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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05608954
Other study ID # Cerebral Palsy longitudinal
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2022
Est. completion date March 2024

Study information

Verified date December 2022
Source Federal University of Health Science of Porto Alegre
Contact Fernanda Cechetti, PhD
Phone (51) 3303 8776
Email fernandacec@ufcspa.edu.br
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 33
Est. completion date March 2024
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 0 Months to 12 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Bobath Concept
Handling of the Bobath Concept
Pediasuit
Pediasuit
Locomotor training
Locomotor training
Stretching
Active, passive, active-assisted stretching
Psychomotricity
Psychomotor skills
Virtual reality
Virtual reality

Locations

Country Name City State
Brazil Franciele Zardo Porto Alegre RS

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gross Motor Function Measurement of Gross Motor Function 1 year
Primary Gross Motor Function Classification System Scale Gross Motor Function Classification System Levels I - V. Higher scores mean a worse outcome
Secondary Electromyography Muscle activation 1 year
Secondary Early Clinical Assessment of Balance - ECAB Postural control and balance 1 year
Secondary Modified Ashworth Scale (MAS) Muscle tone 1 year
Secondary Fatigue Severity Scale Muscle fatigue 1 year
Secondary Pediatric Functional Status Scale Functional status 1 year
Secondary 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
Secondary 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
Secondary GAS (Goal Attainment Scaling) Evaluation of results obtained in family therapy, or in an intervention program 1 year
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