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临床试验/NCT04283279
NCT04283279Unknown不适用

Balance and Mobility in Older Adults With Hearing Impairment

Western Norway University of Applied Sciences0 个研究点目标入组 60 人开始时间: 2020年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Short physical performance battery

研究概览

简要总结

Hearing impairment is common in older adults, and recent research points to associations between hearing impairment and balance/mobility. The association may be due to more attentional resources being used to compensate for the sensory loss, with less resources available for maintaining balance. The aim of this projects is therefore to investigate whether an exercise program with focus on motor-cognitive tasks is feasible for older adults with hearing impairment. The study is meant as a proof-of-concept study, where trialling will be evaluated, and results will be used to inform the design of a larger and adequately powered study.

详细描述

Study design:

This is an experimental (exercise) study with follow-ups three and twelve months after exercise completion.

Participants:

Participants will be recruited from two instances:

  • "Praksisnett", which is a collaboration between GPs and researchers in Bergen, Norway, where GPs recruit potential participants to research projects.
  • The Ear, Nose, Throat department at Haukeland University Hospital (Bergen), who provide service to older adults with hearing impairment. The aim is to include 60 patients into three intervention arms: i) virtual reality exercises, ii) vestibular rehabilitation exercises and usual care

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Hearing threshold above 30 dB

排除标准

  • •Inability to give informed consent,
  • •Inability to speak Scandinavian languages or English
  • •Diseases with severe motor impairments (such as mb Parkinsons)

研究组 & 干预措施

Virtual reality exercise

Experimental

20 participants will be randomised to this arm

干预措施: Virtual reality exercise (Other)

Vestibular rehabilitation exercise

Experimental

20 participants will be randomised to this arm

干预措施: Vestibular rehabilitation exercise (Other)

Control

Other

20 participants will be randomised to this arm

干预措施: Control (Other)

结局指标

主要结局

Short physical performance battery

时间窗: Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention

Test of balance and mobility, with three tasks (walking, standing balance, sit-to-stand), scores from 0-12.

次要结局

  • Standing balance - posturography(Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention)
  • Walking balance(Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention)
  • The World Health Organisation Disability Assessment Schedule (WHODAS)(Measured as change from baseline/before intervention, to after intervention (six weeks after baseline), to three months after intervention and to 12 months after intervention)

研究者

发起方
Western Norway University of Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bård Bogen

Associate professor

Western Norway University of Applied Sciences

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