Effects of Fun-Core (Child-Friendly Core Stabilization) Exercises on Balance and Functional Mobility in Children With Spastic Cerebral Palsy

NCT07233824 | Recruiting

• 1 other identifier: E-29624016-050.99-3354321
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 54 children, aged between 6 and 12 years, diagnosed with hemiplegic cerebral palsy and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, between June 1, 2025 and March 1, 2026, were planned to be included in our thesis study, which was planned to be prospective, randomized and single-blind. Children and their parents will be informed verbally and in writing about the study's purpose, duration, and method of implementation, and their informed consent will be obtained. They will be asked to sign an "Informed Consent Form." Patient assessment and follow-up forms will be completed at pre- and post-treatment follow-ups. Patients who meet the inclusion criteria will be numbered according to their order of admission and then randomly assigned to either the intervention or control groups by a computer program. In addition to a brochure showing the number of sets and repetitions to be given to the patients as a standard home exercise program, the Fun-Core video exercise program, designed as a child-friendly core stabilization exercise program to be performed 3 times a week, will be given to the intervention group (G1), and the exercises will be delivered to the participants through a website with special accounts. The control group (G2) will receive a standard home exercise program in brochure format, showing the number of sets and repetitions. The exercise program will be performed at home three times a week for 8 weeks.

Conditions

Hemiplegic Cerebral Palsy; Cerebral Palsy (CP); Core Stabilization; Exercise; Functional Mobility; Balance

Keywords

core stabilization exercises; cerebral palsy; functional mobility; balance; child friendly

Outcome Measures

Primary Outcomes (2)

• Modified Timed Up & Go Test

  The mTUG test is a modified version of the Timed Up and Go (TUG) test for assessing functional mobility in children. It essentially measures how quickly an individual can perform the skills necessary for daily living activities-sitting, standing, walking, turning, and sitting down again. Unlike the standard TUG test, it includes instructions and environmental conditions tailored to the developmental level and cognitive capacity of children. In our study, the mTUG test will be administered to participants wearing shoes equipped with wearable sensors, and the test duration will be measured through the shoes.

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)

• Pediatric Balance Scale

  It will be used to assess balance in children. It consists of 14 items, each item being scored from 0 to 4. The maximum score is 56. The higher the score, the better the child's balance. 1. sitting to standing 2. standing to sitting 3. transfers 4. standing unsupported 5. sitting unsupported 6. standing with eyes closed 7. standing with feet together 8. standing with one foot in front 9. standing on one foot 10. turning 360 degrees 11. turning to look behind 12. retrieving object from floor 13. placing alternate foot on stool 14. reaching forward with outstretched arm

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)

Secondary Outcomes (6)

• Six Minute Walk Test

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)

• Trunk Endurance Tests

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)

• Pediatric Reach Test

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)

• WeeFIM

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)

• PEDQoL 4.0 Pediatric Quality of Life Questionnaire

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)

Study Arms (2)

Intervention Group (G1)

ACTIVE COMPARATOR

In addition to a brochure showing the number of sets and repetitions to be given to the patients as a standard home exercise program, the Fun-Core video exercise program, designed as a child-friendly core stabilization exercise program to be performed 3 times a week, will be given to the intervention group (G1), and the exercises will be delivered to the participants through a website with special accounts.

Other: Exercise

Control Group (G2)

OTHER

Standard home exercise program (brochure)

Other: Exercise

Interventions

Exercise OTHER

Fun-Core Exercises will be narrated, prepared and recorded in video format, and then delivered in order to ensure children's development and motivation.

Intervention Group (G1)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with hemiplegic cerebral palsy between the ages of 6 and 12
• Children with Gross Motor Function Classification System (GMFCS) Levels 1, 2, and 3
• Shoe sizes 30 and above

You may not qualify if:

• Cognitive impairments that prevent understanding and performing simple commands and tasks
• Botulinum toxin injections into the upper and/or lower extremities within the last 6 months
• History of lower extremity or lumbar surgery within the last year
• Presence of uncontrolled severe epileptic seizures
• Presence of severe vision or hearing problems
• Presence of fixed contractures in the lower extremities

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatih, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ayse R Aydin, MD, Prof.

  Istanbul University Istanbul Medical Faculty, Department of Physical Medicine and Rehabilitation

  STUDY CHAIR

Central Study Contacts

Berk Korkut, MD, Res. Assist. Dr.

CONTACT

+905305202866; berkkorkut@windowslive.com

Study Design

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

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 18, 2025
• Study Start: September 17, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TU (1)