The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 2
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients With Decreased Respiratory Function. Study 2: Children With Cystic Fibrosis for Long Term Evaluation
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients with Decreased Respiratory Function is a proposal for investigation of the application of gaming to improving respiratory health. The Jamboxx device combines gaming with traditional incentive spirometry to provide users with a fun experience to keep them engaged in their respiratory therapy routine. The device allows users to play a series of mini-games that walk them through their routines. The Jamboxx also records airflow and lung parameters with an external mouthpiece attachment to provide users with real time feedback, and helps to assess increases or decreases in relative lung function over time. The Jamboxx has the potential to significantly impact the field of respiratory therapy by being one of the first gaming devices for patient therapy, and the first respiratory therapy gaming device that is accessible to users with limited mobility. Jamboxx provides a fun and engaging, low cost alternative to the traditional therapy techniques used and aims to improve patient compliance.
This study addresses the ongoing challenge of clearing the burden of bronchial secretions resulting from cystic fibrosis. These patients are dependent upon mechanical devices to help clear secretions. A device autonomous means for clearing secretions is well defined in the literature (autogenic drainage) but is difficult to learn. This study proposes to teach cystic fibrosis patients to master autogenic drainage, and seeks to determine at what age it can be taught. As it would be expected that gaming could easily teach adults this procedure, the study will include children for whom learning autogenic drainage based upon conceptualization would be expected to be very difficult.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Testing Plan: Children will be randomized into one of two groups via a random number generation software program
Group A (education & gaming): Children will participate in 1 initial training session at Albany Med where they will be taught by a respiratory therapist (RT) to use autogenic drainage: a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways. Patients will be sent home and prescribed to practice the autogenic draining technique 15 minutes three times per week. At week 8 +/- 1 week patients will return for study visits and will be tested by a software program designed to evaluate their ability to perform autogenic drainage sequence (percent accuracy). This will be done through a software program installed on the device that uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a percent accuracy. At the 8 week visit, the Jamboxx gaming device will be introduced through a training session with a RT, which will contain a game to guide them through the proper sequence of breathing for the autogenic draining technique. Patients will be sent home with a Jamboxx device and requested to do 15 minutes of autogenic drainage training three times a week. Patients will return for a research visits at week 16 and again will be tested via software program for ability to perform the autogenic drainage technique.
Group B (gaming only): Children will participate in an initial training session at Albany Med where they will be taught by a RT to use Jamboxx respiratory thearpy device to guide them through autogenic drainage: a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways. Patients will be sent home and prescribed to use the Jamboxx respiratory therapy device 15 minutes three times per week. At week 8 and week 16 +/- 1 week patients will return for study visits and will be tested by a software program designed to evaluate their ability to perform autogenic drainage sequence (percent accuracy). This will be done through a software program installed on the device that uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a percent accuracy.
This protocol does not replace prescribed chest physiotherapy. There is no alteration of the standard of care beyond 15 minutes of autogenic drainage three times per week. Demographic data (age, gender, ethnicity) will be collected. Medical records will be evaluated for relevant health history, medication use, and hospitalizations including dates.
Тип исследования
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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New York
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Albany, New York, Соединенные Штаты, 12208
- Albany Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Children with CF requiring chest physiotherapy ages 5-17
Exclusion Criteria:
- Children with lung function of <25% FEV, hypercapnia, or requiring supplemental oxygen will be excluded.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: Group A: Education & Gaming
Children will participate in 1 initial training session where they will be taught by a RT to use autogenic drainage (AD).
Patients will be sent home & prescribed to practice the technique 15 minutes 3 times / week.
At week 8 +/- 1 week patients will return and will be tested by a software program designed to evaluate their ability to perform the AD sequence (percent accuracy).
At the 8 week visit, the Jamboxx gaming device will be introduced, which will contain a game to guide them through the proper sequence of breathing for the AD technique.
Patients will be sent home with a Jamboxx device and requested to do 15 minutes of AD training 3 times / week.
Patients will return at week 16 and again will be tested via software program for ability to perform the AD technique.
|
The Jamboxx Respiratory Therapy Device is a novel device that uses interactive gaming to encourage patient compliance with their prescribed respiratory therapy routines.
The device consists of a computer game controller with mouthpiece, and breath flow sensor that connects to a tablet.
With the Jamboxx respiratory therapy device, users can choose from a suite of breath controlled respiratory therapy games to guide them through their routines while receiving real-time feedback, and long-term progress tracking.
A respiratory therapist will teach children how to conduct the autogenic draining technique (a series of exhalations and inhalations) by demonstrating the technique to them, and having them practice in their office.
Children will also receive an informational packet and short video about the technique for reference
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Экспериментальный: Group B: Gaming Only
Children will participate in an initial training session at Albany Med where they will be taught by a RT to use the Jamboxx respiratory therapy device to guide them through autogenic drainage (AD): a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways.
Patients will be sent home and prescribed to use the Jamboxx respiratory therapy device 15 minutes three times per week.
At week 8 and week 16 +/- 1 week patients will return and will be tested by a software program designed to evaluate their ability to perform AD sequence (percent accuracy).
|
The Jamboxx Respiratory Therapy Device is a novel device that uses interactive gaming to encourage patient compliance with their prescribed respiratory therapy routines.
The device consists of a computer game controller with mouthpiece, and breath flow sensor that connects to a tablet.
With the Jamboxx respiratory therapy device, users can choose from a suite of breath controlled respiratory therapy games to guide them through their routines while receiving real-time feedback, and long-term progress tracking.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in accuracy with the autogenic draining technique
Временное ограничение: Weeks 0, 8, 16
|
A software program has been developed by the study team to evaluate ability to perform autogenic drainage sequence (percent accuracy).
This program will be installed on the Jamboxx Respiratory Therapy device (without the associated games), and uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a change in percent accuracy from the baseline value to the end of the 16 week study.
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Weeks 0, 8, 16
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Cystic Fibrosis Questionnaire- Revised
Временное ограничение: Weeks 0, 16
|
A study developed by the Cystic Fibrosis Foundation to evaluate respiratory function and overall health and wellbeing for children living with CF
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Weeks 0, 16
|
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Clinically relevant events & exacerbations
Временное ограничение: Weeks 0, 8, 16
|
e.g.
patient being sent for a chest x-ray, being ordered chest physiotherapy, prescribed to new systemic antibiotics, hospital admission
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Weeks 0, 8, 16
|
Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Marilyn Fisher, MD, Albany Medical Center IRB
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Jamboxx RT Device Study 2
- 4R42HL132735-02 (Грант/контракт NIH США)
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.
продукт, произведенный в США и экспортированный из 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. .
Клинические исследования Jamboxx Respiratory Therapy Device
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New York Presbyterian Brooklyn Methodist HospitalЗавершенныйХроническое обструктивное заболевание легкихСоединенные Штаты
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Brooke Army Medical CenterНеизвестныйБоль в пояснице | Периферическая невропатияСоединенные Штаты