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

NCT04977609 | Unknown

• 1 other identifier: MUSIC-IN-ACTION
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis

Keywords

Music; Motor coordination; Embodied cognition; Rehabilitation; Virtual reality; Action observation

Outcome Measures

Primary Outcomes (3)

• Motricity Index (Collin, 1990)

  Motricity scale

  2 weeks post-test

• Medical Research Council (MRC) Muscle strength scale (Paternostro-Slug et al., 2008)

  Muscle strenght scale

  2 weeks post-test

• The Chedoke arm and Hand Activity Inventory (CAHAI) - short form (Barreca, 2013)

  Hand activity scale

  2 weeks post-test

Study Arms (3)

VR+MUSIC

EXPERIMENTAL

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

VR

EXPERIMENTAL

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

TAU

ACTIVE COMPARATOR

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

Behavioral: TAU

Interventions

VR+MUSIC BEHAVIORAL

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.

VR+MUSIC

VR BEHAVIORAL

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.

VR

TAU BEHAVIORAL

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

TAU

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Fondazione Poliambulanza: collaborator

Study Sites (1)

Fondazione Poliambulanza

Brescia, 25124, Italy

RECRUITING

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: July 27, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

IT (1)