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

NCT ID: NCT06692569

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2025-07-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Conventional Physical Therapy

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type: 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

Experimental

Conventional Physical Therapy and modified constraint induced movement therapy

Group Type: EXPERIMENTAL

Modified Constraint Induced Movement Therapy

Intervention Type: 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.

Interventions

Conventional Physical Therapy

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

Intervention Type: OTHER

Modified Constraint Induced Movement Therapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Majmaah University

OTHER

Sponsor Role: collaborator

University of Jazan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Karthick Balasubramanian

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karthick BALASUBRAMANIAN, MPT

Role: PRINCIPAL_INVESTIGATOR

University of Jazan

Locations

Majmaah Rehabilitation center

Riyadh, Riyadh Region, Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Mohammed Mansour Al Shehri, PhD

Role: CONTACT

moalshehri@jazanu.edu.sa

00966-503946253

Facility Contacts

Center head

Role: primary

aalanazi@mu.edu.sa

016-4041122

Other Identifiers

MUREC-May.22/COM-2022/6-1

Identifier Type: -

Identifier Source: org_study_id