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

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).

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Physical Therapy Modalities
• Intervention / Treatment: Other: Bobath Concept; Other: Pediasuit; Other: Locomotor training; Other: Stretching; Other: Psychomotricity; Other: Virtual reality

• Study Type: Observational
• Enrollment (Anticipated): 33

Contacts and Locations

• Study Contact: Name: Fernanda Cechetti, PhD; Phone Number: (51) 3303 8776; Email: fernandacec@ufcspa.edu.br

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil
      • Recruiting
      • Franciele Zardo
      • Contact: Franciele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Physical Therapy Modalities; Children diagnosed with cerebral palsy will be followed longitudinally in their therapies within the physiotherapeutic treatment.	Other: Bobath Concept; Handling of the Bobath Concept; Other: Pediasuit; Pediasuit; Other: Locomotor training; Locomotor training; Other: Stretching; Active, passive, active-assisted stretching; Other: Psychomotricity; Psychomotor skills; Other: Virtual reality; Virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography	Muscle activation	1 year
Early Clinical Assessment of Balance - ECAB	Postural control and balance	1 year
Modified Ashworth Scale (MAS)	Muscle tone	1 year
Fatigue Severity Scale	Muscle fatigue	1 year
Pediatric Functional Status Scale	Functional status	1 year
YC-PEM - Young Children's Participation and Environment Measure	Level of participation and qualities of the environment in which these activities take place.	1 year
PEDI (Pediatric Evaluation Disability Inventory)	Detailed description of the child's functional performance, documenting its longitudinal changes in three functional areas: self-care, mobility and social function.	1 year
GAS (Goal Attainment Scaling)	Evaluation of results obtained in family therapy, or in an intervention program	1 year

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Investigators: Principal Investigator: Franciele Zardo, Msc, UFCSPA: Universidade Federal de Ciencias da Saude de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Longitudinal Studies; Physical Therapy Modalities; Disabled Children
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: Cerebral Palsy longitudinal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No