mCIMT Effect Via TelerehabilitationNCT07237490
Effectiveness of Modified Constraint-Induced Movement Therapy Delivered Via Telerehabilitation in Children With Unilateral Cerebral Palsy: A Prospective Randomized Controlled Trial
A study testing mCIMT via Telerehabilitation and home exercise program in people with mCIMT Effect Via Telerehabilitation, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Aim:In this prospective and randomized controlled thesis study; we aimed to compare Modified Constraint-Induced Movement Therapy (mCIMT) delivered via Telerehabilitation with the home program in children with Unilateral Cerebral Palsy (CP) and to determine whether Telerehabilitation has a positive effect on upper… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- mCIMT Effect Via Telerehabilitation
- What is being tested?
- mCIMT via Telerehabilitation and home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2023to 25 Sep 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of unilateral CP by a specialist
- Ability to extend the suspected wrist more than 10°
- Demonstration of ability to follow simple commands and participation in assigned tasks
- Gross Motor Function Classification System Level 1 or 2
- Manual Skills Classification System Level 1, 2 or 3
- Muscle tone is normal/mild/moderate (Modified Ashworth Scale level 0-1-2)
- No contractures in the upper extremity
- Agrees to attend intensive therapy sessions and to stop all other upper extremity therapeutic interventions for the 3-month follow-up period
Who cannot join
- Significant contractures in the wrist, elbow, and fingers that prevent daily activities
- Lack of active movement in the affected upper extremity
- Cognitive impairment that causes inability to understand and perform simple commands and tasks
- Inability to continue treatment protocol due to school schedule
- Uncontrolled disease (endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal), active systemic inflammatory disease, and/or history of malignancy
- Current or previous treatments not compatible with the study treatment protocol
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- Orthopedic surgery (tendon transfer/tendon lengthening) performed on the affected upper extremity
- Botulinum toxin injection into upper extremity muscles within the last 6 months
- Dorsal rhizotomy
- Intrathecal baclofen pump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Our Prospective and Randomized Controlled Study, 42 Children With Unilateral Cerebral Palsy Were Included and Randomized as the mCIMT Group Delivered Via Telerehabilitation (n=21) and the Control Group (n=21). The First Group Received mCIMT Treatment Together With Telerehabilitation for 1 Hour, 3 Times a Week for 6 Weeks. In Addition, 30 Minutes of Indoor Activity Practices Were Performed Every Day. The Second Group Received a Home Program Under the Supervision of Parents for 1 Hour, 3 Times a Week for 6 Weeks.
Aim:In this prospective and randomized controlled thesis study; we aimed to compare Modified Constraint-Induced Movement Therapy (mCIMT) delivered via Telerehabilitation with the home program in children with Unilateral Cerebral Palsy (CP) and to determine whether Telerehabilitation has a positive effect on upper extremity functions and quality of life.
Method: In our prospective and randomized controlled study, 42 children with unilateral cerebral palsy were included and randomized as the mCIMT group delivered via Telerehabilitation (n=21) and the control group (n=21).
Read more
The first group received mCIMT treatment together with Telerehabilitation for 1 hour, 3 times a week for 6 weeks. In addition, 30 minutes of indoor activity practices were performed every day.
The second group received a home program under the supervision of parents for 1 hour, 3 times a week for 6 weeks.
.In the randomized double-blind study, initial assessments, post-treatment and follow-up assessments were performed by the researcher who was blinded to the group distribution.
The primary outcome measure was the Assisting Hand Assessment (AHA), which was used to evaluate upper extremity function. The researcher administering this assessment was blinded to group allocation. Secondary outcome measures included the Modified Jebsen Taylor Hand Function Test, range of motion assessed with a goniometer, spasticity evaluated using the Modified Ashworth Scale, grip strength measured with a Jamar dynamometer, manual ability classified using the Manual Ability Classification System (MACS), activities of daily living assessed by ABILHAND-Kids, and quality of life evaluated using the KINDL questionnaire.
Post-treatment assessments were performed at the beginning of the study and 6 weeks after treatment.
- Conditions
- mCIMT Effect Via Telerehabilitation
- Being tested
- mCIMT via Telerehabilitation, home exercise program
- Keywords
- Cerebral palsy, telerehabilitation , mCIMT, exercise, hand functions
- Medical subject headings
- Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCIMT via TelerehabilitationOther
In this group, patients aged 4-12 with unilateral cerebral palsy received mCIMT via the Eczacıbaşı EVITAL app for upper extremity rehabilitation. For six weeks, they performed mCIMT three times a week for one hour under therapist supervision and with parental supervision, two times a week for one hour under parental supervision, and half an hour each day of selected daily activities using the affected extremity, with gloves on the unaffected extremity.
home exercise programOther
Patients in this group with unilateral CP underwent a home exercise program, which they continued for one hour, three days a week.
The upper extremity exercise program included range of motion exercises, stretching exercises, activities of daily living exercises, and play-based exercises.
This program lasted an average of 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| via Telerehabilitation mCIMT | Active comparator | The first group received mCIMT treatment together with Telerehabilitation for 1 hour, 3 times a week for 6 weeks. In addition, 30 minutes of indoor activity practices were performed every day.
The second group received a home program under the supervision of parents for 1 hour, 3 times a week for 6 weeks. Receives: Other: mCIMT via Telerehabilitation |
| home exercises control group | Active comparator | A 1-hour home program will be implemented 3 days a week. Receives: Other: home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assessment
The AHA is a test that measures how patients with upper extremity dysfunction, such as hemiplegic CP or congenital brachial plexus injury, use their affected hand in conjunction with their unaffected hand during two-handed play. It was first validated in children aged 18 months to 5 years (Small Kids AHA), and then two play tables were created for children aged 6 to 12 years (School Kids AHA). In this assessment method, a camera records the child performing tasks and playing with both hands. This assessment method can be administered by healthcare professionals who have completed the training and received certification. The test consists of two stages: first, the assessor (therapist, physician) sits opposite the child, and an environment is prepared using age-appropriate toys from the AHA kit to enable the child to perform all upper extremity functions using both hands. A camera positioned behind the assessor records this process.
Measured: before treatment and 6 weeks after treatment
Secondary outcomes (6)
ABILHAND KIDS
ABILHAND-Kids is a scale that assesses the extent to which children with cerebral palsy can use their manual skills in daily living activities such as self-care, and the difficulties perceived by parents during these activities.
Measured: before treatment and 6 weeks after treatment
Modified Jebsen-Taylor Hand Function Test
The Jebsen-Taylor Hand Function Test (JFTT) is a standardized performance test developed to assess unimanual daily skills. In this test, children are asked to perform tasks such as grasping, releasing, and moving objects at varying levels of difficulty as quickly and accurately as possible. The assessment time is recorded in seconds.
Measured: before treatment and 6 weeks after treatment
Joint Range of Motion
In our study, ROM in the affected extremity was measured separately using a joint goniometer, both actively and passively, for finger flexion/extension, wrist flexion/extension, supination/pronation, elbow flexion/extension, and shoulder flexion/extension/abduction/adduction/internal rotation/external rotation.
Measured: before treatment and 6 weeks after treatment
Grip Strength
Grip strength was measured separately in both upper extremities using a Baseline® Smedley spring dynamometer (child, 110 lb, USA).
The standard procedure outlined by Mathiowetz et al. was followed during the assessment: three maximum voluntary grips were performed for each hand. The average of these three measurements was taken, and the results were recorded in kilograms of force (kgF).
Measured: before treatment and 6 weeks after treatment
Modified Ashworth Scale
Muscle tone was assessed in five major muscle groups in the affected upper extremity. The Modified Ashworth Scale (MAS) was used, and muscle tone was graded from 0 (normal) to 4 (significantly increased).
The muscle groups assessed were: elbow flexors, elbow extensors, wrist flexors, wrist extensors, and finger flexors.
Measured: before treatment and 6 weeks after treatment
KINDL
The Children's General Health-Related Quality of Life Scale (KINDL-R) is a self-report scale developed to assess the health-related quality of life of children and adolescents. It is available in three versions to suit different age groups: the Kiddy-KINDL-R (interviewer-administered version) for children aged 4-7, the Kid-KINDL-R for children aged 8-12, and the Kiddo-KINDL-R for adolescents aged 13-16. In addition, two parent forms are available that allow families to indirectly assess the quality of life of younger children (ages 4-7) and older children and adolescents (ages 8-16).
Measured: before treatment and 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start12 Dec 2023
- Primary completion10 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mCIMT Effect Via TelerehabilitationStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Model description
- Prospective Randomized Controlled Trial - Single Blinded
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Hakan KAPUCU, Istanbul University
- Investigators
- Ayşe R AYDIN, Professor Doctor, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237490
- Sponsor's protocol ID
- 2480576
- Status last verified
- Jul 2025
- First submitted
- 24 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Our Prospective and Randomized Controlled Study, 42 Children With Unilateral Cerebral Palsy Were Included and Randomized as the mCIMT Group Delivered Via Telerehabilitation (n=21) and the Control Group (n=21). The First Group Received mCIMT Treatment Together With Telerehabilitation for 1 Hour, 3 Times a Week for 6 Weeks. In Addition, 30 Minutes of Indoor Activity Practices Were Performed Every Day. The Second Group Received a Home Program Under the Supervision of Parents for 1 Hour, 3 Times a Week for 6 Weeks.
- ClinicalTrials.gov ID
- NCT07237490
- Acronym / sponsor ID
- 2480576
- Conditions
- mCIMT Effect Via Telerehabilitation
- Keywords
- Cerebral palsy, telerehabilitation , mCIMT, exercise, hand functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 19 Nov 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.
Aim:In this prospective and randomized controlled thesis study; we aimed to compare Modified Constraint-Induced Movement Therapy (mCIMT) delivered via Telerehabilitation with the home program in children with Unilateral Cerebral Palsy (CP) and to determine whether Telerehabilitation has a positive effect on upper extremity functions and quality of life.
Method: In our prospective and randomized controlled study, 42 children with unilateral cerebral palsy were included and randomized as the mCIMT group delivered via Telerehabilitation (n=21) and the control group (n=21).
The first group received mCIMT treatment together with Telerehabilitation for 1 hour, 3 times a week for 6 weeks. In addition, 30 minutes of indoor activity practices were performed every day.
The second group received a home program under the supervision of parents for 1 hour, 3 times a week for 6 weeks.
.In the randomized double-blind study, initial assessments, post-treatment and follow-up assessments were performed by the researcher who was blinded to the group distribution.
The primary outcome measure was the Assisting Hand Assessment (AHA), which was used to evaluate upper extremity function. The researcher administering this assessment was blinded to group allocation. Secondary outcome measures included the Modified Jebsen Taylor Hand Function Test, range of motion assessed with a goniometer, spasticity evaluated using the Modified Ashworth Scale, grip strength measured with a Jamar dynamometer, manual ability classified using the Manual Ability Classification System (MACS), activities of daily living assessed by ABILHAND-Kids, and quality of life evaluated using the KINDL questionnaire.
Post-treatment assessments were performed at the beginning of the study and 6 weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled Trial - Single Blinded
| Arm | Type | Receives |
|---|---|---|
| via Telerehabilitation mCIMT | Active comparator | Other: mCIMT via TelerehabilitationThe first group received mCIMT treatment together with Telerehabilitation for 1 hour, 3 times a week for 6 weeks. In addition, 30 minutes of indoor activity practices were performed every day. The second group received a home program under the supervision of parents for 1 hour, 3 times a week for 6 weeks. |
| home exercises control group | Active comparator | Other: home exercise programA 1-hour home program will be implemented 3 days a week. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Diagnosis of unilateral CP by a specialist
- Ability to extend the suspected wrist more than 10°
- Demonstration of ability to follow simple commands and participation in assigned tasks
- Gross Motor Function Classification System Level 1 or 2
- Manual Skills Classification System Level 1, 2 or 3
Key exclusion criteria (10 listed)
- Significant contractures in the wrist, elbow, and fingers that prevent daily activities
- Lack of active movement in the affected upper extremity
- Cognitive impairment that causes inability to understand and perform simple commands and tasks
- Inability to continue treatment protocol due to school schedule
- Uncontrolled disease (endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal), active systemic inflammatory disease, and/or history of malignancy
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 |
|---|---|---|
| mCIMT via TelerehabilitationIn this group, patients aged 4-12 with unilateral cerebral palsy received mCIMT via the Eczacıbaşı EVITAL app for upper extremity rehabilitation. For six weeks, they performed mCIMT three times a week for one hour under therapist supervision and with parental supervision, two times a week for one hour under parental supervision, and half an hour each day of selected daily activities using the affected extremity, with gloves on the unaffected extremity. | Other | via Telerehabilitation mCIMT |
| home exercise programPatients in this group with unilateral CP underwent a home exercise program, which they continued for one hour, three days a week. The upper extremity exercise program included range of motion exercises, stretching exercises, activities of daily living exercises, and play-based exercises. This program lasted an average of 60 minutes. | Other | home exercises control group |
Primary outcome
Assisting Hand Assessment
Time frame: before treatment and 6 weeks after treatment
The AHA is a test that measures how patients with upper extremity dysfunction, such as hemiplegic CP or congenital brachial plexus injury, use their affected hand in conjunction with their unaffected hand during two-handed play. It was first validated in children aged 18 months to 5 years (Small Kids AHA), and then two play tables were created for children aged 6 to 12 years (School Kids AHA). In this assessment method, a camera records the child performing tasks and playing with both hands. This assessment method can be administered by healthcare professionals who have completed the training and received certification. The test consists of two stages: first, the assessor (therapist, physician) sits opposite the child, and an environment is prepared using age-appropriate toys from the AHA kit to enable the child to perform all upper extremity functions using both hands. A camera positioned behind the assessor records this process.
6 secondary outcomes
ABILHAND KIDS
Time frame: before treatment and 6 weeks after treatment
Modified Jebsen-Taylor Hand Function Test
Time frame: before treatment and 6 weeks after treatment
Joint Range of Motion
Time frame: before treatment and 6 weeks after treatment
Grip Strength
Time frame: before treatment and 6 weeks after treatment
Modified Ashworth Scale
Time frame: before treatment and 6 weeks after treatment
KINDL
Time frame: before treatment and 6 weeks after treatment
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 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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.
Ayşe R AYDIN, Professor Doctor principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mCIMT via Telerehabilitation and home exercise program in people with mCIMT Effect Via Telerehabilitation, run by Istanbul University at 1 site in Turkey (Türkiye).
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 8 inclusion and 10 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 19 Nov 2025. 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 Turkey (Türkiye). 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?
Assisting Hand Assessment (time frame: before treatment and 6 weeks after treatment). 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 19 Nov 2025.