Clinical trial NCT05221307: Effects of Modified Pilates Training on Hemodynamic Responses
Official title: Effects of Modified Pilates Training on Hemodynamic Responses in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Physical Inactivity
Gait Disorders in Children
Gait, Spastic
Keywords: Cerebral Palsy
modified pilates exercises
neurodevelopmental therapy
hemodynamic responses
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 18
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 6MWT
timeFrame: the change of the 6MWT meter after 8 weeks
measure: The Observational Gait Scale (OGS)
timeFrame: change from baseline after 8 weeks
measure: Sharman's core stability test (PBU=Pressure Biofeedback Unit Test)
timeFrame: change from baseline after 8 weeks
measure: Modifiye Beiring Sorensen Test
timeFrame: change from baseline after 8 weeks
measure: Prone Plank Test
timeFrame: change from baseline after 8 weeks
measure: Side Plank Test
timeFrame: change from baseline after 8 weeks
measure: Abdominal Fatigue Test
timeFrame: change from baseline after 8 weeks
measure: Sits Ups Test
timeFrame: change from baseline after 8 weeks
measure: Push ups Test
timeFrame: change from baseline after 8 weeks
measure: blood pressure (BP)
timeFrame: 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.
measure: pulse (P)
timeFrame: change of the pulse before and after 6MWT on the first day of intervention and after the 8 weeks intervention before and after 6MWT.
measure: respiratory rate (RR)
timeFrame: 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:
measure: Expanded and revised Gross Motor Function Classification System (GMFCS-E&R)
timeFrame: first day of assessment
measure: Modified Ashworth Scale (MAS)
timeFrame: first day of assessment
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Hatice Adıgüzel
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: hatice adıguzel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Bulent Elbasan, Proffessor
role: STUDY_DIRECTOR
References: