Comparison of Three Treatment in Children With Cerebral Palsy

December 21, 2024 updated by: Hatice Özoymak Akçin, Pamukkale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kınıklı
      • Denizli, Kınıklı, Turkey, 20070
        • Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 (study group): Neurodevelopmental therapy (NDT) combined with core stabilization exercises (
In addition to neurodevelopmental treatment, which is 30 minutes per day, 3 sessions per week and 24 sessions in total, core stabilization training was applied 3 sessions per week for 8 weeks and 24 sessions in total. The core stabilization training session lasted 30 minutes.
Other: Neurodevelopmental Therapy (NDT) + Core Stabilization Training
In addition to the neurodevelopmental treatment of 30 minutes per day, 3 sessions per week, and a total of 24 sessions, core stabilization training was applied 3 sessions per week for 8 weeks and a total of 24 sessions. The core stabilization training session lasted 30 minutes.
Other Names:
  • NDT+CSE
Active Comparator: Group 2 (study group) neurodevelopmental treatment combined with balance exercises
In addition to the neurodevelopmental treatment of 30 minutes per day, 3 sessions per week, and a total of 24 sessions, balance training was applied 3 sessions per week for 8 weeks and a total of 24 sessions. The balance training session lasted 30 minutes.
Other: Neurodevelopmental therapy + Balance Exercises
In addition to NDT, which is 30 minutes per day, 3 sessions per week and 24 sessions in total, balance training was applied 3 sessions per week for 8 weeks and 24 sessions in total. The balance exercise session lasted 30 minutes.
Other Names:
  • NDT+BE
Active Comparator: Group 3: Neurodevelopmental treatment control group
Only neurodevelopmental treatment was applied for 60 minutes per day, 3 sessions per week, for 8 weeks, for a total of 24 sessions.
Other: Neurodevelopmental therapy
NDT was applied for 60 minutes per day, 3 sessions per week, for 8 weeks and a total of 24 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
eight weeks
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.
eight weeks
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.
eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six Minute Walk Test (6MWT)
Time Frame: 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.
eight weeks
The Trunk Involvement Scale (TIS)
Time Frame: 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.
eight weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Classification System (GMFSS)
Time Frame: at the beginning of the study
In our study, GMFCS was used to determine the gross motor functions of the subjects. This classification system is based on the movements initiated by the child by looking at sitting, moving and mobility. It consists of a five-level classification system.Level 1 and Level 2 children were included in the study
at the beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Study Director: Nılufer CETISLI-KORKMAZ, PT.PhD.Prof, Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Actual)

December 16, 2024

Study Completion (Actual)

December 16, 2024

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 21, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAU-FTR-HÖA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on Neurodevelopmental Therapy (NDT) + Core Stabilization Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe