Burns, Burn Scar, Contracture
Conditions
Keywords
exercise, therapy, rehabilitation, home
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.
Interventions
BEHAVIORALTechnology-assisted rehabilitation
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.
BEHAVIORALUsual care
The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of physical activity | 3 months after study enrollment | level of activity among enrolled subjects by actigraphy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcome measures (PROMIS): sleep | Study enrollment, 3, 6, 12 months after enrollment | Sleep and sleep disturbance Short Form (SF)8B PROMIS tool |
| Patient-reported outcome measures (PROMIS): social participation | Study enrollment, 3, 6, 12 months after enrollment | Participation in social roles and activities PROMIS tool SF6A |
| Patient-reported outcome measures (PROMIS): pain interference | Study enrollment, 3, 6, 12 months after enrollment | Pain interference PROMIS tool SF6A |
| Patient-reported outcome measures (PROMIS): fatigue | Study enrollment, 3, 6, 12 months after enrollment | Fatigue PROMIS tool SF6A |
| Range of motion (ROM) | Study enrollment, 3, 6 and 12 months after enrollment | ROM by subjects in each group |
| Patient-reported outcome measures (PROMIS): mobility | Study enrollment, 3, 6, 12 months after enrollment | Mobility PROMIS tool |
| Patient-reported outcome measures (PROMIS): upper extremity | Study enrollment, 3, 6, 12 months after enrollment | Upper extremity PROMIS SF7A |
| Return to work/school | up to 1 year | Date when subject returns to work or school |
| Patient reported level of activity difficulty | Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment | 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 |
| Patient-reported outcome measures (PROMIS): stiffness | Study enrollment, 3, 6, 12 months after enrollment | Stiffness impact Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) V2.0 |
Countries
United States
Outcome results
None listed