Virtual Reality-Based Upper Limb Rehabilitation in Chronic Stroke: A Randomized Trial

NCT07534124 | Completed

• 1 other identifier: 22/459_E
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Rehabilitation; Upper Limb Paresis; Chronic Stroke Patient

Keywords

Ischemic Stroke; Non-Immersive Virtual Reality; Upper Extremity; FM-UE; Fugl-Meyer Assessment; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• 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, a validated scale widely used to evaluate motor recovery after stroke. The scale ranges from 0 to 66 points, with higher scores indicating better motor function of the affected upper limb.

  Baseline and 3 months after baseline.

Secondary Outcomes (4)

• Quality of Life (SF-12 Health Survey)

  Baseline and 3 months after baseline.

• Emotional Status (Hospital Anxiety and Depression Scale - HADS)

  Baseline and 3 mon

• Caregiver Burden (Zarit Burden Interview)

  Baseline and 3 months after base

• Functional Impairment (Sheehan Disability Scale)

  Baseline and 3 months after baseline.

Study Arms (2)

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.

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.

Behavioral: Non-Immersive Virtual Reality Rehabilitation

Interventions

Non-Immersive Virtual Reality Rehabilitation BEHAVIORAL

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.

Non-Immersive Virtual Reality Rehabilitation

Occupational Therapy BEHAVIORAL

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.

Conventional Occupational Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. 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.

You may not qualify if:

• 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. 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Complutense University of Madrid

Madrid, Spain

Location

Related Publications (22)

• Hao, J., He, Z., Yu, X., & Remis, A. (2023). Comparison of immersive and non-immersive virtual reality for upper extremity functional recovery in patients with stroke: A systematic review and network meta-analysis. Neurological Sciences, 44(8), 2679-2697. https://doi.org/10.1007/s10072-023-06742-8

  BACKGROUND

• Hao, J., Xie, H., Harp, K., Chen, Z., & Siu, K. C. (2022). Effects of Virtual Reality Intervention on Neural Plasticity in Stroke Rehabilitation: A Systematic Review. In Archives of Physical Medicine and Rehabilitation (Vol. 103, Issue 3). https://doi.org/10.1016/j.apmr.2021.06.024

  BACKGROUND

• Howard, 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

• Jyotirekha, D., & Rajanikant, G. K. (2018). Post stroke depression: The sequelae of cerebral stroke. 90, 104-114. https://doi.org/10.1016/j.neubiorev.2018.04.005

  BACKGROUND

• Karamians, R., Proffitt, R., Kline, D., & Gauthier, L. V. (2020b). Effectiveness of Virtual Reality- and Gaming-Based Interventions for Upper Extremity Rehabilitation Poststroke: A Meta-analysis. Archives of Physical Medicine and Rehabilitation, 101(5), 885-896. https://doi.org/10.1016/j.apmr.2019.10.195

  BACKGROUND

• Kenea, C. D., Abessa, T. G., Lamba, D., & Bonnechère, B. (2025). Immersive Virtual Reality in Stroke Rehabilitation: A Systematic Review and Meta-Analysis of Its Efficacy in Upper Limb Recovery. Journal of Clinical Medicine, 14(6), 1783. https://doi.org/10.3390/jcm14061783

  BACKGROUND

• Laver, K. E., Lange, B., George, S., Deutsch, J. E., Saposnik, G., Chapman, M., & Crotty, M. (2025). Virtual reality for stroke rehabilitation. Cochrane Database of Systematic Reviews, 2025(6). https://doi.org/10.1002/14651858.CD008349.pub5

  BACKGROUND

• Lee, H. S., Park, Y. J., & Park, S. W. (2019). The Effects of Virtual Reality Training on Function in Chronic Stroke Patients: A Systematic Review and Meta-Analysis. BioMed Research International, 2019, 1-12. https://doi.org/10.1155/2019/7595639

  BACKGROUND

• Martin-Carrasco, M., Otermin, P., & Pérez-Camo, J. (2020). EDUCA study: Psychometric properties of the Spanish version of the Zarit Caregiver Burden Scale. 14(6), 705-711. https://doi.org/doi: 10.1080/13607860903586094.

  BACKGROUND

• Mekbib, D. B., Debeli, D. K., Zhang, L., Fang, S., Shao, Y., Yang, W., Han, J., Jiang, H., Zhu, J., Zhao, Z., Cheng, R., Ye, X., Zhang, J., & Xu, D. (2021). A novel fully immersive virtual reality environment for upper extremity rehabilitation in patients with stroke. Annals of the New York Academy of Sciences, 1493(1), 75-89. https://doi.org/10.1111/nyas.14554

  BACKGROUND

• Ministerio 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

• Négyessy, L., Pálfi, E., Ashaber, M., Palmer, C., Jákli, B., Friedman, R. M., Chen, L. M., & Roe, A. W. (2013). Intrinsic horizontal connections process global tactile features in the primary somatosensory cortex: Neuroanatomical evidence. Journal of Comparative Neurology, 521(12), 2798-2817. https://doi.org/10.1002/cne.23317

  BACKGROUND

• Olana, D. D., Abessa, T. G., Lamba, D., Triccas, L. T., & Bonnechere, B. (2025). 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. Journal of NeuroEngineering and Rehabilitation, 22(1), 92. https://doi.org/10.1186/s12984-025-01603-1

  BACKGROUND

• Pollock, A., Farmer, S. E., Brady, M. C., Langhorne, P., Mead, G. E., Mehrholz, J., & Van Wijck, F. (2014). Interventions for improving upper limb function after stroke. Cochrane Database of Systematic Reviews, 2014(11). https://doi.org/10.1002/14651858.CD010820.pub2

  BACKGROUND

• Quintana, J. M., Padierna, A., & Esteban, C. (2003). Evaluation of the psychometric characteristics of the Spanish version of the Hospital Anxiety and Depression Scale. 107(3), 216-221. https://doi.org/10.1034/j.1600-0447.2003.00062.x

  BACKGROUND

• Schaechter, J. D. (2004). Motor rehabilitation and brain plasticity after hemiparetic stroke. Progress in Neurobiology, 73(1), 61-72. https://doi.org/10.1016/j.pneurobio.2004.04.001

  BACKGROUND

• Serino, A., & Haggard, P. (2010). Touch and the body. Neuroscience & Biobehavioral Reviews, 34(2), 224-236. https://doi.org/10.1016/j.neubiorev.2009.04.004

  BACKGROUND

• Soleimani, M., Ghazisaeedi, M., & Heydari, S. (2024). The efficacy of virtual reality for upper limb rehabilitation in stroke patients: A systematic review and meta-analysis. BMC Medical Informatics and Decision Making, 24(1), 135. https://doi.org/10.1186/s12911-024-02534-y

  BACKGROUND

• Sung, H. J., You, S. H., Hallett, M., Yun, W. C., Park, C. M., Cho, S. H., Lee, H. Y., & Kim, T. H. (2005). Cortical reorganization and associated functional motor recovery after virtual reality in patients with chronic stroke: An experimenter-blind preliminary study. Archives of Physical Medicine and Rehabilitation, 86(11). https://doi.org/10.1016/j.apmr.2005.04.015

  BACKGROUND

• Vilagut, G., & Valderas, J. M. (2008). Interpretación de los cuestionarios de salud SF-36 y SF-12 en España: Componentes físico y mental. 130(19), 726-735. https://doi.org/10.1157/13121076

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• Zhang, J. J. Q., Fong, K. N. K., Welage, N., & Liu, K. P. Y. (2018). The activation of the mirror neuron system during action observation and action execution with mirror visual feedback in stroke: A systematic review. In Neural Plasticity (Vol. 2018). https://doi.org/10.1155/2018/2321045

  BACKGROUND

• Zhang, J., Liu, M., Yue, J., Yang, J., Xiao, Y., Yang, J., & Cai, E. (2025). Effects of virtual reality with different modalities on upper limb recovery: A systematic review and network meta-analysis on optimizing stroke rehabilitation. Frontiers in Neurology, 16, 1544135. https://doi.org/10.3389/fneur.2025.1544135

  BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis; Ischemic Stroke

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pardo-Garcia R

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: September 1, 2022
• Primary Completion: May 30, 2025
• Study Completion: August 1, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

ES (1)