HemiparesisNCT04977609
A Music-based VR Intervention for Upper Limb Motor Rehabilitation in Hemiparetic Patients
A study testing VR+MUSIC, VR and TAU in people with Hemiparesis, run by Catholic University of the Sacred Heart at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiparesis
- What is being tested?
- VR+MUSIC, VR and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2021to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychiatric disorders,
- Neglect
- Epilepsy
- MMSE rating < 24
- Difficulty with visual-spatial exploration
- Visual deficits.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Poliambulanza
Brescia, 25124
Alessandra Maietti, 03035151, alessandra.maietti@poliambulanza.it
About this study
Official title: Music in Action: A Music-based Virtual Reality Intervention for Upper Limb Motor Rehabilitation in Post-stroke Hemiparetic Patients
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
- Being tested
- VR+MUSIC, VR, TAU
- Keywords
- Music, Motor coordination, Embodied cognition, Rehabilitation, Virtual reality, Action observation
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR+MUSICBehavioural
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.
VRBehavioural
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.
TAUBehavioural
Traditional post-stroke upper limb motor rehabilitation under the supervision of a physical therapist, for 0 daily sessions of 30 minutes, over 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: VR |
| TAU | Active comparator | Treatment as usual (TAU). Patients will be engaged in upper limb repetitive training activities through traditional physiotherapy rehabilitation. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motricity Index (Collin, 1990)
Motricity scale
Measured: 2 weeks post-test
Medical Research Council (MRC) Muscle strength scale (Paternostro-Slug et al., 2008)
Muscle strenght scale
Measured: 2 weeks post-test
The Chedoke arm and Hand Activity Inventory (CAHAI) - short form (Barreca, 2013)
Hand activity scale
Measured: 2 weeks post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Poliambulanza
- Responsible party
- Principal investigator, Alice Cancer, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977609
- Sponsor's protocol ID
- MUSIC-IN-ACTION
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music in Action: A Music-based Virtual Reality Intervention for Upper Limb Motor Rehabilitation in Post-stroke Hemiparetic Patients
- ClinicalTrials.gov ID
- NCT04977609
- Acronym / sponsor ID
- MUSIC-IN-ACTION
- Conditions
- Hemiparesis
- Keywords
- Music, Motor coordination, Embodied cognition, Rehabilitation, Virtual reality, Action observation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Fondazione Poliambulanza
- Study start
- Jul 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR+MUSIC | Experimental | Behavioral: VR+MUSICUpper 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. |
| VR | Experimental | Behavioral: VRUpper 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. |
| TAU | Active comparator | Behavioral: TAUTreatment as usual (TAU). Patients will be engaged in upper limb repetitive training activities through traditional physiotherapy rehabilitation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Psychiatric disorders,
- Neglect
- Epilepsy
- MMSE rating < 24
- Difficulty with visual-spatial exploration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR+MUSICA 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. | Behavioural | VR+MUSIC |
| VRA 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. | Behavioural | VR |
| TAUTraditional post-stroke upper limb motor rehabilitation under the supervision of a physical therapist, for 0 daily sessions of 30 minutes, over 2 weeks. | Behavioural | TAU |
Primary outcome
Motricity Index (Collin, 1990)
Time frame: 2 weeks post-test
Motricity scale
Medical Research Council (MRC) Muscle strength scale (Paternostro-Slug et al., 2008)
Time frame: 2 weeks post-test
Muscle strenght scale
The Chedoke arm and Hand Activity Inventory (CAHAI) - short form (Barreca, 2013)
Time frame: 2 weeks post-test
Hand activity scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR+MUSIC, VR and TAU in people with Hemiparesis, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motricity Index (Collin, 1990) (time frame: 2 weeks post-test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.