A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

Burns Clinical Trial

Official title:

Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03475654
• Other study ID #: STUDY00003707
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2020
• Source: University of Washington
• Contact: Gretchen Carrougher
• Phone: 206-744-3140
• Email: carrough[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Contracture

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of physical activity	level of activity among enrolled subjects by actigraphy	3 months after study enrollment
Secondary	Range of motion (ROM)	ROM by subjects in each group	Study enrollment, 3, 6 and 12 months after enrollment
Secondary	Patient-reported outcome measures (PROMIS): sleep	Sleep and sleep disturbance Short Form (SF)8B PROMIS tool	Study enrollment, 3, 6, 12 months after enrollment
Secondary	Patient-reported outcome measures (PROMIS): social participation	Participation in social roles and activities PROMIS tool SF6A	Study enrollment, 3, 6, 12 months after enrollment
Secondary	Patient-reported outcome measures (PROMIS): pain interference	Pain interference PROMIS tool SF6A	Study enrollment, 3, 6, 12 months after enrollment
Secondary	Patient-reported outcome measures (PROMIS): fatigue	Fatigue PROMIS tool SF6A	Study enrollment, 3, 6, 12 months after enrollment
Secondary	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
Secondary	Patient-reported outcome measures (PROMIS): mobility	Mobility PROMIS tool	Study enrollment, 3, 6, 12 months after enrollment
Secondary	Patient-reported outcome measures (PROMIS): upper extremity	Upper extremity PROMIS SF7A	Study enrollment, 3, 6, 12 months after enrollment
Secondary	Return to work/school	Date when subject returns to work or school	up to 1 year
Secondary	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