Back to resultsIntensive Goal Training for Adolescents With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intensive goal training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility 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.
Sites / Locations
- Associação Mineira de ReabilitaçãoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Functional Goals
Canadian Occupational Performance Measure (COPM) (ranging 1-10; higher values, better outcomes)
Change in Daily functioning- Self-Care
Pediatric Evaluation Disability Inventory (PEDI) self-care: ranging from 0-63; higher values, better outcomes
Change in Daily functioning- Mobility
Pediatric Evaluation Disability Inventory (PEDI) mobility: ranging from 0-55; higher values, better outcomes
Secondary Outcome Measures
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)
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
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
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
Full Information
NCT ID
NCT03530982
First Posted
April 26, 2018
Last Updated
February 12, 2019
Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT03530982
Brief Title
Intensive Goal Training for Adolescents With Cerebral Palsy
Official Title
Intensive Training of Functional Priorities Reported by Adolescents With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intensive goal training
Other Intervention Name(s)
intensive individualized functional training
Intervention Description
Intensive goal training : 30 hours during 2 weeks
Primary Outcome Measure Information:
Title
Change in Functional Goals
Description
Canadian Occupational Performance Measure (COPM) (ranging 1-10; higher values, better outcomes)
Time Frame
1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Title
Change in Daily functioning- Self-Care
Description
Pediatric Evaluation Disability Inventory (PEDI) self-care: ranging from 0-63; higher values, better outcomes
Time Frame
1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Title
Change in Daily functioning- Mobility
Description
Pediatric Evaluation Disability Inventory (PEDI) mobility: ranging from 0-55; higher values, better outcomes
Time Frame
1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Secondary Outcome Measure Information:
Title
Change in Manual dexterity
Description
Box & Blocks Test (BBT)- number of blocks that are transported during 1 minute (there is no established max-min, higher values, better outcome)
Time Frame
1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Title
Change in Gross motor function
Description
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
Time Frame
1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Title
Change in Participation at home
Description
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
Time Frame
1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
Title
Change in Participation in household activities
Description
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
Time Frame
1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARINA B BRANDAO, PhD
Phone
3188396466
Email
marinabbrandao@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
MARINA D BRANDAO, PhD
Phone
+553188396466
Email
marinabbrandao@gmail.com
Facility Information:
Facility Name
Associação Mineira de Reabilitação
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscilla B Figueiredo
Phone
3198839646
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28133725
Citation
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.
Results Reference
background
PubMed Identifier
17044964
Citation
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.
Results Reference
background
PubMed Identifier
23106987
Citation
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.
Results Reference
background
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Intensive Goal Training for Adolescents With Cerebral Palsy
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