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临床试验/NCT05221307
NCT05221307已完成不适用

Effects of Modified Pilates Training on Hemodynamic Responses in Children With Cerebral Palsy

Kahramanmaras Sutcu Imam University2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
6MWT

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

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.

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • xclusion 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

结局指标

主要结局

6MWT

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: change from baseline after 8 weeks

core stabilitiy performance test of Modifiye Beiring Sorensen Test will be recorded as second (s).

Prone Plank Test

时间窗: change from baseline after 8 weeks

core stability performance test of Prone Plank Test will be recorded as second (s).

Side Plank Test

时间窗: change from baseline after 8 weeks

core stability performance test of Side Plank Test will be recorded as second (s).

Abdominal Fatigue Test

时间窗: change from baseline after 8 weeks

core stability performance test of Abdominal Fatigue Test will be recorded as second (s).

Sits Ups Test

时间窗: change from baseline after 8 weeks

Sits Ups Test will be recorded as second (s).

Push ups Test

时间窗: change from baseline after 8 weeks

core power tests of Push ups Test will be recorded as second (s).

blood pressure (BP)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • Expanded and revised Gross Motor Function Classification System (GMFCS-E&R)(first day of assessment)
  • Modified Ashworth Scale (MAS)(first day of assessment)

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatice Adiguzel

Assistant Proffessor

Kahramanmaras Sutcu Imam University

研究点 (2)

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