A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

Sponsor

University of Washington (Other)

Overall Status

Recruiting

CT.gov ID

NCT03475654

Collaborator

(none)

Enrollment

Location

Arms

55.7

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns Burn Scar Contracture	Behavioral: Technology-assisted rehabilitation Behavioral: Usual care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective randomized controlled trialprospective randomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial

Actual Study Start Date :

Feb 8, 2018

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Level of physical activity [3 months after study enrollment]
level of activity among enrolled subjects by actigraphy

Secondary Outcome Measures

Range of motion (ROM) [Study enrollment, 3, 6 and 12 months after enrollment]
ROM by subjects in each group
Patient-reported outcome measures (PROMIS): sleep [Study enrollment, 3, 6, 12 months after enrollment]
Sleep and sleep disturbance Short Form (SF)8B PROMIS tool
Patient-reported outcome measures (PROMIS): social participation [Study enrollment, 3, 6, 12 months after enrollment]
Participation in social roles and activities PROMIS tool SF6A
Patient-reported outcome measures (PROMIS): pain interference [Study enrollment, 3, 6, 12 months after enrollment]
Pain interference PROMIS tool SF6A
Patient-reported outcome measures (PROMIS): fatigue [Study enrollment, 3, 6, 12 months after enrollment]
Fatigue PROMIS tool SF6A
Patient-reported outcome measures (PROMIS): stiffness [Study enrollment, 3, 6, 12 months after enrollment]
Stiffness impact Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) V2.0
Patient-reported outcome measures (PROMIS): mobility [Study enrollment, 3, 6, 12 months after enrollment]
Mobility PROMIS tool
Patient-reported outcome measures (PROMIS): upper extremity [Study enrollment, 3, 6, 12 months after enrollment]
Upper extremity PROMIS SF7A
Return to work/school [up to 1 year]
Date when subject returns to work or school
Patient reported level of activity difficulty [Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)