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.
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
- Are there results?
- None posted in the registry
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Hesham Mohamed Abdelhady, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint-induced Movement Therapy Versus Task-oriented Training
- ClinicalTrials.gov ID
- NCT07057050
- Acronym / sponsor ID
- Reem-Phd
- Conditions
- Constraint Induced Movement Therapy, Task Oriented Training, Botox Injection, Upper Extremity Function, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| constrained induced movement therapy | Experimental | Other: The designed physiotherapy program, Drug: The Botulinum toxin injection, Other: Constrained induced movement therapyPatients 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. |
| task-oriented training | Active comparator | Other: The designed physiotherapy program, Drug: The Botulinum toxin injection, Other: Task oriented trainingPatients 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. |
| designed physical therapy program | Active comparator | Other: The designed physiotherapy program, Drug: The Botulinum toxin injectionPatients will undergo a 60-minute physiotherapy program, such as traditional upper extremity training, following botulinum toxin A injection, for 12 consecutive weeks. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (2 listed)
- Joint immobility in the upper limb due to contracture, bony deformity, or heterotopic ossification
- Significant cognitive deficits (Mini-Mental Status Examination score <24).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.) | Other | constrained induced movement therapy, designed physical therapy program, task-oriented training |
| The Botulinum toxin injectionThe 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. | Drug | constrained induced movement therapy, designed physical therapy program, task-oriented training |
| Task oriented trainingThe 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. | Other | task-oriented training |
| Constrained induced movement therapyThe 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. | Other | constrained induced movement therapy |
Primary outcome
assessment of change of arm motor impairment
Time frame: at baseline and after 12 weeks
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.
4 secondary outcomes
Evaluation of degree of spasticity
Time frame: at baseline and after 12 weeks
assessment of change of handgrip strength
Time frame: at baseline and after 12 weeks
assessment of change of shoulder and elbow movement
Time frame: at baseline and after 12 weeks
assessment of change of upper limb function
Time frame: at baseline and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of change of arm motor impairment (time frame: at baseline and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.