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临床试验/NCT01370083
NCT01370083已完成2 期

Tongue Pressure Profile Training for Dysphagia Post Stroke

Toronto Rehabilitation Institute1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
14
试验地点
1
主要终点
Change in Swallow Response Time for 5 cc Thin Liquid Swallows

研究概览

简要总结

People with swallowing impairment experience particular difficulty swallowing thin liquids safely; the fast flow of liquids makes them difficult to control. The tongue plays a critical role in containing liquids in the mouth, channeling the direction of their flow towards the pharynx (throat) and controlling their flow along that channel. The investigators are engaged in a program of research to better understand tongue function in swallowing, particularly with respect to controlling the flow of liquids. In this study the investigators will compare two different tongue-pressure resistance training protocols, to determine whether a protocol that emphasizes strength-and-accuracy or one that emphasizes pressure timing work better for improving liquid flow control in swallowing.

详细描述

Drinking thin liquids is something that most of us take for granted; yet this task is one that many patients with dysphagia (swallowing impairment) cannot do safely. Instead, these individuals receive liquids in thickened form: thickened juice, thickened coffee... even thickened water. The literature tells us that patients dislike the taste and feel of thickened liquids and find that their thirst is not quenched. Patients on thickened liquids are prone to inadequate fluid intake and dehydration. Many patients are non- compliant and drink thin liquids, despite documented risk for aspiration (i.e., airway invasion) and its consequences. Given these limitations, it is important that dysphagia researchers continue to pursue treatments with the potential to restore safe and functional thin liquid swallowing in people with dysphagia.

In the past decade, tongue pressure resistance training has emerged as an innovative treatment for dysphagia. Dr. JoAnne Robbins (University of Wisconsin - Madison)has shown that 8-weeks of intensive tongue pressure resistance training improves tongue strength in healthy seniors and those with dysphagia following stroke. In our lab (the Swallowing Rehabilitation Research Laboratory at the Toronto Rehabilitation Institute), the investigators have studied a variation on Dr. Robbins' treatment called "Tongue Pressure Strength and Accuracy Training". This approach also improves tongue strength and improves aspiration. However, the investigators continue to be bothered by the fact that people with dysphagia post stroke often have difficulty controlling the flow of thin liquids, even after these strength-focused protocols of tongue-pressure training.

The investigators have recently completed a study of tongue pressures profiles (strength and timing) in healthy people, which shows that tongue pressures are released more slowly with thin liquids than with thick liquids. This reveals active control of thin liquid flow, and suggests that both the strength and timing of tongue pressure play a role in flow-control. The investigators believe that treatment outcomes may be better if tongue pressure resistance training protocols take both strength and timing into consideration. To this end, the investigators have recently identified a subset of tongue pressure training tasks for which the strength and timing profile of tongue pressure onset and release is similar to that seen in liquid swallowing. The investigators propose that a treatment protocol will have better potential to yield favourable outcomes for thin liquid flow-control if it focuses on such tasks.

In this study, the investigators want to determine whether tongue pressure profile training, which addresses both timing and amplitude issues in tongue pressure generation, yields better functional outcomes in swallowing than strength-and-accuracy focused treatment. The investigators will pursue this question in a small randomized prospective trial, building on our prior work in this area.

The investigators will recruit 60 new patients with who demonstrate thin liquid flow-control difficulties secondary to stroke. These individuals will be randomized either to tongue-pressure strength-and-accuracy training (TPSAT) or to the novel intervention, tongue-pressure profile training (TPPT). The investigators will study their treatment outcomes after 12 weeks (24-sessions) of treatment.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Individuals with dysphagia characterized by prolonged swallow response duration for 5 cc boluses of thin liquid (i.e., > 350 ms, confirmed in videofluoroscopy).

排除标准

  • •premorbid reported history of swallowing, motor speech, gastro-esophageal or neurological difficulties.
  • •prior history of surgery to the speech apparatus (other than routine tonsillectomy or adenoidectomy).

研究组 & 干预措施

Stroke: TPPT

Experimental

Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.

干预措施: Tongue Pressure Profile Training (Behavioral)

Stroke: TPSAT Control

Active Comparator

Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.

干预措施: Tongue-Pressure Strength-and-Accuracy Training (Behavioral)

结局指标

主要结局

Change in Swallow Response Time for 5 cc Thin Liquid Swallows

时间窗: Post treatment (12 weeks)

Swallow response time (the time duration between bolus passing the ramus of the shadow of the mandible and onset of hyolaryngeal excursion for airway protection 5cc thin liquid barium boluses in videofluoroscopy. Measures \> 350 ms are considered to reflect impairment and a heightened risk of penetration-aspiration. The participant's mean swallow response time will be calculated across a series of 3 X 5 cc swallows and then reduced to a binary score \< vs \> 350 milliseconds.

次要结局

  • Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows(Post-treatment (12 weeks))
  • Tongue-palate Pressure Amplitude for Maximum Isometric Pressures(Post-treatment value)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catriona M. Steele

Senior Scientist

Toronto Rehabilitation Institute

研究点 (1)

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