Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Deglutition Disorders
- Sponsor
- Purdue University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Normalized Task-related sEMG Amplitude (Signal Quality Parameter)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Wearable tele-rehabilitation technology allows for the efficient provision of rehabilitation services from a distance, facilitating tele-management of many disorders. The proposed research will develop and validate a set of mechanically compliant, easy-to-use, and inexpensive wearable tele-monitoring systems, for future use in the rehabilitation of swallowing disorders (dysphagia). The hypothesis is that the newly developed wearable sensors will have equal or better performance than traditional wired sensors used today in clinical practice. Factors related to signal quality and patient reported outcomes (e.g., satisfaction/comfort level, adverse effects etc.) will be examined.
Investigators
Georgia A. Malandraki
Associate Professor, Department of Speech, Language and Hearing Sciences
Purdue University
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for healthy adults:
- •Age 18-30 OR 50-90 years of age
- •No history of dysphagia
- •No history of a neurological disorder
- •A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA):
- •A score of \<3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).
- •Inclusion criteria for patients with dysphagia:
- •Age 18-90 years of age
- •Diagnoses of dysphagia as a result of a neurological disorder (e.g., stroke, Parkinson's disease).
- •A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA).
Exclusion Criteria
- •Significant cognitive impairment (a score in the moderate-severe range on MoCA):
Outcomes
Primary Outcomes
Normalized Task-related sEMG Amplitude (Signal Quality Parameter)
Time Frame: Post each experiment (i.e., 1 hour after the sensors have been placed)
Normalized sEMG amplitude values during standardized swallow tasks and maneuvers will be recorded and compared between the two sEMG devices. Normalized amplitude is used as a signal quality parameter and is not a health related outcome.
Signal to Noise Ratio (Signal Quality Parameter)
Time Frame: Post each experiment (i.e., 1 hour after the sensors have been placed)
Signal to Noise ratio will be calculated and compared between sensor types tested. Signal to noise ration is a signal quality parameter and not a health related outcome.
Secondary Outcomes
- Ease of Use/Comfort(Post each experiment (i.e., 1 hour after the sensors have been placed))
- Adverse Effects and Safety(Pre and Post each experiment (i.e., right before the placement of sensors on the subject and 1 hour after the sensors have been placed and 5 minutes after their removal))