Effectiveness of Modified Constraint-Induced Movement Therapy Delivered Via Telerehabilitation in… (NCT07237490) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Modified Constraint-Induced Movement Therapy Delivered Via Telerehabilitation in Children With Unilateral Cerebral Palsy: A Prospective Randomized Controlled Trial
Turkey (Türkiye)42 participantsStarted 2023-12-12
Plain-language 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 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.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inclusion between the ages of 4-12
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assisting Hand Assessment
Timeframe: before treatment and 6 weeks after treatment