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

Hemiparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04977609
• Other study ID #: MUSIC-IN-ACTION
• Status: Recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: March 2022

Study information

• Verified date: July 2021
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiparesis
• Paresis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Fondazione Poliambulanza	Brescia

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Fondazione Poliambulanza

Country where clinical trial is conducted

Italy, 

Outcome

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