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Intensive Goal Training With Educational Strategies for Adolescents With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Individualized goal training
Individualized goal training with educational strategies
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adolescents with: (a) medical diagnosis of CP (unilateral or bilateral); (b) age between 12 and 17 years and 11 months; (c) manual ability Classified by the Manual Ability Classification System - MACS, at levels I (adolescents capable of handling objects of effectively and independently) to III (adolescents with limited repertoire of activities, who handle objects with supervision or adaptation); (d) gross motor function classified by the Gross Motor Function Classification System - GMFCS Expanded and Revised (GMFCS E & R), in the levels I (adolescents who walk in different contexts, but have limited speed, balance and coordination to run and jump) to IV (adolescents who use a wheelchair in most contexts, but are able to sustain weight on their lower limbs to help in transfers and walking short distances with physical help from a person); (e) communication function classified by the Communication Function Classification System for Individuals with Cerebral Palsy (CFCS) at levels: I (communicates at a appropriate pace with little or no delay in understanding, elaborating a speech, or resolve a misunderstanding); II (independently alternates sender and receiver roles with most people in most situations, but the pace of conversation is slow). Exclusion Criteria: Adolescents undergoing any type of intensive intervention, orthopedic surgery or application of botulinum toxin in the upper limbs and/or less than six months will be excluded.

Sites / Locations

  • Marina de Brito Brandão

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Individualized goal training

Individualized goal training with educational strategies

Arm Description

This group will be submitted to individualized goal training, 3 hours/day, 5 times/week, over the course of two weeks, totaling 30 hours. Training will happen in a clinical setting. Adolescents will select their functional goals to be trained during the intervention period.

This group will be submitted to individualized goal training with their caregivers, for 2 weeks, with 5 face-to-face meetings lasting 3 hours a day at the rehabilitation center. The other 5 meetings will be held online with the adolescent and their caregiver at the same time, via video communication platform. Adolescents will select their functional goals to be trained during the intervention period.

Outcomes

Primary Outcome Measures

Canadian Occupational Performance Measure (COPM)
Canadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes)

Secondary Outcome Measures

Pediatric Evaluation of Disability Inventory- Computer Adaptive Test
The test is divided into four domains that assess adolescent's daily functioning: Daily Activities (AD), Mobility (MB), Social/Cognitive (SC) and Responsibility (RS). The AD, MB, and SC domains are scored on a scale of 1 (Unable, unable to manages) to 4 (Easy), whereas the RS domain the scale varies from 1 (adult assumes complete responsibility) to 5 (child/youth assumes full responsibility). Each domain has scaled scores, ranging from 0-100 (higher means that the participant has more functional abilities and responsibility).
Domains of Mastery Motivation (DMQ) - Self-reported
The self-reported version is developed for individuals from 13 to 19 years old . The questionnaire evaluates aspects of the perceptions of adults and adolescents about the domain of adolescents in challenging structured tasks. DMQ has 41 items and seven scales: (1) Persistence on objects or cognitive tasks; (2) Gross motor persistence; (3) Social domain motivation with adults (4) Social domain motivation; (5) Pleasure of mastery and (6) Negative reactions (failures) in situations of domain; (7) General competence. Participants will be asked to rate, on a five-point scale, points (from "not at all typical" to "very typical"), how typical is the behavior of the adolescents in each item. The total score is the index of motivation, with higher scores representing more level of overall motivation.
Domains of Mastery Motivation (DMQ) - Parent- report
The parent- report version is developed for parents of individuals from 13 to 19 years old . The questionnaire evaluates aspects of the perceptions of parents regarding their child's motivation in challenging tasks. DMQ has 41 items and seven scales: (1) Persistence on objects or cognitive tasks; (2) Gross motor persistence; (3) Social domain motivation with adults (4) Social domain motivation; (5) Pleasure of mastery and (6) Negative reactions (failures) in situations of domain; (7) General competence. Parents will be asked to rate, on a five-point scale, points (from "not at all typical" to "very typical"), how typical is the behavior of the adolescents in each item. The total score ( is the index of motivation, with higher scores representing more level of overall motivation, according to parents.
Depression, Anxiety and Stress Scales (DASS-21)
The DASS-21 will be conducted with parents. It is a set of three four-point Likert subscales, aimed at assessing the emotional states of depression, anxiety and stress. Each statement is answered by underlining how the person has felt during the last week. Answers are ranked on a scale from 0 to 3 and the result of each dimension is obtained by adding up the answers to the items in each subscale. The final score is the sum of the three sub-scales. The higher the score (0-63 points), the worst is the mental health condition.
Depression, Anxiety and Stress Scale for Adolescents (EDAE-A)
The EDAE-A will be conducted with adolescents.It is a set of three four-point Likert subscales, aimed at assessing the emotional states of depression, anxiety and stress. Each statement is answered by underlining how the person has felt during the last week. Answers are ranked on a scale from 0 to 3 and the result of each dimension is obtained by adding up the answers to the items in each subscale. The final score is the sum of the three sub-scales. The higher the score (0-63 points), the worst is the mental health condition.

