Intensive Goal Training for Adolescents With Cerebral Palsy

Not Applicable

• Conditions: Cerebral Palsy
• Interventions: Other: Intensive goal training

• Registration Number: NCT03530982
• Lead Sponsor: Federal University of Minas Gerais

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.

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Study Start: 2018-06-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Intensive goal training	Intensive goal training of relevant activities reported by adolescents in the beginning of the study. Therapists will grade the level of complexity of the proposed activities, considering the relevant movements, task demands and contextual factors involved in the performance of each task. Adolescents will be asked to practice these activities at home (1 hour/daily) and to discuss their difficulties and improvements with the therapists. The intervention will be provided in a day-camp model.

Primary Outcome Measures

Name	Time	Method
Change in Daily functioning- Mobility	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up	Pediatric Evaluation Disability Inventory (PEDI) mobility: ranging from 0-55; higher values, better outcomes
Change in Daily functioning- Self-Care	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up	Pediatric Evaluation Disability Inventory (PEDI) self-care: ranging from 0-63; higher values, better outcomes
Change in Functional Goals	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up	Canadian Occupational Performance Measure (COPM) (ranging 1-10; higher values, better outcomes)

Secondary Outcome Measures

Name	Time	Method
Change in Manual dexterity	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up	Box \& Blocks Test (BBT)- number of blocks that are transported during 1 minute (there is no established max-min, higher values, better outcome)
Change in Gross motor function	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up	Gross Motor Function Measure (GMFM): gross motor function abilities assessed in activities from 5 domains: lying and rolling; seating; crawling and kneeling; standing; walking, running and jumping. higher scores, better outcome
Change in Participation at home	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up	Participation Environment Measure: Children and Youth (PEM-CY): Structured questionnaire to assess the frequency and level of involvement in daily living tasks (home scale will be used) higher scores, better outcomes
Change in Participation in household activities	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up	Children´s Helping Out: Responsibility, Expectations and Supports (CHORES): structured questionnaire to assess the frequency and level of assistance in household activities: higher scores, better outcomes

Trial Locations

Locations (1)

Associação Mineira de Reabilitação; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil