Intensive Goal Training for Adolescents With Cerebral Palsy

NCT03530982 | Unknown

• 1 other identifier: 54597916.1.0000.5149
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in Manual dexterity

  1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

• Change in Gross motor function

  1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

• Change in Participation at home

  1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

• Change in Participation in household activities

  1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

Intensive goal training OTHER

Intensive goal training : 30 hours during 2 weeks

Also known as: intensive individualized functional training

Intervention group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Associação Mineira de Reabilitação

Belo Horizonte, Minas Gerais, Brazil

RECRUITING

Related Publications (3)

• 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.

  PMID: 28133725 BACKGROUND

• 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.

  PMID: 17044964 BACKGROUND

• 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.

  PMID: 23106987 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

MARINA B BRANDAO, PhD

CONTACT

3188396466; marinabbrandao@gmail.com

MARINA D BRANDAO, PhD

CONTACT

+553188396466; marinabbrandao@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The assessor will not know the aims and content of the intervention procedures.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 21, 2018
• Study Start: June 2, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)