Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery

NCT06162052 | Recruiting DMC

• 1 other identifier: 21-0331
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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)

Study Arms (2)

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.

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

Other: Tele-Rehabilitation

Interventions

Tele-Rehabilitation OTHER

Technology will be used to enhance rehabilitation.

A Standard of Care group (SOC); A Standard of Care group (SOC) combined with technology enhancement

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Burns

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Celeste Finnerty, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celeste Finnerty, PhD

CONTACT

(409)772-1011; ccfinner@utmb.edu

Steven E. Wolf, MD

CONTACT

(409)772-1011; swolf@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 8, 2023
• Study Start: April 2, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)