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Completed

NCT Number: NCT03475654

A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

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.

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Key information

Conditions

Burns Behavior Burn Scar Contracture Joint Diseases Motor Activity Muscular Diseases Musculoskeletal Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Level of physical activity

    Time frame: 3 months after study enrollment

    level of activity among enrolled subjects by actigraphy

Secondary outcomes

  1. Range of motion (ROM)

    Time frame: Study enrollment, 3, 6 and 12 months after enrollment

    ROM by subjects in each group

  2. Patient-reported outcome measures (PROMIS): sleep

    Time frame: Study enrollment, 3, 6, 12 months after enrollment

    Sleep and sleep disturbance Short Form (SF)8B PROMIS tool

  3. Patient-reported outcome measures (PROMIS): social participation

    Time frame: Study enrollment, 3, 6, 12 months after enrollment

    Participation in social roles and activities PROMIS tool SF6A

  4. Patient-reported outcome measures (PROMIS): pain interference

    Time frame: Study enrollment, 3, 6, 12 months after enrollment

    Pain interference PROMIS tool SF6A

  5. Patient-reported outcome measures (PROMIS): fatigue

    Time frame: Study enrollment, 3, 6, 12 months after enrollment

    Fatigue PROMIS tool SF6A

  6. Patient-reported outcome measures (PROMIS): stiffness

    Time frame: Study enrollment, 3, 6, 12 months after enrollment

    Stiffness impact Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) V2.0

  7. Patient-reported outcome measures (PROMIS): mobility

    Time frame: Study enrollment, 3, 6, 12 months after enrollment

    Mobility PROMIS tool

  8. Patient-reported outcome measures (PROMIS): upper extremity

    Time frame: Study enrollment, 3, 6, 12 months after enrollment

    Upper extremity PROMIS SF7A

  9. Return to work/school

    Time frame: up to 1 year

    Date when subject returns to work or school

  10. Patient reported level of activity difficulty

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2018
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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