- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03529682
Circuit Training in Children With Cerebral Palsy
May 17, 2018 updated by: Ünal Aras Değer, Eastern Mediterranean University
The Effects of Circuit Training on Lower Extremities Functionality and Postural Control in Children With Cerebral Palsy
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: UNAL DEGER, MSc
- Phone Number: 05428532184
- Email: unal.deger@emu.edu.tr
Study Locations
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Famagusta, Cyprus, 99450
- Eastern Mediterranean University
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Contact:
- UNAL DEGER, MSc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Circuit Training Group
Circuit exercise training will be given to the experimental group participants during 10 weeks, 60 minutes in a day and 3 times a week.
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10 minutes warm-up exercises and stretching exercises, 40 mınutes consecutive exercises (strengthening exercises for trunk and lower extremities) and 10 mınutes cooling down exercises and stretching exercises will be applied.
Other Names:
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Other: Control Group
The control group participants will continue to their own previous physiotherapy approaches as the same as minimum 3 times a week and total 3 hours.
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60 mınutes in a day and 3 times in a week traditional physiotherapy program will be applied
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gross Motor Function will be evaluated
Time Frame: Change from baseline GMFS at 10 weeks
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As for the Gross Motor Function evaluation, the Gross Motor Function Scale (GMFS) will be used and only its D and E sections (standing, walking, running, jumping evaluation parts) will be used.
By considering the instructions in to be tested parts in the scale, the case is expected to do the motor functions actively.
Without the consideration of the quality of the movement, the case will be observed whether s/he started, was able to continue and completed the movement as well as whether s/he needed any support so that points between 0-3 will be given according to the level.
The obtained total score determines the interaction severity of gross motor function
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Change from baseline GMFS at 10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional muscular strength of the trunk and the lower extremities will be evaluated.
Time Frame: Change from baseline Functional muscular strength at 10 weeks
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In order to determine the functional muscular strength of the body and the lower extremities, the step number will be recorded by taking straight step to the stair test and taking side step to the stair test in 15 seconds.
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Change from baseline Functional muscular strength at 10 weeks
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Isometric strength of bilateral lower extremity muscles and trunk muscles will be evaluated.
Time Frame: Change from baseline isometric strength at 10 weeks
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For the evaluation of isometric strength of bilateral lower extremity muscles and body muscles, a hand held dynamometer will be used which is in standard positions and independent from the gravity and the obtained measurement will be recorded by adjusting it to the body weight.
The strength obtained by isometric contraction and by equipment resistance applied on key chosen muscles, will be recorded as a numerical value.
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Change from baseline isometric strength at 10 weeks
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Muscular tonus in lower extremities will be evaluated.
Time Frame: Change from baseline muscular tonus at 10 weeks
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The muscular tonus in lower extremities will be evaluated as bilateral by Modified Ashworth Scale (MAS).
The joint will be moved passively, fast and reverse to the muscular functions that will be tested in this scale -which is used for the determination of spasticity severity.
According to the resistivity occurred, scoring is done between 0-4 points.
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Change from baseline muscular tonus at 10 weeks
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Walking speed and main mobility will be evaluated.
Time Frame: Change from baseline walking speed and main mobility at 10 weeks
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For the determination of walking speed and main mobility; timed up and go (TUG) test will be used.
3 meter walking distance will be recorded.
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Change from baseline walking speed and main mobility at 10 weeks
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Functional motor performance will be evaluated.
Time Frame: Change from baseline functional motor performance at 10 weeks
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For the determination of functional motor performance; sitting and getting up test of Motor Assessment Scale will be used.
Without a back and arm support, the chair sitting and getting up number in 1 minute will be recorded.
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Change from baseline functional motor performance at 10 weeks
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Satisfaction of children from the exercises will be evaluated.
Time Frame: At 10 weeks.
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For the measurement of satisfaction of children from the exercises to be applied, Physical Activity Enjoyment Scale (PACES) will be used.
The children will be asked to mark the numbers suitable for themselves after reading child items in the 5 likert point scale.
The points taken on the scale, change between 5 and 25.
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At 10 weeks.
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Activity and participation level will be evaluated.
Time Frame: Change from baseline COPM at 10 weeks
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Canadian Occupational Performance Test (COPM) will be used in order to evaluate activity and participation level.
COPM is an interview based method and the participant is asked to express the daily activities they needed, desired and they are not able to do.
They are asked to express these activities under 3 headlines (self care activities, productivity and free time activities) and they are asked to determine these according to the priority for themselves.
The first desire/problem is 10 points, and last is 1 point.
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Change from baseline COPM at 10 weeks
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Quality of life will be evaluated.
Time Frame: Change from baseline LQSC at 10 weeks
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For the evaluation of life quality; Life Quality Scale for Children (LQSC) will be used (PedsQL) (5-7 age SP family reported model,5-7 age SP model, 8-12 age SP model, 13-18 age SP model).
23 questions will be used for the case which consists of 0-4 points and Working/Job Functions, Social, Physical and Emotional Functions in the last one month.
The obtained point gives information about the life quality
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Change from baseline LQSC at 10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Unal Deger, MSc, Eastern Mediterranean University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2018
Primary Completion (Anticipated)
August 1, 2018
Study Completion (Anticipated)
November 1, 2018
Study Registration Dates
First Submitted
May 3, 2018
First Submitted That Met QC Criteria
May 17, 2018
First Posted (Actual)
May 18, 2018
Study Record Updates
Last Update Posted (Actual)
May 18, 2018
Last Update Submitted That Met QC Criteria
May 17, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/51-21
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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