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Wearable electronics for swallow-graphy in stroke patients

Recruiting
Conditions
Healthy volunteers agreeing to be a part of the study without any swallowing dysfunction.
Dysphagia,
Registration Number
CTRI/2023/11/060345
Lead Sponsor
All India Institute Of Medical Sciences
Brief Summary

Swallowing dysfunction in stroke patients is a major burden and 30% more mortality is observed in such cases. Swallowing assessment should be done repeatedly to assure that the patients is doing well before oral feeding is initiated. There are existing methods to assess swallowing in stroke patients such as; bedside clinical assessment, video-fluoroscopy, barium swallow. Video-fluoroscopy/Barium swallow is gold standard for evaluation of swallowing dysfunction. These existing methods are provocative and may lead to aspiration, also it is not feasible to conduct these tests repeatedly. Expert specialists or trained healthcare workers are required to perform these tests on patients. Hence, there is pressing need of a non-invasive device which can detect swallowing dysfunction, also a device which can be used repeatedly to determine the status of swallowing dysfunction. This device can also be used by non-healthcare worker or patient’s attendants; it will not require any special training. To our knowledge there is no such device which is being used globally. For these reasons we propose to conduct this study to determine the efficacy of the non-invasive developed tool in testing swallowing difficulty in stroke patients.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
10
Inclusion Criteria
  • FOR PATIENTS:.
  • Age between 18-80 years.
  • Persistent swallowing difficulty in ischemic or hemorrhagic stroke patients, at two weeks of onset of stroke or beyond.
  • Both male and female genders will be included FOR CONTROLS:.
  • Participants; healthy patient’s attendants’ or patients referred for barium swallow assessment/video fluoroscopy and noted to have normal swallowing functions and consenting for the study will be included.
  • Age (±5 years) and gender matched.
Exclusion Criteria
  • FOR PATIENTS:.
  • Patients will be excluded if not consenting will be excluded.
  • Patients who are in altered sensorium, comatose, on mechanical ventilation support and malignant infarction.
  • Patients having severe disabling co-morbidities, throat disease causing swallowing difficulty.
  • Patients allergic to contrast/barium used for video-fluoroscopy/barium swallow. FOR CONTROLS:.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Development of a diagnostic tool to detect swallowing dysfunction in cases with stroke and pilot data for clinical assessment.2 years
Secondary Outcome Measures
NameTimeMethod
Objective measurement of swallowing with a new metric based on the data from developed tool.2 years

Trial Locations

Locations (2)

All India Institute Of Medical Sciences

🇮🇳

South, DELHI, India

Indian Institute of Technology Delhi

🇮🇳

South, DELHI, India

All India Institute Of Medical Sciences
🇮🇳South, DELHI, India
Dr Awadh Kishor Pandit
Principal investigator
01126594049
akpandit.med@gmail.com

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