StrokeNCT07534124
Virtual Reality-Based Upper Limb Rehabilitation in Chronic Stroke
A study testing Non-Immersive Virtual Reality Rehabilitation and Occupational Therapy in people with Stroke and Rehabilitation, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
This randomized controlled study aims to evaluate the effectiveness of non-immersive virtual reality-based rehabilitation using the MindMotion™ GO system compared with conventional occupational therapy for improving upper limb motor function in individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Rehabilitation, Upper Limb Paresis
- What is being tested?
- Non-Immersive Virtual Reality Rehabilitation and Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 1 Aug 2025
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Age between 18 and 80 years.
- Chronic phase of ischemic stroke affecting the dominant hemisphere in the Middle Cerebral Artery territory (more than 6 months and less than 4 years since stroke onset).
- Ability to actively extend the wrist at least 20 degrees and extend the fingers at least 10 degrees.
- Upper limb muscle strength of the paretic limb ≥2 in the shoulder, elbow, and wrist.
- Adequate trunk control.
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- Adequate vision and hearing to interact with the rehabilitation platform.
- Ability to collaborate and follow study procedures.
- Meeting safety criteria for Electroencephalography recording.
- Signed informed consent.
Who cannot join
- Participants will be excluded if any of the following conditions are present:
- Severe cognitive impairment (Montreal Cognitive Assessment score <10).
- Major depression or emotional disorders associated with severe attention or cooperation deficits that may interfere with hand function.
- Severe psychiatric disease.
- Severe spasticity in the affected limb (Modified Modified Ashworth Scale ≥3-4).
- Aphasia preventing comprehension of verbal instructions.
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- Visuospatial neglect preventing interaction with the rehabilitation interface.
- Participation in other upper limb rehabilitation therapies during the study period.
- Severe functional dependency prior to stroke.
- History of other strokes occurring after the index stroke.
- Any medical condition that, in the opinion of the investigator, could interfere with study participation or data interpretation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Immersive Virtual Reality (MindMotion™ GO) Improves Upper Limb Motor Function in Chronic Left MCA Stroke: A Randomized Controlled Trial
This randomized controlled study aims to evaluate the effectiveness of non-immersive virtual reality-based rehabilitation using the MindMotion™ GO system compared with conventional occupational therapy for improving upper limb motor function in individuals with chronic stroke. Stroke is a leading cause of long-term disability in adults worldwide, and barriers such as limited access to rehabilitation services, low motivation, and reduced adherence may hinder recovery in the chronic phase.
Participants will be randomly assigned to either an experimental group receiving non-immersive virtual reality training or a control group receiving conventional occupational therapy according to standard clinical practice. Both groups will complete two rehabilitation sessions per week for eight weeks, with each session lasting approximately 40 minutes.
Read more
The study will assess upper limb motor function, performance in activities of daily living, and quality of life. In addition, electroencephalography (EEG) will be used before and after the intervention to explore potential neuroplastic changes associated with rehabilitation.
Outcome assessments will be conducted at baseline and at follow-up approximately three months after the initial evaluation. The results of this study may help determine whether non-immersive virtual reality is an effective and accessible tool to enhance rehabilitation outcomes in individuals with chronic stroke.
Read the detailed description
Stroke is one of the leading causes of death and long-term disability worldwide and represents a major public health challenge. Many individuals who survive a stroke experience persistent motor impairments, particularly affecting upper limb function, which significantly limits independence in activities of daily living and reduces quality of life. In the chronic phase of stroke, access to intensive rehabilitation programs may be limited by several barriers, including reduced availability of services, high costs, transportation difficulties, low motivation, and lack of social support.
Virtual reality (VR)-based rehabilitation has emerged as a promising therapeutic approach to enhance engagement, increase therapy intensity, and potentially improve functional outcomes in neurological rehabilitation. Non-immersive virtual reality systems allow patients to interact with simulated environments through computer interfaces while performing goal-directed motor tasks. These systems may provide real-time feedback, increase motivation, and promote repetitive, task-oriented practice that supports motor learning and neuroplasticity.
The present study is a randomized controlled trial designed to evaluate the effectiveness of non-immersive virtual reality-based rehabilitation using the MindMotion™ GO system compared with conventional occupational therapy in individuals with chronic stroke affecting the middle cerebral artery territory.
Participants who meet the inclusion criteria will be randomly assigned to one of two groups:
Experimental group: Participants will receive rehabilitation using the non-immersive virtual reality platform MindMotion™ GO. Training sessions will be performed under the supervision of a researcher and will consist of task-oriented exercises within a virtual environment designed to stimulate upper limb movements and functional activities.
Control group: Participants will receive conventional occupational therapy according to standard clinical practice. Therapy sessions will include therapist-guided task-oriented exercises aimed at improving upper limb function.
Both groups will complete two rehabilitation sessions per week for eight weeks (16 sessions in total). Each session will last approximately 40 minutes, including short rest periods during training.
Participants will undergo baseline evaluation including clinical assessment and electroencephalography (EEG) recording in resting-state and task conditions. Functional outcomes will be evaluated using standardized clinical scales assessing upper limb motor function, activities of daily living, and quality of life. After completion of the intervention, participants will undergo follow-up assessments approximately three months after the baseline visit, including repeat EEG recordings to explore potential neuroplastic changes associated with the rehabilitation intervention.
The results of this study will contribute to understanding whether non-immersive virtual reality-based rehabilitation can improve functional recovery and promote neuroplasticity in individuals with chronic stroke.
- Conditions
- Stroke, Rehabilitation, Upper Limb Paresis, Chronic Stroke Patient
- Being tested
- Non-Immersive Virtual Reality Rehabilitation, Occupational Therapy
- Keywords
- Ischemic Stroke, Non-Immersive Virtual Reality, Upper Extremity, FM-UE, Fugl-Meyer Assessment, Neurorehabilitation
- Medical subject headings
- Stroke, Paresis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Immersive Virtual Reality RehabilitationBehavioural
Participants assigned to the experimental group will receive upper limb rehabilitation using a non-immersive virtual reality platform (MindMotion™ GO). Training will consist of task-oriented exercises performed within interactive virtual environments designed to promote active movements of the affected upper limb and facilitate motor learning through real-time visual and auditory feedback.
Sessions will be performed under the supervision of a member of the research team. Participants will attend two sessions per week for seven weeks, with each session lasting approximately 40 minutes and including short rest periods as needed. The total number and duration of sessions will be equivalent to those provided in the control group receiving conventional occupational therapy.
Occupational TherapyBehavioural
Arm Description: Participants assigned to the control group will receive conventional occupational therapy according to standard clinical practice for upper limb rehabilitation after stroke. Therapy sessions will be supervised by an experienced occupational therapist and will consist of task-oriented exercises aimed at improving motor function, coordination, and functional use of the affected upper limb in activities of daily living. Sessions will be conducted twice per week for seven weeks, with each session lasting approximately 40 minutes and including short rest periods as needed. The number of sessions, duration, and intensity of therapy will be equivalent to those provided in the experimental virtual reality group.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Occupational Therapy | Active comparator | Participants assigned to the control group will receive conventional occupational therapy according to standard clinical practice for upper limb rehabilitation after stroke. Therapy sessions will be supervised by an experienced occupational therapist and will consist of task-oriented exercises aimed at improving motor function, coordination, and functional use of the affected upper limb in activities of daily living.
Sessions will be conducted twice per week for seven weeks, with each session lasting approximately 40 minutes and including short rest periods as needed. The number of sessions, duration, and intensity of therapy will be equivalent to those provided in the experimental virtual reality group. Receives: Behavioral: Occupational Therapy |
| Non-Immersive Virtual Reality Rehabilitation | Experimental | Description: Participants assigned to the experimental group will receive upper limb rehabilitation using a non-immersive virtual reality platform (MindMotion™ GO). Training will consist of task-oriented exercises performed within interactive virtual environments designed to promote active movements of the affected upper limb and facilitate motor learning through real-time visual and auditory feedback. Sessions will be performed under the supervision of a member of the research team. Participants will attend two sessions per week for seven weeks, with each session lasting approximately 40 minutes and including short rest periods as needed. The total number and duration of sessions will be equivalent to those provided in the control group receiving conventional occupational therapy. Receives: Behavioral: Non-Immersive Virtual Reality Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Motor Function
Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity, FM-UE) Change in upper limb motor function will be assessed using the Fugl-Meyer Assessment Upper Extremity (FM-UE), Spanish-validated version (Ferrer B., 2015).
This scale is widely used to evaluate motor recovery after stroke. Total scores range from 0 to 66, with higher scores indicating better motor function of the affected upper limb. The minimal clinically important difference (MCID) has been reported as 7.35 points.
Measured: Baseline and 3 months after baseline.
Secondary outcomes (4)
Quality of Life (SF-12 Health Survey)
Quality of Life (Short Form-12 Health Survey, SF-12) Quality of life will be assessed using the Short Form-12 Health Survey (SF-12), which provides two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each component score ranges from 0 to 100, with higher scores indicating better perceived health status.
Measured: Baseline and 3 months after baseline.
Emotional Status (Hospital Anxiety and Depression Scale - HADS)
Emotional status will be evaluated using the Hospital Anxiety and Depression Scale (HADS), a validated instrument designed to assess symptoms of anxiety and depression in clinical populations. The scale consists of two subscales (anxiety and depression), each ranging from 0 to 21, with higher scores indicating greater symptom severity.
Measured: Baseline and 3 months
Caregiver Burden (Zarit Burden Interview)
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a validated instrument that measures the perceived burden experienced by caregivers of individuals with chronic conditions. Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.
Measured: Baseline and 3 months after baseline.
Functional Impairment (Sheehan Disability Scale)
Functional impairment in work/school, social life, and family life will be evaluated using the Sheehan Disability Scale (SDS), a validated self-report instrument. The scale consists of three items, each scored from 0 to 10, yielding a total score ranging from 0 to 30, with higher scores indicating greater functional impairment.
Measured: Baseline and 3 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Sep 2022
- Primary completion30 May 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with chronic ischemic stroke of the dominant hemisphere middle cerebral artery will be randomly assigned using simple randomization implemented through REDCap to one of two parallel groups: (1) a non-immersive virtual reality rehabilitation program using the MindMotion™ GO system, or (2) conventional occupational therapy according to standard clinical practice. Both groups will receive supervised rehabilitation sessions of equal duration and frequency (two sessions per week for seven weeks). Outcome assessments will be conducted at baseline and at follow-up by investigators blinded to treatment allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebeca Pardo García, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534124
- Sponsor's protocol ID
- 22/459_E
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding investigator. Data will be shared after de-identification in order to protect participant confidentiality and in accordance with applicable data protection regulations.
Publications
Hao J, He Z, Yu X, Remis A. Comparison of immersive and non-immersive virtual reality for upper extremity functional recovery in patients with stroke: a systematic review and network meta-analysis. Neurol Sci. 2023 Aug;44(8):2679-2697. doi: 10.1007/s10072-023-06742-8. Epub 2023 Mar 23.
PubMed 36959332Hao J, Xie H, Harp K, Chen Z, Siu KC. Effects of Virtual Reality Intervention on Neural Plasticity in Stroke Rehabilitation: A Systematic Review. Arch Phys Med Rehabil. 2022 Mar;103(3):523-541. doi: 10.1016/j.apmr.2021.06.024. Epub 2021 Aug 2.
PubMed 34352269Howard, M. C., Gutworth, M. B., & Jacobs, R. R. (2021). A meta-analysis of virtual reality training programs. Computers in Human Behavior, 121, 106808. https://doi.org/10.1016/j.chb.2021.106808
Das J, G K R. Post stroke depression: The sequelae of cerebral stroke. Neurosci Biobehav Rev. 2018 Jul;90:104-114. doi: 10.1016/j.neubiorev.2018.04.005. Epub 2018 Apr 12.
PubMed 29656030Karamians R, Proffitt R, Kline D, Gauthier LV. Effectiveness of Virtual Reality- and Gaming-Based Interventions for Upper Extremity Rehabilitation Poststroke: A Meta-analysis. Arch Phys Med Rehabil. 2020 May;101(5):885-896. doi: 10.1016/j.apmr.2019.10.195. Epub 2019 Dec 7.
PubMed 31821799Kenea CD, Abessa TG, Lamba D, Bonnechere B. Immersive Virtual Reality in Stroke Rehabilitation: A Systematic Review and Meta-Analysis of Its Efficacy in Upper Limb Recovery. J Clin Med. 2025 Mar 7;14(6):1783. doi: 10.3390/jcm14061783.
PubMed 40142592Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Chapman M, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2025 Jun 20;6(6):CD008349. doi: 10.1002/14651858.CD008349.pub5.
PubMed 40537150Lee HS, Park YJ, Park SW. The Effects of Virtual Reality Training on Function in Chronic Stroke Patients: A Systematic Review and Meta-Analysis. Biomed Res Int. 2019 Jun 18;2019:7595639. doi: 10.1155/2019/7595639. eCollection 2019.
PubMed 31317037Martin-Carrasco M, Otermin P, Perez-Camo V, Pujol J, Aguera L, Martin MJ, Gobartt AL, Pons S, Balana M. EDUCA study: Psychometric properties of the Spanish version of the Zarit Caregiver Burden Scale. Aging Ment Health. 2010 Aug;14(6):705-11. doi: 10.1080/13607860903586094.
PubMed 20544413Mekbib DB, Debeli DK, Zhang L, Fang S, Shao Y, Yang W, Han J, Jiang H, Zhu J, Zhao Z, Cheng R, Ye X, Zhang J, Xu D. A novel fully immersive virtual reality environment for upper extremity rehabilitation in patients with stroke. Ann N Y Acad Sci. 2021 Jun;1493(1):75-89. doi: 10.1111/nyas.14554. Epub 2021 Jan 14.
PubMed 33442915Ministerio de Sanidad. (2024). Estrategia en Ictus del Sistema Nacional de Salud. Actualización 2024. MINISTERIO DE SANIDAD CENTRO DE PUBLICACIONES. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.sanidad.gob.es/areas/calidadAsistencial/estrategias/ictus/docs/Estrategia_en_Ictus_del_SNS._Actualizacion_2024_accesible.pdf
Negyessy L, Palfi E, Ashaber M, Palmer C, Jakli B, Friedman RM, Chen LM, Roe AW. Intrinsic horizontal connections process global tactile features in the primary somatosensory cortex: neuroanatomical evidence. J Comp Neurol. 2013 Aug 15;521(12):2798-817. doi: 10.1002/cne.23317.
PubMed 23436325Olana DD, Abessa TG, Lamba D, Triccas LT, Bonnechere B. Effect of virtual reality-based upper limb training on activity of daily living and quality of life among stroke survivors: a systematic review and meta-analysis. J Neuroeng Rehabil. 2025 Apr 24;22(1):92. doi: 10.1186/s12984-025-01603-1.
PubMed 40269877Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.
PubMed 25387001Quintana JM, Padierna A, Esteban C, Arostegui I, Bilbao A, Ruiz I. Evaluation of the psychometric characteristics of the Spanish version of the Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 2003 Mar;107(3):216-21. doi: 10.1034/j.1600-0447.2003.00062.x.
PubMed 12580829
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Immersive Virtual Reality (MindMotion™ GO) Improves Upper Limb Motor Function in Chronic Left MCA Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07534124
- Acronym / sponsor ID
- 22/459_E
- Conditions
- Stroke, Rehabilitation, Upper Limb Paresis, Chronic Stroke Patient
- Keywords
- Ischemic Stroke, Non-Immersive Virtual Reality, Upper Extremity, FM-UE, Fugl-Meyer Assessment, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 16 Apr 2026 (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.
This randomized controlled study aims to evaluate the effectiveness of non-immersive virtual reality-based rehabilitation using the MindMotion™ GO system compared with conventional occupational therapy for improving upper limb motor function in individuals with chronic stroke. Stroke is a leading cause of long-term disability in adults worldwide, and barriers such as limited access to rehabilitation services, low motivation, and reduced adherence may hinder recovery in the chronic phase.
Participants will be randomly assigned to either an experimental group receiving non-immersive virtual reality training or a control group receiving conventional occupational therapy according to standard clinical practice. Both groups will complete two rehabilitation sessions per week for eight weeks, with each session lasting approximately 40 minutes.
The study will assess upper limb motor function, performance in activities of daily living, and quality of life. In addition, electroencephalography (EEG) will be used before and after the intervention to explore potential neuroplastic changes associated with rehabilitation.
Outcome assessments will be conducted at baseline and at follow-up approximately three months after the initial evaluation. The results of this study may help determine whether non-immersive virtual reality is an effective and accessible tool to enhance rehabilitation outcomes in individuals with chronic stroke.
Detailed description
Stroke is one of the leading causes of death and long-term disability worldwide and represents a major public health challenge. Many individuals who survive a stroke experience persistent motor impairments, particularly affecting upper limb function, which significantly limits independence in activities of daily living and reduces quality of life. In the chronic phase of stroke, access to intensive rehabilitation programs may be limited by several barriers, including reduced availability of services, high costs, transportation difficulties, low motivation, and lack of social support.
Virtual reality (VR)-based rehabilitation has emerged as a promising therapeutic approach to enhance engagement, increase therapy intensity, and potentially improve functional outcomes in neurological rehabilitation. Non-immersive virtual reality systems allow patients to interact with simulated environments through computer interfaces while performing goal-directed motor tasks. These systems may provide real-time feedback, increase motivation, and promote repetitive, task-oriented practice that supports motor learning and neuroplasticity.
The present study is a randomized controlled trial designed to evaluate the effectiveness of non-immersive virtual reality-based rehabilitation using the MindMotion™ GO system compared with conventional occupational therapy in individuals with chronic stroke affecting the middle cerebral artery territory.
Participants who meet the inclusion criteria will be randomly assigned to one of two groups:
Experimental group: Participants will receive rehabilitation using the non-immersive virtual reality platform MindMotion™ GO. Training sessions will be performed under the supervision of a researcher and will consist of task-oriented exercises within a virtual environment designed to stimulate upper limb movements and functional activities.
Control group: Participants will receive conventional occupational therapy according to standard clinical practice. Therapy sessions will include therapist-guided task-oriented exercises aimed at improving upper limb function.
Both groups will complete two rehabilitation sessions per week for eight weeks (16 sessions in total). Each session will last approximately 40 minutes, including short rest periods during training.
Participants will undergo baseline evaluation including clinical assessment and electroencephalography (EEG) recording in resting-state and task conditions. Functional outcomes will be evaluated using standardized clinical scales assessing upper limb motor function, activities of daily living, and quality of life. After completion of the intervention, participants will undergo follow-up assessments approximately three months after the baseline visit, including repeat EEG recordings to explore potential neuroplastic changes associated with the rehabilitation intervention.
The results of this study will contribute to understanding whether non-immersive virtual reality-based rehabilitation can improve functional recovery and promote neuroplasticity in individuals with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants with chronic ischemic stroke of the dominant hemisphere middle cerebral artery will be randomly assigned using simple randomization implemented through REDCap to one of two parallel groups: (1) a non-immersive virtual reality rehabilitation program using the MindMotion™ GO system, or (2) conventional occupational therapy according to standard clinical practice. Both groups will receive supervised rehabilitation sessions of equal duration and frequency (two sessions per week for seven weeks). Outcome assessments will be conducted at baseline and at follow-up by investigators blinded to treatment allocation.
| Arm | Type | Receives |
|---|---|---|
| Conventional Occupational Therapy | Active comparator | Behavioral: Occupational TherapyParticipants assigned to the control group will receive conventional occupational therapy according to standard clinical practice for upper limb rehabilitation after stroke. Therapy sessions will be supervised by an experienced occupational therapist and will consist of task-oriented exercises aimed at improving motor function, coordination, and functional use of the affected upper limb in activities of daily living. Sessions will be conducted twice per week for seven weeks, with each session lasting approximately 40 minutes and including short rest periods as needed. The number of sessions, duration, and intensity of therapy will be equivalent to those provided in the experimental virtual reality group. |
| Non-Immersive Virtual Reality Rehabilitation | Experimental | Behavioral: Non-Immersive Virtual Reality RehabilitationDescription: Participants assigned to the experimental group will receive upper limb rehabilitation using a non-immersive virtual reality platform (MindMotion™ GO). Training will consist of task-oriented exercises performed within interactive virtual environments designed to promote active movements of the affected upper limb and facilitate motor learning through real-time visual and auditory feedback. Sessions will be performed under the supervision of a member of the research team. Participants will attend two sessions per week for seven weeks, with each session lasting approximately 40 minutes and including short rest periods as needed. The total number and duration of sessions will be equivalent to those provided in the control group receiving conventional occupational therapy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 18 and 80 years.
- Chronic phase of ischemic stroke affecting the dominant hemisphere in the Middle Cerebral Artery territory (more than 6 months and less than 4 years since stroke onset).
- Ability to actively extend the wrist at least 20 degrees and extend the fingers at least 10 degrees.
- Upper limb muscle strength of the paretic limb ≥2 in the shoulder, elbow, and wrist.
- Adequate trunk control.
Key exclusion criteria (11 listed)
- Severe cognitive impairment (Montreal Cognitive Assessment score <10).
- Major depression or emotional disorders associated with severe attention or cooperation deficits that may interfere with hand function.
- Severe psychiatric disease.
- Severe spasticity in the affected limb (Modified Modified Ashworth Scale ≥3-4).
- Aphasia preventing comprehension of verbal instructions.
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 |
|---|---|---|
| Non-Immersive Virtual Reality RehabilitationParticipants assigned to the experimental group will receive upper limb rehabilitation using a non-immersive virtual reality platform (MindMotion™ GO). Training will consist of task-oriented exercises performed within interactive virtual environments designed to promote active movements of the affected upper limb and facilitate motor learning through real-time visual and auditory feedback. Sessions will be performed under the supervision of a member of the research team. Participants will attend two sessions per week for seven weeks, with each session lasting approximately 40 minutes and including short rest periods as needed. The total number and duration of sessions will be equivalent to those provided in the control group receiving conventional occupational therapy. | Behavioural | Non-Immersive Virtual Reality Rehabilitation |
| Occupational TherapyArm Description: Participants assigned to the control group will receive conventional occupational therapy according to standard clinical practice for upper limb rehabilitation after stroke. Therapy sessions will be supervised by an experienced occupational therapist and will consist of task-oriented exercises aimed at improving motor function, coordination, and functional use of the affected upper limb in activities of daily living. Sessions will be conducted twice per week for seven weeks, with each session lasting approximately 40 minutes and including short rest periods as needed. The number of sessions, duration, and intensity of therapy will be equivalent to those provided in the experimental virtual reality group. | Behavioural | Conventional Occupational Therapy |
Primary outcome
Upper Limb Motor Function
Time frame: Baseline and 3 months after baseline.
Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity, FM-UE) Change in upper limb motor function will be assessed using the Fugl-Meyer Assessment Upper Extremity (FM-UE), Spanish-validated version (Ferrer B., 2015). This scale is widely used to evaluate motor recovery after stroke. Total scores range from 0 to 66, with higher scores indicating better motor function of the affected upper limb. The minimal clinically important difference (MCID) has been reported as 7.35 points.
4 secondary outcomes
Quality of Life (SF-12 Health Survey)
Time frame: Baseline and 3 months after baseline.
Emotional Status (Hospital Anxiety and Depression Scale - HADS)
Time frame: Baseline and 3 months
Caregiver Burden (Zarit Burden Interview)
Time frame: Baseline and 3 months after baseline.
Functional Impairment (Sheehan Disability Scale)
Time frame: Baseline and 3 months after baseline.
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 23 Apr 2026.
- Background: PubMed 36959332Hao J, He Z, Yu X, Remis A. Comparison of immersive and non-immersive virtual reality for upper extremity functional recovery in patients with stroke: a systematic review and network meta-analysis. Neurol Sci. 2023 Aug;44(8):2679-2697. doi: 10.1007/s10072-023-06742-8. Epub 2023 Mar 23.
- Background: PubMed 34352269Hao J, Xie H, Harp K, Chen Z, Siu KC. Effects of Virtual Reality Intervention on Neural Plasticity in Stroke Rehabilitation: A Systematic Review. Arch Phys Med Rehabil. 2022 Mar;103(3):523-541. doi: 10.1016/j.apmr.2021.06.024. Epub 2021 Aug 2.
- BackgroundHoward, M. C., Gutworth, M. B., & Jacobs, R. R. (2021). A meta-analysis of virtual reality training programs. Computers in Human Behavior, 121, 106808. https://doi.org/10.1016/j.chb.2021.106808
- Background: PubMed 29656030Das J, G K R. Post stroke depression: The sequelae of cerebral stroke. Neurosci Biobehav Rev. 2018 Jul;90:104-114. doi: 10.1016/j.neubiorev.2018.04.005. Epub 2018 Apr 12.
- Background: PubMed 31821799Karamians R, Proffitt R, Kline D, Gauthier LV. Effectiveness of Virtual Reality- and Gaming-Based Interventions for Upper Extremity Rehabilitation Poststroke: A Meta-analysis. Arch Phys Med Rehabil. 2020 May;101(5):885-896. doi: 10.1016/j.apmr.2019.10.195. Epub 2019 Dec 7.
- Background: PubMed 40142592Kenea CD, Abessa TG, Lamba D, Bonnechere B. Immersive Virtual Reality in Stroke Rehabilitation: A Systematic Review and Meta-Analysis of Its Efficacy in Upper Limb Recovery. J Clin Med. 2025 Mar 7;14(6):1783. doi: 10.3390/jcm14061783.
- Background: PubMed 40537150Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Chapman M, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2025 Jun 20;6(6):CD008349. doi: 10.1002/14651858.CD008349.pub5.
- Background: PubMed 31317037Lee HS, Park YJ, Park SW. The Effects of Virtual Reality Training on Function in Chronic Stroke Patients: A Systematic Review and Meta-Analysis. Biomed Res Int. 2019 Jun 18;2019:7595639. doi: 10.1155/2019/7595639. eCollection 2019.
- Background: PubMed 20544413Martin-Carrasco M, Otermin P, Perez-Camo V, Pujol J, Aguera L, Martin MJ, Gobartt AL, Pons S, Balana M. EDUCA study: Psychometric properties of the Spanish version of the Zarit Caregiver Burden Scale. Aging Ment Health. 2010 Aug;14(6):705-11. doi: 10.1080/13607860903586094.
- Background: PubMed 33442915Mekbib DB, Debeli DK, Zhang L, Fang S, Shao Y, Yang W, Han J, Jiang H, Zhu J, Zhao Z, Cheng R, Ye X, Zhang J, Xu D. A novel fully immersive virtual reality environment for upper extremity rehabilitation in patients with stroke. Ann N Y Acad Sci. 2021 Jun;1493(1):75-89. doi: 10.1111/nyas.14554. Epub 2021 Jan 14.
- BackgroundMinisterio de Sanidad. (2024). Estrategia en Ictus del Sistema Nacional de Salud. Actualización 2024. MINISTERIO DE SANIDAD CENTRO DE PUBLICACIONES. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.sanidad.gob.es/areas/calidadAsistencial/estrategias/ictus/docs/Estrategia_en_Ictus_del_SNS._Actualizacion_2024_accesible.pdf
- Background: PubMed 23436325Negyessy L, Palfi E, Ashaber M, Palmer C, Jakli B, Friedman RM, Chen LM, Roe AW. Intrinsic horizontal connections process global tactile features in the primary somatosensory cortex: neuroanatomical evidence. J Comp Neurol. 2013 Aug 15;521(12):2798-817. doi: 10.1002/cne.23317.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding investigator. Data will be shared after de-identification in order to protect participant confidentiality and in accordance with applicable data protection regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Immersive Virtual Reality Rehabilitation and Occupational Therapy in people with Stroke and Rehabilitation, run by Universidad Complutense de Madrid at 1 site in Spain.
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 10 inclusion and 11 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 23 Apr 2026. 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 Spain. 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?
Upper Limb Motor Function (time frame: Baseline and 3 months after baseline.). 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 NCT07534124, which also lists 22 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 23 Apr 2026.