Effects of Modified Pilates Training on Hemodynamic Responses (cp)
Primary Purpose
Cerebral Palsy, Physical Inactivity, Gait Disorders in Children
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercises
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, modified pilates exercises, neurodevelopmental therapy, hemodynamic responses
Eligibility Criteria
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
Sites / Locations
- Hatice Adıgüzel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1/Children with cerebral palsy
2/children with cerebral palsy
Arm Description
Modified Pilates Exercises (MPEs) will be applied 3 days a week, 45 minutes a day for 8 weeks.
Traditional Neurodevelopmental Therapy (NGT-Bobath) approach will be applied for 45 minutes a day, 3 days a week for 8 weeks.
Outcomes
Primary Outcome Measures
6MWT
Six minute walk test (6MWT) distance will be recorded as meter.
The Observational Gait Scale (OGS)
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.
Sharman's core stability test (PBU=Pressure Biofeedback Unit Test)
TrAb muscle strength measurement Sharman's core stability test (PBU=Pressure Biofeedback Unit Test) will be recorded as mm Hg.
Modifiye Beiring Sorensen Test
core stabilitiy performance test of Modifiye Beiring Sorensen Test will be recorded as second (s).
Prone Plank Test
core stability performance test of Prone Plank Test will be recorded as second (s).
Side Plank Test
core stability performance test of Side Plank Test will be recorded as second (s).
Abdominal Fatigue Test
core stability performance test of Abdominal Fatigue Test will be recorded as second (s).
Sits Ups Test
Sits Ups Test will be recorded as second (s).
Push ups Test
core power tests of Push ups Test will be recorded as second (s).
blood pressure (BP)
Both systolic and diastolic blood pressure before and after the 6MWT will be measured and recorded as mmHg.
pulse (P)
pulse before and after the 6MWT will be recorded number.
respiratory rate (RR)
respiratory rate (RR) before and after the 6MWT will be recorded as number.
Secondary Outcome Measures
Expanded and revised Gross Motor Function Classification System (GMFCS-E&R)
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.
Modified Ashworth Scale (MAS)
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.
Full Information
NCT ID
NCT05221307
First Posted
January 5, 2022
Last Updated
August 16, 2022
Sponsor
Kahramanmaras Sutcu Imam University
1. Study Identification
Unique Protocol Identification Number
NCT05221307
Brief Title
Effects of Modified Pilates Training on Hemodynamic Responses
Acronym
cp
Official Title
Effects of Modified Pilates Training on Hemodynamic Responses in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder that starts in the early stages of life, causes activity limitation, and consists of movement and posture deficiencies. Children with CP usually have difficulties in mobility, transfer and social participation due to many motor and sensory disorders such as muscle weakness, decreased postural control, balance, spasticity. Core stability maintains posture and provides support for extremity movements by connecting with the deep abdominal muscles, spine, pelvis and shoulder girdle muscles. During reaching, walking and sudden perturbations in the body, the Transversus Abdominus (TrAb) muscle is activated primarily than other trunk and extremity muscles, creating a core stability. Core activity includes not only spinal stability and power generation, but also many upper and lower extremity movements. By focusing on the TrAb muscle with Pilates, the stabilization of the trunk muscles can be increased by creating control thanks to the core stabilization training. In addition, the TrAb muscle works together with the diaphragm muscle, which is the main respiratory muscle. The expected increased respiratory capacity with training may also affect hemodynamic responses.
Detailed Description
Children with CP usually have difficulties in mobility, transfer and social participation due to many motor and sensory disorders such as muscle weakness, decreased postural control, balance, spasticity. Abnormal motor patterns and tone, poor trunk control, and postural disorders adversely affect the physical development of these children. Children with CP show deficits in proximal muscle co-contraction and posture stabilization, which leads to limitations in postural reactions and antigravity movements. Dysfunctions are also observed in antisipatory and reactive postural adjustments, and limitations occur especially in upper extremity functions such as walking, reaching, and eating. Although these limitations associated with postural control dysfunctions are known, optimal intervention methods have not yet been determined. Because of these dysfunctions, many individuals with CP have difficulty walking independently, walking on slopes/uneven ground, and performing daily physical functions. Trunk control, which is formed by the activation of the core muscles, is the determinant of postural control, automatic postural reactions, balance, walking and functional activities from the early period.By focusing on the TrAb muscle with Pilates, the stabilization of the trunk muscles can be increased by creating control thanks to the core stabilization training. In addition, the TrAb muscle works together with the diaphragm muscle, which is the main respiratory muscle. The expected increased respiratory capacity with training may also affect hemodynamic responses. Proximal extremity muscles around the hip are also important for maintaining upright posture and maintaining mobility. Studies have shown that hip abductor muscle strength is more associated with gait variables and motor functions in children with CP compared to knee and ankle muscles. Although the importance of this in terms of gait has been determined, studies investigating the activation patterns of trunk and hip muscles during walking of individuals with CP are limited.For this reason, it is thought that pilates training can be applied in terms of muscle strength and postural control in selected individuals with CP who can walk, stand independently, but need to develop some components for controlled movement.Although there are a limited number of studies investigating the effects of modified pilates exercises (MPE) in individuals with CP in different clinical types, their effects on trunk control, core muscle endurance, hemodynamic responses and gait have not been investigated. It is known that most children with CP have significantly lower performance in cardiorespiratory and metabolic tests than their healthy peers.For many of these children, these mobility limitations associated with physical activity adversely affect musculoskeletal and cardiovascular function and increase the risk for secondary medical conditions. Therefore, viable, effective interventions are needed to improve the mobility and cardiorespiratory performance of children with CP. For example, bodyweight supported treadmill training has been used to address these children's walking and fitness goals. However, its routine use in smaller clinics, schools and home settings is often not feasible given the physical requirements associated with helping a child with significant weakness, spasticity or cardiovascular endurance deficiencies keep pace.For this purpose, it is noteworthy that the effects of MPE training targeting the TrAb muscle on gait and hemodynamic responses have not been investigated, especially in children with CP.This study aims to determine the effects of modified pilates exercises (MPE) and traditional neurodevelopmental therapy (NDT-Bobath) on hemodynamic responses in children with CP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Physical Inactivity, Gait Disorders in Children, Gait, Spastic
Keywords
Cerebral Palsy, modified pilates exercises, neurodevelopmental therapy, hemodynamic responses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention will be rehabilitation methods applied with different exercise trainings, Neurodevelopmental Therapy (NGT-Bobath) will be applied to one group and Modified Pilates Exercises (MPE) (non-invasive) will be applied to the other group.
Masking
Investigator
Masking Description
Treatments will be carried out by the same physiotherapist. Evaluations will be made twice, before and after the treatment. All assessments will be made by a different physician physiotherapist who is unfamiliar with the treatment groups. Individuals with CP in the study groups will continue with a blind physiotherapist experienced in pediatric rehabilitation who has completed the training in modified pilates, is certified by The Australian Physiotherapy Pilates Institute (APPI) and has NDT-Bobath certification.
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1/Children with cerebral palsy
Arm Type
Experimental
Arm Description
Modified Pilates Exercises (MPEs) will be applied 3 days a week, 45 minutes a day for 8 weeks.
Arm Title
2/children with cerebral palsy
Arm Type
Active Comparator
Arm Description
Traditional Neurodevelopmental Therapy (NGT-Bobath) approach will be applied for 45 minutes a day, 3 days a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
6MWT
Description
Six minute walk test (6MWT) distance will be recorded as meter.
Time Frame
the change of the 6MWT meter after 8 weeks
Title
The Observational Gait Scale (OGS)
Description
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.
Time Frame
change from baseline after 8 weeks
Title
Sharman's core stability test (PBU=Pressure Biofeedback Unit Test)
Description
TrAb muscle strength measurement Sharman's core stability test (PBU=Pressure Biofeedback Unit Test) will be recorded as mm Hg.
Time Frame
change from baseline after 8 weeks
Title
Modifiye Beiring Sorensen Test
Description
core stabilitiy performance test of Modifiye Beiring Sorensen Test will be recorded as second (s).
Time Frame
change from baseline after 8 weeks
Title
Prone Plank Test
Description
core stability performance test of Prone Plank Test will be recorded as second (s).
Time Frame
change from baseline after 8 weeks
Title
Side Plank Test
Description
core stability performance test of Side Plank Test will be recorded as second (s).
Time Frame
change from baseline after 8 weeks
Title
Abdominal Fatigue Test
Description
core stability performance test of Abdominal Fatigue Test will be recorded as second (s).
Time Frame
change from baseline after 8 weeks
Title
Sits Ups Test
Description
Sits Ups Test will be recorded as second (s).
Time Frame
change from baseline after 8 weeks
Title
Push ups Test
Description
core power tests of Push ups Test will be recorded as second (s).
Time Frame
change from baseline after 8 weeks
Title
blood pressure (BP)
Description
Both systolic and diastolic blood pressure before and after the 6MWT will be measured and recorded as mmHg.
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.
Title
pulse (P)
Description
pulse before and after the 6MWT will be recorded number.
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.
Title
respiratory rate (RR)
Description
respiratory rate (RR) before and after the 6MWT will be recorded as number.
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.
Secondary Outcome Measure Information:
Title
Expanded and revised Gross Motor Function Classification System (GMFCS-E&R)
Description
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.
Time Frame
first day of assessment
Title
Modified Ashworth Scale (MAS)
Description
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.
Time Frame
first day of assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hatice adıguzel, PhD
Organizational Affiliation
Kahramanmaras Sutcu Imam University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bulent Elbasan, Proffessor
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Hatice Adıgüzel
City
Kahramanmaras
ZIP/Postal Code
46100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Modified Pilates Training on Hemodynamic Responses
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