Intensive Goal Training for Adolescents With Cerebral Palsy

Intensive Training of Functional Priorities Reported by Adolescents With Cerebral Palsy

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Intensive goal training

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MARINA B BRANDAO, PhD; Phone Number: 3188396466; Email: marinabbrandao@gmail.com
• Study Contact Backup: Name: MARINA D BRANDAO, PhD; Phone Number: +553188396466; Email: marinabbrandao@gmail.com

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Recruiting
      • Associação Mineira de Reabilitação
      • Contact: Priscilla B Figueiredo; Phone Number: 3198839646

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Other: Intensive goal training; Intensive goal training : 30 hours during 2 weeks; Other Names: intensive individualized functional training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Manual dexterity	Box & Blocks Test (BBT)- number of blocks that are transported during 1 minute (there is no established max-min, higher values, better outcome)	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Change in Gross motor function	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	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Change in Participation at home	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	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Change in Participation in household activities	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	1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 54597916.1.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No