Effects of Modified Pilates Training on Hemodynamic Responses

NCT ID: NCT05221307

Last Updated: 2022-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-15

Study Completion Date

2022-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy Physical Inactivity Gait Disorders in Children Gait, Spastic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1/Children with cerebral palsy

Modified Pilates Exercises (MPEs) will be applied 3 days a week, 45 minutes a day for 8 weeks.

Group Type EXPERIMENTAL

exercises

Intervention Type OTHER

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.

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 Type ACTIVE_COMPARATOR

exercises

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

exercises

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hatice Adiguzel

Assistant Proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

hatice adıguzel, PhD

Role: PRINCIPAL_INVESTIGATOR

Kahramanmaras Sutcu Imam University

Bulent Elbasan, Proffessor

Role: STUDY_DIRECTOR

Gazi University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hatice Adıgüzel

Kahramanmaraş, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KSU4

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.