StrokeNCT05335772
VR-based Action Observation Treatment for Upper Limb Rehabilitation in Stroke: a Multimodal Study.
A study testing Action Observation and following Action Execution and Landscape Observation and following Action Execution in people with Stroke, run by CNR Institute of Neuroscience, Parma at 1 site in Italy.
Trial summary
The loss of upper-limb motor functioning due to ischemic stroke has a negative impact on quality of life of patients. Action Observation Treatment (AOT), recently developed based on the mirror mechanism functioning, has proved effective in promoting plasticity into the motor system, ultimately boosting the motor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Action Observation and following Action Execution and Landscape Observation and following Action Execution
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2022to 30 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18
- Ischemic stroke in the territory of middle cerebral artery (MCA, lesion extension lower than half of its territory) or lacunar stroke
- MRC score 2-4 in at least one segment of the affected limb
- Modified Rankin Scale (mRS) prior to stroke ≤ 2
- Able to perform study requirements
- Able to give informed consent according to ICH/ GCP, and national/local regulations
Who cannot join
- Presence of global aphasia
- History of seizures
- Posterior circulation stroke
- Significant ipovisus
- Moderate-to severe neglect
- Cognitive impairment or language barriers
Show all 10Show fewer
- Psychiatric comorbidities
- Drug or alcohol abuse
- Autoimmune disease
- Contraindication to perform MRI
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Pietro Avanzini
Parma, 43125
Pietro Avanzini, PhD, +39 0521 903877, pietro.avanzini@gmail.com
About this study
Official title: The Upper-limb Functional Rehabilitation in Chronic Stroke Patients: From Neuroimaging and Bio-humoral Biomarkers of a Personalized Action Observation Treatment Based on Virtual Reality to a Maximized and Predictable Rehabilitative Outcome.
The loss of upper-limb motor functioning due to ischemic stroke has a negative impact on quality of life of patients. Action Observation Treatment (AOT), recently developed based on the mirror mechanism functioning, has proved effective in promoting plasticity into the motor system, ultimately boosting the motor recovery. The use of virtual reality further empowers the effectiveness of AOT, making the visual experience more first-person, and thus more realistic. A complete picture of the neurobiological mechanisms underlying AOT effectiveness is lacking to date, including the neuroradiological and biohumoral markers modulated by AOT, and their role in predicting the clinical outcome. Starting from these premises, the investigators propose a study aiming at evaluating the AOT effectiveness in post-stroke patients, and at identifying the biomarkers indexing the motor recovery process.
Sixty patients affected by ischemic stroke will be enrolled at Humanitas Clinical and Research Center IRCCS (ICH) Stroke Unit will be included and randomized in the following groups:
Read more
- VR-AOT: experimental group, observing actions in virtual reality
- VR-LO: control groups, observing a matched dose of videos depicting landscapes in virtual reality.
Clinical, neuroimaging and biohumoral evaluations, performed at Screening (Ts), Basal visit (T0), end-of-treatment (T1), 2 months follow up (FU-2), will include the following endpoints: Fugl-Meyer upper extremity motor scale (FM-UE); Nine-hole-peg test; Box and block test; Modified Ashworth scale; MRC; Pain Numeric-rating-scale; Functional Independence measure.
Patients will undergo treatment sessions for 6 weeks (5 days/week). VR-AOT patients will observe in virtual reality -rehearse and execute specific upper limb motor task belonging to activities of daily living. VR-LO participants will observe virtually explorable landscapes lasting for a matched duration. Then, participants will be asked to actively perform the same set of hand actions requested to VR-AOT experimental groups.
An intention-to-treat (ITT) analysis will be performed, using rmANOVA, minimal clinically important difference (MCID) in clinical outcomes, and chi-square test. For the primary endpoints, a two-arms rmANOVA with time as within-subject factor (3 levels: T0, T1, FU2) and group (VR-AOT vs VR-LO) as between-subjects factor will be conducted. The same approach will be adopted for secondary outcome measures. Subsequently, the effect of clinical, neuroradiological and biohumoral baseline features will be tested as regressors on the primary outcome variations via linear or ranked regression models. Significance will be set at 5%, and adjusted for MC.
- Conditions
- Stroke
- Being tested
- Action Observation and following Action Execution, Landscape Observation and following Action Execution
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Observation and following Action ExecutionBehavioural
VR-AOT patients will observe, rehearse and execute specific upper limb motor task belonging to activities of daily living.
Landscape Observation and following Action ExecutionBehavioural
VR-LO participants will observe virtually explorable landscapes lasting for a matched duration. Then, they will be asked to actively perform the same set of hand actions requested to VR-AOT experimental groups.
| Study group | Role | What they receive |
|---|---|---|
| VR-AOT | Experimental | Experimental group, observing actions in virtual reality Receives: Behavioral: Action Observation and following Action Execution |
| VR-LO | Other | Control group, observing a matched dose of videos depicting landscapes in virtual reality Receives: Behavioral: Landscape Observation and following Action Execution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Fugl-Meyer upper extremity motor scale at 6 weeks
Stroke-specific, performance-based, impairment index (range 0-66, higher values indicate a better performance)
Measured: Six weeks from baseline
Secondary outcomes (9)
Change from baseline Nine-hole-peg test at 6 weeks
Standardized, quantitative test of upper extremity function
Measured: Six weeks from baseline
Change from baseline Nine-hole-peg test at 2 months
Standardized, quantitative test of upper extremity function
Measured: Two months from baseline
Change from baseline Box and block test at 6 weeks
Unilateral gross manual dexterity measure
Measured: Six weeks from baseline
Change from baseline Box and block test at 2 months
Unilateral gross manual dexterity measure
Measured: Two months from baseline
Change from baseline Modified Ashworth Scale at 6 weeks
Spasticity measure, evaluating limb's tone responsiveness to passive mobilization (Range: 0-4, higher values indicates higher degree of spasticity)
Measured: Six weeks from baseline
Change from baseline Modified Ashworth Scale at 2 months
Spasticity measure, evaluating limb's tone responsiveness to passive mobilization (Range: 0-4, higher values indicates higher degree of spasticity)
Measured: Two months from baseline
Change from baseline Functional Independence Measure at 6 weeks
Questionnaire measuring the independence in Activities of Daily Living (ADL). (Range: 18-126, higher values indicate an higher degree of functional independence)
Measured: Six weeks from baseline
Change from baseline Functional Independence Measure at 2 months
Questionnaire measuring the independence in Activities of Daily Living (ADL). (Range: 18-126, higher values indicate an higher degree of functional independence)
Measured: Two months from baseline
Change from baseline Fugl-Meyer upper extremity motor scale at 2 months
Stroke-specific, performance-based, impairment index (range 0-66, higher values indicate a better performance)
Measured: Two months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start13 May 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNR Institute of Neuroscience, Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Humanitas Hospital, Italy
- Responsible party
- Principal investigator, Pietro Avanzini, CNR Institute of Neuroscience, Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335772
- Sponsor's protocol ID
- VR-AOT-GR-2019
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2022
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Upper-limb Functional Rehabilitation in Chronic Stroke Patients: From Neuroimaging and Bio-humoral Biomarkers of a Personalized Action Observation Treatment Based on Virtual Reality to a Maximized and Predictable Rehabilitative Outcome.
- ClinicalTrials.gov ID
- NCT05335772
- Acronym / sponsor ID
- VR-AOT-GR-2019
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CNR Institute of Neuroscience, ParmaUniversity, hospital or other
- Collaborators
- Humanitas Hospital, Italy
- Study start
- 13 May 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 19 Apr 2022 (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.
The loss of upper-limb motor functioning due to ischemic stroke has a negative impact on quality of life of patients. Action Observation Treatment (AOT), recently developed based on the mirror mechanism functioning, has proved effective in promoting plasticity into the motor system, ultimately boosting the motor recovery. The use of virtual reality further empowers the effectiveness of AOT, making the visual experience more first-person, and thus more realistic. A complete picture of the neurobiological mechanisms underlying AOT effectiveness is lacking to date, including the neuroradiological and biohumoral markers modulated by AOT, and their role in predicting the clinical outcome. Starting from these premises, the investigators propose a study aiming at evaluating the AOT effectiveness in post-stroke patients, and at identifying the biomarkers indexing the motor recovery process.
Sixty patients affected by ischemic stroke will be enrolled at Humanitas Clinical and Research Center IRCCS (ICH) Stroke Unit will be included and randomized in the following groups:
- VR-AOT: experimental group, observing actions in virtual reality
- VR-LO: control groups, observing a matched dose of videos depicting landscapes in virtual reality.
Clinical, neuroimaging and biohumoral evaluations, performed at Screening (Ts), Basal visit (T0), end-of-treatment (T1), 2 months follow up (FU-2), will include the following endpoints: Fugl-Meyer upper extremity motor scale (FM-UE); Nine-hole-peg test; Box and block test; Modified Ashworth scale; MRC; Pain Numeric-rating-scale; Functional Independence measure.
Patients will undergo treatment sessions for 6 weeks (5 days/week). VR-AOT patients will observe in virtual reality -rehearse and execute specific upper limb motor task belonging to activities of daily living. VR-LO participants will observe virtually explorable landscapes lasting for a matched duration. Then, participants will be asked to actively perform the same set of hand actions requested to VR-AOT experimental groups.
An intention-to-treat (ITT) analysis will be performed, using rmANOVA, minimal clinically important difference (MCID) in clinical outcomes, and chi-square test. For the primary endpoints, a two-arms rmANOVA with time as within-subject factor (3 levels: T0, T1, FU2) and group (VR-AOT vs VR-LO) as between-subjects factor will be conducted. The same approach will be adopted for secondary outcome measures. Subsequently, the effect of clinical, neuroradiological and biohumoral baseline features will be tested as regressors on the primary outcome variations via linear or ranked regression models. Significance will be set at 5%, and adjusted for MC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-AOT | Experimental | Behavioral: Action Observation and following Action ExecutionExperimental group, observing actions in virtual reality |
| VR-LO | Other | Behavioral: Landscape Observation and following Action ExecutionControl group, observing a matched dose of videos depicting landscapes in virtual reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age>18
- Ischemic stroke in the territory of middle cerebral artery (MCA, lesion extension lower than half of its territory) or lacunar stroke
- MRC score 2-4 in at least one segment of the affected limb
- Modified Rankin Scale (mRS) prior to stroke ≤ 2
- Able to perform study requirements
Key exclusion criteria (10 listed)
- Presence of global aphasia
- History of seizures
- Posterior circulation stroke
- Significant ipovisus
- Moderate-to severe neglect
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 |
|---|---|---|
| Action Observation and following Action ExecutionVR-AOT patients will observe, rehearse and execute specific upper limb motor task belonging to activities of daily living. | Behavioural | VR-AOT |
| Landscape Observation and following Action ExecutionVR-LO participants will observe virtually explorable landscapes lasting for a matched duration. Then, they will be asked to actively perform the same set of hand actions requested to VR-AOT experimental groups. | Behavioural | VR-LO |
Primary outcome
Change from baseline Fugl-Meyer upper extremity motor scale at 6 weeks
Time frame: Six weeks from baseline
Stroke-specific, performance-based, impairment index (range 0-66, higher values indicate a better performance)
9 secondary outcomes
Change from baseline Nine-hole-peg test at 6 weeks
Time frame: Six weeks from baseline
Change from baseline Nine-hole-peg test at 2 months
Time frame: Two months from baseline
Change from baseline Box and block test at 6 weeks
Time frame: Six weeks from baseline
Change from baseline Box and block test at 2 months
Time frame: Two months from baseline
Change from baseline Modified Ashworth Scale at 6 weeks
Time frame: Six weeks from baseline
Change from baseline Modified Ashworth Scale at 2 months
Time frame: Two months from baseline
Change from baseline Functional Independence Measure at 6 weeks
Time frame: Six weeks from baseline
Change from baseline Functional Independence Measure at 2 months
Time frame: Two months from baseline
Change from baseline Fugl-Meyer upper extremity motor scale at 2 months
Time frame: Two months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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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 Action Observation and following Action Execution and Landscape Observation and following Action Execution in people with Stroke, run by CNR Institute of Neuroscience, Parma 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 6 inclusion and 10 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 13 Mar 2023. 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?
Change from baseline Fugl-Meyer upper extremity motor scale at 6 weeks (time frame: Six weeks from baseline). 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 13 Mar 2023.