Clinical trial NCT03530982: Intensive Goal Training for Adolescents With Cerebral Palsy
Official title: Intensive Training of Functional Priorities Reported by Adolescents With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2018-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Individualized intensive training of functional priorities presented by adolescents with CP. The intervention will happen during 2 weeks, 5 days/week, during 3 hours in a local rehabilitation center. Trained occupational and physical therapists will conduct the intervention procedures
Primary purpose: TREATMENT

Brief summary: Adolescents with cerebral palsy (CP) present important limitations for the performance of daily living activities. The aims of the study is to evaluate the feasibility and effects of an intensive goal training protocol for adolescents with CP. He hypothesize that adolescents submitted to the studied protocol will present improvements in performance and satisfaction of prioritized functional goals.

Detailed description: We will conduct a feasibility study to assess the implementation and the possible effects of an intensive individualized goal training with adolescents with CP. Adolescents will select up to 5 functional goals to be trained during a 2 weeks, 3 hour-daily training, totalling 30 hours across 2 weeks. Moreover, they will be asked to daily practice these activities at home along the intervention period.

Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of bilateral CP;
* Age between 12 and 17 years old;
* Manual Ability Classification System (MACS) ranging from levels I to III;
* Gross Motor Function Classification System (GMFCS) ranging from levels I to IV;
* Ability to understand verbal instructions.

Exclusion Criteria:

* Botulinum toxin or surgery in upper limbs in the previous 6 months of the study.

Primary outcomes:
measure: Change in Functional Goals
timeFrame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
measure: Change in Daily functioning- Self-Care
timeFrame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
measure: Change in Daily functioning- Mobility
timeFrame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Secondary outcomes:
measure: Change in Manual dexterity
timeFrame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
measure: Change in Gross motor function
timeFrame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
measure: Change in Participation at home
timeFrame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
measure: Change in Participation in household activities
timeFrame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Associação Mineira de Reabilitação
state: Minas Gerais
Study officials:
References:
citation: Bleyenheuft Y, Ebner-Karestinos D, Surana B, Paradis J, Sidiropoulos A, Renders A, Friel KM, Brandao M, Rameckers E, Gordon AM. Intensive upper- and lower-extremity training for children with bilateral cerebral palsy: a quasi-randomized trial. Dev Med Child Neurol. 2017 Jun;59(6):625-633. doi: 10.1111/dmcn.13379. Epub 2017 Jan 30.
citation: Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.
citation: de Brito Brandao M, Gordon AM, Mancini MC. Functional impact of constraint therapy and bimanual training in children with cerebral palsy: a randomized controlled trial. Am J Occup Ther. 2012 Nov-Dec;66(6):672-81. doi: 10.5014/ajot.2012.004622.