Clinical trial NCT03475654: A Prospective Trial of Virtual Home Rehabilitation After Burn Injury
Official title: Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Burn Scar
Contracture
Keywords: exercise
therapy
rehabilitation
home
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled trial
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Level of physical activity
timeFrame: 3 months after study enrollment
Secondary outcomes:
measure: Range of motion (ROM)
timeFrame: Study enrollment, 3, 6 and 12 months after enrollment
measure: Patient-reported outcome measures (PROMIS): sleep
timeFrame: Study enrollment, 3, 6, 12 months after enrollment
measure: Patient-reported outcome measures (PROMIS): social participation
timeFrame: Study enrollment, 3, 6, 12 months after enrollment
measure: Patient-reported outcome measures (PROMIS): pain interference
timeFrame: Study enrollment, 3, 6, 12 months after enrollment
measure: Patient-reported outcome measures (PROMIS): fatigue
timeFrame: Study enrollment, 3, 6, 12 months after enrollment
measure: Patient-reported outcome measures (PROMIS): stiffness
timeFrame: Study enrollment, 3, 6, 12 months after enrollment
measure: Patient-reported outcome measures (PROMIS): mobility
timeFrame: Study enrollment, 3, 6, 12 months after enrollment
measure: Patient-reported outcome measures (PROMIS): upper extremity
timeFrame: Study enrollment, 3, 6, 12 months after enrollment
measure: Return to work/school
timeFrame: up to 1 year
measure: Patient reported level of activity difficulty
timeFrame: Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Tam Pham, MD
role: PRINCIPAL_INVESTIGATOR
References: