Comparison of Three Treatment in Children With Cerebral Palsy

Pamukkale University

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: Neurodevelopmental therapy + Balance Exercises; Other: Neurodevelopmental Therapy (NDT) + Core Stabilization Training; Other: Neurodevelopmental therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06747078

PAU-FTR-HÖA-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 36 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

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

Active Comparator group

Description:

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.

Treatment:

Other: Neurodevelopmental Therapy (NDT) + Core Stabilization Training

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

Active Comparator group

Description:

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.

Treatment:

Other: Neurodevelopmental therapy + Balance Exercises

Group 3: Neurodevelopmental treatment control group

Active Comparator group

Description:

Only neurodevelopmental treatment was applied for 60 minutes per day, 3 sessions per week, for 8 weeks, for a total of 24 sessions.

Treatment:

Other: Neurodevelopmental therapy