Development of Software to Provide the SpeechVive Device Via the Internet
2019년 9월 18일 업데이트: 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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (실제)
등록
143
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Indiana
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Lafayette, Indiana, 미국, 47905
- SpeechVive, Inc
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West Lafayette, Indiana, 미국, 47907
- Purdue University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
30년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Caregiver Quality of Life
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Speech rate
기간: 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
기간: 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
기간: Change from baseline after 6 months of treatment
|
Caregiver Burden Inventory
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Change from baseline after 6 months of treatment
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Change in Apathy
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: At the end of the study period (after 6 months)
|
Survey requesting ratings of satisfaction with the telemedicine application and treatment process
|
At the end of the study period (after 6 months)
|
|
Patient with PD satisfaction - in person group
기간: At the end of the study period (after 6 months)
|
Survey requesting ratings of satisfaction with the in-person treatment process
|
At the end of the study period (after 6 months)
|
|
Caregiver satisfaction - in person group
기간: At the end of the study period (after 6 months)
|
Survey requesting ratings of satisfaction with the in-person treatment process
|
At the end of the study period (after 6 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2018년 1월 26일
기본 완료 (실제)
기본 완료
2019년 6월 15일
연구 완료 (실제)
연구 완료
2019년 6월 15일
연구 등록 날짜
최초 제출
최초 제출
2016년 4월 6일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2016년 4월 19일
처음 게시됨 (추정)
처음 게시됨
2016년 4월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2019년 9월 19일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2019년 9월 18일
마지막으로 확인됨
마지막으로 확인됨
2019년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- 1R44DC014867-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .