跳至主要内容
临床试验/NCT04458376
NCT04458376已完成不适用

Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness; a Pilot Study

Helse Møre og Romsdal HF1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
user experience ease of use

研究概览

简要总结

Chronic dizziness,or persistent positional perceptual dizziness (PPPS) is a common condition that results in impaired quality of life and work ability of those affected. Vestibular Rehabilitation (VR) is an evidence-based and recommended treatment for chronic dizziness. The treatment involves training in specific exercises that challenge the balance system and eventually improve dizziness. The main challenge with this treatment is that it is usually best provided with individual follow-up of therapists trained in the method. Limited resources and the lack of dissemination of this knowledge mean that only a minority of patients receive adequate treatment. An internet-based self-help program in vestibular rehabilitation has been developed in Norwegian with demonstration and instructions of exercises. The program has six lessons, together lasting for six weeks. Patients are given the opportunity to exercise at home, without the use of treatment resources and without spending time traveling to the treatment site. Patients will have access through their general practitioner or health institution at no extra cost. If it turns out that the program works according to the intention, the investigators will be able to offer VR to a large number of PPPS patients who previously would not receive treatment for their condition.

The aim of the pilot study is to find out if the internet program for PPPS works as intended and evaluate incoming data and make changes to the program. In addition, the investigators will gain experience in using the program before designing a randomized clinical trial (RCT). The aim of such an RCT would be to compare this internet based treatment to traditional treatment.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Satisfy diagnostic criteria for persistent positional perceptual dizziness (PPPS) or satisfy criteria with a duration of <3 months
  • Vertigo symptom scale (VSS-SF) >12

排除标准

  • Cognitive dysfunction that is so pronounced that it will make participation difficult
  • Unable to read, understand Norwegian
  • Severe medical or psychiatric illness (including substance abuse) that reduces the patient's ability to follow the VR program

结局指标

主要结局

user experience ease of use

时间窗: 3 months

semi-structured conversation interview with score tools. The ease of use of the course will be scored in a 7 question questionnaire, rated 1-7 from very good to very bad. The questions are whether the program worked well, was boring, if it was the right dose of exercises, if the text was understandable, instructive, how was the yield and degree of subjective improvement. Participants will also be asked for preparation suggestions.

Symptom change

时间窗: 3 months

The Niigata persistent positional perceptual dizziness (PPPD) Questionnaire (NPQ) contains 12 questions in which patients answer questions about provocation from three aggravating factors of PPPD (upright posture / gait, movement and visual stimulation). Each factor is evaluated using questions that score the severity from 0 (none) to 6 (unbearable) ailments

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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