Full Information

First Posted
November 23, 2022
Last Updated
November 23, 2022
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT05635565
Brief Title
Intensive Goal Training With Educational Strategies for Adolescents With Cerebral Palsy
Official Title
Intensive Goal Training With Educational Strategies for Parents and Adolescents With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

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) have limitations to perform daily routine activities. The use of educational strategies associated to an approach based on motor learning principles was found to be effective in promoting motor outcomes in individuals with CP. The aim of the present study is to investigate the effectiveness of an intensive, goal-directed training associated with education for parents and adolescents in promoting the daily functioning of adolescents with CP. A randomized clinical trial, with 20 adolescents with CP, aged between 12 and 17 years and 11 months, and their respective caregivers. Adolescents will be randomly allocated into one of two groups: (a) intensive training of functional goals with adolescents or (b) intensive functional goal training with adolescents, including parenting and adolescent education strategies.
Detailed Description
Adolescents with cerebral palsy (CP) have limitations to perform daily routine activities. The use of educational strategies associated to an approach based on motor learning principles was found to be effective in promoting motor outcomes in individuals with CP. However, there is a shortage of services focused on the specific needs of adolescents with CP and on the skills considered important for the success of the transition period to adulthood. Complementarily, the literature reveals the scarcity of services that provide educational support to parents on how to deal with the functional limitations of their adolescent children with CP. Therefore, it is possible that the development of an intervention protocol that associates high intensity training with specific functional goals with an educational program for parents and adolescents, can contribute to the provision of rehabilitation services targeted at adolescents with CP and their families. The overall objective of the present study is to investigate the effectiveness of an intensive, goal-directed protocol associated with education for parents and adolescents in promoting the daily functioning of adolescents with CP. A randomized clinical trial will be conducted with 20 adolescents with CP, aged between 12 and 17 years and 11 months, and their respective caregivers. Adolescents will be randomly allocated into one of two groups: (a) intensive training of functional goals with adolescents (3 hours/day, 5 days/week, during two weeks, totaling 30 hours, in a clinical setting) or (b) intensive functional goal training with adolescents, including parenting and adolescent education strategies (3 hours/day, 5 days/week, during two weeks, totaling 30 hours, with telehealth strategies and visits at the clinical setting).

