Clinical trial NCT04977609: A Music-based VR Intervention for Upper Limb Motor Rehabilitation in Hemiparetic Patients
Official title: Music in Action: A Music-based Virtual Reality Intervention for Upper Limb Motor Rehabilitation in Post-stroke Hemiparetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiparesis
Keywords: Music
Motor coordination
Embodied cognition
Rehabilitation
Virtual reality
Action observation
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Fondazione Poliambulanza
First posted: 2021-07-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Motricity Index (Collin, 1990)
timeFrame: 2 weeks post-test
measure: Medical Research Council (MRC) Muscle strength scale (Paternostro-Slug et al., 2008)
timeFrame: 2 weeks post-test
measure: The Chedoke arm and Hand Activity Inventory (CAHAI) - short form (Barreca, 2013)
timeFrame: 2 weeks post-test
Secondary outcomes:
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
Study officials:
References: