StrokemCIMTNCT06692569
The Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Function in Stroke Rehabilitation
A study testing Conventional Physical Therapy and Modified Constraint Induced Movement Therapy in people with Stroke and Hemiplegia, run by University of Jazan at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke, Hemiplegia, Chronic Stroke Patients
- What is being tested?
- Conventional Physical Therapy and Modified Constraint Induced Movement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Nov 2024to 13 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- Unable to follow visual and oral commands.
- Unilateral neglect.
- Severe cognitive, or language deficits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Majmaah Rehabilitation center
Riyadh, Riyadh Region
Center head, 016-4041122, aalanazi@mu.edu.sa
About this study
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
- Being tested
- Conventional Physical Therapy, Modified Constraint Induced Movement Therapy
- Keywords
- stroke, hemiplegia, constraint induced movement therapy, modified constraint induced movement therapy, trunk restrain, upper extremity motor function
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical TherapyOther
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
Modified Constraint Induced Movement TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Conventional Physical Therapy Receives: Other: Conventional Physical Therapy |
| Experimental | Experimental | Conventional Physical Therapy and modified constraint induced movement therapy Receives: Other: Modified Constraint Induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
Wolf Motor Function Test assessment tool was specifically developed to assess and evaluate the exercise capacity of individuals with varying degrees of upper extremity motion impairments, ranging from mild to severe, in both laboratory and clinical settings. It represents an enhancement over a previous tool that was more suitable for assessing high-functioning patients but posed challenges when used with individuals who had limited hand and finger mobility
Measured: Week 0 and week 6
Berg Balance Scale
The Berg Balance Scale (BBS) is a widely used clinical assessment tool designed to evaluate and quantify an individual's balance and stability during various tasks. It consists of a series of 14 tasks or activities that challenge balance and mobility, such as standing on one foot, reaching for objects, and turning in place. Each task is scored on a scale ranging from 0 to 4, with 0 indicating the lowest level of performance and 4 indicating the highest level of performance
Measured: week 0 and week 6
Stroke Specific Quality of Life Scale
Stroke Specific Quality of Life Scale (SS-QOL) is a specialized assessment tool designed to measure the quality of life in individuals who have experienced a stroke. This scale is specifically tailored to evaluate the impact of stroke on various aspects of a person's life, encompassing physical, psychological, and social domains. The SS-QOL questionnaire typically consists of multiple items or questions that cover a range of topics, including physical health, mobility, communication abilities, emotional well-being, and social relationships. Respondents rate their level of satisfaction or well-being in each domain, often on a scale from 0 to 5 or 0 to 100, with higher scores indicating better quality of life
Measured: week 0 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start12 Nov 2024
- Primary completion13 Jul 2025 (estimated)
- Study completion13 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Collaborators
- Majmaah University
- Responsible party
- Principal investigator, Karthick Balasubramanian, University of Jazan
- Investigators
- Karthick BALASUBRAMANIAN, MPT, Principal investigator, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692569
- Sponsor's protocol ID
- MUREC-May.22/COM-2022/6-1
- Acronym
- mCIMT
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
M Shahhar A, Shaik AR, Esht V, Alshehri MM, Balasubramanian K, Ramasamy Sanjeevi R, Abdulrahman Alfaleh K, Okab Alsalem W, Fathi WA, A Alothman S. Modified Constraint-Induced Movement Therapy with Trunk Restraint for Upper Extremity Functional Motor Recovery, Balance and Health-Related Quality of Life in Chronic Stroke: A Single-Blinded Randomized Controlled Clinical Trial. NeuroRehabilitation. 2026 May;58(3):413-428. doi: 10.1177/10538135261417372. Epub 2026 Feb 2.
PubMed 41627128
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Function in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT06692569
- Acronym / sponsor ID
- mCIMT / MUREC-May.22/COM-2022/6-1
- Conditions
- Stroke, Hemiplegia, Chronic Stroke Patients
- Keywords
- stroke, hemiplegia, constraint induced movement therapy, modified constraint induced movement therapy, trunk restrain, upper extremity motor function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of JazanOther government
- Collaborators
- Majmaah University
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 13 Jul 2025 (estimated)
- Study completion
- 13 Jul 2025 (estimated)
- First posted
- 18 Nov 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Conventional Physical TherapyConventional Physical Therapy |
| Experimental | Experimental | Other: Modified Constraint Induced Movement TherapyConventional Physical Therapy and modified constraint induced movement therapy |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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+.
Key exclusion criteria (3 listed)
- Unable to follow visual and oral commands.
- Unilateral neglect.
- Severe cognitive, or language deficits.
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 |
|---|---|---|
| Conventional Physical TherapyThe 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 | Other | Control |
| Modified Constraint Induced Movement TherapyModified 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. | Other | Experimental |
Primary outcome
Wolf Motor Function Test
Time frame: Week 0 and week 6
Wolf Motor Function Test assessment tool was specifically developed to assess and evaluate the exercise capacity of individuals with varying degrees of upper extremity motion impairments, ranging from mild to severe, in both laboratory and clinical settings. It represents an enhancement over a previous tool that was more suitable for assessing high-functioning patients but posed challenges when used with individuals who had limited hand and finger mobility
Berg Balance Scale
Time frame: week 0 and week 6
The Berg Balance Scale (BBS) is a widely used clinical assessment tool designed to evaluate and quantify an individual's balance and stability during various tasks. It consists of a series of 14 tasks or activities that challenge balance and mobility, such as standing on one foot, reaching for objects, and turning in place. Each task is scored on a scale ranging from 0 to 4, with 0 indicating the lowest level of performance and 4 indicating the highest level of performance
Stroke Specific Quality of Life Scale
Time frame: week 0 and week 6
Stroke Specific Quality of Life Scale (SS-QOL) is a specialized assessment tool designed to measure the quality of life in individuals who have experienced a stroke. This scale is specifically tailored to evaluate the impact of stroke on various aspects of a person's life, encompassing physical, psychological, and social domains. The SS-QOL questionnaire typically consists of multiple items or questions that cover a range of topics, including physical health, mobility, communication abilities, emotional well-being, and social relationships. Respondents rate their level of satisfaction or well-being in each domain, often on a scale from 0 to 5 or 0 to 100, with higher scores indicating better quality of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 41627128M Shahhar A, Shaik AR, Esht V, Alshehri MM, Balasubramanian K, Ramasamy Sanjeevi R, Abdulrahman Alfaleh K, Okab Alsalem W, Fathi WA, A Alothman S. Modified Constraint-Induced Movement Therapy with Trunk Restraint for Upper Extremity Functional Motor Recovery, Balance and Health-Related Quality of Life in Chronic Stroke: A Single-Blinded Randomized Controlled Clinical Trial. NeuroRehabilitation. 2026 May;58(3):413-428. doi: 10.1177/10538135261417372. Epub 2026 Feb 2.
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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.
Karthick BALASUBRAMANIAN, MPT principal investigator
University of Jazan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy and Modified Constraint Induced Movement Therapy in people with Stroke and Hemiplegia, run by University of Jazan at 1 site in Saudi Arabia.
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 9 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Nov 2024. 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Mansour Al Shehri, PhD (00966-503946253, moalshehri@jazanu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (time frame: Week 0 and week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06692569, which also lists 1 linked publication.
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 18 Nov 2024.