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

Primary Purpose

Hemiparesis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
VR+MUSIC
VR
TAU
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis focused on measuring Music, Motor coordination, Embodied cognition, Rehabilitation, Virtual reality, Action observation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fondazione PoliambulanzaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

VR+MUSIC

VR

TAU

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 3, 2021
Last Updated
July 15, 2021
Sponsor
Catholic University of the Sacred Heart
Collaborators
Fondazione Poliambulanza
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1. Study Identification

Unique Protocol Identification Number
NCT04977609
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
Fondazione Poliambulanza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis
Keywords
Music, Motor coordination, Embodied cognition, Rehabilitation, Virtual reality, Action observation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR+MUSIC
Arm Type
Experimental
Arm Description
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.
Arm Title
VR
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Treatment as usual (TAU). Patients will be engaged in upper limb repetitive training activities through traditional physiotherapy rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
VR+MUSIC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
VR
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
Traditional post-stroke upper limb motor rehabilitation under the supervision of a physical therapist, for 0 daily sessions of 30 minutes, over 2 weeks.
Primary Outcome Measure Information:
Title
Motricity Index (Collin, 1990)
Description
Motricity scale
Time Frame
2 weeks post-test
Title
Medical Research Council (MRC) Muscle strength scale (Paternostro-Slug et al., 2008)
Description
Muscle strenght scale
Time Frame
2 weeks post-test
Title
The Chedoke arm and Hand Activity Inventory (CAHAI) - short form (Barreca, 2013)
Description
Hand activity scale
Time Frame
2 weeks post-test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Fondazione Poliambulanza
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Maietti
Phone
03035151
Email
alessandra.maietti@poliambulanza.it

12. IPD Sharing Statement

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

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