Intensive Goal Training for Adolescents With Cerebral Palsy

Overview

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.

Full Title of Study: “Intensive Training of Functional Priorities Reported by Adolescents With Cerebral Palsy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2019

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.

Interventions

  • Other: Intensive goal training
    • Intensive goal training : 30 hours during 2 weeks

Arms, Groups and Cohorts

  • Experimental: Intervention group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Functional Goals
    • Time Frame: 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)
  • Change in Daily functioning- Self-Care
    • Time Frame: 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 Daily functioning- Mobility
    • Time Frame: 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

Secondary Measures

  • Change in Manual dexterity
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of Minas Gerais
  • Collaborator
    • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Provider of Information About this Clinical Study
    • Principal Investigator: MARINA B BRANDAO, Professor – Federal University of Minas Gerais
  • Overall Contact(s)
    • MARINA B BRANDAO, PhD, 3188396466, marinabbrandao@gmail.com

References

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.

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.

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.

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