Clinical trial NCT03529682: Circuit Training in Children With Cerebral Palsy
Official title: The Effects of Circuit Training on Lower Extremities Functionality and Postural Control in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spastic Cerebral Palsy
Keywords: Circuit Exercise
Trunk Control
Functional Strength Training
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to reveal the results of circuit training to be applied to the children with Cerebral Palsy (CP) for improving their muscular strength and trunk control and also to determine their effects in terms of activity limitations and participation limits.

Detailed description: According the power analyzes totally 62 children, as 31 per each group, who were diagnosed with Spastic type CP and accepting participation for the study will be included in this study. For every case, socio demographic data and clinical features will be recorded. In the first session their gross motor function, muscular tonus in lower extremities, isometric strength of lower extremity muscles, functional muscular strength of the trunk and the lower extremities, walking speed and main mobility, functional motor performance will be assessed by a physiotherapist. Also satisfaction of children from the exercises, activity and participation level and quality of life will be evaluated. Then Covariant Focused Randomization Method will be used for having similarity in terms of factors such as; age, gender and motor function levels and also for having a balanced and equal case number of control and intervention group. The control group participants will continue to their own previous physiotherapy approaches (Bobath approach, traditional physiotherapy, etc.). "Circuit exercise training" will be given to the intervention group participants during 10 weeks, 3 times a week and that changes 50-60 minutes. At the end of the 10 weeks, the above evaluation parameters will be repeated

Eligibility criteria: Inclusion Criteria:

* The children who were diagnosed with Spastic type Cerebral Palsy.
* is aged between 6-18,
* is on the I,II and III levels according to Gross Motor Function Classification System

Exclusion Criteria:

* having any surgical operation related to lower extremities for the last 1 year,
* having botulinum toxin injection or intrathecal pump for the last 6 months,
* taking a new medicine or medicine change for the last 1 month,
* visual, hearing and epilepsy problem,
* inability to contınuously attend the exercise program,
* mental problem that could not be cooperated.

Primary outcomes:
measure: Gross Motor Function will be evaluated
timeFrame: Change from baseline GMFS at 10 weeks
Secondary outcomes:
measure: Functional muscular strength of the trunk and the lower extremities will be evaluated.
timeFrame: Change from baseline Functional muscular strength at 10 weeks
measure: Isometric strength of bilateral lower extremity muscles and trunk muscles will be evaluated.
timeFrame: Change from baseline isometric strength at 10 weeks
measure: Muscular tonus in lower extremities will be evaluated.
timeFrame: Change from baseline muscular tonus at 10 weeks
measure: Walking speed and main mobility will be evaluated.
timeFrame: Change from baseline walking speed and main mobility at 10 weeks
measure: Functional motor performance will be evaluated.
timeFrame: Change from baseline functional motor performance at 10 weeks
measure: Satisfaction of children from the exercises will be evaluated.
timeFrame: At 10 weeks.
measure: Activity and participation level will be evaluated.
timeFrame: Change from baseline COPM at 10 weeks
measure: Quality of life will be evaluated.
timeFrame: Change from baseline LQSC at 10 weeks
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
affiliation: Eastern Mediterranean University
name: UNAL DEGER, MSc
role: PRINCIPAL_INVESTIGATOR
References: