Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Burns
- Sponsor
- University of Washington
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Level of physical activity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Tam Pham
Professor, School of Medicine: Surgery: Trauma, Burn and Critical Care Division
University of Washington
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Level of physical activity
Time Frame: 3 months after study enrollment
level of activity among enrolled subjects by actigraphy
Secondary Outcomes
- 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)