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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
48
The Jintronix software platform, coupled with the Microsoft Kinect for movement capture, contains individualized exercise modules to increase ROM, endurance and strength. Within this PRCT, online monitoring of activity and actigraphy measurements through a wearable device and completion of an online diary will provide enhanced monitoring of home activities.
The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge.
Harborview Medical Center
Seattle, Washington, United States
Level of physical activity
level of activity among enrolled subjects by actigraphy
Time frame: 3 months after study enrollment
Range of motion (ROM)
ROM by subjects in each group
Time frame: Study enrollment, 3, 6 and 12 months after enrollment
Patient-reported outcome measures (PROMIS): sleep
Sleep and sleep disturbance Short Form (SF)8B PROMIS tool
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): social participation
Participation in social roles and activities PROMIS tool SF6A
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): pain interference
Pain interference PROMIS tool SF6A
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): fatigue
Fatigue PROMIS tool SF6A
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): stiffness
Stiffness impact Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) V2.0
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): mobility
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Mobility PROMIS tool
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): upper extremity
Upper extremity PROMIS SF7A
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Return to work/school
Date when subject returns to work or school
Time frame: up to 1 year
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
Time frame: Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment