Spastic Cerebral PalsyNCT03529682
Circuit Training in Children With Cerebral Palsy
A study testing exercise in people with Spastic Cerebral Palsy, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCyprus
- Study dates
- May 2018to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Spastic Cerebral Palsy
- Being tested
- exercise, control group
- Keywords
- Circuit Exercise, Trunk Control, Functional Strength Training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Also called circuit training
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.
control groupOther
Also called traditional physiotherapy
60 mınutes in a day and 3 times in a week traditional physiotherapy program will be applied
| Study group | Role | What they receive |
|---|---|---|
| Circuit Training Group | Experimental | Circuit exercise training will be given to the experimental group participants during 10 weeks, 60 minutes in a day and 3 times a week. Receives: Other: exercise |
| Control Group | Other | 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. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline GMFS at 10 weeks
Secondary outcomes (8)
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.
Measured: Change from baseline Functional muscular strength at 10 weeks
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.
Measured: Change from baseline isometric strength at 10 weeks
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.
Measured: Change from baseline muscular tonus at 10 weeks
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.
Measured: Change from baseline walking speed and main mobility at 10 weeks
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.
Measured: Change from baseline functional motor performance at 10 weeks
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.
Measured: At 10 weeks.
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.
Measured: Change from baseline COPM at 10 weeks
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
Measured: Change from baseline LQSC at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study startMay 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ünal Aras Değer, Eastern Mediterranean University
- Investigators
- UNAL DEGER, MSc, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529682
- Sponsor's protocol ID
- 2017/51-21
- Status last verified
- May 2018
- First submitted
- 3 May 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Circuit Training on Lower Extremities Functionality and Postural Control in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03529682
- Acronym / sponsor ID
- 2017/51-21
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Circuit Exercise, Trunk Control, Functional Strength Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circuit Training Group | Experimental | Other: exerciseCircuit exercise training will be given to the experimental group participants during 10 weeks, 60 minutes in a day and 3 times a week. |
| Control Group | Other | Other: control groupThe control group participants will continue to their own previous physiotherapy approaches as the same as minimum 3 times a week and total 3 hours. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseAlso: circuit training10 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 | Circuit Training Group |
| control groupAlso: traditional physiotherapy60 mınutes in a day and 3 times in a week traditional physiotherapy program will be applied | Other | Control Group |
Primary outcome
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
8 secondary outcomes
Functional muscular strength of the trunk and the lower extremities will be evaluated.
Time frame: Change from baseline Functional muscular strength 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
Walking speed and main mobility will be evaluated.
Time frame: Change from baseline walking speed and main mobility at 10 weeks
Functional motor performance will be evaluated.
Time frame: Change from baseline functional motor performance at 10 weeks
Satisfaction of children from the exercises will be evaluated.
Time frame: At 10 weeks.
Activity and participation level will be evaluated.
Time frame: Change from baseline COPM at 10 weeks
Quality of life will be evaluated.
Time frame: Change from baseline LQSC at 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UNAL DEGER, MSc principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Spastic Cerebral Palsy, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact UNAL DEGER, MSc (05428532184, unal.deger@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function will be evaluated (time frame: Change from baseline GMFS at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.