CClinicalTrials.gg
CompletedNCT03475654Updated Dec 11, 2024

A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

An interventional study of Technology-assisted rehabilitation and Usual care in Burns, Burn Scar and Contracture, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.

Sponsored by University of Washington · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Burns
  • Burn Scar
  • Contracture

Browse trials for

Keywords

  • exercise
  • therapy
  • rehabilitation
  • home
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralTechnology-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.

  • BehavioralUsual 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.

05

What researchers measure

Primary outcomes

  1. Level of physical activity

    level of activity among enrolled subjects by actigraphy

    Time frame: 3 months after study enrollment

Secondary outcomes

  1. Range of motion (ROM)

    ROM by subjects in each group

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

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

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

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

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

    Participation in social roles and activities PROMIS tool SF6A

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

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

    Pain interference PROMIS tool SF6A

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

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

    Fatigue PROMIS tool SF6A

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

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

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

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

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

    Mobility PROMIS tool

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

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

    Upper extremity PROMIS SF7A

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

  9. Return to work/school

    Date when subject returns to work or school

    Time frame: up to 1 year

  10. 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

    Time frame: Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment

06

Study locations

1 site
  • Harborview Medical Center
    Seattle, Washington 98104, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03475654
Lead sponsor
University of Washington
Responsible party
Tam Pham (Professor, School of Medicine: Surgery: Trauma, Burn and Critical Care Division, University of Washington) — Principal investigator
First posted
Mar 23, 2018
Start date
Feb 8, 2018
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022
Last update
Dec 11, 2024

Study contacts

Tam Pham, MD
principal investigator · University of Washington

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion