Impact of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairments After Ischemic Stroke

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Swallowing impairments (dysphagia) frequently occur after stroke and have devastating consequences on overall health and quality of life, and long-term deficits in swallow function also increase risk of morbidity (e.g. depression) and mortality (i.e. aspiration pneumonia). As such, rehabilitation of swallow function to improve safety and efficiency of swallowing is essential in this population. This study aims to: 1) Provide preliminary data to evaluate the effect of a novel lingual endurance exercise on swallow function in individuals with post-stroke dysphagia; and 2) Collect preliminary data regarding changes in white matter tract diffusion and cortical thickness and from MRI data to better understand effects of lingual exercise training on neuroplasticity.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\) 3-6 months since most recent diagnosis of ischemic, confirmed from clinical imaging) with or without small hemorrhagic transformation (HI-1)

• 2\) Have some indication of on-going swallowing issues

• 3\) English Speaking

Locations
United States
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Contact Information
Primary
Anna Hopkins, MS
hopkiak@ucmail.uc.edu
+1 513 558 4152
Backup
Rebecca Reinert
gibsonrk@ucmail.uc.edu
+1 513 558 1719
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 70
Treatments
Experimental: Lingual Endurance Exercise
The experimental exercise group will participate in 3 training sessions per day for 8 weeks. Endurance exercise will include completing isotonic endurance repetitions 3 times a day. Number of repetitions per session will be determined during baseline testing, and re-evaluated every 2 weeks, for each participant.
Sham_comparator: Sham Exercise
The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (approximately 1-15 kPa), which will be monitored weekly via device output sent to the study team to avoid use of excessive force that would qualify as exercise.
Related Therapeutic Areas
Sponsors
Collaborators: TriHealth Inc., National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: University of Cincinnati

This content was sourced from clinicaltrials.gov