Cerebral PalsycpNCT05221307
Effects of Modified Pilates Training on Hemodynamic Responses
A study testing exercises in people with Cerebral Palsy and Physical Inactivity, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Cerebral Palsy, Physical Inactivity, Gait Disorders in Children
- What is being tested?
- exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 30 Jul 2022
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Modified Pilates Training on Hemodynamic Responses in Children With Cerebral Palsy
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.
Read the 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.
- Being tested
- exercises
- Keywords
- Cerebral Palsy, modified pilates exercises, neurodevelopmental therapy, hemodynamic responses
- Medical subject headings
- Cerebral Palsy, Sedentary Behavior, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1/Children with cerebral palsy | Experimental | Modified Pilates Exercises (MPEs) will be applied 3 days a week, 45 minutes a day for 8 weeks. Receives: Other: exercises |
| 2/children with cerebral palsy | Active comparator | Traditional Neurodevelopmental Therapy (NGT-Bobath) approach will be applied for 45 minutes a day, 3 days a week for 8 weeks. Receives: Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWT
Six minute walk test (6MWT) distance will be recorded as meter.
Measured: the change of the 6MWT meter after 8 weeks
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.
Measured: change from baseline after 8 weeks
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.
Measured: change from baseline after 8 weeks
Modifiye Beiring Sorensen Test
core stabilitiy performance test of Modifiye Beiring Sorensen Test will be recorded as second (s).
Measured: change from baseline after 8 weeks
Prone Plank Test
core stability performance test of Prone Plank Test will be recorded as second (s).
Measured: change from baseline after 8 weeks
Side Plank Test
core stability performance test of Side Plank Test will be recorded as second (s).
Measured: change from baseline after 8 weeks
Abdominal Fatigue Test
core stability performance test of Abdominal Fatigue Test will be recorded as second (s).
Measured: change from baseline after 8 weeks
Sits Ups Test
Sits Ups Test will be recorded as second (s).
Measured: change from baseline after 8 weeks
Push ups Test
core power tests of Push ups Test will be recorded as second (s).
Measured: change from baseline after 8 weeks
blood pressure (BP)
Both systolic and diastolic blood pressure before and after the 6MWT will be measured and recorded as mmHg.
Measured: 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.
pulse (P)
pulse before and after the 6MWT will be recorded number.
Measured: change of the pulse before and after 6MWT on the first day of intervention and after the 8 weeks intervention before and after 6MWT.
respiratory rate (RR)
respiratory rate (RR) before and after the 6MWT will be recorded as number.
Measured: 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 outcomes (2)
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.
Measured: first day of assessment
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.
Measured: first day of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start15 May 2022
- Primary completion15 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
- Investigators
- hatice adıguzel, PhD, Principal investigator, Kahramanmaras Sutcu Imam UniversityBulent Elbasan, Proffessor, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221307
- Sponsor's protocol ID
- KSU4
- Acronym
- cp
- Status last verified
- Aug 2022
- First submitted
- 5 Jan 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified Pilates Training on Hemodynamic Responses in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05221307
- Acronym / sponsor ID
- cp / KSU4
- Keywords
- Cerebral Palsy, modified pilates exercises, neurodevelopmental therapy, hemodynamic responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 2 Feb 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1/Children with cerebral palsy | Experimental | Other: exercisesModified Pilates Exercises (MPEs) will be applied 3 days a week, 45 minutes a day for 8 weeks. |
| 2/children with cerebral palsy | Active comparator | Other: exercisesTraditional Neurodevelopmental Therapy (NGT-Bobath) approach will be applied for 45 minutes a day, 3 days a week for 8 weeks. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| exercisesGroup 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. | Other | 1/Children with cerebral palsy, 2/children with cerebral palsy |
Primary outcome
6MWT
Time frame: the change of the 6MWT meter after 8 weeks
Six minute walk test (6MWT) distance will be recorded as meter.
The Observational Gait Scale (OGS)
Time frame: change from baseline after 8 weeks
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)
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.
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).
Prone Plank Test
Time frame: change from baseline after 8 weeks
core stability performance test of Prone Plank Test will be recorded as second (s).
Side Plank Test
Time frame: change from baseline after 8 weeks
core stability performance test of Side Plank Test will be recorded as second (s).
Abdominal Fatigue Test
Time frame: change from baseline after 8 weeks
core stability performance test of Abdominal Fatigue Test will be recorded as second (s).
Sits Ups Test
Time frame: change from baseline after 8 weeks
Sits Ups Test will be recorded as second (s).
Push ups Test
Time frame: change from baseline after 8 weeks
core power tests of Push ups Test will be recorded as second (s).
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.
Both systolic and diastolic blood pressure before and after the 6MWT will be measured and recorded as mmHg.
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.
pulse before and after the 6MWT will be recorded number.
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.
respiratory rate (RR) before and after the 6MWT will be recorded as number.
2 secondary outcomes
Expanded and revised Gross Motor Function Classification System (GMFCS-E&R)
Time frame: first day of assessment
Modified Ashworth Scale (MAS)
Time frame: first day of assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: No
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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.
hatice adıguzel, PhD principal investigator
Kahramanmaras Sutcu Imam University
Bulent Elbasan, Proffessor study director
Gazi 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 exercises in people with Cerebral Palsy and Physical Inactivity, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 18 Aug 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWT (time frame: the change of the 6MWT meter after 8 weeks). The study lists 12 primary outcomes in all. 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 Aug 2022.