A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

Not Applicable

Completed

• Conditions: Contracture; Burns; Burn Scar

• Registration Number: NCT03475654
• Lead Sponsor: University of Washington

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.

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 Timeline

• Study Start: 2018-02-08
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-23
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Level of physical activity	3 months after study enrollment	level of activity among enrolled subjects by actigraphy

Secondary Outcome Measures

Name	Time	Method
Return to work/school	up to 1 year	Date when subject returns to work or school
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): 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): sleep	Study enrollment, 3, 6, 12 months after enrollment	Sleep and sleep disturbance Short Form (SF)8B PROMIS tool
Patient-reported outcome measures (PROMIS): upper extremity	Study enrollment, 3, 6, 12 months after enrollment	Upper extremity PROMIS SF7A
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): mobility	Study enrollment, 3, 6, 12 months after enrollment	Mobility PROMIS tool
Range of motion (ROM)	Study enrollment, 3, 6 and 12 months after enrollment	ROM by subjects in each group
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

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States