K01 Impacts of Lingual Endurance Exercise

Официальное название

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

Обзор

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.

Подробное описание

This randomized, controlled clinical trial investigates the efficacy of a 8-week lingual endurance exercise program in adults with dysphagia following stroke. The study uses a two-arm, parallel-group design with participants randomized to either a lingual endurance exercise group or a sham therapy control group. Both interventions are delivered using a lingual manometer, which participants use at home under monitored conditions.

The primary aim is to evaluate changes in oral-phase swallowing physiology using the Modified Barium Swallow Impairment Profile (MBSImP) Oral Total Score, as assessed through video-fluoroscopic swallowing study (VFSS).

An exploratory aim will assess potential neuroplasticity associated with lingual endurance exercise using multimodal neuroimaging. Participants who meet MRI eligibility criteria undergo pre- and post-intervention imaging, including diffusion tensor imaging (DTI) to assess white matter integrity, high-resolution structural imaging for cortical thickness estimation, and functional MRI (task-based and resting state). Data will be used to evaluate intervention-related changes in regions associated with swallowing motor control and sensory integration.

This study also supports the investigator's training in clinical trial methodology, swallowing outcomes analysis, and neuroimaging techniques, and will inform a future, fully powered efficacy trial.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (7)

• Pharyngeal Swallow Efficiency [Срок оценки: Change from Baseline (at the end of 8 weeks)]
• Penetration Aspiration Scale (PAS) Scores [Срок оценки: Change from Baseline (at the end of 8 weeks)]
• Adherence [Срок оценки: At the end of 8 weeks]
• Pharyngeal Swallow Safety [Срок оценки: Change from Baseline (at the end of 8 weeks)]
• Maximum Isometric Pressure imaging with video-fluoroscopy [Срок оценки: Change from Baseline (at the end of 8 weeks)]
• Dietary Intake (Average Daily Calorie Intake) Outcome [Срок оценки: Change from Baseline (at the end of 8 weeks)]
• Food Textures Consumed Outcome [Срок оценки: Change from Baseline (at the end of 8 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 1\) ≤18 years of age
• 2\) history of dysphagia prior to or after the stroke caused by any of the following conditions: gastrointestinal disease, traumatic brain injury, head and neck cancer, surgery involving the pharynx or larynx
• 3\) history of other neurological disease (i.e. multiple sclerosis, ALS, Parkinson's, dementia).
• 4\) Medium to large hemorrhagic transformation/involvement documented on clinical stroke imaging 5) 5) History of temporomandibular joint and muscle disorders (also known as TMJ).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Cincinnati — Cincinnati

Идентификаторы

NCT: NCT06072924 · 2023-0582 Lingual Endurance · 1K01HD111680-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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