K01 Impacts of Lingual Endurance Exercise

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT06072924
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Isotonic Endurance Exercise — BEHAVIORAL
    Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day
  • Sham Exercise — BEHAVIORAL
    Pressing tongue against pressure sensor at a low threshold (1-15kPa) 30x/day

Study Details

The goal of this clinical trial is to learn whether a tongue endurance exercise program can improve swallowing function in adults with dysphagia after a stroke. It also aims to explore how this exercise may affect brain structure and connectivity involved in swallowing. The main questions it aims to answer are: Primary Aim: Does lingual endurance exercise improve swallowing function compared to a sham therapy? Secondary Aim: Does lingual endurance exercise lead to changes in brain structure or neuroplasticity, as measured by MRI? Researchers will compare a group receiving tongue endurance exercises to a sham therapy group to see whether the treatment improves tongue function, swallowing. Participants will: * Complete a baseline swallowing assessment and MRI * Be randomly assigned to either the lingual exercise or sham therapy group * Complete 8 weeks of home-based tongue exercise therapy * Return for follow-up swallowing assessments * A subgroup of participants will complete a pre-treatment and post-treatment MRI.

Key Dates

Start date
Sep 1, 2023
Status verified
Dec 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score) [ Time Frame: Change from Baseline (at the end of 8 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45220
Anna Hopkins, MS
[email protected]
+1 513 558 4152
Brittany Krekeler, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cincinnati, OH

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Cincinnati· Cincinnati, OH

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