University of Texas Medical Branch
Galveston, Texas, 77555, United States
Location status: Recruiting
NCT Number: NCT06162052
The purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn.
Interested in participating?
Request Info18 year–79 year
All sexes
Interventional
Not applicable
Galveston, Texas, 77555, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Technology will be used to enhance rehabilitation.
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 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)
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)
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)
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)
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)
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 100 = worst pain imaginable).
Time frame: 6 months (± 2 weeks) post discharge
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.
Time frame: Months 2, 4, and 5 (+15 days, each timepoint) in addition to 1, 3, & 6 months after discharge.
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.
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)
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).
Contact information is provided by the study sponsor or research team.
Celeste Finnerty, PhD
CONTACT
Steven E. Wolf, MD
CONTACT
The University of Texas Medical Branch, Galveston
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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