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

NCT07237490 | Completed

• 1 other identifier: 2480576
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Cerebral palsy, telerehabilitation , mCIMT, exercise, hand functions

Outcome Measures

Primary Outcomes (1)

• 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.

  before treatment and 6 weeks after treatment

Secondary Outcomes (6)

• ABILHAND KIDS

  before treatment and 6 weeks after treatment

• Modified Jebsen-Taylor Hand Function Test

  before treatment and 6 weeks after treatment

• Joint Range of Motion

  before treatment and 6 weeks after treatment

• Grip Strength

  before treatment and 6 weeks after treatment

• Modified Ashworth Scale

  before treatment and 6 weeks after treatment

Study Arms (2)

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.

Other: mCIMT via Telerehabilitation

home exercises control group

ACTIVE COMPARATOR

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

Other: home exercise program

Interventions

mCIMT via Telerehabilitation 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.

via Telerehabilitation mCIMT

home exercise program 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.

home exercises control group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Fatih, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Ayşe R AYDIN, Professor Doctor

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (Res. Assist. Dr.)

Model Details: Prospective Randomized Controlled Trial - Single Blinded

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 19, 2025
• Study Start: December 12, 2023
• Primary Completion: September 10, 2025
• Study Completion: September 25, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-07

Locations

TU (1)