Determining an Optimal Delivery Method for Tongue Strengthening During Swallowing Rehabilitation: Building a Framework for Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Change in effortful swallow pressure (ESP)
研究概览
简要总结
The research team will conduct a multi-site, randomized controlled trial examining the effectiveness of exercise intensity progression compared to standard practice (no progression) in the context of swallowing rehabilitation. The study will also determine the impact of using biofeedback during resistance training on tongue strength. The study is a first step in determining an optimal delivery of tongue strengthening exercise in typically aging older persons, with the plan to develop a framework for guiding clinical practice of tongue strengthening in various dysphagic populations. Participants will be randomized into one of four treatment groups and complete 8 weeks of tongue resistance training.
详细描述
Rehabilitative exercises have been central to dysphagia (swallowing difficulty) treatment for decades, with the goal to increase strength, endurance, and/or coordination of the muscles responsible for swallowing. With any exercise-based therapy, an understanding of dosing is critical to optimize outcomes and to avoid over- or under-prescribing exercise, which can have a negative effect. For example, overtraining can lead to reductions in strength, which may put patients who are completing a swallowing rehabilitation program at increased risk. Therefore, it is important to develop dosing recommendations specific to swallowing musculature. Clinical practice remains unguided in terms of whether a progressive or maximum intensity, both common forms of rehabilitative exercise for dysphagic patients, should be used for lingual resistance training. Speech-Language Pathologists (SLP) currently base these decisions on preference and experience; however, research is desperately needed in this area to support and guide clinical decisions. The investigators aim to fill this gap in evidence by determining an optimal dosing for tongue strengthening in older persons. It is anticipated that the study findings will directly influence clinical decisions in both inpatient rehabilitation facilities and home health post-acute care settings, and ultimately improve patient outcomes in the area of swallowing. This study represents the start of a research program intended to provide significant information on optimal delivery of tongue strengthening exercise in various populations with difficulty swallowing.
To determine an optimal delivery method for tongue resistance training in healthy older persons by examining how intensity progression and biofeedback impacts tongue strength, participant motivation, and program adherence. The data collected in this initial study will inform future studies designed to develop a framework for guiding clinical practice with SLPs prescribing tongue strengthening exercise to patients with swallowing issues.
Primary Research Questions:
- Is tongue strength impacted by exercise resistance intensity when comparing progressive resistance to maximum resistance?
- Is tongue strength impacted by visual biofeedback during tongue resistance training?
Secondary Research Questions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant will only know exercise instructions for the group he/she is randomized to. Participant will not be provided with information about other groups.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are age 55 or older
- •< 3 score on Eating Assessment Tool-10 (screening tool for swallowing difficulty)
- •> 24 score on Mini Mental State Examination (screening tool for cognitive impairment)
- •Have a normal oral structure as assessed with an oral mechanism screener
排除标准
- •A history of seizures (contraindication for Tongueometer™ use)
- •Past or present pain disorders involving the jaw or mandible (e.g., TMJ disorder, myofascial pain disorder) (contraindication for Tongueometer™ use)
- •A history of oral surgery (routine dental surgery acceptable)
- •A history of neurogenic disorder (e.g., Parkinson's disease)
- •A history of swallowing difficulty
- •Not being able to complete an 8-week study protocol
结局指标
主要结局
Change in effortful swallow pressure (ESP)
时间窗: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
ESP in kilopascals (kPa)
Change in maximum isometric tongue pressure (MIP)
时间窗: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
MIP in kilopascals (kPa)
Change in regular effort saliva swallow pressure (RESS)
时间窗: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
RESS is kilopascals (kPa)
次要结局
- Change in participant-perceived motivation for assigned exercise regimen(Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program)
- Exercise adherence tracking(Collected at Weeks, 2, 4, 6, 8; and 1-month post if participant was randomized to a maintenance program)
- Change in participant-perceived confidence for assigned exercise regimen(Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program)