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
Parallel Assignment
Model Description
Randomized clinical trial with 2 groups
Masking
Outcomes Assessor
Masking Description
The assessor will not have access to the group allocation of the participants.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individualized goal training
Arm Type
Active Comparator
Arm Description
This group will be submitted to individualized goal training, 3 hours/day, 5 times/week, over the course of two weeks, totaling 30 hours. Training will happen in a clinical setting. Adolescents will select their functional goals to be trained during the intervention period.
Arm Title
Individualized goal training with educational strategies
Arm Type
Experimental
Arm Description
This group will be submitted to individualized goal training with their caregivers, for 2 weeks, with 5 face-to-face meetings lasting 3 hours a day at the rehabilitation center. The other 5 meetings will be held online with the adolescent and their caregiver at the same time, via video communication platform. Adolescents will select their functional goals to be trained during the intervention period.
Intervention Type
Other
Intervention Name(s)
Individualized goal training
Intervention Description
This group will be submitted to individualized goal training, 3 hours/day, 5 times/week, over the course of two weeks, totaling 30 hours. Training will happen in a clinical setting. Adolescents will select their functional goals to be trained during the intervention period.
Intervention Type
Other
Intervention Name(s)
Individualized goal training with educational strategies
Intervention Description
This group will be submitted to individualized goal training with their caregivers, for 2 weeks, with 5 face-to-face meetings lasting 3 hours a day at the rehabilitation center. The other 5 meetings will be held online with the adolescent and their caregiver at the same time, via video communication platform. Adolescents will select their functional goals to be trained during the intervention period.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
Canadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes)
Time Frame
4 Months
Secondary Outcome Measure Information:
Title
Pediatric Evaluation of Disability Inventory- Computer Adaptive Test
Description
The test is divided into four domains that assess adolescent's daily functioning: Daily Activities (AD), Mobility (MB), Social/Cognitive (SC) and Responsibility (RS). The AD, MB, and SC domains are scored on a scale of 1 (Unable, unable to manages) to 4 (Easy), whereas the RS domain the scale varies from 1 (adult assumes complete responsibility) to 5 (child/youth assumes full responsibility). Each domain has scaled scores, ranging from 0-100 (higher means that the participant has more functional abilities and responsibility).
Time Frame
4months
Title
Domains of Mastery Motivation (DMQ) - Self-reported
Description
The self-reported version is developed for individuals from 13 to 19 years old . The questionnaire evaluates aspects of the perceptions of adults and adolescents about the domain of adolescents in challenging structured tasks. DMQ has 41 items and seven scales: (1) Persistence on objects or cognitive tasks; (2) Gross motor persistence; (3) Social domain motivation with adults (4) Social domain motivation; (5) Pleasure of mastery and (6) Negative reactions (failures) in situations of domain; (7) General competence. Participants will be asked to rate, on a five-point scale, points (from "not at all typical" to "very typical"), how typical is the behavior of the adolescents in each item. The total score is the index of motivation, with higher scores representing more level of overall motivation.
Time Frame
4 months
Title
Domains of Mastery Motivation (DMQ) - Parent- report
Description
The parent- report version is developed for parents of individuals from 13 to 19 years old . The questionnaire evaluates aspects of the perceptions of parents regarding their child's motivation in challenging tasks. DMQ has 41 items and seven scales: (1) Persistence on objects or cognitive tasks; (2) Gross motor persistence; (3) Social domain motivation with adults (4) Social domain motivation; (5) Pleasure of mastery and (6) Negative reactions (failures) in situations of domain; (7) General competence. Parents will be asked to rate, on a five-point scale, points (from "not at all typical" to "very typical"), how typical is the behavior of the adolescents in each item. The total score ( is the index of motivation, with higher scores representing more level of overall motivation, according to parents.
Time Frame
4 months
Title
Depression, Anxiety and Stress Scales (DASS-21)
Description
The DASS-21 will be conducted with parents. It is a set of three four-point Likert subscales, aimed at assessing the emotional states of depression, anxiety and stress. Each statement is answered by underlining how the person has felt during the last week. Answers are ranked on a scale from 0 to 3 and the result of each dimension is obtained by adding up the answers to the items in each subscale. The final score is the sum of the three sub-scales. The higher the score (0-63 points), the worst is the mental health condition.
Time Frame
4 months
Title
Depression, Anxiety and Stress Scale for Adolescents (EDAE-A)
Description
The EDAE-A will be conducted with adolescents.It is a set of three four-point Likert subscales, aimed at assessing the emotional states of depression, anxiety and stress. Each statement is answered by underlining how the person has felt during the last week. Answers are ranked on a scale from 0 to 3 and the result of each dimension is obtained by adding up the answers to the items in each subscale. The final score is the sum of the three sub-scales. The higher the score (0-63 points), the worst is the mental health condition.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescents with: (a) medical diagnosis of CP (unilateral or bilateral); (b) age between 12 and 17 years and 11 months; (c) manual ability Classified by the Manual Ability Classification System - MACS, at levels I (adolescents capable of handling objects of effectively and independently) to III (adolescents with limited repertoire of activities, who handle objects with supervision or adaptation); (d) gross motor function classified by the Gross Motor Function Classification System - GMFCS Expanded and Revised (GMFCS E & R), in the levels I (adolescents who walk in different contexts, but have limited speed, balance and coordination to run and jump) to IV (adolescents who use a wheelchair in most contexts, but are able to sustain weight on their lower limbs to help in transfers and walking short distances with physical help from a person); (e) communication function classified by the Communication Function Classification System for Individuals with Cerebral Palsy (CFCS) at levels: I (communicates at a appropriate pace with little or no delay in understanding, elaborating a speech, or resolve a misunderstanding); II (independently alternates sender and receiver roles with most people in most situations, but the pace of conversation is slow). Exclusion Criteria: Adolescents undergoing any type of intensive intervention, orthopedic surgery or application of botulinum toxin in the upper limbs and/or less than six months will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Brandão, PhD
Phone
+55 31 988396466
Email
marinabbrandao@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aline Feitosa, MSc
Phone
+55 31 974008707
Email
alinemfei@hotmail.com
Facility Information:
Facility Name
Marina de Brito Brandão
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30431-232
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Upon request, due to confidentiality issues.
Citations:
PubMed Identifier
33653225
Citation
Feitosa AM, Mancini MC, Silverio APM, Gordon AM, Brandao MB. "Help Me to Improve my Own Priorities!": A Feasibility Study of an Individualized Intensive Goal Training for Adolescents with Cerebral Palsy. Phys Occup Ther Pediatr. 2021;41(6):601-619. doi: 10.1080/01942638.2021.1891186. Epub 2021 Mar 2.
Results Reference
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Intensive Goal Training With Educational Strategies for Adolescents With Cerebral Palsy

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