StrokeNCT03062345
In Home VR Therapy
A study testing Single-User Virtual Reality Upper Extremity Therapy and Multi-User Virtual Reality Upper Extremity Therapy in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
Virtual reality is a video game in which a person and their real-time movements are represented on a screen in a virtual environment. This study will compare the use of multi-user virtual reality (VR) to single-user VR to determine if either provides superior engagement in upper extremity therapy and greater… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Single-User Virtual Reality Upper Extremity Therapy and Multi-User Virtual Reality Upper Extremity Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2017to 30 May 2020
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are between the ages of 21 and 80
- Experienced a single stroke at least 6 months prior to enrollment
- Have moderate arm impairment as indicated by a score between 4 and 6 on the Chedoke-McMaster Stroke Assessment, arm subscale
- Live within 20 miles of the Rehabilitation Institute of Chicago (as study personnel will need to travel to their home)
Who cannot join
- Other neurological, neuromuscular, or orthopedic disease
- Pain in the upper extremity with movements required in the treatment
- Contracture that limits use of the VR system
- Vision problems which would preclude the ability to use the VR system
- Cognitive or language deficits that would prevent them from understanding the tasks
- Concurrent enrollment in another intervention study involving the affected arm or hand
- Botox injection in the arm within the previous 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60601
About this study
Official title: Multi-user Virtual Training for Upper Extremity in the Home
Virtual reality is a video game in which a person and their real-time movements are represented on a screen in a virtual environment. This study will compare the use of multi-user virtual reality (VR) to single-user VR to determine if either provides superior engagement in upper extremity therapy and greater motivation to perform repetitive training.
Stroke survivors will participate in a longitudinal study in which they will have the opportunity to perform rehabilitative training with multi-user VR and single-user VR modes in their homes. They will use each mode for 2 weeks, completing 4 session per week, each session is 1 hour long. Upper extremity motor control, level of engagement, and active range of motion will be assessed at time points during the intervention period.
Read more
Subject evaluations will take place before the intervention, at the midpoint of intervention (between switching from multi-user to single-user modes, or vice versa), and at the end of the intervention.
The investigators hope to address two aims:
Aim 1: To determine if the use in-home multi-user virtual reality treatment results in greater engagement in therapy compared with in-home single user virtual reality treatment.
Aim 2: To determine if in-home virtual reality treatment results in greater practice
The investigators hypothesize that stroke survivors will be more engaged in therapy when training with the multi-user VR system and this will translate into greater practice.
- Conditions
- Stroke
- Being tested
- Single-User Virtual Reality Upper Extremity Therapy, Multi-User Virtual Reality Upper Extremity Therapy
- Keywords
- Stroke, Virtual Reality Therapy, Rehabilitation, Upper Extremity, Arm, Telerehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-User Virtual Reality Upper Extremity TherapyOther
Also called Single-User Mode, Single-User Mode first, Multi-User Mode second, Multi-User Mode first, Single-User Mode second
Virtual Reality games with the user as the only person required for participation
Multi-User Virtual Reality Upper Extremity TherapyOther
Also called Multi-User Mode, Single-User Mode first, Multi-User Mode second, Multi-User Mode first, Single-User Mode second
Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.
| Study group | Role | What they receive |
|---|---|---|
| Single-User Mode first, Multi-User Mode second | Experimental | Not described Receives: Other: Single-User Virtual Reality Upper Extremity Therapy; Other: Multi-User Virtual Reality Upper Extremity Therapy |
| Multi-User Mode first, Single-User Mode second | Experimental | Not described Receives: Other: Single-User Virtual Reality Upper Extremity Therapy; Other: Multi-User Virtual Reality Upper Extremity Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand displacement during each session
total distance hand moves during all therapy sessions divided by the number of sessions in which a subject participates.
Measured: Distance hand moves on average per session during each 2-week treatment phase (each subject will complete 2, 2-week phases of treatment. One 2-week phase being the Single-user mode and the other 2-week phase being the Multi-user mode)
Secondary outcomes (3)
Therapy mode amount of use
Total amount of time subject spends in their assigned therapy mode during the 2-week treatment phase.
Measured: 2 week treatment phase
Change in Active Range of Motion
Change from baseline in angle of upper extremity movement (shoulder and elbow)
Measured: First measure taken at baseline, then also at the end of the first 2-week treatment phase and finally at the end of the second 2-week treatment phase.
Comparison of Intrinsic Motivation Inventory Score between therapy modes
Difference in Intrinsic Motivation Inventory score between single-user and multi-user modes
Measured: First measure taken at the end of the first 2-week treatment phase; Second measure taken at the end of the second 2-week treatment phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start26 Jan 2017
- Primary completion31 May 2018
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Patton, Shirley Ryan AbilityLab
- Investigators
- James Patton, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062345
- Sponsor's protocol ID
- STU00204187
- Status last verified
- Jun 2021
- First submitted
- 19 Feb 2017
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thielbar KO, Triandafilou KM, Barry AJ, Yuan N, Nishimoto A, Johnson J, Stoykov ME, Tsoupikova D, Kamper DG. Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. Arch Phys Med Rehabil. 2020 Feb;101(2):196-203. doi: 10.1016/j.apmr.2019.10.182. Epub 2019 Nov 9.
