapy; modified constraint induced movement therapy; trunk restrain; upper extremity motor function

Outcome Measures

Primary Outcomes (3)

• Wolf Motor Function Test

  Wolf Motor Function Test assessment tool was specifically developed to assess and evaluate the exercise capacity of individuals with varying degrees of upper extremity motion impairments, ranging from mild to severe, in both laboratory and clinical settings. It represents an enhancement over a previous tool that was more suitable for assessing high-functioning patients but posed challenges when used with individuals who had limited hand and finger mobility

  Week 0 and week 6

• Berg Balance Scale

  The Berg Balance Scale (BBS) is a widely used clinical assessment tool designed to evaluate and quantify an individual's balance and stability during various tasks. It consists of a series of 14 tasks or activities that challenge balance and mobility, such as standing on one foot, reaching for objects, and turning in place. Each task is scored on a scale ranging from 0 to 4, with 0 indicating the lowest level of performance and 4 indicating the highest level of performance

  week 0 and week 6

• Stroke Specific Quality of Life Scale

  Stroke Specific Quality of Life Scale (SS-QOL) is a specialized assessment tool designed to measure the quality of life in individuals who have experienced a stroke. This scale is specifically tailored to evaluate the impact of stroke on various aspects of a person's life, encompassing physical, psychological, and social domains. The SS-QOL questionnaire typically consists of multiple items or questions that cover a range of topics, including physical health, mobility, communication abilities, emotional well-being, and social relationships. Respondents rate their level of satisfaction or well-being in each domain, often on a scale from 0 to 5 or 0 to 100, with higher scores indicating better quality of life

  week 0 and week 6

Study Arms (2)

Control

ACTIVE COMPARATOR

Conventional Physical Therapy

Other: Conventional Physical Therapy

Experimental

EXPERIMENTAL

Conventional Physical Therapy and modified constraint induced movement therapy

Other: Modified Constraint Induced Movement Therapy

Interventions

Conventional Physical Therapy OTHER

The conventional Physical Therapy, the treatment will be based on the client's capabilities. It included functional reeducation, muscle strengthening and stretching, muscle tone regulation methods, and training for activities of daily living

Control

Modified Constraint Induced Movement Therapy OTHER

Modified Constraint Induced Movement Therapy (mCIMT) which involves trunk constraint along with conventional Physical Therapy treatment. Under the attentive guidance of a physiotherapist, the patient engages in specific hand activities aligned with personalized goals. These activities encompass tasks such as picking up marbles, flipping cards, stacking blocks, combing hair, writing, and other actions relevant to daily life. The difficulty level is dynamically adjusted according to the patient's abilities and progress during the training sessions.Tasks may vary from one patient to another, and each session introduces fresh, goal-oriented challenges to further enhance rehabilitation outcomes, along with the conventional physical therapy treatment. The patients were wearing a trunk west which had a Velcro strap on the non-effected side part of the west, and it was attached to the Velcro straps on the non-affected part on the back support of the treatment chair.

Experimental

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right or left-sided chronic hemiplegic patients.
• Onset of stroke More than six months.
• Age between 45 to 65 years of both genders.
• Mini-Mental State Examination - Scored more than 24/30.
• Modified Ashworth Scale for spasticity 1 or 1+.
• Have at least 20° wrist active extension and at least 10° of metacarpophalangeal active extension of the paretic upper extremity.
• Have at least grade 2/5 of muscle power on upper extremity especially in wrist extensors.
• Have normal visual perception.
• With no other neurological disorders.

You may not qualify if:

• Unable to follow visual and oral commands.
• Unilateral neglect.
• Severe cognitive, or language deficits.

Sponsors & Collaborators

• University of Jazan: lead
• Majmaah University: collaborator

Study Sites (1)

Majmaah Rehabilitation center

Riyadh, Riyadh Region, Saudi Arabia

RECRUITING

Related Publications (1)

• M Shahhar A, Shaik AR, Esht V, Alshehri MM, Balasubramanian K, Ramasamy Sanjeevi R, Abdulrahman Alfaleh K, Okab Alsalem W, Fathi WA, A Alothman S. Modified Constraint-Induced Movement Therapy with Trunk Restraint for Upper Extremity Functional Motor Recovery, Balance and Health-Related Quality of Life in Chronic Stroke: A Single-Blinded Randomized Controlled Clinical Trial. NeuroRehabilitation. 2026 Feb 2:10538135261417372. doi: 10.1177/10538135261417372. Online ahead of print.

  PMID: 41627128 DERIVED

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karthick BALASUBRAMANIAN, MPT

  University of Jazan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Mansour Al Shehri, PhD

CONTACT

00966-503946253; moalshehri@jazanu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: November 12, 2024
• Primary Completion: July 13, 2025
• Study Completion: July 13, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

SA (1)