Physiological Flow of Liquids Used in Dysphagia Management (Neuro)

NCT03192358 | Completed Results

• 4 other identifiers: 17-54215R01DC011020-05CAPCR 17-5421 (NIH_Neuro)IRB201701608
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

For individuals with neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis and Parkinson disease, swallowing impairment (i.e., dysphagia) is a common and serious symptom. Dysphagia places the affected individual at risk for secondary health consequences, including malnutrition and aspiration pneumonia, and negatively affects quality of life. Thickened liquids are commonly recommended for individuals with dysphagia, as they flow more slowly and reduce the risk of entry into the airway. However, there is limited understanding about how changes in liquid thickness modulate swallowing physiology in individuals with neurodegenerative conditions, and previous reports have shown that increased liquid thickness may contribute to the accumulation of residue in the throat. The purpose of this study is to explore swallowing physiology and function in individuals with neurodegenerative conditions, across five levels of liquid thickness (thin, slightly-thick, mildly-thick, moderately-thick, and extremely-thick), and to identify boundaries of "optimal liquid thickness", which maintain airway safety, without contributing to the accumulation of significant residue. Results from this study will help guide the clinical recommendations for thickened liquids in dysphagia management.

Conditions

Amyotrophic Lateral Sclerosis; Parkinson Disease; Dysphagia

Keywords

Thickened Liquids; Dysphagia Management; Videofluoroscopy; Swallowing Physiology

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Residue of Concern (Observational)

  Residue is material remaining behind in the pharynx after the swallow. We measured residue by tracing the area of barium visible on a lateral view x-ray (in pixels, using ImageJ software) and dividing that area by the squared length C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, and enables the comparison of residue severity across different people with different neck length and pharynx size. Smaller values are considered better. The 75th percentile healthy reference values for this measure are 1.7% on thin liquids, 1.9% on slightly thick liquids, 2.2% on mildly thick liquids, 1.6% on moderately thick liquids and 1.5% on extremely thick liquids. Values above these thresholds are considered atypical and of clinical concern. We report the number of participants who display atypical total pharyngeal residue measures per consistency.

  Single timeframe (baseline only)

• Maximum Anterior Isometric Tongue Pressure

  Tongue strength was measured using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air was placed in the mouth, just behind the front teeth. Participants were asked to press the front of their tongue upwards against the bulb as hard as possible. This task was repeated 3 times. The maximum value obtained across 3 repetitions was recorded as "maximum anterior isometric pressure". Higher values represent greater tongue strength. We report group mean values and standard deviations for this measure.

  Single timeframe (baseline only)

• Regular Effort Saliva Swallow Tongue Pressure

  Tongue strength was measured using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air was placed in the mouth, just behind the front teeth. Participants were asked to swallow their saliva with the bulb in this position. This task was repeated 3 times. The mean value obtained across 3 repetitions was recorded as "regular effort saliva swallow tongue pressure". Higher values represent greater tongue strength. We report group mean values and standard deviations for this measure.

  Single timeframe (baseline only)

• Number of Participants With Unsafe Swallows (Observational)

  Swallowing safety was measured using the 8-point Penetration-Aspiration Scale, an 8-point categorical scale which captures the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels \> 2 are considered unsafe. Actual scale scores (1-8) were recorded and then converted to binary categorical scores (\< 3 vs \>/= 3). We report the frequency (count) of participants showing scores \> 2 by bolus consistency.

  Baseline (Single timepoint only)

Secondary Outcomes (3)

• Maximum Posterior Isometric Tongue Pressure (Observational).

  Single timeframe (baseline only)

• Number of Participants With Multiple Swallows Per Bolus (Observational)

  Single timeframe (baseline only)

• Number of Participants Displaying Prolonged Pharyngeal Bolus Transit (Observational)

  Single timeframe (baseline only)

Study Arms (2)

Amyotrophic Lateral Sclerosis

We will be recruiting individuals with confirmed or probably ALS, who experience speech or swallowing problems, to attend one data collection session. All participants will undergo the same protocol, including a Videofluoroscopic Swallowing Examination, and Tongue Strength Measurement.

Diagnostic Test: Videofluoroscopic Swallowing Examination; Other: Tongue Strength Measurement

Parkinson's Disease

We will be recruiting individuals with a diagnosis of Parkinson's disease, who experience speech or swallowing problems, to attend one data collection session. All participants will undergo the same protocol, including a Videofluoroscopic Swallowing Examination, and Tongue Strength Measurement.

Diagnostic Test: Videofluoroscopic Swallowing Examination; Other: Tongue Strength Measurement

Interventions

Videofluoroscopic Swallowing Examination DIAGNOSTIC_TEST

During the videofluoroscopy, subjects will take up to 21 sips of liquid, ranging in thickness from thin (like water), to extremely-thick (like pudding or custard). The liquids will be mixed with E-Z-Paque barium sulfate, to allow it to be visible on the x-ray.

Amyotrophic Lateral Sclerosis; Parkinson's Disease

Tongue Strength Measurement OTHER

We will measure tongue strength using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air will be placed in the mouth, just behind the front teeth. Participants will be asked to press their tongue upwards against the bulb as hard as they can, three (3) times at the front of the tongue and three (3) times at the back of the tongue (i.e., total of six (6) maximum isometric tongue presses). Participants will also be asked to swallow their saliva with the bulb placed in their mouth, three (3) times. Tongue pressure measurement will be completed twice in the data collection session - once at the beginning, and once at the end (following the videofluoroscopy).

Amyotrophic Lateral Sclerosis; Parkinson's Disease

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with ALS will be recruited from the multidisciplinary ALS clinics at the University of Florida during regularly scheduled care visits. Participants with Parkinson's disease will be recruited from the University of Florida Center for Movement Disorders.

You may qualify if:

• Adults (18+) with a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) or Parkinson's disease (PD)

You may not qualify if:

• People with a prior medical history of stroke
• People with a prior medical history of acquired brain injury
• People with a prior medical history of spinal or spinal cord injury
• People with a prior medical history of cancer or surgery in the head and neck region
• People who have had radiation to the head and neck for cancer
• People who have a prior history of swallowing problems (e.g., from childhood, medical complication)
• People with significant breathing difficulties (e.g., rely on mechanical ventilation)
• People who rely solely on tube-feeding for all meals and nutrition
• People who have Type I (insulin-dependent) Diabetes
• Women who are pregnant
• People who have allergies to barium, potato starch, corn starch, xanthan gum, milk products, latex or dental glue

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Florida: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (2)

• Pearson WG Jr, Molfenter SM, Smith ZM, Steele CM. Image-based measurement of post-swallow residue: the normalized residue ratio scale. Dysphagia. 2013 Jun;28(2):167-77. doi: 10.1007/s00455-012-9426-9. Epub 2012 Oct 23.

  PMID: 23089830 BACKGROUND

• Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.

  PMID: 8721066 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Parkinson Disease; Deglutition Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Movement Disorders; Synucleinopathies; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Limitations and Caveats

This was an observational study. For the majority of measures, we report count data for each cohort but do not compare frequencies across cohorts or across conditions (i.e. bolus consistencies) within cohort.

Results Point of Contact

• Title: Director, Swallowing Rehabilitation Research Laboratory
• Organization: University Health Network

tri-swallowinglab@uhn.ca

416 597 3422

Study Officials

• Catriona M Steele, PhD

  University Health Network - Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

• Emily K Plowman, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 20, 2017
• Study Start: November 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 15, 2022
• Results First Posted: July 14, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)