Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638944
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Wearable Biofeedback for the Rehabilitation and Tele-rehabilitation of Neurogenic Dysphagia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dysphagia or difficulty swallowing is a common symptom of many neurological diseases but its treatment is not well established or easily accessible
To start addressing this gap the researchers developed and validated a cost-effective wearable surface electromyography sEMG biofeedback sensor technology i-Phagia optimized to record muscle activity from the headneck and provide biofeedback to patients and adherence data to clinicians during swallow therapy This system has been developed with commercially available and widely used materials and the Purdue University IRB has determined that the device is non-significant risk device
The goal of this clinical trial is to learn if this biofeedback using this new technologyi-Phagia when used as an adjunct to a standard swallow therapy protocol works to improve swallowing function in patients post chronic stroke or diagnosed with Parkinsons disease It will also help the investigators learn whether this therapy protocol is equally effective when provided in-person versus via telehealth Finally it will determine which patient factors may influence how well the treatment works
The main questions it aims to answer are
Does biofeedback using this new technologyi-Phagia when used as an adjunct to a standard swallow therapy protocol works better than a standard of care treatment to improve swallowing function in patients post chronic stroke or diagnosed with Parkinsons disease
Is completing the swallow therapy protocol at home via telehealth as effective as completing it in-person in the clinic
What factors related to the patients eg age diagnosis etc may influence how well the treatment works
Participants will
Complete a 12-week swallow treatment protocol 12 treatment visits either in-person or at home via telehealth
Complete 3 in-person evaluations pre-treatment post-treatment and at a 12-week post treatment follow-up time point
Exercise at home several days per week and keep a diarylog of their home exercise
The hypothesis is that upon study completion the efficacy of sEMG biofeedback-facilitated swallow therapy for both in-person and telehealth service delivery in two neurogenic dysphagia populations will have been established and variables determining response to treatment will begin to be identified
To start addressing this gap the researchers developed and validated a cost-effective wearable surface electromyography sEMG biofeedback sensor technology i-Phagia optimized to record muscle activity from the headneck and provide biofeedback to patients and adherence data to clinicians during swallow therapy This system has been developed with commercially available and widely used materials and the Purdue University IRB has determined that the device is non-significant risk device
The goal of this clinical trial is to learn if this biofeedback using this new technologyi-Phagia when used as an adjunct to a standard swallow therapy protocol works to improve swallowing function in patients post chronic stroke or diagnosed with Parkinsons disease It will also help the investigators learn whether this therapy protocol is equally effective when provided in-person versus via telehealth Finally it will determine which patient factors may influence how well the treatment works
The main questions it aims to answer are
Does biofeedback using this new technologyi-Phagia when used as an adjunct to a standard swallow therapy protocol works better than a standard of care treatment to improve swallowing function in patients post chronic stroke or diagnosed with Parkinsons disease
Is completing the swallow therapy protocol at home via telehealth as effective as completing it in-person in the clinic
What factors related to the patients eg age diagnosis etc may influence how well the treatment works
Participants will
Complete a 12-week swallow treatment protocol 12 treatment visits either in-person or at home via telehealth
Complete 3 in-person evaluations pre-treatment post-treatment and at a 12-week post treatment follow-up time point
Exercise at home several days per week and keep a diarylog of their home exercise
The hypothesis is that upon study completion the efficacy of sEMG biofeedback-facilitated swallow therapy for both in-person and telehealth service delivery in two neurogenic dysphagia populations will have been established and variables determining response to treatment will begin to be identified
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None