Evaluation of Oral Screen Training With IQoro as Treatment for Dysphagia After Stroke

NCT04868955 | Unknown

• 1 other identifier: 2019-00636
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose The purpose of the study is to evaluate if training with oral screen IQoro® improves swallowing in patients with dysphagia after stroke. Method Inpatient from a stroke unit in Sweden who have been assessed with fiberoptic endoscopic evaluation of swallowing(FEES) which proves swallowing difficulties (dysphagia) were recruited. The participants were randomise to control- or intervention group. Both groups received usual care. The intervention group were instructed to oral screen (IQoro®) training for 13 weeks. Follow up with FEES was made 13 weeks post of recruitment. The assess with FEES was recorded and the recordings are going to be analyzed afterwards to compare the swallowing ability between baseline and follow up in group and between group.

Conditions

Stroke; Dysphagia

Outcome Measures

Primary Outcomes (3)

• Change in swallowing function due to secretion in the pharynx.

  Changes in swallowing function based on the parameter secretion in the pharynx. Estimates from "Secretion severity rating scale", 0-3. 0= Normal rating and 3= Secretion in the laryngeal vestibule that are not cleared. Estimates are based on recording from FEES.

  From baseline to follow up (13 weeks after baseline).

• Change in swallowing function due to aspiration and penetration.

  Changes in swallowing function based on the parameters aspiration and penetration in the pharynx. Estimates from "Penetration aspiration scale", 0-8. 0= No entry of material into the larynx or trachea, 8= Materials enter the trachea with no attempt to clear. Estimates are based on recording from FEES.

  From baseline to follow up (13 weeks after baseline).

• Change in swallowing function due to residual in the pharynx.

  Change in swallowing function due to residual in the pharynx, 0-1. 0= No or a small amount of residual, 1= A pool of residual after the first swallow. Estimates are based on recording from FEES.

  From baseline to follow up (13 weeks after baseline).

Secondary Outcomes (2)

• The patient's experience of swallowing

  From baseline to follow up (13 weeks after baseline)

• Change in swallowing function due to oral intake.

  From baseline to follow up (13 weeks after baseline).

Study Arms (2)

Intervention group

EXPERIMENTAL

Usual care and oral screen (IQoro®) training.

Other: Oral screen training

Control group

NO INTERVENTION

Usual care.

Interventions

Oral screen training OTHER

Oral screen training (IQoro®) during 13 weeks.

Intervention group

Eligibility Criteria

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

You may qualify if:

• Inpatient at stroke unit at Vrinnevisjukhuset ward 1, due to stroke.
• Patient assessed to have dysphagia (score ≥1 on one of the studied parameters)according to FEES.
• Patient who is able to handle IQoro® according to instructions, independently or with support of assistance from relatives or staff.

You may not qualify if:

• Patients with dysphagia of a cause other than stroke.
• Patient with impaired cognitive skill, motor and / or language ability that prevents the possibility of performing training with IQoro®, despite possible support from assistance from relatives or staff.
• Patient who wishes training with the Muppy oral screen® related to saliva leakage.

Sponsors & Collaborators

• Rebecca Norrman and Elin Rova: lead

Study Sites (1)

Vrinnevisjukhuset

Norrköping, Östergötland County, 60182, Sweden

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Rebecca U Norrman, Master

  Ostergotland County Council, Sweden

  PRINCIPAL INVESTIGATOR

• Elin AM Rova, Master

  Ostergotland County Council, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Speech and language pathologists

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 3, 2021
• Study Start: April 26, 2019
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)