- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04035954
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
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
Interventional
Enrollment (Actual)
18
Phase
- 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
-
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Şehitkamil
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Gaziantep, Şehitkamil, Turkey, 27090
- SANKO University
-
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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
Ages Eligible for Study
3 years to 16 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 |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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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
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
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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.
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first day of intervention and after the 8 weeks
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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.
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first day of intervention and after the 8 weeks
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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.
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first day of intervention and after the 8 weeks
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Secondary Outcome Measures
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.
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first day of intervention and after the 8 weeks
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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.
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first day of intervention and after the 8 weeks
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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.
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first day of intervention and after the 8 weeks
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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.
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first day of intervention and after the 8 weeks
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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.
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first day of intervention and after the 8 weeks
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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.
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first day of intervention and after the 8 weeks
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Change of Seated Postural Control Measure (SPCM)
Time Frame: first day of intervention and after the 8 weeks
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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.
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first day of intervention and after the 8 weeks
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Change of Gross Motor Function Classification System (GMFCS)
Time Frame: first day of intervention and after the 8 weeks
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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.
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first day of intervention and after the 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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.
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)
August 1, 2019
Primary Completion (Actual)
July 30, 2020
Study Completion (Actual)
July 30, 2020
Study Registration Dates
First Submitted
July 24, 2019
First Submitted That Met QC Criteria
July 25, 2019
First Posted (Actual)
July 29, 2019
Study Record Updates
Last Update Posted (Actual)
April 13, 2021
Last Update Submitted That Met QC Criteria
April 10, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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