Constraint-induced Movement Therapy Versus Task-oriented Training On Upper Extremity Function Post-Botox Injection in Stroke Patients

NCT ID: NCT07057050

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-11-01

Brief Summary

This study will be conducted to determine the impact of Constraint-Induced Movement Therapy versus Task-Oriented Training on upper extremity function post-Botox injection in stroke patients.

Detailed Description

Arm and hand movement problems are significant contributors to disability in stroke patients, with only 5% regaining full arm function and 20% regaining no functional use. Alternative strategies are needed to reduce long-term disability and upper limb impairment in hemiparesis patients. Previous studies have used various treatment methods, including botulinum toxin, but the degree of motor improvement depends on task complexity. Future research should focus on adjunct therapy, such as task-specific training and constrained induced therapy, in addition to botulinum toxin treatments, to facilitate functional improvement in spastic upper extremity.

Conditions

Constraint Induced Movement Therapy; Task Oriented Training; Botox Injection; Upper Extremity Function; Stroke

Study Design

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

Study Groups

constrained induced movement therapy

Patients will undergo a 60-minute physiotherapy program, such as traditional upper extremity training, following botulinum toxin A injection, as well as constrained induced movement therapy tasks for 12 consecutive weeks.

Group Type: EXPERIMENTAL

The designed physiotherapy program

Intervention Type: OTHER

• Scapular and thoracic mobilization, active assisted and passive exercises, and positioning such as weight bearing on the affected upper limb.
• Strengthening of the shoulder flexors and elbow and wrist extensors.
• Stretching exercises of the spastic muscles (shoulder extensors, elbow and wrist flexors.)

The Botulinum toxin injection

Intervention Type: DRUG

The injection of 1000 units per upper extremity will be done into the biceps brachii muscle at 2 sites, and 150 units into the flexor carpi radialis muscle at 1 site per muscle, using anatomical landmarks similar to routine electromyography.

Constrained induced movement therapy

Intervention Type: OTHER

The therapy session focuses on enhancing the affected arm's functional tasks, such as throwing a ball, holding a glass, combing hair, turning on and off a light switch, grasping and releasing blocks, pouring from glass to another, moving cups, and moving pegs. Participants are instructed to wear a restrictive mitt on their non-paretic hand for 6 hours a day for 4 days, 7 weeks, and 12 weeks, with the mitt removed for safety, hygiene, or agreed-on activities.

task-oriented training

Patients will undergo a 60-minute physiotherapy program, such as traditional upper extremity training, following botulinum toxin A injection, as well as task-oriented training tasks for 12 consecutive weeks.

Group Type: ACTIVE_COMPARATOR

The designed physiotherapy program

Intervention Type: OTHER

• Scapular and thoracic mobilization, active assisted and passive exercises, and positioning such as weight bearing on the affected upper limb.
• Strengthening of the shoulder flexors and elbow and wrist extensors.
• Stretching exercises of the spastic muscles (shoulder extensors, elbow and wrist flexors.)

The Botulinum toxin injection

Intervention Type: DRUG

The injection of 1000 units per upper extremity will be done into the biceps brachii muscle at 2 sites, and 150 units into the flexor carpi radialis muscle at 1 site per muscle, using anatomical landmarks similar to routine electromyography.

Task oriented training

Intervention Type: OTHER

The training involves 30 minutes of bilateral functional tasks like carrying a block, grabbing and folding a towel, staking cups upright, holding a glass and drinking water, throwing a ball into a basket, and moving pegs.

designed physical therapy program

Patients will undergo a 60-minute physiotherapy program, such as traditional upper extremity training, following botulinum toxin A injection, for 12 consecutive weeks.

Group Type: ACTIVE_COMPARATOR

The designed physiotherapy program

Intervention Type: OTHER

• Scapular and thoracic mobilization, active assisted and passive exercises, and positioning such as weight bearing on the affected upper limb.
• Strengthening of the shoulder flexors and elbow and wrist extensors.
• Stretching exercises of the spastic muscles (shoulder extensors, elbow and wrist flexors.)

The Botulinum toxin injection

Intervention Type: DRUG

The injection of 1000 units per upper extremity will be done into the biceps brachii muscle at 2 sites, and 150 units into the flexor carpi radialis muscle at 1 site per muscle, using anatomical landmarks similar to routine electromyography.

Interventions

The designed physiotherapy program

• Scapular and thoracic mobilization, active assisted and passive exercises, and positioning such as weight bearing on the affected upper limb.
• Strengthening of the shoulder flexors and elbow and wrist extensors.
• Stretching exercises of the spastic muscles (shoulder extensors, elbow and wrist flexors.)

Intervention Type: OTHER

The Botulinum toxin injection

The injection of 1000 units per upper extremity will be done into the biceps brachii muscle at 2 sites, and 150 units into the flexor carpi radialis muscle at 1 site per muscle, using anatomical landmarks similar to routine electromyography.

Intervention Type: DRUG

Task oriented training

The training involves 30 minutes of bilateral functional tasks like carrying a block, grabbing and folding a towel, staking cups upright, holding a glass and drinking water, throwing a ball into a basket, and moving pegs.

Intervention Type: OTHER

Constrained induced movement therapy

The therapy session focuses on enhancing the affected arm's functional tasks, such as throwing a ball, holding a glass, combing hair, turning on and off a light switch, grasping and releasing blocks, pouring from glass to another, moving cups, and moving pegs. Participants are instructed to wear a restrictive mitt on their non-paretic hand for 6 hours a day for 4 days, 7 weeks, and 12 weeks, with the mitt removed for safety, hygiene, or agreed-on activities.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The study focuses on patients aged 45-60 years
• Patients who have subacute spastic hemiplegia with occlusion of the middle cerebral artery
• Patients who are able to maintain balance in sitting positions.
• Patients are diagnosed with the affected upper extremity being the dominant side.
• Physiotherapy sessions are initiated 3-7 days post-injection,
• Patients have pre-injection Modified Ashworth scores equal to 2 (moderate spasticity) in wrist or elbow flexors.
• Patients can actively extend joints at least 10° at metacarpophalangeal and interphalangeal joints and 20° at the wrist of the affected upper limb.

Exclusion Criteria

• Joint immobility in the upper limb due to contracture, bony deformity, or heterotopic ossification
• Significant cognitive deficits (Mini-Mental Status Examination score <24).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Reem Hesham Mohamed Abdelhady

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

outpatient clinics of Mansoura university hospital

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

Reem-Phd

Identifier Type: -

Identifier Source: org_study_id