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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| technology-assisted rehabilitation | Experimental | 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. |
|
| Usual care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology-assisted rehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of physical activity | level of activity among enrolled subjects by actigraphy | 3 months after study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Range of motion (ROM) | ROM by subjects in each group | 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tam Pham, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D003286 | Contracture |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009135 | Muscular Diseases |
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prospective randomized controlled trial
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| Usual care | Behavioral | The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. |
|
| Study enrollment, 3, 6, 12 months after enrollment |
| Patient-reported outcome measures (PROMIS): social participation | Participation in social roles and activities PROMIS tool SF6A | Study enrollment, 3, 6, 12 months after enrollment |
| Patient-reported outcome measures (PROMIS): pain interference | Pain interference PROMIS tool SF6A | Study enrollment, 3, 6, 12 months after enrollment |
| Patient-reported outcome measures (PROMIS): fatigue | Fatigue PROMIS tool SF6A | 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 | Study enrollment, 3, 6, 12 months after enrollment |
| Patient-reported outcome measures (PROMIS): mobility | Mobility PROMIS tool | Study enrollment, 3, 6, 12 months after enrollment |
| Patient-reported outcome measures (PROMIS): upper extremity | Upper extremity PROMIS SF7A | Study enrollment, 3, 6, 12 months after enrollment |
| Return to work/school | Date when subject returns to work or school | 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 | Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment |
| D001519 |
| Behavior |