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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608954
• Other study ID #: Cerebral Palsy longitudinal
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis
• Physical Therapy Modalities

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