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Circuit Training in Children With Cerebral Palsy

Primary Purpose

Spastic Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
exercise
control group
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Circuit Exercise, Trunk Control, Functional Strength Training

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eastern Mediterranean University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Circuit Training Group

Control Group

Arm Description

Circuit exercise training will be given to the experimental group participants during 10 weeks, 60 minutes in a day and 3 times a week.

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.

Outcomes

Primary Outcome Measures

Gross Motor Function will be evaluated
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

Functional muscular strength of the trunk and the lower extremities will be evaluated.
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.
Isometric strength of bilateral lower extremity muscles and trunk muscles will be evaluated.
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.
Muscular tonus in lower extremities will be evaluated.
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.
Walking speed and main mobility will be evaluated.
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.
Functional motor performance will be evaluated.
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.
Satisfaction of children from the exercises will be evaluated.
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.
Activity and participation level will be evaluated.
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.
Quality of life will be evaluated.
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

Full Information

First Posted
May 3, 2018
Last Updated
May 17, 2018
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT03529682
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2018 (Anticipated)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
Keywords
Circuit Exercise, Trunk Control, Functional Strength Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Circuit Training Group
Arm Type
Experimental
Arm Description
Circuit exercise training will be given to the experimental group participants during 10 weeks, 60 minutes in a day and 3 times a week.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
exercise
Other Intervention Name(s)
circuit training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control group
Other Intervention Name(s)
traditional physiotherapy
Intervention Description
60 mınutes in a day and 3 times in a week traditional physiotherapy program will be applied
Primary Outcome Measure Information:
Title
Gross Motor Function will be evaluated
Description
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
Time Frame
Change from baseline GMFS at 10 weeks
Secondary Outcome Measure Information:
Title
Functional muscular strength of the trunk and the lower extremities will be evaluated.
Description
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.
Time Frame
Change from baseline Functional muscular strength at 10 weeks
Title
Isometric strength of bilateral lower extremity muscles and trunk muscles will be evaluated.
Description
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.
Time Frame
Change from baseline isometric strength at 10 weeks
Title
Muscular tonus in lower extremities will be evaluated.
Description
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.
Time Frame
Change from baseline muscular tonus at 10 weeks
Title
Walking speed and main mobility will be evaluated.
Description
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.
Time Frame
Change from baseline walking speed and main mobility at 10 weeks
Title
Functional motor performance will be evaluated.
Description
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.
Time Frame
Change from baseline functional motor performance at 10 weeks
Title
Satisfaction of children from the exercises will be evaluated.
Description
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.
Time Frame
At 10 weeks.
Title
Activity and participation level will be evaluated.
Description
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.
Time Frame
Change from baseline COPM at 10 weeks
Title
Quality of life will be evaluated.
Description
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
Time Frame
Change from baseline LQSC at 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UNAL DEGER, MSc
Phone
05428532184
Email
unal.deger@emu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UNAL DEGER, MSc
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
ZIP/Postal Code
99450
Country
Cyprus
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UNAL DEGER, MSc

12. IPD Sharing Statement

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Circuit Training in Children With Cerebral Palsy

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