Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Level of physical activity
研究概览
简要总结
The overarching goal for this prospective randomized controlled trial (PRCT) is to determine whether a virtual-environment, home-rehabilitation program improves functional outcomes for individuals after a burn injury. Specifically, this study will test the efficacy of a technology-assisted rehabilitation program against current standard of home therapy.
详细描述
This is a prospective, randomized controlled trial (PRCT) involving 50 adult burn survivors. This study tests the efficacy of a technology-assisted rehabilitation program against current standard of home therapy. There are two study groups for which subjects will be randomized: control and experimental.The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. The experimental group receives treatment as usual, in addition to training and use of the Jintronix platform for 3 months after hospital discharge. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age greater than or equal to 18 years old (no upper age limit)
- •Ability to provide written, informed consent for study participation
- •Ability to read and understand English
- •Anticipated discharge to home environment
- •Home environment includes access to:
- •television (larger than 20 inches in diameter with High Definition Multimedia Interface input (HDMI)
- •internet and email address
- •telephone (cell phone or landline)
排除标准
- •Age less than 18 years
- •Inability to provide written, informed consent for study participation
- •Inability to read or understand English
- •Delirium (as determined by the Delirium Observation Score test)
- •Near-fall event at time of screening
- •Pregnant women
- •Discharge to non-home environment (e.g., shelter, street, skilled nursing facility)
结局指标
主要结局
Level of physical activity
时间窗: 3 months after study enrollment
level of activity among enrolled subjects by actigraphy
次要结局
- Return to work/school(up to 1 year)
- Patient-reported outcome measures (PROMIS): social participation(Study enrollment, 3, 6, 12 months after enrollment)
- Patient-reported outcome measures (PROMIS): stiffness(Study enrollment, 3, 6, 12 months after enrollment)
- Patient-reported outcome measures (PROMIS): sleep(Study enrollment, 3, 6, 12 months after enrollment)
- Patient-reported outcome measures (PROMIS): upper extremity(Study enrollment, 3, 6, 12 months after enrollment)
- Patient-reported outcome measures (PROMIS): pain interference(Study enrollment, 3, 6, 12 months after enrollment)
- Patient-reported outcome measures (PROMIS): fatigue(Study enrollment, 3, 6, 12 months after enrollment)
- Patient-reported outcome measures (PROMIS): mobility(Study enrollment, 3, 6, 12 months after enrollment)
- Range of motion (ROM)(Study enrollment, 3, 6 and 12 months after enrollment)
- Patient reported level of activity difficulty(Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment)
研究者
Tam Pham
Professor, School of Medicine: Surgery: Trauma, Burn and Critical Care Division
University of Washington