Effects of Modified Pilates Exercises on Body Control, Gait and Function in Children With Cerebral Palsy

April 10, 2021 updated by: Hatice Adıgüzel, Sanko University
Children with cerebral palsy (CP) have limitations in postural reactions and antigravity movements. Trunk control is the determinant of posture, balance, walking and functional activities. Core stability connects deep abdominal muscles, spine, pelvis, and shoulder girdle to protect the posture and provides support for extremity movements. Pilates and core stabilization were associated with postural control in elderly, MS and stroke individuals and it was concluded that pilates caused an increase in trunk stabilization. There are not enough studies investigating the effectiveness of pilates exercises in CP. The aim of this study was to investigate the effects of modified pilates exercises on body control, gait and functionality in children with CP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Postural control is the ability of the body to control its position in space for stability and orientation. Postural stability and balance are achieved by keeping the center of gravity of the body within the support surface. Stability can also occur with a static response when the body is stationary, and a dynamic response to internal or external perturbations when it is mobile. Antisipation of perturbation forces requires an effective core stabilization muscle activation as well as an effective integration of stimuli from different sensory systems. Trunk control is also provided by this relationship between neural systems and skeletal muscles. Children with CP show deficits in proximal muscle co-contraction and vertical posture stabilization, with limitations in postural reactions and antigravity movements. Trunk control is the determinant of balance, gait and functional activities from the early period. Core stability; it connects with deep abdominal muscles, spine, pelvis and shoulder girdle muscles to protect the posture and provide support for limb movement. During reaching out, stepping and sudden perturbations, the Transversus Abdominus muscle is activated primarily from other trunk and limb muscles, creating a core stability. Core activity includes not only spinal stability and power generation, but also many upper and lower extremity movements. Control is established by focusing on the transversus abdominis muscle by core stabilization training with Pilates, stabilization of trunk muscles. The proximal extremity muscles of the hip are also important to maintain the upright posture and maintain mobility. For example; hip abductor muscle strength compared to the knee and ankle muscles, walking variables and motor functions in children with CP were more correlated. Although the importance of walking was determined, activation patterns of trunk and hip muscles during walking were examined in a limited number of studies in individuals with CP. The effects of pilates on healthy adults, elderly, multiple sclerosis, stroke and musculoskeletal disorders were investigated and resulted in increased trunk stabilization.Therefore, it is thought that pilates can be applied in terms of muscle strength and postural control in children who can walk, stand independently, but need to develop some components for controlled movement. There are not enough studies investigating the effectiveness of pilates exercises in CP. The aim of this study was to investigate the effects of modified pilates exercises on body control, gait and function in children with CP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Şehitkamil
      • Gaziantep, Şehitkamil, Turkey, 27090
        • Sanko University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To be diagnosed with CP at the level of GMFCS I-II-III between the ages of 5-18
  • Not having any Btx / surgery in the last 6 months
  • Lower extremity spasticity 1 and 1+ according to modified Ashworth score
  • Signing the written informed consent form
  • Who can follow verbal commands

Exclusion Criteria:

  • Individuals with multiple disabilities (hearing, speaking, seeing)
  • Individuals with any behavior disorder (Autism, etc.) / Mental problems
  • Patients with congenital cardiorespiratory status
  • Have received any specific core stabilization training over the last 6 months
  • Mixed musculoskeletal / axial deformities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Interventional
The control group will continue the routine physiotherapy program based on NDT: Neurodevelopmental Therapy twice a week, 2 days / 1 hour / day during 8 weeks.
Other: exercise
The control group will continue the routine NDT: Neurodevelopmental Therapy-based physiotherapy program twice a week. The treatment group will participate in clinical pilates exercises for 2 hours / day for 1 hour / 8 weeks. They will also continue their weekly routine physiotherapy programs.
Experimental: Experimental
The treatment group will participate in clinical pilates exercises 2 days / 1 hour / day during 8 weeks.They will also continue their weekly routine physiotherapy programs.
Other: exercise
The control group will continue the routine NDT: Neurodevelopmental Therapy-based physiotherapy program twice a week. The treatment group will participate in clinical pilates exercises for 2 hours / day for 1 hour / 8 weeks. They will also continue their weekly routine physiotherapy programs.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Prone Plank Test
Time Frame: first day of intervention and after the 8 weeks
Its a core stability performance test. Patients are asked to raise their trunk by giving weight to the forearms and toes while the prone and elbows are in the flexion position.It meausures core stability in this position.Subjects will be encouraged to maintain the isometric postures for prone plank position as long as possible. The length of time subjects could maintain the correct position was recorded.The longest time of 2 trials, to the nearest 0.1 second, will be used for data analysis.
first day of intervention and after the 8 weeks
Change of Side Plank Test
Time Frame: first day of intervention and after the 8 weeks
Its a core stability performance test. Patients are asked to raise their trunk by giving weight to the forearms and toes while the prone and elbows are in the flexion position.It meausures core stability in this position.Subjects will be encouraged to maintain the isometric postures side plank test position as long as possible. The length of time subjects could maintain the correct position was recorded.The longest time of 2 trials, to the nearest 0.1 second, will be used for data analysis.
first day of intervention and after the 8 weeks
Change of Modifiye Beiring Sorensen Test
Time Frame: first day of intervention and after the 8 weeks
Tests the endurance capacity of posterior spinal musculature. The subject is positioning in prone lying position with pelvis at edge of the treatment table with the pelvis and legs well stabilized either manually. Initially the subjects supports their upper extremity on stool/bench in front of table until they are instructed to cross their arm and assume a horizontal position which is to be maintained as long as possible. Total time (in seconds) for which he/she was able to maintain horizontal position (i.e. the time between the assumption of the horizontal position up to the moment when they lost the horizontal position), was manually recorded using digital stopwatch up to two decimal places.
first day of intervention and after the 8 weeks
Change of Abdominal Fatigue test
Time Frame: first day of intervention and after the 8 weeks
It measures the endurance of the anterior abdominal wall by asking the person to hold a sit- up position as long as they can. The subjects are required to sit on the test bench t and place the upper trunk against a support with an angle of 60 degree from the test bench. Both knee and hip are flexed to 90 degree .Both arms are folded across the chest with the hands placed on the opposite shoulder and toes are stabilized to the bed (either by manual support or by straps). The subjects are asked to maintain the body position while the supporting back support is withdrawn. The stopwatch is started at the moment, when the support is withdrawn. The stopwatch is stopping when the upper body fell below the 60 degree position.Time duration between these two points are recorded as the endurance holding score of the anterior abdominal muscle group.
first day of intervention and after the 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of Sharman's core stabilite testi (PBU=Pressure Biofeedback Unit Test)
Time Frame: first day of intervention and after the 8 weeks
It is objective and clinically feasible method to evaluate core stability in the laboratory settings which uses a stabilizer Pressure Biofeedback Unit with its inflatable pad placed in the inflatable cell was placed centrally beneath the abdomen with the lower edge at the level of the anterior superior iliac spines while the subject is lying supine, and is inflated to certain pressure of 70 mm Hg.The person is asked to pull his belly in as much as he can in a tight pants. While this is observed, the development of any other movement strategy (breast swelling, breath holding, pelvis movement) is noted and inhibited. The pressure may drop 6-10mmHg from the limit line. After the start, the test is terminated when 10 repetitions and 10 seconds of contraction are formed. Times are measured with a stopwatch. At each contraction, the onset of PBU is 70 mmHg, pressure changes and averages after 10 contraction are calculated. No feedback is given to the patient during the measurement.
first day of intervention and after the 8 weeks
Change of Sit Ups Test
Time Frame: first day of intervention and after the 8 weeks
Its a core test of power. The patient is asked to perform trunk flexion while the knees are in the flexed position and the feet are stabilized.The number of sit ups it can perform in 30 seconds is recorded.
