StrokeNCT05856669
The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke
A study testing Virtual reality gaming in people with Stroke and Hemiparesis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The goal of this study is to learn about the benefits of using a virtual reality gaming system that can be adjusted for a person who has upper arm weakness from stroke. The main question it aims to answer is whether strength and movement in the upper arm be improved by use of the gaming system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Virtual reality gaming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 16 Oct 2023
- 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
- Self-reported diagnosis of stroke
- Greater than 2 years post-stroke
- Access to reliable transportation
- History of weakness/hemiparesis of one upper limb
Who cannot join
- Significant vision impairment or blindness
- Non-English speaking
- History of seizure or seizure disorder
- Health conditions which would be exacerbated by low-intensity exercise
- Inability to use arms independently for exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Lakeshore Foundation Research Collaborative
Birmingham, Alabama, 35294
About this study
The goal of this study is to learn about the benefits of using a virtual reality gaming system that can be adjusted for a person who has upper arm weakness from stroke. The main question it aims to answer is whether strength and movement in the upper arm be improved by use of the gaming system.
Participants will be asked to complete initial measurements of upper arm function, play a video game for one hour, four times a week for five weeks, and repeat the measurements of upper arm function at the end.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Virtual reality gaming
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality gamingDevice
This study aims to combine the motivational delivery of therapy which is an immersive virtual reality with the foundational concepts of mirror therapy. By utilizing a recalibration software, the participant will be able to achieve magnified movements on their screen as compared to the limited movement that is occurring in reality. The recalibration software takes each plane of movement of the gaming controller and magnifies the participant's range of motion in order to promote greater participation and success in the game that they are playing (Walkin VR). By using the fundamental concepts of mirror therapy in an immersive virtual reality setting, the investigators aim to mimic the results of mirror therapy while increasing motivation and adherence to the therapeutic program to increase overall upper extremity function.
| Study group | Role | What they receive |
|---|---|---|
| Single subject case study | Experimental | Not described Receives: Device: Virtual reality gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper extremity active range of motion
Measured via goniometer
Measured: 6 weeks
Change in grip strength
Measured via hand dynamometer
Measured: 6 weeks
Secondary outcomes (1)
Change in aerobic fitness
Measured via oxygen consumption using a wearable metabolic monitor while pedaling an arm bike
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Sep 2023
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Eugene Vice, University of Alabama at Birmingham
- Investigators
- Jason Vice, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856669
- Sponsor's protocol ID
- IRB-300010445
- Status last verified
- Jul 2024
- First submitted
- 16 Apr 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.
PubMed 25206611Mekbib DB, Zhao Z, Wang J, Xu B, Zhang L, Cheng R, Fang S, Shao Y, Yang W, Han J, Jiang H, Zhu J, Ye X, Zhang J, Xu D. Proactive Motor Functional Recovery Following Immersive Virtual Reality-Based Limb Mirroring Therapy in Patients with Subacute Stroke. Neurotherapeutics. 2020 Oct;17(4):1919-1930. doi: 10.1007/s13311-020-00882-x.
PubMed 32671578Modrono C, Navarrete G, Rodriguez-Hernandez AF, Gonzalez-Mora JL. Activation of the human mirror neuron system during the observation of the manipulation of virtual tools in the absence of a visible effector limb. Neurosci Lett. 2013 Oct 25;555:220-4. doi: 10.1016/j.neulet.2013.09.044. Epub 2013 Sep 27.
PubMed 24080372
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke
- ClinicalTrials.gov ID
- NCT05856669
- Acronym / sponsor ID
- IRB-300010445
- Conditions
- Stroke, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 12 May 2023 (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 goal of this study is to learn about the benefits of using a virtual reality gaming system that can be adjusted for a person who has upper arm weakness from stroke. The main question it aims to answer is whether strength and movement in the upper arm be improved by use of the gaming system.
Participants will be asked to complete initial measurements of upper arm function, play a video game for one hour, four times a week for five weeks, and repeat the measurements of upper arm function at the end.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single subject case study | Experimental | Device: Virtual reality gaming |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-reported diagnosis of stroke
- Greater than 2 years post-stroke
- Access to reliable transportation
- History of weakness/hemiparesis of one upper limb
Key exclusion criteria (5 listed)
- Significant vision impairment or blindness
- Non-English speaking
- History of seizure or seizure disorder
- Health conditions which would be exacerbated by low-intensity exercise
- Inability to use arms independently for exercise
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 |
|---|---|---|
| Virtual reality gamingThis study aims to combine the motivational delivery of therapy which is an immersive virtual reality with the foundational concepts of mirror therapy. By utilizing a recalibration software, the participant will be able to achieve magnified movements on their screen as compared to the limited movement that is occurring in reality. The recalibration software takes each plane of movement of the gaming controller and magnifies the participant's range of motion in order to promote greater participation and success in the game that they are playing (Walkin VR). By using the fundamental concepts of mirror therapy in an immersive virtual reality setting, the investigators aim to mimic the results of mirror therapy while increasing motivation and adherence to the therapeutic program to increase overall upper extremity function. | Device | Single subject case study |
Primary outcome
Change in upper extremity active range of motion
Time frame: 6 weeks
Measured via goniometer
Change in grip strength
Time frame: 6 weeks
Measured via hand dynamometer
1 secondary outcome
Change in aerobic fitness
Time frame: 6 weeks
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 Jul 2024.
- Results publication: PubMed 25206611Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.
- Results publication: PubMed 32671578Mekbib DB, Zhao Z, Wang J, Xu B, Zhang L, Cheng R, Fang S, Shao Y, Yang W, Han J, Jiang H, Zhu J, Ye X, Zhang J, Xu D. Proactive Motor Functional Recovery Following Immersive Virtual Reality-Based Limb Mirroring Therapy in Patients with Subacute Stroke. Neurotherapeutics. 2020 Oct;17(4):1919-1930. doi: 10.1007/s13311-020-00882-x.
- Results publication: PubMed 24080372Modrono C, Navarrete G, Rodriguez-Hernandez AF, Gonzalez-Mora JL. Activation of the human mirror neuron system during the observation of the manipulation of virtual tools in the absence of a visible effector limb. Neurosci Lett. 2013 Oct 25;555:220-4. doi: 10.1016/j.neulet.2013.09.044. Epub 2013 Sep 27.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Jason Vice, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality gaming in people with Stroke and Hemiparesis, run by University of Alabama at Birmingham 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 5 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 Jul 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?
Change in upper extremity active range of motion (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT05856669, which also lists 3 linked publications.
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 Jul 2024.