Comparison of Three Treatment in Children With Cerebral Palsy

NCT06747078 | Completed DMC

• 1 other identifier: PAU-FTR-HÖA-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

balance; Cerebral Palsy; Core Stabilization Exercise; Neurodevelopmental Therapy; Quality of life

Outcome Measures

Primary Outcomes (3)

• Pediatric Balance Scale (PBS)

  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)

  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)

  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 Outcomes (2)

• Six Minute Walk Test (6MWT)

  eight weeks

• The Trunk Involvement Scale (TIS)

  eight weeks

Other Outcomes (1)

• Gross Motor Function Classification System (GMFSS)

  at the beginning of the study

Study Arms (3)

Group 1 (study group): Neurodevelopmental therapy (NDT) combined with core stabilization exercises (

ACTIVE COMPARATOR

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

Group 2 (study group) neurodevelopmental treatment combined with balance exercises

ACTIVE COMPARATOR

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

Group 3: Neurodevelopmental treatment control group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: NDT+CSE

Group 1 (study group): Neurodevelopmental therapy (NDT) combined with core stabilization exercises (

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.

Also known as: NDT+BE

Group 2 (study group) neurodevelopmental treatment combined with balance exercises

Neurodevelopmental therapy OTHER

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

Group 3: Neurodevelopmental treatment control group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cases between the ages of 7-18
• Cases with GMFCS level I and II
• Cases diagnosed with hemiparetic and diparetic CP

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A

Denizli, Kınıklı, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nılufer CETISLI-KORKMAZ, PT.PhD.Prof

  Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator MSc. Physiotherapist

Model Details: 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

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: August 25, 2021
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)