Clinical trial NCT06162052: Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery
Official title: Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in range of motion, measured with a goniometer
timeFrame: 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:
measure: Scar Volume
timeFrame: 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)
measure: Elasticity, color, temperature, trans epidermal water loss, and scar thickness
timeFrame: 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)
measure: Blood Flow
timeFrame: 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)
measure: Patient and Observer Scar Assessment Scale v2.0
timeFrame: 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)
measure: Pain Visual Analog Scale (VAS) Score
timeFrame: 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)
measure: Post Interview
timeFrame: 6 months (± 2 weeks) post discharge
measure: Overall Activity
timeFrame: Months 2, 4, and 5 (+15 days, each timepoint) in addition to 1, 3, & 6 months after discharge.
measure: Itch Scale
timeFrame: 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:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Celeste Finnerty, PhD
role: PRINCIPAL_INVESTIGATOR
References: