NCT04035954

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

July 24, 2019

Last Update Submit

April 10, 2021

Conditions

Keywords

Cerebral Palsymodified pilatestrunkgaitfunctioncore stability

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 COMPARATOR

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

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

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.

ExperimentalInterventional

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

Sanko University

Gaziantep, Şehitkamil, 27090, Turkey (Türkiye)

Location

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.

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hatice Adıgüzel, PhD cd.

    Sanko University

    PRINCIPAL INVESTIGATOR
  • Bülent Elbasan, Ass. Prof.

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will include16 children with cerebral palsy (SP) diagnosed at the GMFCS I-II-III level with 8 controls and 8 treatment groups by random minimization between 7-14 years of age with 1 and 1+ spasticity on the lower extremity according to the Modified Ashworth Score.
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

Locations