Effect of Home Based Swallowing Exercise in Stroke Patients With Dysphagia

NCT05758350 | Unknown

• 1 other identifier: CF22483A
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysphagia Following Cerebrovascular Accident

Keywords

dysphagia; ischemic stroke; intracranial hemorrhage

Outcome Measures

Primary Outcomes (5)

• Anterior tongue pressure

  1 week after treatment

• Posterior tongue pressure

  1 week after treatment

• Right buccal pressure

  1 week after treatment

• Left buccal pressure

  1 week after treatment

• Labial pressure

  1 week after treatment

Secondary Outcomes (1)

• The score of Eat-10 scale

  1 week after treatment

Study Arms (2)

Iowa Oral Performance Instrument (IOPI) training group

EXPERIMENTAL

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

controlled group

NO INTERVENTION

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

Interventions

home based IOPI swallow training BEHAVIORAL

Use IOPI for tongue and labial muscle resistance training. Conventional training was the same as controlled group.

Iowa Oral Performance Instrument (IOPI) training group

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute stroke within 1 year, videofluoroscopic swallow study revealed abnormalities
• Mini-Mental Status Examination \>20, could cooperate swallow therapy

You may not qualify if:

• Already known dysphagia before stroke event
• Malocclusion or severe facial palsy
• Localized oral lesion interfering swallowing

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Related Publications (4)

• Lee JH, Kim HS, Yun DH, Chon J, Han YJ, Yoo SD, Kim DH, Lee SA, Joo HI, Park JS, Kim JC, Soh Y. The Relationship Between Tongue Pressure and Oral Dysphagia in Stroke Patients. Ann Rehabil Med. 2016 Aug;40(4):620-8. doi: 10.5535/arm.2016.40.4.620. Epub 2016 Aug 24.

  PMID: 27606268 BACKGROUND

• Park JS, Kim HJ, Oh DH. Effect of tongue strength training using the Iowa Oral Performance Instrument in stroke patients with dysphagia. J Phys Ther Sci. 2015 Dec;27(12):3631-4. doi: 10.1589/jpts.27.3631. Epub 2015 Dec 28.

  PMID: 26834320 BACKGROUND

• Park HS, Oh DH, Yoon T, Park JS. Effect of effortful swallowing training on tongue strength and oropharyngeal swallowing function in stroke patients with dysphagia: a double-blind, randomized controlled trial. Int J Lang Commun Disord. 2019 May;54(3):479-484. doi: 10.1111/1460-6984.12453. Epub 2019 Jan 28.

  PMID: 30693627 BACKGROUND

• Kim HD, Choi JB, Yoo SJ, Chang MY, Lee SW, Park JS. Tongue-to-palate resistance training improves tongue strength and oropharyngeal swallowing function in subacute stroke survivors with dysphagia. J Oral Rehabil. 2017 Jan;44(1):59-64. doi: 10.1111/joor.12461.

  PMID: 27883209 RESULT

MeSH Terms

Conditions

Deglutition Disorders; Ischemic Stroke; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

CHUN MING FU

CONTACT

(886)04-2359-2525; jimmyrehab@vghtc.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 7, 2023
• Study Start: March 15, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-03