Burns Clinical Trial
Official title:
Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Harborview Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of physical activity | level of activity among enrolled subjects by actigraphy | 3 months after study enrollment | |
Secondary | Range of motion (ROM) | ROM by subjects in each group | Study enrollment, 3, 6 and 12 months after enrollment | |
Secondary | Patient-reported outcome measures (PROMIS): sleep | Sleep and sleep disturbance Short Form (SF)8B PROMIS tool | Study enrollment, 3, 6, 12 months after enrollment | |
Secondary | Patient-reported outcome measures (PROMIS): social participation | Participation in social roles and activities PROMIS tool SF6A | Study enrollment, 3, 6, 12 months after enrollment | |
Secondary | Patient-reported outcome measures (PROMIS): pain interference | Pain interference PROMIS tool SF6A | Study enrollment, 3, 6, 12 months after enrollment | |
Secondary | Patient-reported outcome measures (PROMIS): fatigue | Fatigue PROMIS tool SF6A | Study enrollment, 3, 6, 12 months after enrollment | |
Secondary | Patient-reported outcome measures (PROMIS): stiffness | Stiffness impact Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) V2.0 | Study enrollment, 3, 6, 12 months after enrollment | |
Secondary | Patient-reported outcome measures (PROMIS): mobility | Mobility PROMIS tool | Study enrollment, 3, 6, 12 months after enrollment | |
Secondary | Patient-reported outcome measures (PROMIS): upper extremity | Upper extremity PROMIS SF7A | Study enrollment, 3, 6, 12 months after enrollment | |
Secondary | Return to work/school | Date when subject returns to work or school | up to 1 year | |
Secondary | Patient reported level of activity difficulty | Using 1-5 difficulty scale (1=no difficulty and 5=very difficult), subject is asked how difficult his/her activity has been for the past 2 days | Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment |
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