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

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Recruiting

CT.gov ID

NCT04977609

Collaborator

Fondazione Poliambulanza (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiparesis	Behavioral: VR+MUSIC Behavioral: VR Behavioral: TAU	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Music in Action: A Music-based Virtual Reality Intervention for Upper Limb Motor Rehabilitation in Post-stroke Hemiparetic Patients

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: VR+MUSIC A novel VR intervention designed for upper limb motor rehabilitation in post-stroke hemiparetic patients consisting in 10 daily sessions of 30 minutes, over 2 weeks, supervised by a physical therapist.
Experimental: 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.	Behavioral: VR A novel VR intervention designed for upper limb motor rehabilitation in post-stroke hemiparetic patients consisting in 10 daily sessions of 30 minutes, over 2 weeks, supervised by a physical therapist.
Active Comparator: TAU Treatment as usual (TAU). Patients will be engaged in upper limb repetitive training activities through traditional physiotherapy rehabilitation.	Behavioral: TAU Traditional post-stroke upper limb motor rehabilitation under the supervision of a physical therapist, for 0 daily sessions of 30 minutes, over 2 weeks.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: VR+MUSIC

A novel VR intervention designed for upper limb motor rehabilitation in post-stroke hemiparetic patients consisting in 10 daily sessions of 30 minutes, over 2 weeks, supervised by a physical therapist.

Experimental: 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.

Behavioral: VR

Active Comparator: TAU

Treatment as usual (TAU). Patients will be engaged in upper limb repetitive training activities through traditional physiotherapy rehabilitation.

Behavioral: TAU

Traditional post-stroke upper limb motor rehabilitation under the supervision of a physical therapist, for 0 daily sessions of 30 minutes, over 2 weeks.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Poliambulanza	Brescia		Italy	25124

Sponsors and Collaborators

Catholic University of the Sacred Heart
Fondazione Poliambulanza

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alice Cancer, Principal Investigator, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT04977609

Other Study ID Numbers:

MUSIC-IN-ACTION

First Posted:

Jul 27, 2021

Last Update Posted:

Jul 27, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alice Cancer, Principal Investigator, Catholic University of the Sacred Heart

Additional relevant MeSH terms:

Paresis

Study Results

No Results Posted as of Jul 27, 2021