Cerebral Palsy Clinical Trial
Official title:
Intensive Goal Training With Educational Strategies for Parents and Adolescents With Cerebral Palsy
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | July 2024 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Marina de Brito Brandão | Belo Horizonte | Minas Gerais |
Lead Sponsor | Collaborator |
---|---|
Federal University of Minas Gerais |
Brazil,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Canadian Occupational Performance Measure (COPM) | Canadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes) | 4 Months | |
Secondary | 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). | 4months | |
Secondary | 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. |
4 months | |
Secondary | 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. | 4 months | |
Secondary | 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. | 4 months | |
Secondary | 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. | 4 months |
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