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Идёт набор NCT07543614

Frame Running for Exercise and Participation for Children and Young People With Physical Disabilities

Без фазы С лечением Physical Disability Physical Activity Physical Function Quality of Life

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Frame Running Training.
Кому может быть актуально
Состояния в реестре: Physical Disability, Physical Activity, Physical Function, Quality of Life. Базовые параметры: 8 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

'FRAME-EX´ - FRAME Running for EXercise in Children and Young People With Disabilities - a Study Protocol for a Quasi-Experimental Single-Arm Trial

Обзор

The goal of this quasi-experimental single-arm trial is to evaluate whether a structured Frame Running training program can improve functional ability, participation, and quality of life in children and young people with physical disabilities. The study includes participants aged 8-18 years with cerebral palsy or other conditions causing physical disabilities. The aim of the study is to investigate changes in the primary outcome measure; functional ability using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT), and a series of secondary outcome measures on mobility capacity, physical endurance, performance of everyday activities, and health-related quality of life in children and young people with physical disabilities. Participants will complete a 24-week training program carried out in community athletics clubs: 12-week low-intensity control period with one supervised weekly Frame Running session focused on familiarization. 12-week moderate-to-high intensity intervention period with two weekly training sessions, including warm-up, technique training, endurance and speed intervals, and participation-focused activities. Data collection comprises four standardized questionnaires, four physical performance tests conducted at multiple time points, an electronic training diary, and Rating of Perceived Exertion-Pediatric Scale (RPE-P) obtained before and after selected endurance tests.

Подробное описание

The full protocol detailing all study procedures and methodology is available under Study Documents.

Вмешательства

  • Поведенческое Frame Running Training
    The intervention consists of supervised Frame Running sessions including warm-up, technical skills practice, endurance and speed intervals, and participation-focused activities delivered according to a standardized manual.

Первичные конечные точки

  • Change in Children's Functional Mobility Measured by the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) From Baseline to Week 12 and Week 24. [Срок оценки: Baseline, Week 12, and Week 24]
Вторичные конечные точки (7)
  • Change in Endurance Measured by the 6-Minute Frame Running Test From Baseline to Week 12 and Week 24 [Срок оценки: Baseline, Week 12, and Week 24]
  • Change in running speed measured by the 10-Meter Frame Running Sprint Test (Seconds) from Baseline to Week 12 and Week 24. [Срок оценки: Baseline, Week 12, and Week 24]
  • Change in Functional Strength Measured by the 1-Minute Sit-to-Stand Test From Baseline to Week 12 and Week 24. [Срок оценки: Baseline, Week 12, and Week 24]
  • Change in Walking Capacity Measured by the 1-Minute Walk Test From Baseline to Week 12 and Week 24 [Срок оценки: Baseline, Week 12, and Week 24]
  • Change in Functional Performance Measured by the Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) Daily Activities, Social/Cognitive, and Responsibility Domains Scaled Scores from Baseline to Week 12 and Week 24 [Срок оценки: Baseline, Week 12, and Week 24]
  • Change in Health-Related Quality of Life Measured by the Pediatric Quality of Life Inventory (PedsQL) From Baseline to Week 12 and Week 24. [Срок оценки: Baseline, Week 12, and Week 24]
  • Change in Participation Diversity and Intensity Measured by the Children's Assessment of Participation and Enjoyment / Preferences for Activities of Children (CAPE-PAC) from Baseline To Week 12 and Week 24 [Срок оценки: Baseline, Week 12, and Week 24]

Критерии участия

Критерии включения

  • Children and adolescents aged 8-18 years.
  • Diagnosed with cerebral palsy (CP) or another condition resulting in a physical disability affecting mobility.
  • Some prior Frame Running experience, such as informal use or occasional training, but must not have taken part in structured, organized, or performance-oriented Frame Running training within the past 12 weeks.
  • Able to propel the Frame Running bike forward independently
  • Able to understand and follow instructions related to Frame Running activities.

Критерии исключения

  • Severe visual and/or cognitive impairments that would compromise safe participation
  • Known medical conditions that could limit or contraindicate involvement in the study (e.g., significant cardiovascular or pulmonary disease).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Дания · 1 центр
  • Odense University Hospital — Odense

Идентификаторы

NCT: NCT07543614 · S-20232000 - 99

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