Cerebral Palsy
Conditions
Interventions
This is a feasibility study of a randomized controlled trial (RCT). Screening and sample size: eighteen children and their families will be recruited from the national registry of the Participa Brasil
E02.779
Sponsors
Universidade Federal de Minas Gerais
Universidade Federal de Minas Gerais
Eligibility
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: Children aged 1-5 years with a diagnosis of cerebral palsy (CP) VERIFICAR SIGLAS , classified at levels IV and V of the Gross Motor Function Classification System (GMFCS), who receive conventional Physical Therapy 1 or 2 times a week, in the state of Minas Gerais, Brazil.
Exclusion criteria
Exclusion criteria: Children with clinical instability, tracheostomy or oxygen dependents; or those who had undergone surgery or botulinum toxin injections in the last six months. Those who are currently participating in an intensive physiotherapy protocol will only be included when the protocol ends and three months after they return to the Conventional Physical Therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluated the feasibility of an RCT: (1) willingness to participate in an RCT, (2) feasibility of assessor blinding, (3) eligibility and recruitment rates, (4) acceptability of screening procedures and random allocation, (5) intervention adherence, (6) treatment satisfaction, (7) difficulty in understanding the assessment instruments and adequacy of the instruments to the intervention being provided and (8) difficulty in understanding the intervention being provided. The feasibility outcomes adapted for Almeida; Trevizan; Laterza, (2019), Sharma et al., (2018) and Feitosa et al., (2021). (1) willingness to participate in an RCT: all the participants who inclusion criteria will be approached and invited to participate. The number and rate of participants willing versus not willing to participate will be recorded, as well the reasons for not wanting to participate. Participants' reasons for not wanting to participate in the study will also be recorded. Total number of patients not willing to participate will be summed and reasons for non-participation collated. (2) Feasibility of assessor blinding: will be assessed by asking the assessor two questions at the end of the 12 weeds for intervention conclude, in follow-up assessment: (1) Did you receive any information that indicated to you which group the participant was assigned to?, the answers being coded in 'yes' and 'no'; and (2) if so, how did you receive the information that indicated the assigned group? After, assessor’s guess regarding group assignment group will be recorded for each participant. The responses will be coded as ‘correct’ or ‘incorrect’. Finally, reasons for guesses will be recorded as verbatim and reported. The frequency and relative rates of ‘Yes’ and ‘No’ as the answer to the first question will be computed, as will the frequency and relative rates of correct and incorrect guesses. (3) Eligibility and recruitment rates: the total number of participants screened, found eligible and recruited will | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the children participation at home based in the parents’ perception through the Young Children’s Participation & Environment Measure (YC-PEM), questionnaire completed by parents to evaluate the participation and environment of children aged 0 to 5 years at home, in daycare/preschool and in the community. The questionnaire value of parents’ perspectives about frequency, involvement level and desire for change for the children participate in each environment. In the present study will be considered the frequency, involvement and desire for change at home environment. Frequency is measured on an eight-point scale with response options ranging from never to one or more times a day; level of involvement, with a five-point scale with responses ranging from little to very involved; desire for change (no and yes). Activities in the home environment will be summed to provide a score and the score will be calculated as mean frequency (0-7), involvement (1-5) and desire for change (0-100%). The questionnaire will be completed before, immediately after 12 weeks of intervention and 12 weeks after the end of the intervention during an online interview with the caregivers of each child. ;Evaluate the gross motor function through the Gross Motor Function Family Report (GMF-FR), tool developed recently based in Gross Motor Function Measure, 88 itens (GMFM-88), used to measure performance in gross motor activity in home and community environments of children and teenager of cerebral palsy. Can be used with tool of assessment in telehealth and others contexts. Google forms to obtain the family's response, expanding the assessment of gross motor activity, as it allows the immediate capture of the child's current skills. Families can report scores based on the child or adolescent's performance in the past week, and if they are unsure or do not remember if the child performs the item, they can simply request that they do it. The items reflect activities performed in daily life w | — |
Countries
Brazil
Contacts
Public ContactAna Cristina Camargos
Universidade Federal de Minas Gerais
Outcome results
None listed