first day of intervention and after the 8 weeks
Change of Modified Push-ups Test
Time Frame: first day of intervention and after the 8 weeks
Its a core test of power. When the cases are in the prone position, the arms and elbows are asked to lift the head, shoulders, and trunk from the flexion with the elbows fully extended. During the test, the knees are positioned in flexion.The number of push ups it can perform in 30 seconds is recorded.
first day of intervention and after the 8 weeks
Change of 6 Minute Walk Test
Time Frame: first day of intervention and after the 8 weeks
The 6-minute walk test (6MWT) is a standardized, self-paced walking test commonly used to assess functional ability in children with cerebral palsy (CP).1 The test has been reported to reflect functional capacity in terms of activities of daily living.2 In a recent Delphi study3 surveying the views of 15 physical therapy and exercise physiology experts, the 6MWT has been recommended as a submaximal exercise test for children with CP of Gross Motor Function Classification System4 (GMFCS) levels I to III.
first day of intervention and after the 8 weeks
Change of Pediatric Reach Test (PRT)
Time Frame: first day of intervention and after the 8 weeks
PRT was developed and modified from Functional Reach Test which was originally developed for measuring standing functional reach in adult populations. Due to the consideration that many children with CP are only able to maintain the upright position in sitting, PRT is developed to measure the maximal reach distance of children with CP both in sitting and standing positions. The total score of PRT is the sum of scores of PRT during sitting and PRT during standing.
first day of intervention and after the 8 weeks
Change of Physician Rating Scale (PRS)
Time Frame: first day of intervention and after the 8 weeks
One of these instruments is the Physician Rating Scale (PRS), an observational clinical evaluation of gait. This simple scale records gait in the sagittal plane only. Gait variables are recorded in the subtitle of Crouch, Knee, Foot contact scoring and general Change. Several items are geared to quantify visually the relationship between the ankle and knee position during stance. Maximum total score is 10.Also maximum scores shows the better results.
first day of intervention and after the 8 weeks
Change of Berg Balance Scale (BBS)
Time Frame: first day of intervention and after the 8 weeks
The BBS is a simple measure with 14 items that can be completed within 20 minutes. These items are used to test functional skills relevant to everyday tasks, progressing from stable positions to position changes and finally to the upright position with various maneuvers to challenge balance. The items are scored on a 5-point ordinal scale from 0 to 4 (0-1-2-3-4). The highest score is 56 points; a higher score indicates a better functional balance performance.
first day of intervention and after the 8 weeks
Change of Seated Postural Control Measure (SPCM)
Time Frame: first day of intervention and after the 8 weeks
SPCM has two sections. One section examines postural alignment and consists of 22 items; the other section examines functional movement and consists of 12 items. The SPCM can be administered and scored in 20 minutes or less. An ordinal scale of 0 to 3 is used to score each segmental posture. A given deviation, whether to the right or the left, would receive the same score. Visual observation and palpation are the only methods used to estimate postural alignment. At the beginning of the assessment, the child is placed in the seat in what the assessing therapist considers an optimal position. Verbal encouragement (without manual support) to maintain a correct posture is given. Each of the items in the function section consists of four levels, with higher grades representing better task achievement (from zero to completion). A maximum of 1 minute is allowed for motivating the child and completing each item. If more than one attempt is made, the best performance is scored.
first day of intervention and after the 8 weeks
Change of Gross Motor Function Classification System (GMFCS)
Time Frame: first day of intervention and after the 8 weeks
The GMFCS is a common classification system and is an evidence-based classification tool of five levels ranging from level I, which includes children with minimal or no disability with respect to community mobility, to level V, which includes children who are totally dependent on external assistance for mobility.
first day of intervention and after the 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanko University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hatice Adıgüzel, PhD cd., Sanko University
  • Principal Investigator: Bülent Elbasan, Ass. Prof., Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SANKO UNIVERSITY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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