Clinical trial NCT06747078: Comparison of Three Treatment in Children With Cerebral Palsy
Official title: The Effect of Core and Balance Exercises on Gait, Balance and Quality Of Life in Children With Cerebral Palsy: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: balance
Cerebral Palsy
Core Stabilization Exercise
Neurodevelopmental Therapy
Quality of life
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 36
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Pediatric Balance Scale (PBS)
timeFrame: eight weeks
measure: SportKat550 Kinesthetic Ability Trainer (SportKAT 550)
timeFrame: eight weeks
measure: Pediatric Outcome Data Collection Instrument (PODCI)
timeFrame: eight weeks
Secondary outcomes:
measure: Six Minute Walk Test (6MWT)
timeFrame: eight weeks
measure: The Trunk Involvement Scale (TIS)
timeFrame: eight weeks
Other outcomes:
measure: Gross Motor Function Classification System (GMFSS)
timeFrame: at the beginning of the study
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A
state: Kınıklı
Study officials:
affiliation: Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A
name: Nılufer CETISLI-KORKMAZ, PT.PhD.Prof
role: STUDY_DIRECTOR
References: