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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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