BurnsNCT03475654
A Prospective Trial of Virtual Home Rehabilitation After Burn Injury
A study testing Technology-assisted rehabilitation in people with Burns and Burn Scar, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Burn Scar, Contracture
- What is being tested?
- Technology-assisted rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial
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.
- Conditions
- Burns, Burn Scar, Contracture
- Being tested
- Technology-assisted rehabilitation, Usual care
- Keywords
- exercise, therapy, rehabilitation, home
- Medical subject headings
- Burns, Contracture, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-assisted rehabilitationBehavioural
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 careBehavioural
The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| technology-assisted rehabilitation | Experimental | 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. Receives: Behavioral: Technology-assisted rehabilitation |
| Usual care | Active comparator | 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. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of physical activity
level of activity among enrolled subjects by actigraphy
Measured: 3 months after study enrollment
Secondary outcomes (10)
Range of motion (ROM)
ROM by subjects in each group
Measured: Study enrollment, 3, 6 and 12 months after enrollment
Patient-reported outcome measures (PROMIS): sleep
Sleep and sleep disturbance Short Form (SF)8B PROMIS tool
Measured: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): social participation
Participation in social roles and activities PROMIS tool SF6A
Measured: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): pain interference
Pain interference PROMIS tool SF6A
Measured: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): fatigue
Fatigue PROMIS tool SF6A
Measured: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): stiffness
Stiffness impact Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) V2.0
Measured: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): mobility
Mobility PROMIS tool
Measured: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): upper extremity
Upper extremity PROMIS SF7A
Measured: Study enrollment, 3, 6, 12 months after enrollment
Return to work/school
Date when subject returns to work or school
Measured: up to 1 year
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
Measured: Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start8 Feb 2018
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tam Pham, University of Washington
- Investigators
- Tam Pham, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475654
- Sponsor's protocol ID
- STUDY00003707
- Status last verified
- Dec 2024
- First submitted
- 1 Mar 2018
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03475654
- Acronym / sponsor ID
- STUDY00003707
- Conditions
- Burns, Burn Scar, Contracture
- Keywords
- exercise, therapy, rehabilitation, home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| technology-assisted rehabilitation | Experimental | Behavioral: Technology-assisted rehabilitationThe 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. |
| Usual care | Active comparator | Behavioral: Usual careThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-assisted rehabilitationThe 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. | Behavioural | technology-assisted rehabilitation |
| Usual careThe control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. | Behavioural | Usual care |
Primary outcome
Level of physical activity
Time frame: 3 months after study enrollment
level of activity among enrolled subjects by actigraphy
10 secondary outcomes
Range of motion (ROM)
Time frame: Study enrollment, 3, 6 and 12 months after enrollment
Patient-reported outcome measures (PROMIS): sleep
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): social participation
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): pain interference
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): fatigue
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): stiffness
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): mobility
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): upper extremity
Time frame: Study enrollment, 3, 6, 12 months after enrollment
Return to work/school
Time frame: up to 1 year
Patient reported level of activity difficulty
Time frame: Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tam Pham, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-assisted rehabilitation in people with Burns and Burn Scar, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of physical activity (time frame: 3 months after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.