Development of Software to Provide the SpeechVive Device Via the Internet
18 сентября 2019 г. обновлено: SpeechVive, Inc
Development of a Telehealth Platform for Treatment With the SpeechVive Device
Telehealth, increasingly recognized in the neurology field as a solution to access issues for people with Parkinson's disease, improves access to speech therapy, particularly those living in rural areas or with travel barriers.
The SpeechVive device, developed by SpeechVive, Inc., is a treatment solution that is easy to use and effective.
In an NIH funded study, the SpeechVive device improved communication in 90% of individuals with PD by improving volume, articulation, and speech rate.
The investigators propose to eliminate the one drawback of the SpeechVive device, namely that it currently must be programmed by a speech-language pathologist for each patient in person.
The overall goal of this project is to develop a telehealth platform for the SpeechVive device that will enable video conferencing for treatment and remote programming of the SpeechVive device for each patient.
Once the platform has been developed, the investigators will conduct a study to examine effectiveness and the patient and caregiver satisfaction with telepractice using the SpeechVive device.
Обзор исследования
Статус
Завершенный
Условия
Тип исследования
Интервенционный
Регистрация (Действительный)
143
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Indiana
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Lafayette, Indiana, Соединенные Штаты, 47905
- SpeechVive, Inc
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West Lafayette, Indiana, Соединенные Штаты, 47907
- Purdue University
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
30 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Diagnosis of Parkinson's disease
- Difficulty communicating
- Is currently being seen, or agrees to be seen, by a speech pathologist who fits the SpeechVive device and also has agreed to participate in the study
- Has a regular caregiver living with him/her
Exclusion Criteria:
- Neurological diagnoses (except Parkinson's disease)
- Bilateral hearing aids (since one free ear is required for use of the SpeechVive device)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Telemedicine group
People with Parkinson's disease and their caregivers obtaining treatment using the SpeechVive device via the internet using the telemedicine application.
Also includes speech-language pathologists providing treatment via the telemedicine application.
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The SpeechVive is a wearable device that plays multi-talker babble noise in one ear while the person wearing it is talking.
The noise is voice-activated (only present when the person speaks).
The noise does not interfere with the ability to hear communication partners.
The noise coming from the device functions as a natural external cue for people with Parkinson's disease to talk more loudly and clearly.
Treatment will involve asking the participants to wear the device daily during the treatment period.
Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
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Активный компаратор: In person group
People with Parkinson's disease and their caregivers obtaining treatment using the SpeechVive device in person.
Also includes speech-language pathologists providing treatment in person.
|
The SpeechVive is a wearable device that plays multi-talker babble noise in one ear while the person wearing it is talking.
The noise is voice-activated (only present when the person speaks).
The noise does not interfere with the ability to hear communication partners.
The noise coming from the device functions as a natural external cue for people with Parkinson's disease to talk more loudly and clearly.
Treatment will involve asking the participants to wear the device daily during the treatment period.
Participants will interact with the speech-language pathologist in-person at the speech pathologist's office
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Caregiver Quality of Life
Временное ограничение: Change from baseline after 6 months of treatment
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Scale of Quality of Life of Care-givers
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Change from baseline after 6 months of treatment
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Depression: Caregiver Geriatric Depression Scale
Временное ограничение: Change from baseline after 6 months of treatment
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Geriatric Depression Scale
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Change from baseline after 6 months of treatment
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Change in Patient with PD Ratings of Communication Competence
Временное ограничение: Change from baseline after 6 months of treatment
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Communicative Participation Item Bank-Short Form
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Change from baseline after 6 months of treatment
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Change in Patient with PD quality of life
Временное ограничение: Change from baseline after 6 months of treatment
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Parkinson's Disease Questionnaire-39
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Change from baseline after 6 months of treatment
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Attractiveness of the telehealth platform.
