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Hemiplegic Cerebral PalsyNCT07233824

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

A study testing Exercise in people with Hemiplegic Cerebral Palsy and Cerebral Palsy (CP), run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 6 to 12 years
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Nov 2025to 7 Aug 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

    Istanbul, Fatih

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Fun-Core (Child-Friendly Core Stabilization) Exercises on Balance and Functional Mobility in Children With Spastic Cerebral Palsy: A Single-Blind Randomized Controlled Trial

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.

Being tested
Exercise
Keywords
core stabilization exercises, cerebral palsy, functional mobility, balance, child friendly
Medical subject headings
Cerebral Palsy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

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

  • ExerciseOther

    Standard home based exercise program

Study groups in NCT07233824
Study groupRoleWhat they receive
Intervention Group (G1)Active comparatorIn 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.
Receives: Other: Exercise
Control Group (G2)OtherStandard home exercise program (brochure)
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (7)
  1. Six Minute Walk Test

    It is considered a measurement that assesses an individual's overall functional status. The test assesses the integrated response of respiratory, cardiovascular, skeletal, nervous, and muscular components. A 30-meter track will be used for the test. The total distance walked by the participant over 6 minutes will be recorded in meters. In our study, the 6-minute walk test will be administered to participants wearing shoes equipped with wearable sensors, and the test will be measured through the shoe.

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

  2. 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

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

  3. Trunk Endurance Tests

    Performance assessment is conducted by recording the maximum time the individual can maintain the test position. Before each test, the child is asked to maintain the test position for as long as possible. Each test will be repeated three times, and the average time will be recorded. To minimize the risk of injury or psychological distress, the tests will be explained in detail to the children beforehand, and their administration will be demonstrated. Two healthcare professionals will be present during each test to ensure the child maintains proper form and ensure safety.

    Back extension test: Biering-Sørensen position with trunk held horizontal, pelvis/legs strapped; ended at loss of position or 300s.

    Lateral torso test: Full side-bridge with straight body on elbow; stopped when posture broke or 300s.

    Flexor test: Sit-up at 50° support, arms crossed, feet secured; ended when back touched support or 300s.

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

  4. Pediatric Reach Test

    It is a measurement method that evaluates the dynamic component of balance. The test will be conducted by measuring the distance in centimeters that participants can reach forward, then to the right and left, without lifting their heels while standing upright. The procedures will be explained to participants once, and then they will be asked to perform the exercise three times. They will be expected to hold each position for at least 3 seconds. Measurements where participants lose their balance and lift their feet off the ground will be invalid. The distance reached will be measured in centimeters using a non-stretchable tape measure.

    The test consists of two sections: sitting and standing, with three items in each section (six items in total). The total score is calculated by measuring the distance in centimeters between the starting position (shoulder flexed 90° for forward reach and shoulder abducted 90° for side reach) and the maximum stable reach.

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

  5. WeeFIM

    The WeeFIM is used to measure functional independence in activities of daily living for children aged 6 months to 12 years. It consists of 18 items covering self-care, toilet control, mobility, locomotion, communication, and social development.

    A 7-level ordinal rating system ranging from 7 (complete independence) to 1 (total assistance), is used to score performance in each item. As with the FIM, the Wee- FIM consists of two dimensions: motor and cognitive.

    The WeeFIM is a reliable and valid tool for assessing the functional status of children with CP.

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

  6. PEDQoL 4.0 Pediatric Quality of Life Questionnaire

    The PEDQoL 4.0 Pediatric Quality of Life Questionnaire will be used. Depending on the participant's age, the child report and parent report forms will be used for children aged 7 and 8, and the child report and parent report forms for children aged 8-12. It is designed to measure core health dimensions defined by the World Health Organization (WHO). It is administered in parallel in child self-report and parent proxy report formats. The participant is asked how much of a problem each item has been in the past month.

    Participants are asked to rate how problematic each item has been during the past month. Reverse scoring is applied and converted to a 0-100 scale: 0 = 100 points, 1 = 75 points, 2 = 50 points, 3 = 25 points, and 4 = 0 points. The total scale score is calculated by dividing the sum of responses by the number of items answered. If more than 50% of the items are missing, the scale score is not computed.

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

  7. Children/ Youth with Cerebral Palsy Brief (6-13 years of age)

    Activity and Participation Assessment: Will be evaluated with the Brief ICF Core Set for Children and Adolescents with CP (≥6, <14 Years). Difficulty levels will be evaluated using the ICF Qualifiers. A score of 0 indicates no difficulty (0-4%), 1 mild difficulty (5-24%), 2 moderate difficulty (25-49%), 3 severe difficulty (50-95%), and 4 complete difficulty (96-100%). Scores 8 ("not specified") and 9 ("not applicable") are used when relevant.

    Activity and participation will be assessed under the domains of performance and capacity. Higher scores in each parameter indicate greater limitation.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start20 Nov 2025
  3. Primary completion7 Aug 2026
  4. Study completion7 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07233824
Sponsor's protocol ID
E-29624016-050.99-3354321
Status last verified
Nov 2025
First submitted
29 Sep 2025
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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