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

Recruiting

• Conditions: Cerebral Palsy; Physical Therapy Modalities
• Interventions: Other: Bobath Concept; Other: Pediasuit; Other: Locomotor training; Other: Stretching; Other: Psychomotricity; Other: Virtual reality

• Registration Number: NCT05608954
• Lead Sponsor: Federal University of Health Science of Porto Alegre

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-05
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-08
• Study Start: 2022-11-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-14
• Primary Completion: 2023-05
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Physical Therapy Modalities	Locomotor training	Children diagnosed with cerebral palsy will be followed longitudinally in their therapies within the physiotherapeutic treatment.
Physical Therapy Modalities	Pediasuit	Children diagnosed with cerebral palsy will be followed longitudinally in their therapies within the physiotherapeutic treatment.
Physical Therapy Modalities	Stretching	Children diagnosed with cerebral palsy will be followed longitudinally in their therapies within the physiotherapeutic treatment.
Physical Therapy Modalities	Bobath Concept	Children diagnosed with cerebral palsy will be followed longitudinally in their therapies within the physiotherapeutic treatment.
Physical Therapy Modalities	Virtual reality	Children diagnosed with cerebral palsy will be followed longitudinally in their therapies within the physiotherapeutic treatment.
Physical Therapy Modalities	Psychomotricity	Children diagnosed with cerebral palsy will be followed longitudinally in their therapies within the physiotherapeutic treatment.

Primary Outcome Measures

Name	Time	Method
Gross Motor Function	1 year	Measurement of Gross Motor Function
Gross Motor Function Classification System	Levels I - V. Higher scores mean a worse outcome	Scale Gross Motor Function Classification System

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Franciele Zardo; 🇧🇷 Porto Alegre, RS, Brazil