PubMed 31715140
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-user Virtual Training for Upper Extremity in the Home
- ClinicalTrials.gov ID
- NCT03062345
- Acronym / sponsor ID
- STU00204187
- Conditions
- Stroke
- Keywords
- Stroke, Virtual Reality Therapy, Rehabilitation, Upper Extremity, Arm, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 23 Feb 2017 (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.
Virtual reality is a video game in which a person and their real-time movements are represented on a screen in a virtual environment. This study will compare the use of multi-user virtual reality (VR) to single-user VR to determine if either provides superior engagement in upper extremity therapy and greater motivation to perform repetitive training.
Stroke survivors will participate in a longitudinal study in which they will have the opportunity to perform rehabilitative training with multi-user VR and single-user VR modes in their homes. They will use each mode for 2 weeks, completing 4 session per week, each session is 1 hour long. Upper extremity motor control, level of engagement, and active range of motion will be assessed at time points during the intervention period.
Subject evaluations will take place before the intervention, at the midpoint of intervention (between switching from multi-user to single-user modes, or vice versa), and at the end of the intervention.
The investigators hope to address two aims:
Aim 1: To determine if the use in-home multi-user virtual reality treatment results in greater engagement in therapy compared with in-home single user virtual reality treatment.
Aim 2: To determine if in-home virtual reality treatment results in greater practice
The investigators hypothesize that stroke survivors will be more engaged in therapy when training with the multi-user VR system and this will translate into greater practice.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-User Mode first, Multi-User Mode second | Experimental | Other: Single-User Virtual Reality Upper Extremity Therapy, Other: Multi-User Virtual Reality Upper Extremity Therapy |
| Multi-User Mode first, Single-User Mode second | Experimental | Other: Single-User Virtual Reality Upper Extremity Therapy, Other: Multi-User Virtual Reality Upper Extremity Therapy |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are between the ages of 21 and 80
- Experienced a single stroke at least 6 months prior to enrollment
- Have moderate arm impairment as indicated by a score between 4 and 6 on the Chedoke-McMaster Stroke Assessment, arm subscale
- Live within 20 miles of the Rehabilitation Institute of Chicago (as study personnel will need to travel to their home)
Key exclusion criteria (7 listed)
- Other neurological, neuromuscular, or orthopedic disease
- Pain in the upper extremity with movements required in the treatment
- Contracture that limits use of the VR system
- Vision problems which would preclude the ability to use the VR system
- Cognitive or language deficits that would prevent them from understanding the tasks
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 |
|---|---|---|
| Single-User Virtual Reality Upper Extremity TherapyAlso: Single-User Mode, Single-User Mode first, Multi-User Mode second, Multi-User Mode first, Single-User Mode secondVirtual Reality games with the user as the only person required for participation | Other | Multi-User Mode first, Single-User Mode second, Single-User Mode first, Multi-User Mode second |
| Multi-User Virtual Reality Upper Extremity TherapyAlso: Multi-User Mode, Single-User Mode first, Multi-User Mode second, Multi-User Mode first, Single-User Mode secondVirtual reality games in which more than one user is required for participation. Users interact in the virtual environment. | Other | Multi-User Mode first, Single-User Mode second, Single-User Mode first, Multi-User Mode second |
Primary outcome
Hand displacement during each session
Time frame: Distance hand moves on average per session during each 2-week treatment phase (each subject will complete 2, 2-week phases of treatment. One 2-week phase being the Single-user mode and the other 2-week phase being the Multi-user mode)
total distance hand moves during all therapy sessions divided by the number of sessions in which a subject participates.
3 secondary outcomes
Therapy mode amount of use
Time frame: 2 week treatment phase
Change in Active Range of Motion
Time frame: First measure taken at baseline, then also at the end of the first 2-week treatment phase and finally at the end of the second 2-week treatment phase.
Comparison of Intrinsic Motivation Inventory Score between therapy modes
Time frame: First measure taken at the end of the first 2-week treatment phase; Second measure taken at the end of the second 2-week treatment phase.
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 10 Jun 2021.
- Derived from this study: PubMed 31715140Thielbar KO, Triandafilou KM, Barry AJ, Yuan N, Nishimoto A, Johnson J, Stoykov ME, Tsoupikova D, Kamper DG. Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. Arch Phys Med Rehabil. 2020 Feb;101(2):196-203. doi: 10.1016/j.apmr.2019.10.182. Epub 2019 Nov 9.
- Individual participant dataSharing planned: Undecided
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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.
James Patton, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-User Virtual Reality Upper Extremity Therapy and Multi-User Virtual Reality Upper Extremity Therapy in people with Stroke, run by Shirley Ryan AbilityLab 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 4 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 10 Jun 2021. 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?
Hand displacement during each session (time frame: Distance hand moves on average per session during each 2-week treatment phase (each subject will complete 2, 2-week phases of treatment. One 2-week phase being the Single-user mode and the other 2-week phase being the Multi-user mode)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03062345, which also lists 1 linked publication.
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 10 Jun 2021; AzTrials last refreshed its copy on 31 Oct 2026.