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临床试验/NCT06963645
NCT06963645撤回不适用

Augmented Reality-based Telerehabilitation Platform for Patients With Stroke: A Feasibility Study

Stanford University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
30
试验地点
1
主要终点
Adherence

研究概览

简要总结

The study is to 1) determine the feasibility of the use of our augmented reality (AR) rehabilitation program, including its preliminary efficacy, 2) determine the feasibility of obtaining an augmented reality assessment based on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years or older
  • •≥3 months post ischemic or hemorrhagic stroke
  • •Upper extremity deficit with an FMA-UE score between 20-50
  • •Able to operate the AR device independently or with the help of a caregiver
  • •Sufficiently proficient in the English language to follow instructions from Reia

排除标准

  • •History of developmental, neurological or psychological impairment leading to functional disability
  • •Vision or visual field impairment that interferes with the use of the AR headset
  • •Severe photosensitivity that makes use of the AR headset uncomfortable
  • •History of visually provoked seizures
  • •Hearing aids
  • •Cardiac pacemaker
  • •Implantable cardioverter-defibrillator (ICD)

研究组 & 干预措施

Telerehabilitation Group

Experimental

Participants will use a mobile medical device in a augmented reality (AR) headset for 30 minutes daily to support their rehabilitation process after stroke by completing assessments and training programs.

干预措施: AR rehabilitation app (Device)

结局指标

主要结局

Adherence

时间窗: 8 weeks

Percentage of days during the 8-week intervention period that a patient completes their 30-minute rehabilitation session.

Percentage of participants who successfully complete the vFMA-UE

时间窗: Day 70

Feasibility of obtaining the Fugl-Meyer Assessment - Upper Extremity (vFMA-UE) unsupervised, described by the percentage of participants who successfully complete the vFMA-UE at home on day 70, among patients who attempted to do the unsupervised vFMA-UE.

次要结局

未报告次要终点

研究者

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

Maarten Lansberg

Professor of Neurology

Stanford University

研究点 (1)

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