Intensive Goal Training With Educational Strategies for Parents and Adolescents With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Canadian Occupational Performance Measure (COPM)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor will not have access to the group allocation of the participants.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Canadian Occupational Performance Measure (COPM)
时间窗: 4 Months
Canadian Occupational Performance Measure (COPM) - performance and satisfaction scales (each scale ranging 1-10; higher values, better outcomes)
次要结局
- Domains of Mastery Motivation (DMQ) - Self-reported(4 months)
- Pediatric Evaluation of Disability Inventory- Computer Adaptive Test(4months)
- Domains of Mastery Motivation (DMQ) - Parent- report(4 months)
- Depression, Anxiety and Stress Scales (DASS-21)(4 months)
- Depression, Anxiety and Stress Scale for Adolescents (EDAE-A)(4 months)
研究者
MARINA B BRANDAO
Adjunct professor
Federal University of Minas Gerais