Multimodal Platform Combining VR and TENS for Stroke Rehabilitation

NCT06400823 | Recruiting

• 1 other identifier: VRTENSSTROKE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a disabling medical condition annually affecting up to 15 million people worldwide. It leads to upper-limb impairments encompassing motor and sensory deficits together with cognitive self-body and space misrepresentation, overall limiting the functional independence of 70% of stroke survivors. On the motor side, stroke could account for hemiparesis (weakness or paralysis affecting the side contralateral to the brain lesion), muscle weakness, spasticity, loss of coordination, and others. On the sensory side, especially in the first stages after the stroke occurs, stroke could account for sensory loss, with the patient not being able to perceive what he's touching with the impaired arm.On a cognitive level, it has been shown that chronic stroke patients have distorted body representation and space representation. They perceive their impaired arm as shorter and the impaired hand as larger. 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.

Conditions

Stroke

Keywords

Virtual Reality; TENS; Stoke; Task-oriented rehabilitation; Multimodal intervention

Outcome Measures

Primary Outcomes (3)

• Changes in sensorimotor impairments

  To assess the sensorimotor impairment in individuals who have had a stroke the investigators will use Fugl-Meyer for upper extremity (FMUE). FMUE assesses reflex activity, movement control, muscle strength, and sensory performances. It comprises items scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully.

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in functional performances

  To assess functional performance of the upper extremity through observational means the investigators will use the Action Research Arm Test (ARAT). The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total score goes from 0 to 57. Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test.

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in body-representation metrics

  To measure the body representation of the subjects the investigators will use body-landmark metrics. In VR, the subject is asked to locate the position of specific body landmarks (e.g. elbow, inner wrist, outer wrist, index, ring) while a black panel is on top of his/her arm. The investigators will then compare the real and perceived dimensions of patients' arms and hands

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

Secondary Outcomes (11)

• Changes in degree of assistance required by an individual

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in peripersonal space

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes of spasticity indexes for shoulder, elbow and wrist

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in pain perception

  Every day, from day 1 to day 14; 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in neuropathic pain perception

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

Other Outcomes (4)

• Changes in cognitive abilities

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in neurophysiological correlates of Heart Rate

  Every day, from day 1 to day 14

• Changes in neurophysiological correlates of Skin Conductance

  Every day, from day 1 to day 14

Study Arms (2)

VR+TENS

EXPERIMENTAL

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.

Other: VR+TENS

Conventional rehabilitation

ACTIVE COMPARATOR

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.

Other: Conventional rehabilitation

Interventions

VR+TENS OTHER

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.

VR+TENS

Conventional rehabilitation OTHER

Patients will perform conventional upper-limb stroke rehabilitation. The movement performed will be comparable with the movement performed in the VR+TENS group

Conventional rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic or haemorrhagic stroke patient
• At least 3 months after the stroke incident
• \<= FMUE \<= 60 (motor function)

You may not qualify if:

• Prior neurological or psychiatric disorders
• Severe cognitive impairment (MoCA score \<10)
• Epilepsy
• Pacemakers or other electronic implants
• Unable to give an informed consent form

Sponsors & Collaborators

• Institute Mihajlo Pupin: lead
• ETH Zurich (Switzerland): collaborator

Study Sites (1)

Clinic for rehabilitation dr Miroslav Zotovic

Belgrade, Serbia

RECRUITING

Related Publications (8)

• 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.

  PMID: 31191265 BACKGROUND

• 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.

  PMID: 35950092 BACKGROUND

• 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.

  PMID: 20556766 BACKGROUND

• 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.

  PMID: 34264125 BACKGROUND

• 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.

  PMID: 34295219 BACKGROUND

• 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.

  PMID: 12234086 BACKGROUND

• 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.

  PMID: 16296669 BACKGROUND

• 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.

  PMID: 18055266 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stanisa Raspopovic, PhD

  Mihajlo Pupin Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalija Secerovic, PhD

CONTACT

+381631268862; natalija.katic@pupin.rs

Giuseppe Valerio Aurucci

CONTACT

+393931595791; valerioaurucci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study has a parallel design, with two different groups. 1. TENS+VR group 2. Conventional therapy group

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 6, 2024
• Study Start: April 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-05

Locations

SE (1)