Временное ограничение: At monthly intervals during the study period (6 months for each patient)
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Survey requesting SLP data regarding patients seen during the study period and adoption of the telepractice model by patients
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At monthly intervals during the study period (6 months for each patient)
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Travel cost burden - in-person group
Временное ограничение: At monthly intervals during the study period (6 months for each patient)
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Survey requesting Patient/caregiver travel distances and durations
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At monthly intervals during the study period (6 months for each patient)
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Impact of treatment on time - telemedicine group
Временное ограничение: At monthly intervals during the study period (6 months for each patient)
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Survey requesting Patient and caregiver reports of time spent before and after sessions preparing and setting up equipment and clearing equipment
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At monthly intervals during the study period (6 months for each patient)
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Treatment adherence
Временное ограничение: At monthly intervals during the study period (6 months for each patient)
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Usage data from the SpeechVive and patient attendance at treatment sessions
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At monthly intervals during the study period (6 months for each patient)
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Change in Vocal intensity level
Временное ограничение: Change from baseline after 6 months of treatment
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Sound pressure level from speech samples with and without the device in place
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Change from baseline after 6 months of treatment
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Change in Patient with PD Depression Level
Временное ограничение: Change from baseline after 6 months of treatment
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Geriatric Depression Scale Short form
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Change from baseline after 6 months of treatment
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Impact of Life Events for Patient with PD and Caregiver
Временное ограничение: Change from baseline after 6 months of treatment
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Change in Impact of PD on life satisfaction
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Change from baseline after 6 months of treatment
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Change in general self-efficacy
Временное ограничение: Change from baseline after 6 months of treatment
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Self-efficacy for people with disabilities scale
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Change from baseline after 6 months of treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Speech rate
Временное ограничение: Change from baseline after 6 months of treatment
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Rate of speech from speech samples with and without the device in place
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Change from baseline after 6 months of treatment
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Change in Pausing patterns
Временное ограничение: Change from baseline after 6 months of treatment
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Number and duration of silent and filled pauses from speech samples with and without the device in place
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Change from baseline after 6 months of treatment
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Change in Caregiver Burden
Временное ограничение: Change from baseline after 6 months of treatment
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Caregiver Burden Inventory
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Change from baseline after 6 months of treatment
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Change in Apathy
Временное ограничение: Change in baseline after 6 months of treatment for Patient with PD and Caregiver
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Apathy Scale
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Change in baseline after 6 months of treatment for Patient with PD and Caregiver
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Change in Caregiver Ratings Patient's of Communication Competence
Временное ограничение: Change in baseline after 6 months of treatment
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Communicative Participation Item Bank-Short Form
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Change in baseline after 6 months of treatment
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Change in Patient with PD Participation in Social Activities
Временное ограничение: Change in baseline after 6 months of treatment
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Quality of Life in Neurological Disorders (Neuro-QOL)
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Change in baseline after 6 months of treatment
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Change in Patient with PD Participation in Social Activities
Временное ограничение: Change in baseline after 6 months of treatment
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Ability to Participate in Social Roles and Activities-Short Form
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Change in baseline after 6 months of treatment
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Change in Patient with PD Perceived Autonomy
Временное ограничение: Change in baseline after 6 months of treatment
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7-item Autonomy Subscale of the Basic Psychological Needs Scale
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Change in baseline after 6 months of treatment
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Patient with PD satisfaction - telemedicine group
Временное ограничение: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the telemedicine application and treatment process
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At the end of the study period (after 6 months)
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Caregiver satisfaction - telemedicine group
Временное ограничение: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the telemedicine application and treatment process
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At the end of the study period (after 6 months)
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Patient with PD satisfaction - in person group
Временное ограничение: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the in-person treatment process
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At the end of the study period (after 6 months)
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Caregiver satisfaction - in person group
Временное ограничение: At the end of the study period (after 6 months)
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Survey requesting ratings of satisfaction with the in-person treatment process
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At the end of the study period (after 6 months)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Stathopoulos ET, Huber JE, Richardson K, Kamphaus J, DeCicco D, Darling M, Fulcher K, Sussman JE. Increased vocal intensity due to the Lombard effect in speakers with Parkinson's disease: simultaneous laryngeal and respiratory strategies. J Commun Disord. 2014 Mar-Apr;48:1-17. doi: 10.1016/j.jcomdis.2013.12.001. Epub 2013 Dec 28.
- Huber JE, Darling M, Francis EJ, Zhang D. Impact of typical aging and Parkinson's disease on the relationship among breath pausing, syntax, and punctuation. Am J Speech Lang Pathol. 2012 Nov;21(4):368-79. doi: 10.1044/1058-0360(2012/11-0059). Epub 2012 Jul 30.
- Darling M, Huber JE. Changes to articulatory kinematics in response to loudness cues in individuals with Parkinson's disease. J Speech Lang Hear Res. 2011 Oct;54(5):1247-59. doi: 10.1044/1092-4388(2011/10-0024). Epub 2011 Mar 8.
- Huber JE, Darling M. Effect of Parkinson's disease on the production of structured and unstructured speaking tasks: respiratory physiologic and linguistic considerations. J Speech Lang Hear Res. 2011 Feb;54(1):33-46. doi: 10.1044/1092-4388(2010/09-0184). Epub 2010 Sep 15.
- Sadagopan N, Huber JE. Effects of loudness cues on respiration in individuals with Parkinson's disease. Mov Disord. 2007 Apr 15;22(5):651-9. doi: 10.1002/mds.21375.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
26 января 2018 г.
Первичное завершение (Действительный)
15 июня 2019 г.
Завершение исследования (Действительный)
15 июня 2019 г.
Даты регистрации исследования
Первый отправленный
6 апреля 2016 г.
Впервые представлено, что соответствует критериям контроля качества
19 апреля 2016 г.
Первый опубликованный (Оценивать)
20 апреля 2016 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
19 сентября 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
18 сентября 2019 г.
Последняя проверка
1 сентября 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1R44DC014867-01A1 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
The data from the people with Parkinson's disease and their caregivers will include limited financial information, perceptions of speech telepractice, survey data, and some objective measurements of speech production. Once de-identified and published in peer-reviewed journals, these data will be made available upon request. Any researcher requesting access to these data will need to submit the following to Jessica Huber:
- Name and institution of PI
- Proof of institutional appointment
- Names and roles for all individuals who will access the data for the planned analysis
- Detailed plan for the use of the data
- Timeline for use and publication of the analyses If Dr. Huber approves the data use, the PI must sign a license with Purdue University's Office of Technology Commercialization promising to keep the data confidential, to not share it with anyone not named in the application above, and to destroy the data once analysis is complete.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
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. .