Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

RecruitingOBSERVATIONAL
Enrollment

60

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DIAGNOSTIC_TEST

Iowa Oral Performance Instrument (IOPI)

IOPI measures the peak pressure of the tongue strength and endurance using a disposable bulb placed on a hard palate behind the front teeth or at the base of the tongue. The participants will be asked to press the bulb with their tongue with maximum pressure, three times. To measure the endurance, the participants will be asked to hold the pressure for as long as they can.

DIAGNOSTIC_TEST

Mann Assessment of Swallowing Ability (MASA)

MASA is a standard clinical swallowing assessment protocol including general patient examination, on-the-outside visible signs of oral preparatory and transportation phase and pharyngeal phase of swallowing function.

DIAGNOSTIC_TEST

Fiberoptic Endoscopic Evaluation of Swallowing

The subjects will ingest up to 10 boluses ranging in thickness and volume (from thin to extremely-thick and a cookie).

DIAGNOSTIC_TEST

Respiratory function measurements

Respiratory function measurements will include forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP), all expressed in percentage of predicted values. Conventional methods of testing will be applied.

Trial Locations (1)

1000

RECRUITING

University Medical Centre Ljubljana, Ljubljana

All Listed Sponsors
collaborator

University Medical Centre Ljubljana

OTHER

lead

University Rehabilitation Institute, Republic of Slovenia

OTHER