NCT03529682

Brief Summary

The aim of our study is to reveal the results of circuit training to be applied to the children with Cerebral Palsy (CP) for improving their muscular strength and trunk control and also to determine their effects in terms of activity limitations and participation limits.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

May 3, 2018

Last Update Submit

May 17, 2018

Conditions

Keywords

Circuit ExerciseTrunk ControlFunctional Strength Training

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Function will be evaluated

    As for the Gross Motor Function evaluation, the Gross Motor Function Scale (GMFS) will be used and only its D and E sections (standing, walking, running, jumping evaluation parts) will be used. By considering the instructions in to be tested parts in the scale, the case is expected to do the motor functions actively. Without the consideration of the quality of the movement, the case will be observed whether s/he started, was able to continue and completed the movement as well as whether s/he needed any support so that points between 0-3 will be given according to the level. The obtained total score determines the interaction severity of gross motor function

    Change from baseline GMFS at 10 weeks

Secondary Outcomes (8)

  • Functional muscular strength of the trunk and the lower extremities will be evaluated.

    Change from baseline Functional muscular strength at 10 weeks

  • Isometric strength of bilateral lower extremity muscles and trunk muscles will be evaluated.

    Change from baseline isometric strength at 10 weeks

  • Muscular tonus in lower extremities will be evaluated.

    Change from baseline muscular tonus at 10 weeks

  • Walking speed and main mobility will be evaluated.

    Change from baseline walking speed and main mobility at 10 weeks

  • Functional motor performance will be evaluated.

    Change from baseline functional motor performance at 10 weeks

  • +3 more secondary outcomes

Study Arms (2)

Circuit Training Group

EXPERIMENTAL

Circuit exercise training will be given to the experimental group participants during 10 weeks, 60 minutes in a day and 3 times a week.

Other: exercise

Control Group

OTHER

The control group participants will continue to their own previous physiotherapy approaches as the same as minimum 3 times a week and total 3 hours.

Other: control group

Interventions

10 minutes warm-up exercises and stretching exercises, 40 mınutes consecutive exercises (strengthening exercises for trunk and lower extremities) and 10 mınutes cooling down exercises and stretching exercises will be applied.

Also known as: circuit training
Circuit Training Group

60 mınutes in a day and 3 times in a week traditional physiotherapy program will be applied

Also known as: traditional physiotherapy
Control Group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The children who were diagnosed with Spastic type Cerebral Palsy.
  • is aged between 6-18,
  • is on the I,II and III levels according to Gross Motor Function Classification System

You may not qualify if:

  • having any surgical operation related to lower extremities for the last 1 year,
  • having botulinum toxin injection or intrathecal pump for the last 6 months,
  • taking a new medicine or medicine change for the last 1 month,
  • visual, hearing and epilepsy problem,
  • inability to contınuously attend the exercise program,
  • mental problem that could not be cooperated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99450, Cyprus

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

ExerciseCircuit-Based ExerciseControl Groups

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPhysical Conditioning, HumanEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • UNAL DEGER, MSc

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

UNAL DEGER, MSc

CONTACT

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
Senior Instructor

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 18, 2018

Study Start

May 1, 2018

Primary Completion

August 1, 2018

Study Completion

November 1, 2018

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations