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Comparison of Three Treatment in Children With Cerebral Palsy

NCT ID: NCT06747078

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-25

Study Completion Date

2024-12-16

Brief Summary

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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

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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

Conditions

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Cerebral Palsy

Keywords

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balance Cerebral Palsy Core Stabilization Exercise Neurodevelopmental Therapy Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were divided into 3 groups. Group 1 (study group) received neurodevelopmental therapy (NDT) combined with core stabilization exercises (CSE). Group 2 (study group) received NDT combined with balance exercises (BE). The control group received only NDT
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Neurodevelopmental Therapy (NDT) + Core Stabilization Training

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Neurodevelopmental therapy + Balance Exercises

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Neurodevelopmental therapy

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Neurodevelopmental therapy

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

Intervention Type OTHER

Other Intervention Names

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NDT+CSE NDT+BE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Hatice Özoymak Akçin

Principal Investigator MSc. Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nılufer CETISLI-KORKMAZ, PT.PhD.Prof

Role: STUDY_DIRECTOR

Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A

Locations

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Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A

Denizli, Kınıklı, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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PAU-FTR-HÖA-01

Identifier Type: -

Identifier Source: org_study_id