A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Burn Scar; Burns; Contracture
• Intervention / Treatment: Behavioral: Technology-assisted rehabilitation; Behavioral: Usual care

Detailed Description

This is a prospective, randomized controlled trial (PRCT) involving 50 adult burn survivors. This study tests the efficacy of a technology-assisted rehabilitation program against current standard of home therapy. There are two study groups for which subjects will be randomized: control and experimental.The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. The experimental group receives treatment as usual, in addition to training and use of the Jintronix platform for 3 months after hospital discharge. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: technology-assisted rehabilitation; 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; 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.
Active Comparator: Usual care; 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; The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of physical activity	level of activity among enrolled subjects by actigraphy	3 months after study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion (ROM)	ROM by subjects in each group	Study enrollment, 3, 6 and 12 months after enrollment
Patient-reported outcome measures (PROMIS): sleep	Sleep and sleep disturbance Short Form (SF)8B PROMIS tool	Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): social participation	Participation in social roles and activities PROMIS tool SF6A	Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): pain interference	Pain interference PROMIS tool SF6A	Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): fatigue	Fatigue PROMIS tool SF6A	Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): stiffness	Stiffness impact Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) V2.0	Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): mobility	Mobility PROMIS tool	Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): upper extremity	Upper extremity PROMIS SF7A	Study enrollment, 3, 6, 12 months after enrollment
Return to work/school	Date when subject returns to work or school	up to 1 year
Patient reported level of activity difficulty	Using 1-5 difficulty scale (1=no difficulty and 5=very difficult), subject is asked how difficult his/her activity has been for the past 2 days	Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Tam Pham, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; therapy; home
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Joint Diseases; Burns; Contracture
• Other Study ID Numbers: STUDY00003707

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No