Effects of Modified Pilates Training on Hemodynamic Responses (cp)
Effects of Modified Pilates Training on Hemodynamic Responses in Children With Cerebral Palsy
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kahramanmaras, Turkey, 46100
- Hatice Adıgüzel
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with CP according to Surveillence Of Cerebral Palsy İn Europe (SCPE) criteria
- Can be classified as level I, II or III by GMFCS-E&R [29]
- Children 7-14 years old
- Able to stand up from sitting and walk with or without mobility devices
- No limitation in range of motion in lower extremities and trunk
- Lower extremity spasticity between 1 and 1+ according to the Modified Ashworth (MASH) score
- Individuals with hemiparetic-diparetic CP who can follow verbal commands
Exclusion Criteria:
- Multiple disabilities (hearing, speaking, seeing)
- Congenital cardiorespiratory problem
- Known additional cardiorespiratory disease (asthma, chronic bronchitis, etc.)
- Have taken any special pilates training in the last 6 months
- Not having had any botox/surgery with the lower extremity in the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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EXPERIMENTAL: 1/Children with cerebral palsy
Modified Pilates Exercises (MPEs) will be applied 3 days a week, 45 minutes a day for 8 weeks.
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Group 1 will be given MPEs for 45 minutes, 3 days a week for 8 weeks.
In the second group, traditional Neurodevelopmental Treatment (NGT-Bobath) approach will be applied for 45 minutes a day, 3 days a week for 8 weeks.
Treatments will be carried out by the same physiotherapist.
Evaluations will be made twice, before and after the treatment.
|
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ACTIVE_COMPARATOR: 2/children with cerebral palsy
Traditional Neurodevelopmental Therapy (NGT-Bobath) approach will be applied for 45 minutes a day, 3 days a week for 8 weeks.
|
Group 1 will be given MPEs for 45 minutes, 3 days a week for 8 weeks.
In the second group, traditional Neurodevelopmental Treatment (NGT-Bobath) approach will be applied for 45 minutes a day, 3 days a week for 8 weeks.
Treatments will be carried out by the same physiotherapist.
Evaluations will be made twice, before and after the treatment.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6MWT
Time Frame: the change of the 6MWT meter after 8 weeks
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Six minute walk test (6MWT) distance will be recorded as meter.
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the change of the 6MWT meter after 8 weeks
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The Observational Gait Scale (OGS)
Time Frame: change from baseline after 8 weeks
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The Observational Gait Scale was created by developing and modifying the measurement sensitivity of the Physician Rating Scale (PRS).
OGS consists of knee position in the middle of the stance phase, first foot contact, foot contact in the middle of the stance phase, time of heel lift, rear foot position in the middle of the stance phase, and support area width.
Each leg is evaluated separately and a person with normal gait can get a maximum of 22 points.
Higher score indicates better performance.
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change from baseline after 8 weeks
|
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Sharman's core stability test (PBU=Pressure Biofeedback Unit Test)
Time Frame: change from baseline after 8 weeks
|
TrAb muscle strength measurement Sharman's core stability test (PBU=Pressure Biofeedback Unit Test) will be recorded as mm Hg.
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change from baseline after 8 weeks
|
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Modifiye Beiring Sorensen Test
Time Frame: change from baseline after 8 weeks
|
core stabilitiy performance test of Modifiye Beiring Sorensen Test will be recorded as second (s).
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change from baseline after 8 weeks
|
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Prone Plank Test
Time Frame: change from baseline after 8 weeks
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core stability performance test of Prone Plank Test will be recorded as second (s).
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change from baseline after 8 weeks
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Side Plank Test
Time Frame: change from baseline after 8 weeks
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core stability performance test of Side Plank Test will be recorded as second (s).
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change from baseline after 8 weeks
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Abdominal Fatigue Test
Time Frame: change from baseline after 8 weeks
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core stability performance test of Abdominal Fatigue Test will be recorded as second (s).
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change from baseline after 8 weeks
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Sits Ups Test
Time Frame: change from baseline after 8 weeks
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Sits Ups Test will be recorded as second (s).
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change from baseline after 8 weeks
|
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Push ups Test
Time Frame: change from baseline after 8 weeks
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core power tests of Push ups Test will be recorded as second (s).
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change from baseline after 8 weeks
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blood pressure (BP)
Time Frame: change of the blood pressure before and after 6MWT on the first day of intervention and after the 8 weeks intervention before and after the 6MWT.
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Both systolic and diastolic blood pressure before and after the 6MWT will be measured and recorded as mmHg.
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change of the blood pressure before and after 6MWT on the first day of intervention and after the 8 weeks intervention before and after the 6MWT.
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pulse (P)
Time Frame: change of the pulse before and after 6MWT on the first day of intervention and after the 8 weeks intervention before and after 6MWT.
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pulse before and after the 6MWT will be recorded number.
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change of the pulse before and after 6MWT on the first day of intervention and after the 8 weeks intervention before and after 6MWT.
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respiratory rate (RR)
Time Frame: hange of the respiratory rate (RR) before and after 6MWT on the first day of intervention and after the 8 weeks intervention before and after 6MWT.
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respiratory rate (RR) before and after the 6MWT will be recorded as number.
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hange of the respiratory rate (RR) before and after 6MWT on the first day of intervention and after the 8 weeks intervention before and after 6MWT.
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Expanded and revised Gross Motor Function Classification System (GMFCS-E&R)
Time Frame: first day of assessment
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It is a standard classification system used to classify gross motor functions of children with CP.
GMFCS-E&R classifies levels I to V. Level I indicates the best and V the worst level of motor function.
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first day of assessment
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Modified Ashworth Scale (MAS)
Time Frame: first day of assessment
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Lower extremity muscle spasticity will be measured.
MAS is a method used to determine the severity of spasticity.
It is based on the subjective rating of the resistance felt during the examination.
The tone felt in these muscles against passive movement is classified as follows; 0: No increase in tone, 1: Slight increase in tone characterized by catching and relaxation or mild resistance at the end of the ROM, 1+: Slight increase in tone characterized by minimal resistance in the remaining ROM (less than half) after capture, 2: Significant tone over most of the ROM increase, but the involved joint can be moved easily, 3: Significant increase in muscle tone, passive movement is difficult, 4: The involved part is rigid in flexion or extension.
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first day of assessment
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- KSU4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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