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Circuit Training in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03529682
Recruitment Status : Unknown
Verified May 2018 by Ünal Aras Değer, Eastern Mediterranean University.
Recruitment status was:  Not yet recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Ünal Aras Değer, Eastern Mediterranean University

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.

Condition or disease Intervention/treatment Phase
Spastic Cerebral Palsy Other: exercise Other: control group Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Circuit Training on Lower Extremities Functionality and Postural Control in Children With Cerebral Palsy
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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.
Other: exercise
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 Name: circuit training

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.
Other: control group
60 mınutes in a day and 3 times in a week traditional physiotherapy program will be applied
Other Name: traditional physiotherapy




Primary Outcome Measures :
  1. Gross Motor Function will be evaluated [ Time Frame: Change from baseline GMFS at 10 weeks ]
    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


Secondary Outcome Measures :
  1. Functional muscular strength of the trunk and the lower extremities will be evaluated. [ Time Frame: Change from baseline Functional muscular strength at 10 weeks ]
    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.

  2. Isometric strength of bilateral lower extremity muscles and trunk muscles will be evaluated. [ Time Frame: Change from baseline isometric strength at 10 weeks ]
    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.

  3. Muscular tonus in lower extremities will be evaluated. [ Time Frame: Change from baseline muscular tonus at 10 weeks ]
    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.

  4. Walking speed and main mobility will be evaluated. [ Time Frame: Change from baseline walking speed and main mobility at 10 weeks ]
    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.

  5. Functional motor performance will be evaluated. [ Time Frame: Change from baseline functional motor performance at 10 weeks ]
    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.

  6. Satisfaction of children from the exercises will be evaluated. [ Time Frame: At 10 weeks. ]
    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.

  7. Activity and participation level will be evaluated. [ Time Frame: Change from baseline COPM at 10 weeks ]
    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.

  8. Quality of life will be evaluated. [ Time Frame: Change from baseline LQSC at 10 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529682


Contacts
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Contact: UNAL DEGER, MSc 05428532184 unal.deger@emu.edu.tr

Locations
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Cyprus
Eastern Mediterranean University
Famagusta, Cyprus, 99450
Contact: UNAL DEGER, MSc         
Sponsors and Collaborators
Eastern Mediterranean University
Investigators
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Principal Investigator: UNAL DEGER, MSc Eastern Mediterranean University
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Responsible Party: Ünal Aras Değer, Senior Instructor, Eastern Mediterranean University
ClinicalTrials.gov Identifier: NCT03529682    
Other Study ID Numbers: 2017/51-21
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ünal Aras Değer, Eastern Mediterranean University:
Circuit Exercise
Trunk Control
Functional Strength Training
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases