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

NCT05608954 | Unknown

• 1 other identifier: Cerebral Palsy longitudinal
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Cerebral Palsy; Physical Therapy Modalities

Keywords

Cerebral Palsy; Physical Therapy Modalities; Longitudinal Studies; Disabled Children

Outcome Measures

Primary Outcomes (2)

• Gross Motor Function

  Measurement of Gross Motor Function

  1 year

• Gross Motor Function Classification System

  Scale Gross Motor Function Classification System

  Levels I - V. Higher scores mean a worse outcome

Secondary Outcomes (8)

• Electromyography

  1 year

• Early Clinical Assessment of Balance - ECAB

  1 year

• Modified Ashworth Scale (MAS)

  1 year

• Fatigue Severity Scale

  1 year

• Pediatric Functional Status Scale

  1 year

Study Arms (1)

Physical Therapy Modalities

Children diagnosed with cerebral palsy will be followed longitudinally in their therapies within the physiotherapeutic treatment.

Other: Bobath Concept; Other: Pediasuit; Other: Locomotor training; Other: Stretching; Other: Psychomotricity; Other: Virtual reality

Interventions

Bobath Concept OTHER

Handling of the Bobath Concept

Physical Therapy Modalities

Pediasuit OTHER

Pediasuit

Physical Therapy Modalities

Locomotor training OTHER

Locomotor training

Physical Therapy Modalities

Stretching OTHER

Active, passive, active-assisted stretching

Physical Therapy Modalities

Psychomotricity OTHER

Psychomotor skills

Physical Therapy Modalities

Virtual reality OTHER

Virtual reality

Physical Therapy Modalities

Eligibility Criteria

• Age: 0 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children from 0 to 12 years old, diagnosed with cerebral palsy

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Franciele Zardo

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Franciele Zardo, Msc

  UFCSPA: Universidade Federal de Ciencias da Saude de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda Cechetti, PhD

CONTACT

(51) 3303 8776; fernandacec@ufcspa.edu.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: November 8, 2022
• Study Start: November 30, 2022
• Primary Completion: May 1, 2023
• Study Completion: March 1, 2024
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)