A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

NCT ID: NCT03475654

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-08

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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Burns Burn Scar Contracture

Keywords

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exercise therapy rehabilitation home

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Technology-assisted rehabilitation

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Tam Pham

Professor, School of Medicine: Surgery: Trauma, Burn and Critical Care Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tam Pham, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Harborview Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00003707

Identifier Type: -

Identifier Source: org_study_id