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

NCT07057050 | Completed

• 1 other identifier: Reem-Phd
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• assessment of change of arm motor impairment

  The Fugl-Meyer Upper Extremity scale, validated and reliable, correlates well with upper extremity coordination. It includes four motor sub-items relevant to the affected upper limb: shoulder/elbow/forearm, wrist, hand, and speed/coordination. The test is conducted pre- and post-treatment, requiring volitional movement mixing synergies. The total Fugl-Meyer Upper Extremity scale takes 30-35 minutes, and items are scored using a 3-point ordinal scale. The patient's performance ranges from 0 to 2 on the scale.

  at baseline and after 12 weeks

Secondary Outcomes (4)

• Evaluation of degree of spasticity

  at baseline and after 12 weeks

• assessment of change of handgrip strength

  at baseline and after 12 weeks

• assessment of change of shoulder and elbow movement

  at baseline and after 12 weeks

• assessment of change of upper limb function

  at baseline and after 12 weeks

Study Arms (3)

constrained induced movement therapy

EXPERIMENTAL

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.

Other: The designed physiotherapy program; Drug: The Botulinum toxin injection; Other: Constrained induced movement therapy

task-oriented training

ACTIVE COMPARATOR

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.

Other: The designed physiotherapy program; Drug: The Botulinum toxin injection; Other: Task oriented training

designed physical therapy program

ACTIVE COMPARATOR

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

Other: The designed physiotherapy program; Drug: The Botulinum toxin injection

Interventions

The Botulinum toxin injection 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; designed physical therapy program; task-oriented training

Task oriented training 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.

task-oriented training

The designed physiotherapy program 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.)

constrained induced movement therapy; designed physical therapy program; task-oriented training

Constrained induced movement therapy 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.

constrained induced movement therapy

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

outpatient clinics of Mansoura university hospital

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

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

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 9, 2025
• Study Start: June 30, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

EG (1)