Comparison of Three Treatment in Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy

• Registration Number: NCT06747078
• Lead Sponsor: Pamukkale University

Brief Summary

In this study, considering the importance of walking and balance functions in improving the quality of life and achieving independence in children with cerebral palsy, it was aimed to examine whether core stabilization exercises specifically designed for children with cerebral palsy have an impact on improving balance and walking functions as well as quality of life. Additionally, the study sought to determine whether this approach has superiority over conventional balance exercises.

Detailed Description

Children with cerebral palsy included in the study were randomized into three groups using block randomization based on age, type of cerebral palsy and the Gross Motor Function Classification System (GMFCS). Children with cerebral palsy aged 7-18 years were included. Group 1 (study group, n=12) received neurodevelopmental therapy (NDT) combined with core stabilization exercises (CSE). Group 2 (study group, n=12) received NDT combined with balance exercises (BE). The control group (n=12) received only NDT. Treatments were conducted for 60 minutes per session, three times a week, over 8 weeks, for a total of 24 sessions, with an equal duration across groups. Participants' balance was evaluated using the Pediatric Balance Scale (PBS) and the SportKat 550® device. The Trunk Involvement Scale (TIS) was used to measure trunk impairment, the Six-Minute Walk Test (6MWT) to assess functional mobility and walking capacity and the Pediatric Outcome Data Collection Instrument (PODCI) to evaluate quality of life. All assessments were performed by the same physiotherapist before and after treatment

Study Timeline

• Study Start: 2021-08-25
• Status Verified: 2024-12
• Primary Completion: 2024-12-16
• Study Completion: 2024-12-16
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-21
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Cases between the ages of 7-18
• Cases with GMFCS level I and II
• Cases diagnosed with hemiparetic and diparetic CP

Exclusion Criteria

• Cases with levels III, IV and V according to GMFCS
• Having an intellectual disability that would prevent participation in assessment and exercise training
• Having had Botulinum Toxin (BOTOX) Type A application within the last 6 months
• Having undergone any surgical operation within the last 6 months
• Hearing and vision problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pediatric Balance Scale (PBS)	eight weeks	The Pediatric Balance Scale is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
SportKat550 Kinesthetic Ability Trainer (SportKAT 550)	eight weeks	The SportKAT-550® device used to determine postural sway consists of sensors that detect sway and is also a balance platform. There is a digital screen in front of the platform to provide feedback to the person on it. The person on the platform is asked to hold the "X" mark on the digital screen in the center while the static balance test is performed. A score of 500 or lower than 500 in the static balance measurement indicates that the balance is good and the postural sway is low.For dynamic balance, a score between 750-950 is excellent, and a score between 1350-1550 indicates good balance.
Pediatric Outcome Data Collection Instrument (PODCI)	eight weeks	It is a widely used scale to determine quality of life, functional health status and participation in children with cerebral palsy.The test is a Likert type scale and consists of 5 parts.PVTA, which has validity and reliability in Turkish, is scored between 0-100.

Secondary Outcome Measures

Name	Time	Method
Six Minute Walk Test (6MWT)	eight weeks	The 6-minute walking test (6 MWT) is an easy test that is frequently used to determine functional mobility and walking distance in children with cerebral palsy. In our study, 6MWT was performed by measuring the distance the subject walked quickly but without running on a straight distance of 20 meters.
The Trunk Involvement Scale (TIS)	eight weeks	The Trunk Involvement Scale was used to assess the trunk. It consists of three subsections: dynamic, static and coordination. Scoring can vary between 0-23.

Trial Locations

Locations (1)

Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A; 🇹🇷 Denizli, Kınıklı, Turkey