A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial

Conditions
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Burns, Burn Scar, Contracture

Intervention / Treatment
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* Behavioral: Technology-assisted rehabilitation
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: technology-assisted rehabilitation<br>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<br>* 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.<br>|
| Active Comparator: Usual care<br>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<br>* The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of physical activity | level of activity among enrolled subjects by actigraphy | 3 months after study enrollment | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, therapy, rehabilitation, home