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Intensive Goal Training for Adolescents With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03530982
Recruitment Status : Not yet recruiting
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
MARINA B BRANDAO, 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Intensive goal training Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Masking Description: The assessor will not know the aims and content of the intervention procedures.
Primary Purpose: Treatment
Official Title: Intensive Training of Functional Priorities Reported by Adolescents With Cerebral Palsy
Estimated Study Start Date : June 2, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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 Name: intensive individualized functional training




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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 Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530982


Contacts
Contact: MARINA B BRANDAO, PhD 3188396466 marinabbrandao@gmail.com
Contact: MARINA D BRANDAO, PhD +553188396466 marinabbrandao@gmail.com

Sponsors and Collaborators
Federal University of Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Publications:
Responsible Party: MARINA B BRANDAO, Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT03530982     History of Changes
Other Study ID Numbers: 54597916.1.0000.5149
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases