- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07609563
Therapeutic Climbing for Children With DCD (Climbing TDC)
Therapeutic Group Climbing for Children With Developmental Coordination Disorder: Randomized Crossover Trial
This study looks at whether therapeutic climbing - indoor climbing activities guided by therapists - can help children with Developmental Coordination Disorder (DCD).
DCD is a condition where children have difficulty with motor skills and participation in everyday activities, and sometimes confidence in physical activities.
The climbing program is based on a problem-solving approach called CO-OP (Cognitive Orientation to daily Occupational Performance), in which children learn strategies to achieve goals.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Background: Therapeutic climbing, based on the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, may improve goal performance and satisfaction in children with Developmental Coordination Disorder (DCD), as well as their motivation and self-efficacy toward physical activity.
Objective: This study aims to examine the effectiveness of a CO-OP-based group therapeutic climbing intervention for children with DCD.
Methods: A randomized crossover trial will be conducted with children with DCD. The intervention will consist of a 10-week group-based therapeutic climbing program delivered in an indoor climbing setting. Primary outcomes will include performance and satisfaction related to individualized goals. Secondary outcomes will assess motor skills, self-efficacy, executive functions, motivation toward physical activity, and transfer of learning. Effects of the intervention will be assessed using linear mixed effects models.
Results: It is hypothesized that participants will demonstrate improvements in both primary and secondary outcomes following the intervention.
Conclusions: This study will contribute to the evidence base regarding therapeutic climbing and CO-OP-based interventions for children with DCD, informing future rehabilitation practices.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Emmanuelle Jasmin, Ph.D.
- Номер телефона: 1-819-342-0305
- Электронная почта: emmanuelle.jasmin@usherbrooke.ca
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Diagnosis of DCD by a physician*.
- Ability to follow instructions, communicate verbally, interact with adults and peers, and use cognitive strategies.
- Ability to attend all assessment and intervention sessions in Sherbrooke.
- Ability to understand and speak French.
- Provision of child assent and parental consent. * If the target sample size (n = 16) is not reached, children with suspected DCD based on the Developmental Coordination Disorder Questionnaire (DCDQ) (25,26) will also be considered. Eligibility will then require: (1) a score below the 15th percentile on the total motor composite or below the 5th percentile in a domain of the Bruininks-Oseretsky Test of Motor Proficiency (BOT) (27,28), and (2) the identification of occupational challenges using the Canadian Occupational Performance Measure (COPM) (29,30) during the initial assessment.
Exclusion Criteria:
- Diagnosis of severe behavioral disorders, autism spectrum disorder, intellectual disability, cerebral palsy, muscular dystrophy, and/or severe functional limitations.
- Prior proficiency in climbing or absence of climbing-related goals.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Group 1 - Fall 2026
First group intervention
|
The intervention will consist of a 10-week group-based therapeutic climbing program delivered once weekly on Saturday afternoons at an indoor climbing center.
Sessions will be delivered by an occupational therapist (OT), two occupational therapy interns, and a certified climbing monitor (hereafter referred to as "intervention providers").
Each 90-minute session will follow the same global structure.
The intervention is grounded in the CO-OP approach.
|
|
Экспериментальный: Group 2 - Winter 2027
Second group intervention
|
The intervention will consist of a 10-week group-based therapeutic climbing program delivered once weekly on Saturday afternoons at an indoor climbing center.
Sessions will be delivered by an occupational therapist (OT), two occupational therapy interns, and a certified climbing monitor (hereafter referred to as "intervention providers").
Each 90-minute session will follow the same global structure.
The intervention is grounded in the CO-OP approach.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Performance related to individualized goals
Временное ограничение: Baseline (2-3 months before the intevention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
Assess with the Canadian Occupational Performance Measure (COPM) (visual analog scale of 1-10)
|
Baseline (2-3 months before the intevention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
|
Satisfaction related to individualized goals
Временное ограничение: Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
Assess with the Canadian Occupational Performance Measure (COPM) (visual analog scale of 1-10)
|
Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
|
Performance related to climbing-specific goals
Временное ограничение: Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
Assess with the Performance Quality Rating Scale (PQRS) (visual analog scale of 1-10)
|
Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Motor skills
Временное ограничение: Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
Bruininks-Oseretsky Test of Motor Proficiency, Third Edition (BOT-3) (standard scores (mean = 50, SD = 10) or scale scores for subtests (mean = 10, SD = 3))
|
Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
|
Self-efficacy
Временное ограничение: Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
Assess with the French adaptation of the General Self-Efficacy Scale (GSES) (5-point Likert scale)
|
Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
|
Executive functioning
Временное ограничение: Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
Assess with the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) T-scores (mean = 50, SD = 10)
|
Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
|
Motivation for physical activity
Временное ограничение: Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
Assess with the Pictorial Motivation Scale (PMS) for physical activity (3-point scale)
|
Baseline (2-3 months before the intervention, pre-intervention (immediatly before the intervention), post-intervention (immediatly after the intervention), follow-up 2-3 months post-intervention
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Emmanuelle Jasmin, Ph.D., Université de Sherbrooke
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026-6195
- Mental health 2025-2026 (Другой идентификатор: Pediatric Research Foundation)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .