An interventional study of Technology-assisted rehabilitation and Usual care in Burns, Burn Scar and Contracture, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by University of Washington · Not applicable, Interventional, and Prevention
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.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's enrollment of 48 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Home environment includes access to:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group will receive treatment as usual, in addition to training with the Jintronix platform. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.
Behavioral: Technology-assisted rehabilitation
The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.
Behavioral: Usual care
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.
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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Sep 2022, 55 months.
Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 55 months is above that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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