Multimodal Platform Combining VR and TENS for Stroke Rehabilitation
NCT ID: NCT06400823
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-04-22
2026-06-01
Brief Summary
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Despite initial evidence of the crucial role of sensory-motor integration toward a restored body representation to promote effective rehabilitation, conventional approaches suffer from the bias of prioritizing motor recovery, while disregarding stroke-induced sensory and body representation deficits.
In this view, the creation of a virtual reality (VR) scenario in which the person is fully immersed, could potentially play a significant role in improving stroke patients' rehabilitation.
Taking this into consideration, this project aims to assess whether a multimodal platform combining VR with TENS inducing full-body illusion toward a virtual avatar could positively impact motor performances, sensory assessments, and self-body and space representation of stroke patients.
More into detail, the intervention will consist of the patient performing some task-oriented movement within the virtual reality and congruently tactile receiving feedback through transcutaneous electrical nerve stimulation. The subject will receive clear instruction within the virtual reality scenario to perform specific actions toward a final goal. These actions will be designed to make the subject repeat some crucial movements in their rehabilitation process. Depending on the motor impairment of the patient, the investigators will adapt the characteristics and the difficulty of the task accordingly.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
1. TENS+VR group
2. Conventional therapy group
TREATMENT
SINGLE
Study Groups
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VR+TENS
Patients will undergo goal-oriented movements for upper-limb rehabilitation in a VR scenario. While performing the movement, patients will receive synchronous electrical stimulation targeting the medial nerve. The provided sensation will stimulate the interaction with elements in the virtual world.
The intervention phase will last 3 weeks. Patients will undergo a minimum of three sessions per week (of around 60'). During each of these sessions, the first 10' will be employed for the calibration of the Transcutaneous Electrical Nerve Stimulation (TENS). In the remaining part of the session, subjects will perform some of the VR-based task-oriented games targeting different components.
VR+TENS
During the invention, patients will be in VR scenarios and play task-oriented games, interacting with elements that appear in the virtual world, to improve mobility and functional independence of the upper limbs.
The task-oriented games will target different components depending on the disability of the patient.
Conventional rehabilitation
Patients in the control group will perform physical conventional rehabilitation provided by the rehabilitation clinic.
The total amount of therapy will be the same as that of the VR+TENS group. The exercises will target the same components of the VR+TENS arm.
Conventional rehabilitation
Patients will perform conventional upper-limb stroke rehabilitation. The movement performed will be comparable with the movement performed in the VR+TENS group
Interventions
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VR+TENS
During the invention, patients will be in VR scenarios and play task-oriented games, interacting with elements that appear in the virtual world, to improve mobility and functional independence of the upper limbs.
The task-oriented games will target different components depending on the disability of the patient.
Conventional rehabilitation
Patients will perform conventional upper-limb stroke rehabilitation. The movement performed will be comparable with the movement performed in the VR+TENS group
Eligibility Criteria
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Inclusion Criteria
* At least 3 months after the stroke incident
* 10 \<= FMUE \<= 60 (motor function)
Exclusion Criteria
* Severe cognitive impairment (MoCA score \<10)
* Epilepsy
* Pacemakers or other electronic implants
* Unable to give an informed consent form
18 Years
80 Years
ALL
No
Sponsors
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ETH Zurich (Switzerland)
OTHER
Institute Mihajlo Pupin
OTHER
Responsible Party
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Principal Investigators
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Stanisa Raspopovic, PhD
Role: PRINCIPAL_INVESTIGATOR
Mihajlo Pupin Institute
Locations
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Clinic for rehabilitation dr Miroslav Zotovic
Belgrade, , Serbia
Countries
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Central Contacts
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Facility Contacts
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Olivera Djordjevic
Role: primary
References
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Edwards LL, King EM, Buetefisch CM, Borich MR. Putting the "Sensory" Into Sensorimotor Control: The Role of Sensorimotor Integration in Goal-Directed Hand Movements After Stroke. Front Integr Neurosci. 2019 May 22;13:16. doi: 10.3389/fnint.2019.00016. eCollection 2019.
Bassolino M, Franza M, Guanziroli E, Sorrentino G, Canzoneri E, Colombo M, Crema A, Bertoni T, Mastria G, Vissani M, Sokolov AA, Micera S, Molteni F, Blanke O, Serino A. Body and peripersonal space representations in chronic stroke patients with upper limb motor deficits. Brain Commun. 2022 Aug 5;4(4):fcac179. doi: 10.1093/braincomms/fcac179. eCollection 2022.
Doyle S, Bennett S, Fasoli SE, McKenna KT. Interventions for sensory impairment in the upper limb after stroke. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD006331. doi: 10.1002/14651858.CD006331.pub2.
Ingram LA, Butler AA, Brodie MA, Lord SR, Gandevia SC. Quantifying upper limb motor impairment in chronic stroke: a physiological profiling approach. J Appl Physiol (1985). 2021 Sep 1;131(3):949-965. doi: 10.1152/japplphysiol.00078.2021. Epub 2021 Jul 15.
Odermatt IA, Buetler KA, Wenk N, Ozen O, Penalver-Andres J, Nef T, Mast FW, Marchal-Crespo L. Congruency of Information Rather Than Body Ownership Enhances Motor Performance in Highly Embodied Virtual Reality. Front Neurosci. 2021 Jul 2;15:678909. doi: 10.3389/fnins.2021.678909. eCollection 2021.
Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002 Sep;16(3):232-40. doi: 10.1177/154596802401105171.
Hsieh CL, Hsueh IP, Chiang FM, Lin PH. Inter-rater reliability and validity of the action research arm test in stroke patients. Age Ageing. 1998 Mar;27(2):107-13. doi: 10.1093/ageing/27.2.107.
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
Other Identifiers
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VRTENSSTROKE
Identifier Type: -
Identifier Source: org_study_id