Clinical trial NCT06164054: Virtual Reality Rehabilitation Protocol for Sensory-motor Rehabilitation After a Stoke
Official title: Effectiveness of a Virtual Reality Rehabilitation in Stroke Patients With Sensory-motor and Proprioception Upper Limb Deficit: a Study Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Stroke is the second leading cause of death in Europe. In the case of stroke survival (almost 70%), only 25% of patients recover completely, while the remaining 75% will undergo a rehabilitation phase that varying from months to years. The main consequences of a stroke include motor disability of the upper limbs, which involves a partial or complete inability to move the right or left limb, depending on the damaged hemisphere. Furthermore, the motor deficit distorts the proprioception of the body and the embodiment ability of the injured limb. This could be rehabilitated through the paradigm of body illusion that modulates the motor rehabilitation. The present protocol aims to investigate the effectiveness of a Virtual Reality system for sensorimotor and proprioception upper limb deficit compared to a traditional upper limb rehabilitation program.

Method: This study has a randomized and controlled design with control and experimental groups, a 1:1 allocation ratio, and 4 measurement times: pre-intervention, immediately after the intervention, and two follow-ups (at 6 and 12 months). The inclusion criteria are: (a) Being 18 to 85 years old, both males and females; (b) Suffering from ischemic or hemorrhagic stroke; (c) The stroke event must have occurred from two to eighteen months before recruitment; (d) Patients must have moderate to severe upper limb motor deficit, and the alteration of sensorimotor and proprioception abilities of the injury upper limb; (e) Patients must understand and sign the written consent for enrolment. The rehabilitation last four weeks with three sessions per week at Bellaria Hospital of Bologna (Italy). The VR protocol uses two types of technology: immersive and non-immersive, and the control group follow the traditional rehabilitation program.

Ethics and dissemination: The protocol was accepted by the Local Ethics Committee (ASL_BO n. 0115481) and the clinical trial was promoted.

Detailed description: Randomized control trial with active groups.

Eligibility criteria: Inclusion Criteria:

* Being 18 to 85 years old (both male and female)
* Suffering from ischemic or hemorrhagic stroke
* Time since the stroke from 2 to 18 months before recruitment
* Severe upper limb motor deficit established by a score of ≤ 80 on the Motricity Index
* Alteration of sensorimotor and proprioception abilities of the injury upper limb (failure in 3 proofs up to 4 of the Thumb Location Test)
* Understand and sign the written consent for enrolment

Exclusion Criteria:

* Severe cognitive and behavioral disorders or a state of confusion defined by temporal and/or spatial disorientation detected during an ordinary conversation (evaluate through 4AT)
* Severe upper limb motor deficit (score Motricity Index Scale: gripper \<11, elbow flexion \<14, shoulder abduction \<14)
* Verbal comprehension ability (score \<2 at Token Test)
* Severe spatial neglect ( score of \>3 at Barrage test)

Primary outcomes:
measure: The Fugl-Meyer Assessment (FMA)
timeFrame: 2 years approximately.
Secondary outcomes:
measure: "Limb ability"
timeFrame: 2 years approximately.
measure: "Body's Proprioceptive ability"
timeFrame: 2 years approximately.
measure: "Arm's Proprioceptive ability"
timeFrame: 2 years approximately.
measure: "Autonomy level"
timeFrame: 2 years approximately.
measure: "Self-efficacy"
timeFrame: 2 years approximately.
Other outcomes:
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