Clinical trial NCT05464225: Colorado Oral Strengthening Device
Official title: Colorado Oral Strengthening Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: tongue strength
novel exercise
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Davis Phinney Foundation
First posted: 2022-07-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort of 60 individuals with Parkinson's will be randomly assigned (please read 'Participant Randomization' below) to either exercise using the COSD or to standard of care using tongue depressors, as per the request of the funding source.
Primary purpose: TREATMENT

Brief summary: University of Colorado is looking for adults with Parkinson's disease to participate in a research study. The study aims to explore how a novel low technology device can achieve an increase in tongue strength comparable to standard of care exercise using tongue depressors but with the kinematics and simple biofeedback of existing high cost devices. Research has shown that tongue resistance exercises paired with biofeedback have resulted in improved tongue strength to support chewing, control of food and liquid in the mouth, and propulsion of material for a swallow.

Detailed description: When an individual contacts the PI or the department research coordinator, a preliminary screen will be administered for any obvious exclusion. If there are no exclusions, the first visit will be scheduled. At this initial visit, a full description of the study and exercise protocol will be provided. A health history questionnaire and an EAT-10 questionnaire will be administered.

If consent is obtained, baseline tongue strength will be measured using the IOPI device. Individuals with Parkinson's will be randomized to exercise with the COSD or with the tongue depressors. Those who will use the COSD will be start with no less than 60% max strength and receive an exercise log. Those using the tongue depressors will also receive an exercise log.

All participants will receive a full demonstration of the exercise and will be asked to return the demonstration.

The second visit will be scheduled for all participants the following week. At that time, the EAT-10 and tongue strength will be re-assessed. The exercise logs will be reviewed to ensure compliance. Participants using the COSD will be issued a new device that is no less than 80% of their max strength.

The third visit will be scheduled the following week (week 3). The EAT-10 questionnaire and tongue strength will be reassessed. The exercise log will be reviewed for compliance. COSD will be inspected for any signs of wear and a new one will be issued if the device appears worn.

The last 2 visits will be scheduled during weeks 6 and 8 of the exercise protocol. The EAT-10 and tongue strength will be re-assessed, and the exercise log will be reviewed for compliance. The COSD will be inspected for any signs of wear and a new one will be issued if the device appears worn. In addition, during the final visit, all participants will be asked to complete a questionnaire regarding their satisfaction with the exercise device they were assigned. The COSD will be collected at that visit.

Eligibility criteria: Inclusion Criteria:

1. 18 to 89 years old(inclusive)
2. Diagnosis of Parkinson's Disease
3. Hoen and Yahr stage II-IV
4. Signs or symptoms of dysphagia evidenced by an EAT-10 score of 3 or more

Exclusion Criteria:

1. Unwilling to sign the informed consent
2. Atypical Parkinson's Disease, Parkinson Plus, Lewy Body Dementia, Multiple System Atrophy
3. History of head or neck cancer
4. History of seizures
5. Current or past disorders of the jaw
6. Allergy to device materials

Primary outcomes:
measure: Change in Tongue Strength, as measured in kPa via IOPI
timeFrame: Baseline, up to 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: Department of Otolaryngology
name: Elizabeth Cuadrado
role: PRINCIPAL_INVESTIGATOR
References: