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Clinical Trials/NCT05608954
NCT05608954
Recruiting
Not Applicable

Effects of Physical Therapy on the Multisystems of Children With Cerebral Palsy: a Longitudinal Study

Federal University of Health Science of Porto Alegre1 site in 1 country33 target enrollmentNovember 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Federal University of Health Science of Porto Alegre
Enrollment
33
Locations
1
Primary Endpoint
Gross Motor Function
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Cerebral Palsy (CP) refers to childhood movement and posture disorders, whose severity, patterns of motor involvement and associated impairments are very varied. It is the most prevalent type of physical disability in children. Any non-progressive central nervous system (CNS) lesion that occurs in the prenatal, perinatal and postnatal period up to 2 years of life is considered CP. Thus, the present work aims to evaluate, monitor and verify the effects of physical therapy interventions on gross motor function, spasticity, balance, muscle activation, fatigue, respiratory system, functionality and social participation in children with cerebral palsy. This work will use some evaluation scales such as the Gross Motor Function Measure (GMFM-66), the Modified Ashworth Scale (MAS), the Early Clinical Assessment of Balance (ECAB), electromyography, the Fatigue Severity Scale and the Pediatric Functional Status. Scale. In addition to questionnaires, which will be applied directly to parents/caregivers, such as the Young Children's Participation and Environment Measure (YC-PEM), the PEDI (Pediatric Evaluation Disability Inventory) and the Goal Attainment Scaling (GAS).

Registry
clinicaltrials.gov
Start Date
November 30, 2022
End Date
March 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Federal University of Health Science of Porto Alegre
Responsible Party
Principal Investigator
Principal Investigator

Fernanda Cechetti

Professor

Federal University of Health Science of Porto Alegre

Eligibility Criteria

Inclusion Criteria

  • clinical diagnosis of Cerebral Palsy
  • aged between 0-12 years
  • classified in all the levels of the GMFCS
  • those responsible agree to release the minor to participate in the study and sign the Free and Informed Consent Form (FICT)

Exclusion Criteria

  • have had botulinum toxin applied 6 months before the intervention
  • recent surgery
  • other physical abnormalities, genetic or severe syndromes.

Outcomes

Primary Outcomes

Gross Motor Function

Time Frame: 1 year

Measurement of Gross Motor Function

Gross Motor Function Classification System

Time Frame: Levels I - V. Higher scores mean a worse outcome

Scale Gross Motor Function Classification System

Secondary Outcomes

  • Electromyography(1 year)
  • Fatigue Severity Scale(1 year)
  • Early Clinical Assessment of Balance - ECAB(1 year)
  • Modified Ashworth Scale (MAS)(1 year)
  • YC-PEM - Young Children's Participation and Environment Measure(1 year)
  • Pediatric Functional Status Scale(1 year)
  • PEDI (Pediatric Evaluation Disability Inventory)(1 year)
  • GAS (Goal Attainment Scaling)(1 year)

Study Sites (1)

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