Clinical trial NCT06400823: Multimodal Platform Combining VR and TENS for Stroke Rehabilitation
Official title: Multimodal Platform Combining VR and TENS for Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Virtual Reality
TENS
Stoke
Task-oriented rehabilitation
Multimodal intervention
Lead sponsor: Institute Mihajlo Pupin
Sponsor class: OTHER
Collaborators: name: ETH Zurich (Switzerland)
First posted: 2024-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has a parallel design, with two different groups.

1. TENS+VR group
2. Conventional therapy group
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in sensorimotor impairments
timeFrame: 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)
measure: Changes in functional performances
timeFrame: 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)
measure: Changes in body-representation metrics
timeFrame: 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:
measure: Changes in degree of assistance required by an individual
timeFrame: 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)
measure: Changes in peripersonal space
timeFrame: 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)
measure: Changes of spasticity indexes for shoulder, elbow and wrist
timeFrame: 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)
measure: Changes in pain perception
timeFrame: Every day, from day 1 to day 14; 5 weeks (2 weeks after the last rehabilitation session,T3)
measure: Changes in neuropathic pain perception
timeFrame: 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)
measure: Treatment Satisfaction Measure
timeFrame: 3 weeks (one day after the last rehabilitation session, T2)
measure: Changes in tactile acuity
timeFrame: 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)
measure: Changes in upper-limb mobility (velocity)
timeFrame: Every day, from day 1 to day 14
measure: Changes in upper-limb mobility (smoothness)
timeFrame: Every day, from day 1 to day 14
measure: Changes in upper-limb mobility (efficiency)
timeFrame: Every day, from day 1 to day 14
measure: Changes in upper-limb mobility (precision)
timeFrame: Every day, from day 1 to day 14
Other outcomes:
measure: Changes in cognitive abilities
timeFrame: 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)
measure: Changes in neurophysiological correlates of Heart Rate
timeFrame: Every day, from day 1 to day 14
measure: Changes in neurophysiological correlates of Skin Conductance
timeFrame: Every day, from day 1 to day 14
measure: Changes in brain connectivity
timeFrame: day 0 (before the first rehabilitation session, T0); 3 weeks (one day after the last rehabilitation session, T2)
Locations:
city: Belgrade
country: Serbia
facility: Clinic for rehabilitation dr Miroslav Zotovic
Study officials:
affiliation: Mihajlo Pupin Institute
name: Stanisa Raspopovic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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