Effects of Modified Pilates Exercises on Body Control, Gait and Function in Children With Cerebral Palsy
1 other identifier
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2020
CompletedApril 13, 2021
April 1, 2021
12 months
July 24, 2019
April 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change of Prone Plank Test
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
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
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
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 Outcomes (9)
Change of Sharman's core stabilite testi (PBU=Pressure Biofeedback Unit Test)
first day of intervention and after the 8 weeks
Change of Sit Ups Test
first day of intervention and after the 8 weeks
Change of Modified Push-ups Test
first day of intervention and after the 8 weeks
Change of 6 Minute Walk Test
first day of intervention and after the 8 weeks
Change of Pediatric Reach Test (PRT)
first day of intervention and after the 8 weeks
- +4 more secondary outcomes
Study Arms (2)
Interventional
ACTIVE COMPARATORThe control group will continue the routine physiotherapy program based on NDT: Neurodevelopmental Therapy twice a week, 2 days / 1 hour / day during 8 weeks.
Experimental
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanko Universitylead
Study Sites (1)
Sanko University
Gaziantep, Şehitkamil, 27090, Turkey (Türkiye)
Related Publications (1)
Adiguzel H, Elbasan B. Effects of modified pilates on trunk, postural control, gait and balance in children with cerebral palsy: a single-blinded randomized controlled study. Acta Neurol Belg. 2022 Aug;122(4):903-914. doi: 10.1007/s13760-021-01845-5. Epub 2022 Jan 18.
PMID: 35040072DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hatice Adıgüzel, PhD cd.
Sanko University
- PRINCIPAL INVESTIGATOR
Bülent Elbasan, Ass. Prof.
Gazi University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 24, 2019
First Posted
July 29, 2019
Study Start
August 1, 2019
Primary Completion
July 30, 2020
Study Completion
July 30, 2020
Last Updated
April 13, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share