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K01 Impacts of Lingual Endurance Exercise

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Eligibility criteria shortened, about 19 words Secondary endpoints: 7 to 5v7 Show 1 more changeShow less
    • Secondary endpoints: 7 to 5

    See this version in full on ClinicalTrials.gov ↗

  2. Study description expanded, about 48 words Site contact updatedv6 Show 1 more changeShow less
    • Site contact updated

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  3. Site contact updated Collaborators: 2 to 3v5 Show 1 more changeShow less
    • Collaborators: 2 to 3

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  4. Re-verified, no change to tracked fieldsv4
  5. Secondary endpoints: 4 to 7v3 See this version in full on ClinicalTrials.gov ↗
  6. Eligibility criteria shortened, about 22 words Secondary endpoints: 3 to 4v2 Show 1 more changeShow less
    • Secondary endpoints: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Cincinnati
68 trials monitored
See 6 trials at risk
Stroke
3,289 trials monitored
See 141 trials at risk
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.
Trial Details
NCT Number NCT06072924
Lead Sponsor University of Cincinnati
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), TriHealth Inc.
Conditions Dysphagia, Dysphagia, Oropharyngeal, Ischemic Stroke, Stroke
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov