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

NCT ID: NCT07237490

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-12
• Study Completion Date: 2025-09-25

Brief 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

mCIMT Effect Via Telerehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

via Telerehabilitation mCIMT

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.

Group Type: ACTIVE_COMPARATOR

mCIMT via Telerehabilitation

Intervention Type: OTHER

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 exercises control group

A 1-hour home program will be implemented 3 days a week.

Group Type: ACTIVE_COMPARATOR

home exercise program

Intervention Type: OTHER

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.

Interventions

mCIMT via Telerehabilitation

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.

Intervention Type: OTHER

home exercise program

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Hakan KAPUCU

Medical Doctor (Res. Assist. Dr.)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşe R AYDIN, Professor Doctor

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

Istanbul University

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2480576

Identifier Type: -

Identifier Source: org_study_id