Effectiveness of 5-week Digital Respiratory Practice in Children With Duchenne and Becker Muscular Dystrophies.
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: Digital respiratory intervention program.
- Кому может быть актуально
- Состояния в реестре: Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, Muscular Dystrophy. Базовые параметры: 5 лет — 20 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
- Испания
- 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
Effectiveness of 5-week Digital Respiratory Practice in a Group of Children With Duchenne Muscular Dystrophy and Becker Muscular Dystrophy.
Обзор
The purpose of this study is to analyze the effectiveness of a 5-weeks respiratory digital intervention program in patients with Duchenne muscular dystrophy and Becker muscular dystrophy.
Подробное описание
It will be done 4 times a week for a period of 5 weeks, for a duration of 55-60 minutes (20 sessions), with an intensity adapted to the characteristics of each participant. An intervention program will be used based on respiratory muscle training exercises, upper limb strength work, yoga, diaphragmatic awareness exercises, always trying to do them through the use of games, and even try to include exercises that use motor imagery.
It is advisable during intervention program to have a playful environment stimulated for the children, and that the intervention program is carried out and stimulated through videos and therapeutic teaching to the caregivers in the first evaluation session, as well as with a weekly follow-up using WhatsApp as forms of communication, or a telephone call to ensure correct follow-up of the intervention program.
It is essential that to carry out the intervention, videos obtained from YouTube, own videos prepared to explain the exercises in a playful way applied to children, and even other applications such as Spotify to work with music, will be used, being offered in case of Zoom calls may be necessary to help optimally resolve doubts that arise when carrying out the program by video call.
At the end of the respiratory digital physiotherapy program, variables will be evaluated by the principal examiner.
Вмешательства
- Другое Digital respiratory intervention program
A 4 times a week for a period of 5 weeks will be done, for a duration of 55-60 minutes (20 sessions), with an intensity adapted to the characteristics of each participant. Moreover, an intervention program will be used based on respiratory muscle training exercises, upper limb strength work, yoga, diaphragmatic awareness exercises, always trying to do them through the use of games, and even try to include exercises that use motor imagery. The intervention program is carried out and stimulated t
Первичные конечные точки
- Analyze the improvement of the forced vital capacity (FVC). [Срок оценки: Baseline, up to 5 weeks.]
Вторичные конечные точки (10)
- Perform an anthropometric study of the patient's characteristics, taking into account weight; and also a general physical examination. [Срок оценки: Baseline, up to 5 weeks.]
- Perform an anthropometric study of the patient's characteristics, taking into account age. [Срок оценки: Baseline, up to 5 weeks.]
- Perform an anthropometric study of the patient's characteristics, taking into account height. [Срок оценки: Baseline, up to 5 weeks.]
- Perform an anthropometric study of the patient's characteristics, taking into account sex. [Срок оценки: Baseline, up to 5 weeks.]
- Examine changes in forced expiratory pressure [Срок оценки: Baseline, up to 5 weeks.]
- Analyze changes in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). [Срок оценки: Baseline, up to 5 weeks.]
- Check if there are changes in the sniff nasal inspiratory pressure (SNIP) [Срок оценки: Baseline, up to 5 weeks.]
- Evaluate the fatigue in patients using an EPInfant test. [Срок оценки: Baseline, up to 5 weeks.]
- Evaluate the quality of life of patients using a scale called "Kindscreen-52". [Срок оценки: Baseline, up to 5 weeks.]
- North Star Ambulatory Assessment o NSAA [Срок оценки: Baseline, up to 5 weeks.]
Критерии участия
Критерии включения
- Participants with Duchenne muscular dystrophy and patients with Becker muscular dystrophy will be chosen.
- Aged between 5 and 20 years.
- Child who could walk and follow the intervention program, and were diagnosed according to the International Classification of Diseases, 10 Revision. code (G71-01); and who had an NSSA score greater than 20.
Критерии исключения
- Patients who present associated heart disease.
- Patients who presentor fractures, a heart rate greater than 120 beats per minute, or an oxygen saturation less than 89% will be excluded.
- Participants who do not have the capacity to have internet at home to perform the intervention, as well as all patients whose caregivers did not agree to sign the informed consent.
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
- Лечение
Центры проведения
Испания · 1 центр
- Rocío Martín-Valero — Málaga
Идентификаторы
NCT: NCT06363526 · UMalagaDRIP