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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03529682
Date of registration: 03/05/2018
Prospective Registration: No
Primary sponsor: Eastern Mediterranean University
Public title: Circuit Training in Children With Cerebral Palsy
Scientific title: The Effects of Circuit Training on Lower Extremities Functionality and Postural Control in Children With Cerebral Palsy
Date of first enrolment: May 2018
Target sample size: 62
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT03529682
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Cyprus
Contacts
Name:     UNAL DEGER, MSc
Address: 
Telephone:
Email:
Affiliation: 
Name:     UNAL DEGER, MSc
Address: 
Telephone:
Email:
Affiliation:  Eastern Mediterranean University
Name:     UNAL DEGER, MSc
Address: 
Telephone: 05428532184
Email: unal.deger@emu.edu.tr
Affiliation: 
Key inclusion & exclusion 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 continuously attend the exercise program,

- mental problem that could not be cooperated.



Age minimum: 6 Years
Age maximum: 18 Years
Gender: All
Health Condition(s) or Problem(s) studied
Spastic Cerebral Palsy
Intervention(s)
Other: control group
Other: exercise
Primary Outcome(s)
Gross Motor Function will be evaluated [Time Frame: Change from baseline GMFS at 10 weeks]
Secondary Outcome(s)
Activity and participation level will be evaluated. [Time Frame: Change from baseline COPM at 10 weeks]
Satisfaction of children from the exercises will be evaluated. [Time Frame: At 10 weeks.]
Isometric strength of bilateral lower extremity muscles and trunk muscles will be evaluated. [Time Frame: Change from baseline isometric strength at 10 weeks]
Muscular tonus in lower extremities will be evaluated. [Time Frame: Change from baseline muscular tonus at 10 weeks]
Quality of life will be evaluated. [Time Frame: Change from baseline LQSC at 10 weeks]
Functional motor performance will be evaluated. [Time Frame: Change from baseline functional motor performance at 10 weeks]
Functional muscular strength of the trunk and the lower extremities will be evaluated. [Time Frame: Change from baseline Functional muscular strength at 10 weeks]
Walking speed and main mobility will be evaluated. [Time Frame: Change from baseline walking speed and main mobility at 10 weeks]
Secondary ID(s)
2017/51-21
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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