Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tele-Rehabilitation.
- Who it may be relevant to
- Registry conditions: Burns. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Tele-Rehabilitation
Technology will be used to enhance rehabilitation.
Primary outcome measures
- Change in range of motion, measured with a goniometer [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 outcome measures (8)
- Scar Volume [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)]
- Elasticity, color, temperature, trans epidermal water loss, and scar thickness [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)]
- Blood Flow [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)]
- Patient and Observer Scar Assessment Scale v2.0 [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)]
- Pain Visual Analog Scale (VAS) Score [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)]
- Post Interview [Time frame: 6 months (± 2 weeks) post discharge]
- Overall Activity [Time frame: Months 2, 4, and 5 (+15 days, each timepoint) in addition to 1, 3, & 6 months after discharge.]
- Itch Scale [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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas Medical Branch — Galveston
Identifiers
NCT: NCT06162052 · 21-0331