StrokeMAVASINCT02234531
Comparison Study of 'Virtual Teacher' Support for Rehabilitation After Stroke.
A study testing EVER TEACHER and NEVER TEACHER in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 2 sites in Italy.
Trial summary
The aim of the project is to assess whether the continuous visualization of on-line teacher in virtual reality (VR) is effective for the improvement of upper limb motor function, in stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- EVER TEACHER and NEVER TEACHER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesItaly
- Study dates
- Apr 2013to Jun 2021
- 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
- first single stroke,
- absence of ideomotor apraxia, neglect, aphasia interfering with verbal comprehension,
- 0 < NIHSS-IT < 4
Who cannot join
- bilateral or cerebellum stroke,
- unstable medical conditions,
- fracture,
- major depressive disorders,
- other neurological conditions,
- epilepsy.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
San Camillo IRCCS
Venezia, VE, 30126
Azienda ULSS 3 Serenissima
Venice, 30126
About this study
Official title: Assessment of a Virtual Teacher Feedback for the Recovery of Upper Limb After Stroke.
The aim of the project is to assess whether the continuous visualization of on-line teacher in virtual reality (VR) is effective for the improvement of upper limb motor function, in stroke patients.
Read the detailed description
A single-blind randomized controlled trial (RCT) will be carried out to compare the effects of reinforced feedback in virtual environment (RFVE) treatment with continuous displaying of a virtual teacher (EVER TEACHER group) with RFVE without the presence of a virtual teacher (NEVER TEACHER group).
- Conditions
- Stroke
- Being tested
- EVER TEACHER, NEVER TEACHER
- Keywords
- Virtual Reality,, Enhanced Feedback,, Stroke,, Rehabilitation,, Motor Learning
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVER TEACHERDevice
The treatment will be performed in a darkened room, to avoid distraction provided by environmental stimuli. The patients will be seat on a standard chair in front of a wall screen handling a sensorized object with plegic hand. In case of grasping deficits the hand's surface will be used as end effector (i.e. sensorized glove worn by the patient). During the treatment a specific feedback called "virtual teacher" will be displayed. The Reinforced Feedback in Virtual Environment (RFVE) approach consists of performing different motor tasks moving the end effector simultaneously displayed in the virtual scenario. The Virtual Reality Rehabilitation System (VRRS®. Khymeia Group, Noventa Padovana. Italy) will be used as device to provide the artificial environment.
NEVER TEACHERDevice
The patients allocated to NEVER TEACHER group, will be treated using the VRRS and the proceedings will be the same as described for experimental group. In this group, the patient will move the real object (e.g. ball) following the trajectory of the corresponding virtual object displayed on the wall screen in accordance with the requested virtual task and without the 'virtual teacher' support.
| Study group | Role | What they receive |
|---|---|---|
| EVER TEACHER | Experimental | In EVER TEACHER group a specific feedback called "virtual teacher" will be displayed. The virtual teacher perform the correct movement to emulate, that is supposed to stimulate the motor adaptation exploiting a supervised learning mechanism. This feedback will give an on-line information on motor performance quality, allowing a real time visual comparison between patient's own execution and teacher one. During the experiment, patients will receive 1 hour of virtual reality-based therapy and the treatment will last 1 hour a day, five days weekly for four weeks. Receives: Device: EVER TEACHER |
| NEVER TEACHER | Other | In NEVER TEACHER group the subjects will be asked to perform the same exercises with the upper limb without the virtual teacher assistance. The treatment will last four weeks with daily sessions of 60 minutes, five times per week. Receives: Device: NEVER TEACHER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity scale (FM UE)
Applied at the beginning and at the end of treatment (after 20 sessions).
Measured: Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter)
Secondary outcomes (6)
Fugl-Meyer Assessment - Sensation
Applied at the beginning and at the end of treatment (after 20 sessions).
Measured: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Fugl-Meyer Assessment - Pain and ROM
Applied at the beginning and at the end of treatment (after 20 sessions).
Measured: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Reaching Performance Scale
Applied at the beginning and at the end of treatment (after 20 sessions).
Measured: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Modified Ashworth Scale
Applied at the beginning and at the end of treatment (after 20 sessions).
Measured: Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter)
Functional Independence Measure scale (FIM)
Applied at the beginning and at the end of treatment (after 20 sessions).
Measured: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
Nine Hole Pegboard Test
Applied at the beginning and at the end of treatment (after 20 sessions).
Measured: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startApr 2013
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Model description
- Single blind randomized controlled trial (RCT)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Società Italiana di Fisioterapia (SIF), Ministry of Health, Italy
- Responsible party
- Principal investigator, Andrea Turolla, IRCCS San Camillo, Venezia, Italy
- Investigators
- Andrea Turolla, PhD, Principal investigator, San Camillo IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234531
- Sponsor's protocol ID
- Protocollo 2013.11
- Acronym
- MAVASI
- Status last verified
- Jun 2022
- First submitted
- 29 Aug 2014
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Turolla A, Dam M, Ventura L, Tonin P, Agostini M, Zucconi C, Kiper P, Cagnin A, Piron L. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85.
PubMed 23914733Kiper P, Agostini M, Luque-Moreno C, Tonin P, Turolla A. Reinforced feedback in virtual environment for rehabilitation of upper extremity dysfunction after stroke: preliminary data from a randomized controlled trial. Biomed Res Int. 2014;2014:752128. doi: 10.1155/2014/752128. Epub 2014 Mar 13.
PubMed 24745024Zucconi C, Valt V, Agostini M, Turolla A, Tonin P, Piron L. Assessment of a virtual teacher feedback for the recovery of the upper limb after stroke. Italian Journal of Physiotherapy 2011;1(4):101-6.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Virtual Teacher Feedback for the Recovery of Upper Limb After Stroke.
- ClinicalTrials.gov ID
- NCT02234531
- Acronym / sponsor ID
- MAVASI / Protocollo 2013.11
- Conditions
- Stroke
- Keywords
- Virtual Reality,, Enhanced Feedback,, Stroke,, Rehabilitation,, Motor Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Collaborators
- Società Italiana di Fisioterapia (SIF), Ministry of Health, Italy
- Study start
- Apr 2013 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 9 Sep 2014 (estimated)
- 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 aim of the project is to assess whether the continuous visualization of on-line teacher in virtual reality (VR) is effective for the improvement of upper limb motor function, in stroke patients.
Detailed description
A single-blind randomized controlled trial (RCT) will be carried out to compare the effects of reinforced feedback in virtual environment (RFVE) treatment with continuous displaying of a virtual teacher (EVER TEACHER group) with RFVE without the presence of a virtual teacher (NEVER TEACHER group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| EVER TEACHER | Experimental | Device: EVER TEACHERIn EVER TEACHER group a specific feedback called "virtual teacher" will be displayed. The virtual teacher perform the correct movement to emulate, that is supposed to stimulate the motor adaptation exploiting a supervised learning mechanism. This feedback will give an on-line information on motor performance quality, allowing a real time visual comparison between patient's own execution and teacher one. During the experiment, patients will receive 1 hour of virtual reality-based therapy and the treatment will last 1 hour a day, five days weekly for four weeks. |
| NEVER TEACHER | Other | Device: NEVER TEACHERIn NEVER TEACHER group the subjects will be asked to perform the same exercises with the upper limb without the virtual teacher assistance. The treatment will last four weeks with daily sessions of 60 minutes, five times per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- first single stroke,
- absence of ideomotor apraxia, neglect, aphasia interfering with verbal comprehension,
- 0 < NIHSS-IT < 4
Key exclusion criteria (6 listed)
- bilateral or cerebellum stroke,
- unstable medical conditions,
- fracture,
- major depressive disorders,
- other neurological conditions,
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 |
|---|---|---|
| EVER TEACHERThe treatment will be performed in a darkened room, to avoid distraction provided by environmental stimuli. The patients will be seat on a standard chair in front of a wall screen handling a sensorized object with plegic hand. In case of grasping deficits the hand's surface will be used as end effector (i.e. sensorized glove worn by the patient). During the treatment a specific feedback called "virtual teacher" will be displayed. The Reinforced Feedback in Virtual Environment (RFVE) approach consists of performing different motor tasks moving the end effector simultaneously displayed in the virtual scenario. The Virtual Reality Rehabilitation System (VRRS®. Khymeia Group, Noventa Padovana. Italy) will be used as device to provide the artificial environment. | Device | EVER TEACHER |
| NEVER TEACHERThe patients allocated to NEVER TEACHER group, will be treated using the VRRS and the proceedings will be the same as described for experimental group. In this group, the patient will move the real object (e.g. ball) following the trajectory of the corresponding virtual object displayed on the wall screen in accordance with the requested virtual task and without the 'virtual teacher' support. | Device | NEVER TEACHER |
Primary outcome
Fugl-Meyer Upper Extremity scale (FM UE)
Time frame: Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter)
Applied at the beginning and at the end of treatment (after 20 sessions).
6 secondary outcomes
Fugl-Meyer Assessment - Sensation
Time frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Fugl-Meyer Assessment - Pain and ROM
Time frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Reaching Performance Scale
Time frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Modified Ashworth Scale
Time frame: Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter)
Functional Independence Measure scale (FIM)
Time frame: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
Nine Hole Pegboard Test
Time frame: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Background: PubMed 23914733Turolla A, Dam M, Ventura L, Tonin P, Agostini M, Zucconi C, Kiper P, Cagnin A, Piron L. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85.
- Background: PubMed 24745024Kiper P, Agostini M, Luque-Moreno C, Tonin P, Turolla A. Reinforced feedback in virtual environment for rehabilitation of upper extremity dysfunction after stroke: preliminary data from a randomized controlled trial. Biomed Res Int. 2014;2014:752128. doi: 10.1155/2014/752128. Epub 2014 Mar 13.
- BackgroundZucconi C, Valt V, Agostini M, Turolla A, Tonin P, Piron L. Assessment of a virtual teacher feedback for the recovery of the upper limb after stroke. Italian Journal of Physiotherapy 2011;1(4):101-6.
- Italian Society for Physiotherapy (Società Italiana di Fisioterapia)Link provided by the sponsor.
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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.
Andrea Turolla, PhD principal investigator
San Camillo IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVER TEACHER and NEVER TEACHER in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 2 sites 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 3 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: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity scale (FM UE) (time frame: Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02234531, which also lists 3 linked publications.
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 10 Jun 2022.