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
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:
- Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia?
- Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia?
- Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia?
- 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
- 否
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
Tina Hansen, PhD, MSc.OT
Senior Researcher
Hvidovre University Hospital
