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临床试验/NCT06683417
NCT06683417尚未招募不适用

Vestibular Rehabilitation Aid (VestAid)

BlueHalo2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
2
主要终点
Dizziness Handicap Inventory (DHI)

研究概览

简要总结

This multi-center randomized trial (MCRT) will investigate the effectiveness of the VestAid application to provide equivalent or faster recovery from dizziness compared to standard-of-care delivery of vestibular rehabilitation exercises.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Snellen visual acuity (corrected) greater than 20/40
  • No more than 25dB hearing loss at 500,1000, 2000, and 4000 Hz
  • Ability to detect 4.31 using Semmes-Weinstein monofilament at the lower extremity
  • At least 40 degrees of neck yaw motion with only mild to moderate pain (6 or under on 0-10 numeric pain scale)
  • Internet access at home
  • No significant residual from past musculoskeletal or neuromuscular conditions
  • Ability ambulates unassisted
  • Diagnosed with a concussion or inner ear problem the last 30 days
  • Between 18-60 years of age
  • Can read and understand English
  • Has complaints of dizziness

排除标准

  • Greater then 30 days since diagnosis of concussion/mTBI or inner ear problem
  • No access to internet at home
  • Younger than 18 years of age or older than 60 years of age
  • Cannot read or understand English
  • No complaints of dizziness and/or balance deficits
  • Have significant neuropathy
  • Cannot see tablet clearly at 1 meter
  • Neck pain >5 on a 10-point pain scale.

结局指标

主要结局

Dizziness Handicap Inventory (DHI)

时间窗: From enrollment weekly for 6 weeks.

A self report measure of dizziness (questionnaire)

次要结局

  • Secondary Endpoint(From enrollment weekly for 6 weeks)

研究者

发起方
BlueHalo
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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