Virtual Reality Rehabilitation Protocol for Sensory-motor Rehabilitation After a Stoke

Not Applicable

Not yet recruiting

• Conditions: Stroke
• Interventions: Device: Virtual Reality Rehabilitation System; Behavioral: Traditional therapy

• Registration Number: NCT06164054
• Lead Sponsor: Sara Ventura

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.

Study Timeline

• Study First Submitted: 2023-11-16
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-01
• Last Update Submitted: 2023-12-01
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11
• Study Start: 2024-01-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Rehabilitation Therapy	Virtual Reality Rehabilitation System	Experimental group.
Traditional Therapy	Traditional therapy	Control group.

Primary Outcome Measures

Name	Time	Method
The Fugl-Meyer Assessment (FMA)	2 years approximately.	The primary outcome measures will be the Fugl Meyer (Platz et al., 2005) for motor ability. The Fugl-Meyer includes 33 items to evaluate upper extremity motor impairment and is scored between 0 and 2 (0 = unable, 1 = partly able, and 2 = fully able to complete movement) with a total score range of 0-66. The assessment will be performed before treatment (T1), after the conclusion of the treatment (T2), and after 6 months as a follow-up (T3).

Secondary Outcome Measures

Name	Time	Method
"Body's Proprioceptive ability"	2 years approximately.	The thirdly outcome will include timed tests that measure the proprioception dimension of the patient's body assessed by Multidimensional Assessment of Interoceptive Awareness test (MAIA; with a score from 0 = not at all, to 5 = totally).
"Self-efficacy"	2 years approximately.	The sixth outcome will include timed tests that measure the perceived and real ability in daily life activities assessed by the Stroke Self-Efficacy (with a score from 0 = not at all to 3 = totally).
"Limb ability"	2 years approximately.	The secondary outcome will include timed tests that measure the improvement in motor ability assessed by the Box and Blocks Test for the upper limb ability and motor coordination (the investigators count how many blocks the patients can move from one side of the box to the other within one minute).
"Arm's Proprioceptive ability"	2 years approximately.	The fourth outcome will include timed tests that measure the proprioception dimension of the patient's injury arm assessed by the Rubber Hand Illusion (RHI; with a score from -3 = not at all to +3 = totally).
"Autonomy level"	2 years approximately.	The fifth outcome will include timed tests that measure patient's autonomy level assessed by the Functional Independence Measure (FIM; Motor subscale with a score from 13 to 91, Cognitive subscale with a score from 5 to 35).