A Music-based VR Intervention for Upper Limb Motor Rehabilitation in Hemiparetic Patients

Not Applicable

• Conditions: Hemiparesis
• Interventions: Behavioral: VR+MUSIC; Behavioral: TAU; Behavioral: VR

• Registration Number: NCT04977609
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

Hemiparesis affects the majority of stroke patients in the acute phase. In post-stroke motor rehabilitation patients can re-learn motor sequences through repetitive training. Research showed that virtual reality (VR) can be effectively used in upper limb motor rehabilitation by training motor coordination and gestures in an immersive virtual environment. Another promising line of intervention in post-stroke rehabilitation is the use of music, with evidence supporting the notion that a rhythmic accompaniment promotes the recovery of motor coordination in patients with hemiparetic stroke. Furthermore, studies showed a beneficial effect of the observation of movements performed by a third person in patients with post-stroke hemiparesis. Based this evidence, the present study aims at testing the feasibility and efficacy of a novel music-based VR intervention designed for upper limb motor rehabilitation in post-stroke hemiparetic patients. The treatment consists in upper limb repetitive training activities through the imitation of movements synchronized with a musical accompaniment and is delivered in 10 sessions over 2 weeks, supervised by a physical therapist. Participants wear a VR headset through which they observe egocentric 180° 3D videoclips. The experimental condition (group A) will be compared with a no-music condition (group B), to test the specific effect of music, and with traditional physiotherapy rehabilitation (group C), to test the efficacy of the approach. The investigators expect that the patients undergoing the experimental intervention (group A and group B) will show a greater upper limb motor function improvement, as compared to the active control group. As a secondary endpoint the investigators expect the music component to induce a greater motor improvement as compared to the experimental condition without music.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07
• Study First Submitted: 2021-07-03
• Study First Submitted QC: 2021-07-15
• Last Update Submitted: 2021-07-15
• Study First Posted: 2021-07-27
• Last Update Posted: 2021-07-27
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Post-stroke patients in acute/subacute phase
• Upper limb hemiparesis (Ashworth scale: 0-2; MRC scale: 3-5)
• Age between 18 and 80 years
• Currently enrolled in inpatient rehabilitation

Exclusion Criteria

• Psychiatric disorders,
• Neglect
• Epilepsy
• MMSE rating < 24
• Difficulty with visual-spatial exploration
• Visual deficits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR+MUSIC	VR+MUSIC	Upper limb repetitive training activities through the imitation of movements (i.e., unscrew the cap of a bottle, pour water into a glass, drink water from a glass, sugaring coffee, placing an object in a box) synchronized with a musical accompaniment (i.e., a selection of classical music pieces). Participants will wear a VR headset (Gear VR, Samsung) through which they will observe egocentric 180° 3D videoclips shot from a first-person perspective, as if the patient himself was performing the movement, while listening to music.
TAU	TAU	Treatment as usual (TAU). Patients will be engaged in upper limb repetitive training activities through traditional physiotherapy rehabilitation.
VR	VR	Upper limb repetitive training activities through imitation of movements, without any musical accompaniment. Participants will wear a VR headset through which they will observe egocentric 180° 3D silent videoclips.

Primary Outcome Measures

Name	Time	Method
Motricity Index (Collin, 1990)	2 weeks post-test	Motricity scale
The Chedoke arm and Hand Activity Inventory (CAHAI) - short form (Barreca, 2013)	2 weeks post-test	Hand activity scale
Medical Research Council (MRC) Muscle strength scale (Paternostro-Slug et al., 2008)	2 weeks post-test	Muscle strenght scale

Trial Locations

Locations (1)

Fondazione Poliambulanza; 🇮🇹 Brescia, Italy