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

Istanbul University

Status: Completed

Conditions: mCIMT Effect Via Telerehabilitation

Treatments: Other: mCIMT via Telerehabilitation; Other: home exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT07237490

2480576

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

via Telerehabilitation mCIMT

Active Comparator group

Description:

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.

Treatment:

Other: mCIMT via Telerehabilitation

home exercises control group

Active Comparator group

Description:

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

Treatment:

Other: home exercise program