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Clinical Trials/NCT06747078
NCT06747078
Completed
N/A

The Effect of Core and Balance Exercises on Gait, Balance and Quality Of Life in Children With Cerebral Palsy: A Comparative Study

Pamukkale University1 site in 1 country36 target enrollmentAugust 25, 2021
ConditionsCerebral Palsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Pamukkale University
Enrollment
36
Locations
1
Primary Endpoint
Pediatric Balance Scale (PBS)
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
August 25, 2021
End Date
December 16, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hatice Özoymak Akçin

Principal Investigator MSc. Physiotherapist

Pamukkale University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pediatric Balance Scale (PBS)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • Six Minute Walk Test (6MWT)(eight weeks)
  • The Trunk Involvement Scale (TIS)(eight weeks)

Study Sites (1)

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