Effects of Modified Pilates Training on Hemodynamic Responses

NCT05221307 | Completed DMC

• 1 other identifier: KSU4
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Physical Inactivity; Gait Disorders in Children; Gait, Spastic

Keywords

Cerebral Palsy; modified pilates exercises; neurodevelopmental therapy; hemodynamic responses

Outcome Measures

Primary Outcomes (12)

• 6MWT

  Six minute walk test (6MWT) distance will be recorded as meter.

  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.

  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.

  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).

  change from baseline after 8 weeks

• Prone Plank Test

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

  change from baseline after 8 weeks

• Side Plank Test

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

  change from baseline after 8 weeks

• Abdominal Fatigue Test

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

  change from baseline after 8 weeks

• Sits Ups Test

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

  change from baseline after 8 weeks

• Push ups Test

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

  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.

  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.

  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.

  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)

  first day of assessment

• Modified Ashworth Scale (MAS)

  first day of assessment

Study Arms (2)

1/Children with cerebral palsy

EXPERIMENTAL

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

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.

Other: exercises

Interventions

exercises 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.

1/Children with cerebral palsy; 2/children with cerebral palsy

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Hatice Adıgüzel

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Sedentary Behavior; Gait Disorders, Neurologic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• hatice adıguzel, PhD

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

• Bulent Elbasan, Proffessor

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 2, 2022
• Study Start: May 15, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 30, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)