Clinical Trials Directory

Trials / Completed

CompletedNCT07237490

Effectiveness of Modified Constraint-Induced Movement Therapy Delivered Via Telerehabilitation in Children With Unilateral Cerebral Palsy: A Prospective Randomized Controlled Trial

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Istanbul University · Academic / Other
Sex
All
Age
4 Years – 12 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERmCIMT 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.
OTHERhome 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.

Timeline

Start date
2023-12-12
Primary completion
2025-09-10
Completion
2025-09-25
First posted
2025-11-19
Last updated
2025-11-19

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07237490. Inclusion in this directory is not an endorsement.