BurnsNCT06162052
Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery
A study testing Tele-Rehabilitation in people with Burns, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Burns
- What is being tested?
- Tele-Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Celeste Finnerty, PhD, 409-772-1011, ccfinner@utmb.edu
About this study
The purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn.
Read the 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.
- Conditions
- Burns
- Being tested
- Tele-Rehabilitation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-RehabilitationOther
Technology will be used to enhance rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| A Standard of Care group (SOC) | Experimental | 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. Receives: Other: Tele-Rehabilitation |
| A Standard of Care group (SOC) combined with technology enhancement | Experimental | 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 Receives: Other: Tele-Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (8)
Scar Volume
3D photo taken with LifeViz 3DII camera.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start2 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celeste Finnerty, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162052
- Sponsor's protocol ID
- 21-0331
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery
- ClinicalTrials.gov ID
- NCT06162052
- Acronym / sponsor ID
- 21-0331
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Standard of Care group (SOC) | Experimental | Other: Tele-RehabilitationParticipants 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. |
| A Standard of Care group (SOC) combined with technology enhancement | Experimental | Other: Tele-RehabilitationParticipants 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-RehabilitationTechnology will be used to enhance rehabilitation. | Other | A Standard of Care group (SOC), A Standard of Care group (SOC) combined with technology enhancement |
Primary outcome
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)
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.
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Celeste Finnerty, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Rehabilitation in people with Burns, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celeste Finnerty, PhD ((409)772-1011, ccfinner@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.