A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

NCT03475654 | Completed DMC

• 1 other identifier: STUDY00003707
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal for this prospective randomized controlled trial (PRCT) is to determine whether a virtual-environment, home-rehabilitation program improves functional outcomes for individuals after a burn injury. Specifically, this study will test the efficacy of a technology-assisted rehabilitation program against current standard of home therapy.

Conditions

Burns; Burn Scar; Contracture

Keywords

exercise; therapy; rehabilitation; home

Outcome Measures

Primary Outcomes (1)

• Level of physical activity

  level of activity among enrolled subjects by actigraphy

  3 months after study enrollment

Secondary Outcomes (10)

• Range of motion (ROM)

  Study enrollment, 3, 6 and 12 months after enrollment

• Patient-reported outcome measures (PROMIS): sleep

  Study enrollment, 3, 6, 12 months after enrollment

• Patient-reported outcome measures (PROMIS): social participation

  Study enrollment, 3, 6, 12 months after enrollment

• Patient-reported outcome measures (PROMIS): pain interference

  Study enrollment, 3, 6, 12 months after enrollment

• Patient-reported outcome measures (PROMIS): fatigue

  Study enrollment, 3, 6, 12 months after enrollment

Study Arms (2)

technology-assisted rehabilitation

EXPERIMENTAL

The experimental group will receive treatment as usual, in addition to training with the Jintronix platform. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.

Behavioral: Technology-assisted rehabilitation

Usual care

ACTIVE COMPARATOR

The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.

Behavioral: Usual care

Interventions

Technology-assisted rehabilitation BEHAVIORAL

The Jintronix software platform, coupled with the Microsoft Kinect for movement capture, contains individualized exercise modules to increase ROM, endurance and strength. Within this PRCT, online monitoring of activity and actigraphy measurements through a wearable device and completion of an online diary will provide enhanced monitoring of home activities.

technology-assisted rehabilitation

Usual care BEHAVIORAL

The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge.

Usual care

Eligibility Criteria

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

You may qualify if:

• Age greater than or equal to 18 years old (no upper age limit)
• Ability to provide written, informed consent for study participation
• Ability to read and understand English
• Anticipated discharge to home environment
• Home environment includes access to:
• television (larger than 20 inches in diameter with High Definition Multimedia Interface input (HDMI)
• internet and email address
• telephone (cell phone or landline)

You may not qualify if:

• Age less than 18 years
• Inability to provide written, informed consent for study participation
• Inability to read or understand English
• Delirium (as determined by the Delirium Observation Score test)
• Near-fall event at time of screening
• Pregnant women
• Discharge to non-home environment (e.g., shelter, street, skilled nursing facility)

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Burns; Contracture; Motor Activity

Condition Hierarchy (Ancestors)

Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Behavior

Study Officials

• Tam Pham, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Surgery: Trauma, Burn and Critical Care Division

Model Details: prospective randomized controlled trial

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 23, 2018
• Study Start: February 8, 2018
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)