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

ConditionBurns
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorThe University of Texas Medical Branch, Galveston

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tele-Rehabilitation

    Other intervention

    Technology will be used to enhance rehabilitation.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: A Standard of Care group (SOC)Experimental treatment 1 intervention
Group B: A Standard of Care group (SOC) combined with technology enhancementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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 outcomes

1

Scar Volume

3D photo taken with LifeViz 3DII camera.

Time frame
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)
2

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.

Time frame
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)
3

Blood Flow

A laser speckle device will be used to measure blood flow without contact.

Time frame
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)
4

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).

Time frame
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)

Other outcomes

Sponsors and contacts

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