Development of Software to Provide the SpeechVive Device Via the Internet

SpeechVive

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: SpeechVive device; Behavioral: Telemedicine interaction; Behavioral: In person interaction

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02744911

1R44DC014867-01A1

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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143 participants in 2 patient groups

Telemedicine group

Experimental group

Description:

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.

Treatment:

Behavioral: Telemedicine interaction

Device: SpeechVive device

In person group

Active Comparator group

Description:

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.

Treatment:

Behavioral: In person interaction

Device: SpeechVive device