cerebral palsy
Conditions
Interventions
This is a two-arm randomized feasibility trial. Participants, 18 children with cerebral palsy will be randomized into two groups: 1) Sports Stars plus PREP
2) Sports Stars. The secret allocation sequence will be determined by computer generated random numbers (1-18). These numbers will be hidden in opaque and sealed numbered envelopes to determine the pa
E02.779
Sponsors
Escola de Educação Física, Fisioterapia e Terapia Ocupacional - Universidade Federal de Minas Gerais
Escola de Educação Física, Fisioterapia e Terapia Ocupacional - Universidade Federal de Minas Gerais
Eligibility
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: Children from 6 and 12 years of age; diagnosis of Cerebral Palsy; at the levels of the Gross Motor Function Classification system I and II.
Exclusion criteria
Exclusion criteria: severe cognitive and / or behavioral difficulties that make it impossible to demonstrate their preferences, as reported by their parents; have clinical conditions (cardiorespiratory diseases and / or uncontrolled epilepsy) that prevent them from safely participating in activities; post-operative orthopedic and / or neurological surgery in the last six months or planned during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will include feasibility measures: family’s willingness to participate in a RCT, eligibility and recruitment rates, maintenance of evaluator blinding, acceptability of screening procedures and random allocation, possible contamination between the groups, intervention adherence, treatment satisfaction and difficulty in understanding the intervention being provided | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome – Improvement in School and Community Participation, assessed by the Children and Youth Participation and Environment Measure (PEM CY), with an improvement of at least 10%. Data collected one week before the intervention and one week after the intervention.;Secondary outcome – Improvement in Physical Literacy, assessed by the Physical Literacy Profile Questionnaire, with an improvement of at least 10%. Data collected one week before the intervention and one week after the intervention.;Secondary outcome – Improvement in Family Empowerment, assessed by the Family Empowerment Scale (FES), with an improvement of at least 3.54. Data collected one week before the intervention and one week after the intervention.;Secondary Outcome – Improvement in Physical Activity Level, as assessed by Actigraph wGT3X-BT (ActiGraph®, LLC, Pensacola, FL, USA), with at least 10% improvement. Data collected one week before the intervention and one week after the intervention.;Primary Outcome – Improved Sport Participation, assessed by the Canadian Measure of Occupational Performance (COPM) with an increase of at least 2 points. Data collected one week before the intervention and one week after the intervention. | — |
Countries
Brazil
Contacts
Public ContactHércules Leite
Escola de Educação Física, Fisioterapia e Terapia Ocupacional - Universidade Federal de Minas Gerais
Outcome results
None listed