跳至主要内容
临床试验/NCT05935618
NCT05935618招募中不适用

No Food or Drink Does Any Good Until It is Swallowed: a Proof-of-concept Study on Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
The McGill Ingestive Skills Assessment-version 2 (MISA2).

研究概览

简要总结

The goal of this proof-of-concept study is to assess the potential of a newly developed intervention with combined skill- and strength-based principles for maximizing swallowing-related outcomes and prevent further weakening of the swallowing muscles in older people with dysphagia (difficulty swallowing).

The main questions to be answered are:

  1. Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia?
  2. Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia?
  3. Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia?
  4. Is there an association between perceived autonomy support and intervention engagement when older individuals with dysphagia receive the intervention during hospitalization and continued in community-based rehabilitation after discharge?

Participants will be asked to perform goal-directed and task-specific swallowing exercises in eating and drinking activities where the intensity variables include advancing steps of an altered bolus volume and consistency according to a 17-level task hierarchy, which are introduced according to predetermined progression rules, as well as increases in swallowing repetitions. The dosage is 2-3 individual, face-to-face therapy sessions per week for up to a maximum of eight weeks. A therapy session lasts up to 45 min. In between therapy sessions, participants integrate the achieved level from therapy into their daily meals as self-training.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • A score of 5-18 on the Gugging Swallowing Screen.
  • Speaks and understands Danish.
  • Are able to cooperate in the intervention and give written informed consent; i.e. is oriented in time, place and own data, and able to perform four simple oral motor movements on request.
  • Has given written informed consent.

排除标准

  • Esophageal dysphagia.
  • Progressive neurologenic dysphagia.
  • Psychiatric illness.
  • Delirious.
  • Infections that requires isolation.
  • Need for palliative care.

结局指标

主要结局

The McGill Ingestive Skills Assessment-version 2 (MISA2).

时间窗: From enrollment to the end of treatment at 8 weeks

Maasure of meal-time task performance. The total score range from 36-108, where higher score indicate higher performance

次要结局

  • Mini Nutritional Assessment-Short Form(From enrollment to the end of treatment at 8 weeks)
  • Basic psychological needs in exercise scale (BPNES)(At end of treatment at 8 weeks)
  • Self-reported swallowing difficulties(From enrollment to the end of treatment at 8 weeks)
  • Functional Oral Intake Scale (FOIS)(From enrollment to the end of treatment at 8 weeks)
  • Nordic Orofacial Test - screening (NOT-S)(From enrollment to the end of treatment at 8 weeks)
  • Iowa Oral Performance Instrument (IOPI)(From enrollment to the end of treatment at 8 weeks)
  • Emotional wellbeing and global quality of life(At end of treatment at 8 weeks)

研究者

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

Tina Hansen, PhD, MSc.OT

Senior Researcher

Hvidovre University Hospital

研究点 (2)

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