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临床试验/NCT03874507
NCT03874507已完成不适用

Technology-Based Intervention for Physical Therapy in Pediatric and Adult Populations

Stanford University4 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年7月25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
41
试验地点
4
主要终点
Patient and Physical Therapist Feedback

研究概览

简要总结

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality (VR) headset, Augmented Reality (AR) Headset) are more effective than the standard of care (i.e., no technology-based distraction) for improving clinical outcomes in patients requiring acute rehabilitation due to deconditioning and surgery. Measures will include include range of motion, gait progression, strength progression, time to first out of bed, time to first step.

研究设计

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

入排标准

年龄范围
6 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis need for physical rehabilitation

排除标准

  • Significant Cognitive Impairment
  • History of Severe Motion Sickness
  • Current Nausea
  • Visual Problems
  • Patients whose children are clinically unstable or require urgent/emergent intervention
  • Patients who clinically unstable or requires urgent/emergent intervention

结局指标

主要结局

Patient and Physical Therapist Feedback

时间窗: Survey of patient and PT satisfaction will be administered after the physical therapy session, duration of survey should take approximately 15 minutes or less

Survey of patient and PT satisfaction will be administered after the session. Example of survey questions, to which patient answered 'Yes or No,' for patient include 1) 'The VR game helped me during physical therapy' 2) 'I felt less pain when I moved using the VR game' The survey administered to physical therapists will be rated 1-5 (1=Not at all, 5= A lot) with questions such as 1) 'The technology was helpful to my patients during physical therapy' and 2) 'I would like my patient to have access to this technology for future physical therapy sessions'

Aggregate Movement

时间窗: Duration of physical therapy, approximately 10 minutes

Aggregate movement will be measured by either sensors in the VR/AR headset or by a physical therapist during the participants session

Patient Fatigue

时间窗: OMNI PRE Questionnaire will be administered after the physical therapy session, duration of questionnaire should take approximately 15 minutes or less

Patients will self-report fatigue according to the Adult OMNI-Walk/Run RPE Scale (OMNI RPE) scale after both the VR and standard of care portion. The OMNI RPE is an 11-category perceived exertion rating scale with a numerical rating from 0 to 10 (0= Not Tired at All, 10= Very, Very Tired).

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

Thomas Caruso

Clinical Associate Professor

Stanford University

研究点 (4)

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