Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2024-05-30
2025-04-08
Brief Summary
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Despite these advances, existing dysphagia rehabilitation programs are largely limited to specific disease groups, restricting their generalizability. In clinical practice, dysphagia arises from diverse etiologies, including stroke, neurodegenerative diseases, and other neurological or muscular conditions, which share common rehabilitation goals such as safe swallowing, aspiration prevention, and maintenance of oral intake.
This pilot study aimed to evaluate the feasibility and preliminary effectiveness of a novel mobile-based digital therapeutic (DTx) application for dysphagia rehabilitation across a clinically heterogeneous population. The DTx platform leverages mobile device camera signals to provide real-time feedback, structured reminders, and quantitative monitoring of self-directed training. We hypothesized that integrating this DTx into dysphagia care would enhance patient engagement, adherence, and swallowing-related outcomes. The findings of this study are expected to inform future large-scale trials and support the broader implementation of digital therapeutics in dysphagia rehabilitation.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
Two sessions of swallowing therapy and digital therapeutic (DTx) education were conducted by an occupational therapist to familiarize the participant. Each participant then performed individualized home-based swallowing exercises using the DTx application for 4 weeks, three times daily.
The individuals allowed a preliminary evaluation of the feasibility and applicability of the mobile-based digital therapeutic intervention across a broad spectrum of dysphagia etiologies.
The primary outcome of this study was the assessment of airway protection using the Penetration-Aspiration Scale (PAS) evaluated through videofluoroscopic swallowing study (VFSS).
DEVICE_FEASIBILITY
NONE
Study Groups
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Patients with dysphagia
"Pallow", mobile-based digital therapeutic (DTx)
mobile-based digital therapeutic (DTx) application designed for swallowing rehabilitation
Interventions
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"Pallow", mobile-based digital therapeutic (DTx)
mobile-based digital therapeutic (DTx) application designed for swallowing rehabilitation
Eligibility Criteria
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Inclusion Criteria
2. Swallowing difficulty, indicated by Penetration-Aspiration Score (PAS) ≥2 by VFSS
3. Ability to sit for more than 30 minutes
4. no significant cognitive impairment and mobile device access (MMSE\>24)
Exclusion Criteria
2. Requirement of surgical treatment during the study
18 Years
ALL
No
Sponsors
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Dongtan Sacred Heart Hospital
OTHER
Responsible Party
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Locations
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Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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2024-03-005
Identifier Type: -
Identifier Source: org_study_id
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