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Completed

NCT Number: NCT06747078

Comparison of Three Treatment in Children With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A

Denizli, Kınıklı, 20070, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurodevelopmental Therapy (NDT) + Core Stabilization Training

Other

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

Neurodevelopmental therapy + Balance Exercises

Other

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

Neurodevelopmental therapy

Other

NDT was applied for 60 minutes per day, 3 sessions per week, for 8 weeks and a total of 24 sessions.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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