Clinical trial NCT05608954: Effects of Physical Therapy on the Multisystems of Children With Cerebral Palsy: a Longitudinal Study
Official title: Effects of Physical Therapy on the Multisystems of Children With Cerebral Palsy: a Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Physical Therapy Modalities
Keywords: Cerebral Palsy
Physical Therapy Modalities
Longitudinal Studies
Disabled Children
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 33
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children from 0 to 12 years old, diagnosed with cerebral palsy

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).


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.

Primary outcomes:
measure: Gross Motor Function
timeFrame: 1 year
measure: Gross Motor Function Classification System
timeFrame: Levels I - V. Higher scores mean a worse outcome
Secondary outcomes:
measure: Electromyography
timeFrame: 1 year
measure: Early Clinical Assessment of Balance - ECAB
timeFrame: 1 year
measure: Modified Ashworth Scale (MAS)
timeFrame: 1 year
measure: Fatigue Severity Scale
timeFrame: 1 year
measure: Pediatric Functional Status Scale
timeFrame: 1 year
measure: YC-PEM - Young Children's Participation and Environment Measure
timeFrame: 1 year
measure: PEDI (Pediatric Evaluation Disability Inventory)
timeFrame: 1 year
measure: GAS (Goal Attainment Scaling)
timeFrame: 1 year
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Franciele Zardo
state: RS
Study officials:
affiliation: UFCSPA: Universidade Federal de Ciencias da Saude de Porto Alegre
name: Franciele Zardo, Msc
role: PRINCIPAL_INVESTIGATOR
References: