Cerebral Palsy Clinical Trial
Official title:
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).
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Franciele Zardo | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Federal University of Health Science of Porto Alegre |
Brazil,
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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