Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia

Sponsor
Taichung Veterans General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05758350
Collaborator
(none)
100
2
14.5

Study Details

Study Description

Brief Summary

Dysphagia is a common problem in post-stroke patients and greatly impaired quality of life. Among them, the strength of tongue and lip muscles played a key role in the oral phase of swallowing and many stroke survivors suffered from these muscles weakness. Iowa oral performance instrument (IOPI) is a standardized portable device that can be used to quantify tongue muscle strength, thus allowing the clinician to set the level of resistance necessary to achieve optimal gains in strength, and also providing visual feedback of performance to the patients to guide training. In this study, we use Videofluoroscopic Swallowing Study (VFSS) to screen for the stroke patient suffering from dysphagia and recruited them into the trial. They then participated in a home based resistance-training program using the tongue depressor, 1 time everyday and each time consisted of 30 repetitions, totally 4 weeks. Various tongue strength variables and subjective scale were obtained before and after the intervention. The purpose of the study was to evaluate the effect of the home based swallowing therapy in the post stroke dysphagia patients.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: home based IOPI swallow training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Iowa Oral Performance Instrument (IOPI) training group

Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) and home- IOPI based resistance training

Behavioral: home based IOPI swallow training
Use IOPI for tongue and labial muscle resistance training. Conventional training was the same as controlled group.

No Intervention: controlled group

Including conventional speech therapy (tongue range of motion and strength, oral diet suggestion, masseter muscle strengthening) only

Outcome Measures

Primary Outcome Measures

  1. Anterior tongue pressure [1 week after treatment]

  2. Posterior tongue pressure [1 week after treatment]

  3. Right buccal pressure [1 week after treatment]

  4. Left buccal pressure [1 week after treatment]

  5. Labial pressure [1 week after treatment]

Secondary Outcome Measures

  1. The score of Eat-10 scale [1 week after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Acute stroke within 1 year, videofluoroscopic swallow study revealed abnormalities

  • Mini-Mental Status Examination >20, could cooperate swallow therapy

Exclusion Criteria:
  • Already known dysphagia before stroke event

  • Malocclusion or severe facial palsy

  • Localized oral lesion interfering swallowing

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Taichung Veterans General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT05758350
Other Study ID Numbers:
  • CF22483A
First Posted:
Mar 7, 2023
Last Update Posted:
Mar 7, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Taichung Veterans General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2023