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

NCT ID: NCT06162052

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A Standard of Care group (SOC)

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.

Group Type: EXPERIMENTAL

Tele-Rehabilitation

Intervention Type: OTHER

Technology will be used to enhance rehabilitation.

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

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 Type: EXPERIMENTAL

Tele-Rehabilitation

Intervention Type: OTHER

Technology will be used to enhance rehabilitation.

Interventions

Tele-Rehabilitation

Technology will be used to enhance rehabilitation.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Celeste Finnerty, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Celeste Finnerty, PhD

Role: CONTACT

ccfinner@utmb.edu

(409)772-1011

Steven E. Wolf, MD

Role: CONTACT

swolf@utmb.edu

(409)772-1011

Facility Contacts

Celeste Finnerty, PhD

Role: primary

ccfinner@utmb.edu

409-772-1011

Other Identifiers

21-0331

Identifier Type: -

Identifier Source: org_study_id