Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn.

Detailed Description
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This is a prospective single center randomized trial comparing a traditional approach to physical therapy to a technology-enhanced approach following a burn. We hypothesize that with the implementation of a novel telerehabilitation program incorporating technology enhancement, range of motion and quality of life can be improved. To test the hypothesis in future grant applications, this pilot study will be used to determine feasibility, collect preliminary data, vet endpoints, and gain patient feedback. To achieve these necessary goals, we will compare two methods of supporting home performance of prescribed physical and occupational therapy: Standard (S): patients will be equipped with paper instructions for their physical therapy exercises; and Technology-Enhanced (TE) support: patients will be given paper instructions, set up with a habit and productivity application (Avocation) that gamifies tasks and tracks achievements, a Fitbit activity tracker, a logbook, and have virtual movement therapy once weekly with an exercise physiologist for a total of four weeks. Specific Aim 1: To determine whether range of motion is altered with TE. Range of motion in the affected joint(s) will be measured by goniometry (self-reported by patient and measured by study staff in the clinic) Specific Aim 2: To determine whether TE with prescribed movement affects scar, pain, and quality of life.

Official Title
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Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery

Conditions
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Burns

Intervention / Treatment
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* Other: Tele-Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults: ≥18 to ≤79 years of age Not participating in another interventional trial Admitted to the Blocker Burn Unit for treatment of initial burn Subject is able and willing to follow the protocol requirements Burn wound / scar / contracture occurring across at least one joint. Has regular access to smart phone, tablet, or computer with internet access. Exclusion Criteria: Any medical condition that, in the opinion of the investigator or physician, would place the subject at increased risk for participation. Concurrent participation on another interventional clinical trial History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions. Patients without internet access.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A Standard of Care group (SOC)<br>Participants will receive standard of care education by the physical or occupational therapist regarding performance of the prescribed movements prior to discharge. Participants will complete the study about 6 months after discharge. | Other: Tele-Rehabilitation<br>* Technology will be used to enhance rehabilitation.<br>|
| Experimental: A Standard of Care group (SOC) combined with technology enhancement<br>Participants will receive standard of care education by the physical or occupational therapist regarding performance of the prescribed movements prior to discharge. Participants will undergo additional training in the use of a goniometer to measure range of motion at home and record the measurement once a week for 6 months. Participants will engage in 4 virtual sessions as well as wear a Fitbit | Other: Tele-Rehabilitation<br>* Technology will be used to enhance rehabilitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in range of motion, measured with a goniometer | Patient will be asked to bend the affected joint, and the goniometer held next to the joint to measure the angle. The range of motion for the opposite joint will be measured as well. | Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar Volume | 3D photo taken with LifeViz 3DII camera. | Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint) | 
| Elasticity, color, temperature, trans epidermal water loss, and scar thickness | Measured with Dermalab combo (Cortex Technology, Denmark); each probe is held with constant pressure on the skin or scar surface for one minute; multiple measures are conducted to reduce variability. | Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint) | 
| Blood Flow | A laser speckle device will be used to measure blood flow without contact. | Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint) | 
| Patient and Observer Scar Assessment Scale v2.0 | The scale consists of six items rated from 1 to 10, where 1 is normal skin and 10 is the worst imaginable scar. The observer (i.e., investigator) evaluates scar vascularity, pigmentation, thickness, relief, pliability, and surface area. The scores of each of the six items are summed for a total score (range 6 to 60). | Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint) | 
| Pain Visual Analog Scale (VAS) Score | Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 100 = worst pain imaginable). | Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint) | 
| Post Interview | At the conclusion of each patient's participation, they will meet with an investigator or delegated study staff for a brief non-structured interview to discuss participation in the study including improvements for follow-up studies. | 6 months (± 2 weeks) post discharge | 
| Overall Activity | To be captured via Fitbit on a daily basis to gauge overall activity. These data will be correlated with the pain scale as reduced activity is associated with pain. | Months 2, 4, and 5 (+15 days, each timepoint) in addition to 1, 3, & 6 months after discharge. | 
| Itch Scale | A Visual Analog Scale will be used for patients to rate their itch from 0 to 100. (VAS; 0 = no itch, 100 = worst itch imaginable). | Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint) |