An observational study in Amyotrophic Lateral Sclerosis, sponsored by University Rehabilitation Institute, Republic of Slovenia. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by University Rehabilitation Institute, Republic of Slovenia · Observational
In Amyotrophic Lateral Sclerosis, dysphagia has a high incidence. With deterioration of swallowing function, percutaneous endoscopic gastrostomy (PEG) tube is recommended to ensure sufficient and safe oral intake. Dysphagia and PEG placement alter quality of life (QoL). However, QoL and attitudes toward PEG remain largely unexplored. The purpose of this study is to monitor the swallowing function in relationship to QoL and attitudes toward PEG tube insertion and feeding.
The purpose of this study is to monitor the deterioration of swallowing function in ALS patient population, and to explore its impact on QoL and attitudes toward PEG tube insertion and feeding in the course of the disease. It will take maximum of 60 minutes to fully evaluate the swallowing function and complete the questionnaires. The evaluation procedure will be repeated every 3 months until PEG tube insertion, which will allow us to closely monitor the swallowing function in a relation to attitudes toward PEG and QoL. The data obtained from this study should contribute significantly to the knowledge of QoL in ALS patients with dysphagia, and it will allow for a comparison of QoL in ALS patients with and without PEG tube. This study will also expand the understanding of attitudes in ALS patients and their relatives toward PEG, and the impact of those attitudes on the decision-making process.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's planned enrollment of 60 is below the median of 108 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →University Rehabilitation Institute, Republic of Slovenia is the lead sponsor of 21 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will include adult ALS patients able to visit the study site for in-person procedures every 3 months, and their close relatives.
Inclusion Criteria for patients:
Inclusion Criteria for relatives:
Exclusion Criteria for patients:
Exclusion criteria for relatives:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with confirmed amyotrophic lateral sclerosis.
Diagnostic Test: Iowa Oral Performance Instrument (IOPI) · Diagnostic Test: Mann Assessment of Swallowing Ability (MASA) · Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing · Diagnostic Test: Respiratory function measurements
Close relatives of the patients included in the study.
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.
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.
The subjects will ingest up to 10 boluses ranging in thickness and volume (from thin to extremely-thick and a cookie).
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.
Penetration-Aspiration Scale (PAS) change
PAS is an 8-point scale used to determine swallowing safety. Levels 1 and 2 are considered safe, levels \>3 indicate penetration or aspiration and are considered unsafe.
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Yale Residue Severity Rating Scale (YRSRS) change
YRSRS is a validated measure of swallowing efficiency using an image-based assessment to determine post-swallow pharyngeal residue: location and severity. It is assessed using a 5-point ordinal scale (from 1=0 % residue to 5=50 % residue).
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Iowa Oral Performance Instrument (IOPI) change
IOPI is a device which measures tongue strength (in kilopascals; kPa) and endurance (in seconds) while the participant presses the bulb with the front or the base of their tongue to the hard palate.
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Mann Assessment of Swallowing Ability (MASA) change
MASA is a standard clinical swallowing assessment protocol administered by the speech-language therapist. Total score ranges from 38-200. Lower score indicates higher impairment.
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Eating Assessment Tool 10 (EAT-10) change
EAT-10 is a validated self-administered dysphagia severity symptom survey including 10 items and a five-point scale (0=no problem to 4=sever problem). Higher total score indicates higher impairment.
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Swallowing Quality of Life Questionnaire (SWAL-QoL) change
SWAL-QoL is a 44-item standardised psychometric scale that measures swallowing-related QoL across 10 domains. Scores for each individual domain and a total SWAL-QoL score are calculated. Total score ranges from 0-100 (100 indicating the most favourable state).
Time frame: At baseline and every 3 months until PEG insertion, 3 and 6 months after PEG insertion
Questionnaire on Attitudes Toward PEG Tube Feeding and Insertion Procedure change
The questionnaire comprises 10 questions. The participants specify their level of agreement on a five-point Likert-type scale (1=strongly disagree, 5= strongly agree).
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
ALS Functional Rating Scale-Revised (ALSFRS-R) change
ALSFRS-R is a 12-tem ALS-specific assessment of global functioning using a five-point scale (0=not able, 4= normal ability), with 48 points representing normal function.
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Functional Oral Intake Scale (FOIS) change
FOIS is a validated 7-point scale demonstrating an individual's ability of daily oral food intake (1=no oral intake, 7=total oral intake with no restrictions).
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Dysphagia Outcome and Severity Scale (DOSS) change
DOSS is a 7-point scale that rates the functional severity of dysphagia based on objective assessment and provides information on diet recommendations, independence level and type of nutrition necessary (level 7=normal swallowing function, level 1=severe dysphagia).
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
BMI change
Body mass index (in kg/m\^2)
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Forced Vital Capacity (FVC) change
Standard clinical respiratory assessment of FVC (in %)
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Peak Cough Flow (PCF) change
Standard clinical respiratory assessment of PCF (in L/min)
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Maximal Inspiratory Pressure (MIP) change
Standard clinical respiratory assessment of MIP (in cmH2)
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Maximal Expiratory Pressure (MEP) change
Standard clinical respiratory assessment of MEP (in cmH2)
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Plan to share: No
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Started Jan 2023 (actual). Primary completion is estimated for Sep 2026, 44 months after the start.
Of 127 non-industry observational studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 125. This study's planned 44 months is below that.
Counting every sponsor, half of 136 studies reached it within 64 months; a quarter within 29 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
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Amyotrophic Lateral Sclerosis →
University Rehabilitation Institute, Republic of Slovenia