Constraint Induced Movement TherapyNCT07057050

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

A study testing The designed physiotherapy program, The Botulinum toxin injection and Task oriented training in people with Constraint Induced Movement Therapy and Task Oriented Training, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 45 to 60 years
Conditions the study is for: Constraint Induced Movement Therapy, Task Oriented Training, Botox Injection
What is being tested?: The designed physiotherapy program, The Botulinum toxin injection and Task oriented training
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteEgypt
Study dates: 30 Jun 2025to 1 Nov 2025
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

outpatient clinics of Mansoura university hospital
Al Mansurah

Other trials in Egypt

About this study

Official title: Constraint-induced Movement Therapy Versus Task-oriented Training

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.

Read the 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
Being tested: The designed physiotherapy program, The Botulinum toxin injection, Task oriented training, Constrained induced movement therapy
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The designed physiotherapy programOther
- 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 injectionDrug
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 trainingOther
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.
Constrained induced movement therapyOther
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.

Study groups in NCT07057050
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Other: The designed physiotherapy program; Drug: The Botulinum toxin injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: at baseline and after 12 weeks

Secondary outcomes (4)

Evaluation of degree of spasticity
The Modified Ashworth Scale is a 6-point scale used to measure spasticity in the affected upper limb. The score ranges from 0 to 4, with lower scores indicating normal muscle tone and higher scores indicating spasticity or increased resistance to passive movement. Muscle tone assessment is done in a comfortable, quiet room, with no nociceptive or exteroceptive stimuli. The patient is instructed to empty their bladder and release tight clothes before the assessment.
Measured: at baseline and after 12 weeks
assessment of change of handgrip strength
Maximal voluntary grip forces (MVGF) will be assessed using grip dynamometer. Subjects are seated in a wheelchair. The shoulder is placed at approximately 30 degrees of abduction and 0 degrees of flexion. The elbow is flexed at 90 degrees with the wrist in neutral position. Maximal voluntary grip forces are established as the highest values recorded during three maximal voluntary exertions separated by 2-minute rest intervals. The mean value for each hand was used for analysis
Measured: at baseline and after 12 weeks
assessment of change of shoulder and elbow movement
Kinovea software is a reliable method for measuring shoulder joint position sense, suitable for medical, rehabilitation, and sports environments. It accurately measures shoulder joint position up to 5 meters from an object and 90°-45° angle. Kinovea software also performs motion analysis, capturing shoulder flexion, abduction, elbow flexion, and extension movements. Cross marks are drawn on anatomical landmarks on the dominant upper limb.
Measured: at baseline and after 12 weeks
assessment of change of upper limb function
The Action Research Arm Test (ARAT) is a tool used to evaluate limb function in individuals with hemiplegia due to cortical damage. It measures a client's ability to handle objects of different sizes, weights, and shapes. The ARAT scores range from 0 to 57, with higher scores indicating better performance. The test is conducted pre- and post-treatment and consists of four subscales: grasp, grip, pinch, and gross movement. If a client fails on the most difficult task, the easiest task is performed, and the entire subscale is scored as zero.
Measured: at baseline and after 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 20251 Nov 2025

First posted9 Jul 2025
Study start30 Jun 2025
Primary completion1 Oct 2025
Study completion1 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Constraint Induced Movement TherapyStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07057050
Sponsor's protocol ID: Reem-Phd
Status last verified: Oct 2026
First submitted: 28 Jun 2025
Last updated: 20 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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