StrokeVRNCT04429945
Immersive Virtual Reality in Stroke Pilot Study
A study testing Virtual Reality in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Over 15,000 Veterans are treated by the VA for stroke each year. A stroke means that part of the brain dies. Many people who have a stroke have difficulty with moving their arm, using their hand, and they have pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2021to 14 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Veterans who have been diagnosed with
- an acute ischemic or hemorrhagic stroke and
- post-stroke are admitted to James A. Haley Veterans' Hospital inpatient rehabilitation
- age 18-80 with stroke diagnosis verified by brain imaging.
Who cannot join
- Unable to follow instructions or participate in immersive VR therapy due to significant cognitive impairment,
- History of seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
Official title: Immersive Virtual Reality to Improve Outcomes in Patients With Stroke: A Pilot Study
Over 15,000 Veterans are treated by the VA for stroke each year. A stroke means that part of the brain dies. Many people who have a stroke have difficulty with moving their arm, using their hand, and they have pain. Virtual reality is a video-game based treatment that may help people with stroke improve in these areas. Virtual reality involves using a computer and goggles to make a person feel like they are in a different world with new sights and sounds, relaxing on a beach where there is no pain, or playing the piano. In virtual reality, stroke patients can practice movement in a safe and motivating environment. For example, a person with stroke who has weakness in his/her arm can safely reach for plates in a virtual cupboard. In a virtual environment, the plates can't break. This study will help investigators to determine if people with strokes who are treated with virtual reality like it, and if they have less pain and better movement.
Read the detailed description
Background. Over the last decade, Virtual Reality (VR) has emerged as a cutting-edge technology in stroke rehabilitation. VR is defined as a type of user-computer interface that implements real-time simulation of an activity or environment allowing user interaction via multiple sensory modalities. VR interventions in a stroke population have been shown to be equivalent to usual care therapies and to enhance motor recovery when utilized as an adjunct. Significance/Impact/Innovation. This research will advance knowledge in rehabilitation research by testing state-of-the-art immersive 3-dimensional VR technology with the post-acute stroke Veteran population. The proposed project addresses: (1) the RR\&D goal of maximizing functional recovery, (2) interest in non-pharmacological activity-based interventions for pain, and (3) supports modernization of the Veterans' Health Administration by incorporating technology-assisted rehabilitation.
Specific Aims. (1) Determine the feasibility and tolerability of using a therapeutic VR platform in an inpatient comprehensive stroke rehabilitation program and (2) Estimate the initial clinical efficacy, or effect size, associated with the VR platform using APPS for distraction and upper extremity exercise for Veterans post-stroke.
Methodology. Prospective within-subject pre-post pilot and survey study designs will be used. The target populations are (1) clinical staff who work on the Comprehensive Interdisciplinary Inpatient Rehabilitation Program (CIIRP) at the James A. Haley Veterans' Hospital (JAHVH) in Tampa (sample size N=10) and Veterans who are inpatients in the CIIRP (sample size N=10). The VR intervention consists of wearing a head mounted display that plays APPs ranging from music and nature views for pain distraction to more challenging strengthening and coordination activities such as playing the piano virtually. The intervention will last four weeks. The analytic approach will use descriptive statistics and qualitative methods. Aim 1 will administer a survey with open and closed ended questions to clinicians to examine the feasibility of successfully integrating a VR intervention into the flow of usual care. Feasibility constructs include adaptability (can VR intervention be adapted to an inpatient unit), patient need (do Veterans like and benefit from the intervention), and staff comments/impressions. Responses for each construct will be entered into an excel spreadsheet, one tab for each construct. Responses will then be grouped by similar content. Results will be reported as themes and subthemes. Aim 1 will also track patient VR tolerability by documenting and discussing patient complaints and adverse events. Tolerability data will be extracted from meeting minutes and grouped by similar occurrences. Results will be reported as themes and subthemes. Aim 2 will estimate effect sizes and degree of precision for upper extremity neurologic recovery, hand dexterity, and pain outcomes measured pre and post VR intervention. Neurologic recovery is measured with the Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity, dexterity is measured with the Action Research Arm Test, and pain is measured with the Pain Outcomes Questionnaire-VA. Because standard scores do not necessarily translate to meaningful clinical differences (improvements), the investigators will identify the proportion of subjects who experience the minimal clinically important difference (MCID). Metrics will also be compared across outcomes.
Next Steps/Implementation. Our next step is to work with our Program Partner in the Physical Medicine and Rehabilitation Office to conduct a large multi-site clinical trial that will incorporate the lessons learned from this feasibility pilot study to test the efficacy of a VR intervention in inpatient rehabilitation and transition to home environments.
- Conditions
- Stroke
- Being tested
- Virtual Reality
- Keywords
- stroke, virtual reality, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called Oculus Quest
Virtual Reality Headset with Virtual Reality Applications
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality | Experimental | A Virtual Reality headset will be used for 30 minutes twice per day outside of usual therapy times while in bed with bedrails raised. Virtual Reality games will be selected that will help with relaxation, pain, and arm and hand recovery after a stroke. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
The Action Research Arm Test includes 19 clinician-administered tests across 4 sub-domains: Grasp, Grip, Pinch, Gross Movement. Each test is scored on a 0 (no movement possible) to 3 (movement performed normally) scale. Within each domain a score of 3 on the first and hardest test, the remaining tests are also scored as 3. A score of 0 on the second, easiest test, remaining tests are scored as 0. Tests are summed within each domain: Grasp (range = 0-18), Grip (range = 0-12); Pinch (range = 0-18); Gross Movement (range = 0-9). A total score was then calculated by summing the scores from each sub-domains (range= 0-57) with higher scores indicating better hand dexterity.
Measured: 4 weeks
Fugl-Meyer Assessment Upper Extremity
The Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity is a measure of upper extremity stroke recovery, specifically functional impairment. It consists of 63 functional rests across 4 sub-domains: Joint Pain, Motor Function, Passive Joint Range of Motion, and Sensation. Each functional test is rated on a 0 to 2 scale with higher scores indicating greater functioning. Test scores were then summed within each sub-domain: Joint Pain (range = 0-24), Motor Function (range = 0-66); Passive Joint Range of Motion (range = 0-24); Sensation (range = 0-12). Within each sub-domain, higher scores indicate greater improvement in upper extremity function.
Measured: 4 weeks
Secondary outcomes (1)
Pain Outcomes Questionnaire-VA
The 0 (no pain at all) to 10 (worst pain possible) pain numeric rating scale from the Pain Outcomes Questionnaire-VA was used to measure post-stroke pain intensity.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start17 Jun 2021
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Model description
- Once patients are enrolled, baseline data and pre-intervention outcome measures will be collected. APPs will be selected from the VR Toolkit that best address the individual patient's treatment goals. Patients will be instructed in the use of the head mounted display with VR APPs. VR dosage will be two one-half hour sessions per therapy day. Patients can initiate use of a more challenging APPs that gradually includes hand/arm movement.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Johanna E. Tran, MD, Principal investigator, James A. Haley Veterans' Hospital, Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429945
- Sponsor's protocol ID
- N3449-P
- Other IDs
- I21RX003449
- Acronym
- VR
- Status last verified
- Jan 2024
- First submitted
- 10 Jun 2020
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tieri G, Morone G, Paolucci S, Iosa M. Virtual reality in cognitive and motor rehabilitation: facts, fiction and fallacies. Expert Rev Med Devices. 2018 Feb;15(2):107-117. doi: 10.1080/17434440.2018.1425613. Epub 2018 Jan 10.
PubMed 29313388Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014.
PubMed 24681826Kiper P, Szczudlik A, Agostini M, Opara J, Nowobilski R, Ventura L, Tonin P, Turolla A. Virtual Reality for Upper Limb Rehabilitation in Subacute and Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 May;99(5):834-842.e4. doi: 10.1016/j.apmr.2018.01.023. Epub 2018 Feb 14.
PubMed 29453980Lee MM, Lee KJ, Song CH. Game-Based Virtual Reality Canoe Paddling Training to Improve Postural Balance and Upper Extremity Function: A Preliminary Randomized Controlled Study of 30 Patients with Subacute Stroke. Med Sci Monit. 2018 Apr 27;24:2590-2598. doi: 10.12659/MSM.906451.
PubMed 29702630Perez-Marcos D, Chevalley O, Schmidlin T, Garipelli G, Serino A, Vuadens P, Tadi T, Blanke O, Millan JDR. Increasing upper limb training intensity in chronic stroke using embodied virtual reality: a pilot study. J Neuroeng Rehabil. 2017 Nov 17;14(1):119. doi: 10.1186/s12984-017-0328-9.
PubMed 29149855Askin A, Atar E, Kocyigit H, Tosun A. Effects of Kinect-based virtual reality game training on upper extremity motor recovery in chronic stroke. Somatosens Mot Res. 2018 Mar;35(1):25-32. doi: 10.1080/08990220.2018.1444599. Epub 2018 Mar 13.
PubMed 29529919Paquin K, Crawley J, Harris JE, Horton S. Survivors of chronic stroke - participant evaluations of commercial gaming for rehabilitation. Disabil Rehabil. 2016 Oct;38(21):2144-52. doi: 10.3109/09638288.2015.1114155. Epub 2016 Jan 5.
PubMed 26728133Kong KH, Loh YJ, Thia E, Chai A, Ng CY, Soh YM, Toh S, Tjan SY. Efficacy of a Virtual Reality Commercial Gaming Device in Upper Limb Recovery after Stroke: A Randomized, Controlled Study. Top Stroke Rehabil. 2016 Oct;23(5):333-40. doi: 10.1080/10749357.2016.1139796. Epub 2016 Apr 21.
PubMed 27098818Lai SM, Studenski S, Duncan PW, Perera S. Persisting consequences of stroke measured by the Stroke Impact Scale. Stroke. 2002 Jul;33(7):1840-4. doi: 10.1161/01.str.0000019289.15440.f2.
PubMed 12105363Saposnik G, Cohen LG, Mamdani M, Pooyania S, Ploughman M, Cheung D, Shaw J, Hall J, Nord P, Dukelow S, Nilanont Y, De Los Rios F, Olmos L, Levin M, Teasell R, Cohen A, Thorpe K, Laupacis A, Bayley M; Stroke Outcomes Research Canada. Efficacy and safety of non-immersive virtual reality exercising in stroke rehabilitation (EVREST): a randomised, multicentre, single-blind, controlled trial. Lancet Neurol. 2016 Sep;15(10):1019-27. doi: 10.1016/S1474-4422(16)30121-1. Epub 2016 Jun 27.
PubMed 27365261Saposnik G, Levin M; Outcome Research Canada (SORCan) Working Group. Virtual reality in stroke rehabilitation: a meta-analysis and implications for clinicians. Stroke. 2011 May;42(5):1380-6. doi: 10.1161/STROKEAHA.110.605451. Epub 2011 Apr 7.
PubMed 21474804Palma GC, Freitas TB, Bonuzzi GM, Soares MA, Leite PH, Mazzini NA, Almeida MR, Pompeu JE, Torriani-Pasin C. Effects of virtual reality for stroke individuals based on the International Classification of Functioning and Health: a systematic review. Top Stroke Rehabil. 2017 May;24(4):269-278. doi: 10.1080/10749357.2016.1250373. Epub 2016 Oct 31.
PubMed 27796177Glegg SMN, Levac DE. Barriers, Facilitators and Interventions to Support Virtual Reality Implementation in Rehabilitation: A Scoping Review. PM R. 2018 Nov;10(11):1237-1251.e1. doi: 10.1016/j.pmrj.2018.07.004.
PubMed 30503231Yates M, Kelemen A, Sik Lanyi C. Virtual reality gaming in the rehabilitation of the upper extremities post-stroke. Brain Inj. 2016;30(7):855-63. doi: 10.3109/02699052.2016.1144146. Epub 2016 Mar 30.
PubMed 27029647Ikbali Afsar S, Mirzayev I, Umit Yemisci O, Cosar Saracgil SN. Virtual Reality in Upper Extremity Rehabilitation of Stroke Patients: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2018 Dec;27(12):3473-3478. doi: 10.1016/j.jstrokecerebrovasdis.2018.08.007. Epub 2018 Sep 5.
PubMed 30193810
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality to Improve Outcomes in Patients With Stroke: A Pilot Study
- ClinicalTrials.gov ID
- NCT04429945
- Acronym / sponsor ID
- VR / N3449-P
- Conditions
- Stroke
- Keywords
- stroke, virtual reality, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 15,000 Veterans are treated by the VA for stroke each year. A stroke means that part of the brain dies. Many people who have a stroke have difficulty with moving their arm, using their hand, and they have pain. Virtual reality is a video-game based treatment that may help people with stroke improve in these areas. Virtual reality involves using a computer and goggles to make a person feel like they are in a different world with new sights and sounds, relaxing on a beach where there is no pain, or playing the piano. In virtual reality, stroke patients can practice movement in a safe and motivating environment. For example, a person with stroke who has weakness in his/her arm can safely reach for plates in a virtual cupboard. In a virtual environment, the plates can't break. This study will help investigators to determine if people with strokes who are treated with virtual reality like it, and if they have less pain and better movement.
Detailed description
Background. Over the last decade, Virtual Reality (VR) has emerged as a cutting-edge technology in stroke rehabilitation. VR is defined as a type of user-computer interface that implements real-time simulation of an activity or environment allowing user interaction via multiple sensory modalities. VR interventions in a stroke population have been shown to be equivalent to usual care therapies and to enhance motor recovery when utilized as an adjunct. Significance/Impact/Innovation. This research will advance knowledge in rehabilitation research by testing state-of-the-art immersive 3-dimensional VR technology with the post-acute stroke Veteran population. The proposed project addresses: (1) the RR\&D goal of maximizing functional recovery, (2) interest in non-pharmacological activity-based interventions for pain, and (3) supports modernization of the Veterans' Health Administration by incorporating technology-assisted rehabilitation.
Specific Aims. (1) Determine the feasibility and tolerability of using a therapeutic VR platform in an inpatient comprehensive stroke rehabilitation program and (2) Estimate the initial clinical efficacy, or effect size, associated with the VR platform using APPS for distraction and upper extremity exercise for Veterans post-stroke.
Methodology. Prospective within-subject pre-post pilot and survey study designs will be used. The target populations are (1) clinical staff who work on the Comprehensive Interdisciplinary Inpatient Rehabilitation Program (CIIRP) at the James A. Haley Veterans' Hospital (JAHVH) in Tampa (sample size N=10) and Veterans who are inpatients in the CIIRP (sample size N=10). The VR intervention consists of wearing a head mounted display that plays APPs ranging from music and nature views for pain distraction to more challenging strengthening and coordination activities such as playing the piano virtually. The intervention will last four weeks. The analytic approach will use descriptive statistics and qualitative methods. Aim 1 will administer a survey with open and closed ended questions to clinicians to examine the feasibility of successfully integrating a VR intervention into the flow of usual care. Feasibility constructs include adaptability (can VR intervention be adapted to an inpatient unit), patient need (do Veterans like and benefit from the intervention), and staff comments/impressions. Responses for each construct will be entered into an excel spreadsheet, one tab for each construct. Responses will then be grouped by similar content. Results will be reported as themes and subthemes. Aim 1 will also track patient VR tolerability by documenting and discussing patient complaints and adverse events. Tolerability data will be extracted from meeting minutes and grouped by similar occurrences. Results will be reported as themes and subthemes. Aim 2 will estimate effect sizes and degree of precision for upper extremity neurologic recovery, hand dexterity, and pain outcomes measured pre and post VR intervention. Neurologic recovery is measured with the Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity, dexterity is measured with the Action Research Arm Test, and pain is measured with the Pain Outcomes Questionnaire-VA. Because standard scores do not necessarily translate to meaningful clinical differences (improvements), the investigators will identify the proportion of subjects who experience the minimal clinically important difference (MCID). Metrics will also be compared across outcomes.
Next Steps/Implementation. Our next step is to work with our Program Partner in the Physical Medicine and Rehabilitation Office to conduct a large multi-site clinical trial that will incorporate the lessons learned from this feasibility pilot study to test the efficacy of a VR intervention in inpatient rehabilitation and transition to home environments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Once patients are enrolled, baseline data and pre-intervention outcome measures will be collected. APPs will be selected from the VR Toolkit that best address the individual patient's treatment goals. Patients will be instructed in the use of the head mounted display with VR APPs. VR dosage will be two one-half hour sessions per therapy day. Patients can initiate use of a more challenging APPs that gradually includes hand/arm movement.
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality | Experimental | Device: Virtual RealityA Virtual Reality headset will be used for 30 minutes twice per day outside of usual therapy times while in bed with bedrails raised. Virtual Reality games will be selected that will help with relaxation, pain, and arm and hand recovery after a stroke. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -Veterans who have been diagnosed with
- an acute ischemic or hemorrhagic stroke and
- post-stroke are admitted to James A. Haley Veterans' Hospital inpatient rehabilitation
- age 18-80 with stroke diagnosis verified by brain imaging.
Key exclusion criteria (2 listed)
- Unable to follow instructions or participate in immersive VR therapy due to significant cognitive impairment,
- History of seizures.
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 RealityAlso: Oculus QuestVirtual Reality Headset with Virtual Reality Applications | Device | Immersive Virtual Reality |
Primary outcome
Action Research Arm Test
Time frame: 4 weeks
The Action Research Arm Test includes 19 clinician-administered tests across 4 sub-domains: Grasp, Grip, Pinch, Gross Movement. Each test is scored on a 0 (no movement possible) to 3 (movement performed normally) scale. Within each domain a score of 3 on the first and hardest test, the remaining tests are also scored as 3. A score of 0 on the second, easiest test, remaining tests are scored as 0. Tests are summed within each domain: Grasp (range = 0-18), Grip (range = 0-12); Pinch (range = 0-18); Gross Movement (range = 0-9). A total score was then calculated by summing the scores from each sub-domains (range= 0-57) with higher scores indicating better hand dexterity.
Fugl-Meyer Assessment Upper Extremity
Time frame: 4 weeks
The Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity is a measure of upper extremity stroke recovery, specifically functional impairment. It consists of 63 functional rests across 4 sub-domains: Joint Pain, Motor Function, Passive Joint Range of Motion, and Sensation. Each functional test is rated on a 0 to 2 scale with higher scores indicating greater functioning. Test scores were then summed within each sub-domain: Joint Pain (range = 0-24), Motor Function (range = 0-66); Passive Joint Range of Motion (range = 0-24); Sensation (range = 0-12). Within each sub-domain, higher scores indicate greater improvement in upper extremity function.
1 secondary outcome
Pain Outcomes Questionnaire-VA
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29313388Tieri G, Morone G, Paolucci S, Iosa M. Virtual reality in cognitive and motor rehabilitation: facts, fiction and fallacies. Expert Rev Med Devices. 2018 Feb;15(2):107-117. doi: 10.1080/17434440.2018.1425613. Epub 2018 Jan 10.
- Background: PubMed 24681826Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014.
- Background: PubMed 29453980Kiper P, Szczudlik A, Agostini M, Opara J, Nowobilski R, Ventura L, Tonin P, Turolla A. Virtual Reality for Upper Limb Rehabilitation in Subacute and Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 May;99(5):834-842.e4. doi: 10.1016/j.apmr.2018.01.023. Epub 2018 Feb 14.
- Background: PubMed 29702630Lee MM, Lee KJ, Song CH. Game-Based Virtual Reality Canoe Paddling Training to Improve Postural Balance and Upper Extremity Function: A Preliminary Randomized Controlled Study of 30 Patients with Subacute Stroke. Med Sci Monit. 2018 Apr 27;24:2590-2598. doi: 10.12659/MSM.906451.
- Background: PubMed 29149855Perez-Marcos D, Chevalley O, Schmidlin T, Garipelli G, Serino A, Vuadens P, Tadi T, Blanke O, Millan JDR. Increasing upper limb training intensity in chronic stroke using embodied virtual reality: a pilot study. J Neuroeng Rehabil. 2017 Nov 17;14(1):119. doi: 10.1186/s12984-017-0328-9.
- Background: PubMed 29529919Askin A, Atar E, Kocyigit H, Tosun A. Effects of Kinect-based virtual reality game training on upper extremity motor recovery in chronic stroke. Somatosens Mot Res. 2018 Mar;35(1):25-32. doi: 10.1080/08990220.2018.1444599. Epub 2018 Mar 13.
- Background: PubMed 26728133Paquin K, Crawley J, Harris JE, Horton S. Survivors of chronic stroke - participant evaluations of commercial gaming for rehabilitation. Disabil Rehabil. 2016 Oct;38(21):2144-52. doi: 10.3109/09638288.2015.1114155. Epub 2016 Jan 5.
- Background: PubMed 27098818Kong KH, Loh YJ, Thia E, Chai A, Ng CY, Soh YM, Toh S, Tjan SY. Efficacy of a Virtual Reality Commercial Gaming Device in Upper Limb Recovery after Stroke: A Randomized, Controlled Study. Top Stroke Rehabil. 2016 Oct;23(5):333-40. doi: 10.1080/10749357.2016.1139796. Epub 2016 Apr 21.
- Background: PubMed 12105363Lai SM, Studenski S, Duncan PW, Perera S. Persisting consequences of stroke measured by the Stroke Impact Scale. Stroke. 2002 Jul;33(7):1840-4. doi: 10.1161/01.str.0000019289.15440.f2.
- Background: PubMed 27365261Saposnik G, Cohen LG, Mamdani M, Pooyania S, Ploughman M, Cheung D, Shaw J, Hall J, Nord P, Dukelow S, Nilanont Y, De Los Rios F, Olmos L, Levin M, Teasell R, Cohen A, Thorpe K, Laupacis A, Bayley M; Stroke Outcomes Research Canada. Efficacy and safety of non-immersive virtual reality exercising in stroke rehabilitation (EVREST): a randomised, multicentre, single-blind, controlled trial. Lancet Neurol. 2016 Sep;15(10):1019-27. doi: 10.1016/S1474-4422(16)30121-1. Epub 2016 Jun 27.
- Background: PubMed 21474804Saposnik G, Levin M; Outcome Research Canada (SORCan) Working Group. Virtual reality in stroke rehabilitation: a meta-analysis and implications for clinicians. Stroke. 2011 May;42(5):1380-6. doi: 10.1161/STROKEAHA.110.605451. Epub 2011 Apr 7.
- Background: PubMed 27796177Palma GC, Freitas TB, Bonuzzi GM, Soares MA, Leite PH, Mazzini NA, Almeida MR, Pompeu JE, Torriani-Pasin C. Effects of virtual reality for stroke individuals based on the International Classification of Functioning and Health: a systematic review. Top Stroke Rehabil. 2017 May;24(4):269-278. doi: 10.1080/10749357.2016.1250373. Epub 2016 Oct 31.
- SAS Macro for Effects Size ComputationsLink provided by the sponsor.
- Market projections for VR in HealthcareLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Johanna E. Tran, MD principal investigator
James A. Haley Veterans' Hospital, Tampa, FL
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 in people with Stroke, run by VA Office of Research and Development 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 2 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 28 Feb 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?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Action Research Arm Test (time frame: 4 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 NCT04429945, which also lists 48 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 28 Feb 2024.