Tele-Rehabilitation for Burns

Overseen By Steven E. Wolf, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Psychiatric condition, Drug addiction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a tele-rehabilitation program can aid recovery after a burn. Participants will either follow standard care or enhance it with additional tools like a goniometer (for measuring joint movement) and a Fitbit to track progress. The trial seeks adults treated for a burn affecting a joint who have regular access to a smartphone, tablet, or computer with internet. As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods and contribute to advancing burn rehabilitation techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that tele-rehabilitation is safe for burn patients?

Research has shown that tele-rehabilitation is a safe and effective method for burn recovery. Studies on burn patients found no harmful effects, indicating that this treatment is generally well-tolerated.

A review of various studies on tele-rehabilitation reported no serious negative effects. In fact, several studies noted its success in improving patient recovery without any downsides. This makes tele-rehabilitation a promising option for burn recovery, offering support without additional risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tele-rehabilitation for burn recovery because it offers a unique, tech-enhanced approach to traditional rehabilitation. Unlike standard treatments that rely solely on in-person physical or occupational therapy sessions, this method incorporates remote monitoring and digital tools, such as a goniometer for measuring range of motion and a Fitbit for tracking activity. These technologies enable patients to engage in rehabilitation exercises from the comfort of their own home, while still receiving structured guidance and feedback through virtual sessions. This approach not only increases accessibility and convenience for patients, but also provides continuous data to help therapists tailor treatments more effectively.

What evidence suggests that tele-rehabilitation is effective for burn recovery?

Research has shown that tele-rehabilitation is a safe and effective method for burn recovery. This trial will compare two approaches: one group will receive standard care education, while another will receive standard care combined with technology enhancement, including tele-rehabilitation tools. Technology in rehabilitation can improve burn survivors' quality of life by enabling home exercises, often more convenient than clinic visits. Both patients and therapists report high satisfaction with this approach. Additionally, tele-rehabilitation is generally safe. Overall, early findings suggest tele-rehabilitation could be a valuable tool in burn recovery. ^{2 4 5 6 7}

Who Is on the Research Team?

Celeste Finnerty, PhD

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 79 who have burns across at least one joint and are admitted to the Blocker Burn Unit. Participants need regular internet access via a smart device and must be willing to follow the study's protocol. Those with conditions that increase risk, in other trials, or with compliance issues due to psychiatric conditions can't join.

Inclusion Criteria

I have a burn scar or contracture over a joint.

Not participating in another interventional trial

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either standard care or technology-enhanced support for physical therapy, including virtual movement therapy and use of a Fitbit

4 weeks

4 virtual sessions

Follow-up

Participants are monitored for range of motion, pain, scar assessment, and overall activity at multiple timepoints post-discharge

6 months

Clinic visits at 1, 3, and 6 months post-discharge

Post Interview

Participants meet with study staff for a non-structured interview to discuss their experience and provide feedback

6 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Tele-Rehabilitation

Trial Overview

The study is testing a tele-rehabilitation program designed for post-burn recovery. It aims to see how effective this remote rehab method is when participants use technology like smartphones or computers from their homes.

How Is the Trial Designed?

Group I: A Standard of Care group (SOC) combined with technology enhancement Experimental Treatment 1 Intervention

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

Group II: A Standard of Care group (SOC) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Published Research Related to This Trial

Tele-rehabilitation is an emerging field that combines advancements in rehabilitation studies and technology, allowing for remote control of rehabilitation processes, particularly for upper limb recovery.

The authors report on their preliminary experiences with two tele-rehabilitation systems, H-CAD and HELLODOC, developed during European projects from 2003 to 2007, highlighting the potential for these systems to improve access to rehabilitation services for disabled individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-rehabilitation: present and future. Zampolini, M., Todeschini, E., Bernabeu Guitart, M., et al.[2022]

Physiotherapy with telerehabilitation significantly improves quality of life in surgical patients, with a pooled effect size of 1.01 based on seven studies, indicating a positive outcome compared to usual care.

While telerehabilitation is feasible and at least as effective as traditional physiotherapy, the overall effectiveness on physical outcomes remains uncertain due to variability in intervention content and outcome measures across studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physiotherapy with telerehabilitation in surgical patients: a systematic review and meta-analysis. van Egmond, MA., van der Schaaf, M., Vredeveld, T., et al.[2019]

The SIDERA∧B telerehabilitation system demonstrated high usability (SUS Median = 77.5) and acceptability among 112 patients with chronic conditions, indicating it is user-friendly and effective for home-based rehabilitation.

Participants reported high scores in perceived usefulness and ease of use, suggesting that even those with lower technological expertise can benefit from this digital healthcare solution, although older age and higher disability levels were associated with lower perceived ease of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

System Integrated Digital Empowering and teleRehabilitation to promote patient Activation and well-Being in chronic disabilities: A usability and acceptability study. Rossetto, F., Borgnis, F., Isernia, S., et al.[2023]

A study involving 19 post-stroke patients demonstrated that telerehabilitation (TR) using a Virtual Reality Rehabilitation System significantly improved motor recovery, as measured by the Barthel Index, Fugl-Meyer motor score, and Motricity Index after 12 weeks of treatment.

This research highlights the feasibility and effectiveness of TR in a low-income region of Italy, where access to traditional rehabilitation services is limited, suggesting that TR can be a valuable alternative for patients in similar situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke Telerehabilitation in Calabria: A Health Technology Assessment. Contrada, M., Arcuri, F., Tonin, P., et al.[2022]

This systematic review aims to identify and summarize the outcome measures used in tele-rehabilitation and virtual reality for stroke rehabilitation, addressing a gap in current research despite growing interest in these technologies.

The review will evaluate the psychometric properties of these measures and their alignment with the International Classification of Functioning, ultimately guiding clinicians and policymakers in selecting appropriate assessment tools for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome Measures in Tele-Rehabilitation and Virtual Reality for Stroke Survivors: Protocol for a Scoping Review. Veras, M., Kairy, D., Rogante, M., et al.[2018]

The study developed a tele-rehabilitation platform using the Microsoft Azure Kinect device to enhance shoulder motor function recovery through engaging serious games, which can help improve patient participation in rehabilitation.

Initial testing by medical personnel indicated that the platform is promising for daily shoulder rehabilitation, although further enhancements to the virtual environment of the games are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Tele-Rehabilitation Platform for Shoulder Motor Function Recovery Using Serious Games and an Azure Kinect Device. Belotti, N., Bonfanti, S., Locatelli, A., et al.[2022]

Tele-rehabilitation for stroke survivors shows promise in improving recovery from motor deficits, cognitive dysfunction, and post-stroke depression, based on a systematic review of 22 studies.

While most studies indicated positive effects of tele-rehabilitation, only 8 out of 22 showed significant differences favoring tele-rehabilitation over standard care, suggesting that while effective, results may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-Rehabilitation after Stroke: An Updated Systematic Review of the Literature. Sarfo, FS., Ulasavets, U., Opare-Sem, OK., et al.[2023]

Tele-rehabilitation for patients after total hip replacement has been found to be as effective as traditional face-to-face rehabilitation in improving daily activities and quality of life, based on a systematic review of 11 studies.

Out of the 150 studies initially identified, only 11 met the criteria for detailed review, with 72.7% of these studies rated as 'high' quality, indicating a strong level of evidence supporting the use of tele-rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of tele-rehabilitation in patients following total hip replacement: Systematic review of clinical trials. Sadiq, S., Ahmad, A., Ahmed, A., et al.[2022]

A study involving 604 users of a digital medical device (DMD) for home-based rehabilitation after knee injuries showed that users had significantly higher adherence to their rehabilitation program (86%) compared to a control group (74%), indicating that the DMD effectively supports patient engagement.

The DMD not only improved adherence but also allowed users to perform rehabilitation exercises with greater intensity, contributing to clinically expected improvements in rehabilitation outcomes without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensor-based telerehabilitation system increases patient adherence after knee surgery. Höher, J., Lischke, B., Petersen, W., et al.[2023]

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A retrospective review was performed on 29 patients enrolled in 73 virtual visits through the TH/rehabilitation programme between 2013 and 2014.

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The technological resources analyzed included virtual reality (10 studies), exergames (6 studies), exoskeletons (4 studies), and augmented reality (1 study).

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This review demonstrates that telerehabilitation exhibits a generally safe profile as an alternative to in-person rehabilitation.

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