StrokeNCT06164054
Virtual Reality Rehabilitation Protocol for Sensory-motor Rehabilitation After a Stoke
A study testing Virtual Reality Rehabilitation System and Traditional therapy in people with Stroke, run by Sara Ventura.
Trial summary
Introduction: Stroke is the second leading cause of death in Europe. In the case of stroke survival (almost 70%), only 25% of patients recover completely, while the remaining 75% will undergo a rehabilitation phase that varying from months to years. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual Reality Rehabilitation System and Traditional therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2024to 31 Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 to 85 years old (both male and female)
- Suffering from ischemic or hemorrhagic stroke
- Time since the stroke from 2 to 18 months before recruitment
- Severe upper limb motor deficit established by a score of ≤ 80 on the Motricity Index
- Alteration of sensorimotor and proprioception abilities of the injury upper limb (failure in 3 proofs up to 4 of the Thumb Location Test)
- Understand and sign the written consent for enrolment
Who cannot join
- Severe cognitive and behavioral disorders or a state of confusion defined by temporal and/or spatial disorientation detected during an ordinary conversation (evaluate through 4AT)
- Severe upper limb motor deficit (score Motricity Index Scale: gripper <11, elbow flexion <14, shoulder abduction <14)
- Verbal comprehension ability (score <2 at Token Test)
- Severe spatial neglect ( score of >3 at Barrage test)
About this study
Official title: Effectiveness of a Virtual Reality Rehabilitation in Stroke Patients With Sensory-motor and Proprioception Upper Limb Deficit: a Study Protocol
Introduction: Stroke is the second leading cause of death in Europe. In the case of stroke survival (almost 70%), only 25% of patients recover completely, while the remaining 75% will undergo a rehabilitation phase that varying from months to years. The main consequences of a stroke include motor disability of the upper limbs, which involves a partial or complete inability to move the right or left limb, depending on the damaged hemisphere. Furthermore, the motor deficit distorts the proprioception of the body and the embodiment ability of the injured limb. This could be rehabilitated through the paradigm of body illusion that modulates the motor rehabilitation. The present protocol aims to investigate the effectiveness of a Virtual Reality system for sensorimotor and proprioception upper limb deficit compared to a traditional upper limb rehabilitation program.
Method: This study has a randomized and controlled design with control and experimental groups, a 1:1 allocation ratio, and 4 measurement times: pre-intervention, immediately after the intervention, and two follow-ups (at 6 and 12 months). The inclusion criteria are: (a) Being 18 to 85 years old, both males and females; (b) Suffering from ischemic or hemorrhagic stroke; (c) The stroke event must have occurred from two to eighteen months before recruitment; (d) Patients must have moderate to severe upper limb motor deficit, and the alteration of sensorimotor and proprioception abilities of the injury upper limb; (e) Patients must understand and sign the written consent for enrolment. The rehabilitation last four weeks with three sessions per week at Bellaria Hospital of Bologna (Italy). The VR protocol uses two types of technology: immersive and non-immersive, and the control group follow the traditional rehabilitation program.
Ethics and dissemination: The protocol was accepted by the Local Ethics Committee (ASL_BO n. 0115481) and the clinical trial was promoted.
Read the detailed description
Randomized control trial with active groups.
- Conditions
- Stroke
- Being tested
- Virtual Reality Rehabilitation System, Traditional therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Rehabilitation SystemDevice
Participants of the experimental group will undergo treatment with Virtual Reality, both IVR and HB. The intervention will consist of 12 sessions lasting about 1 hour each and carried out with a frequency of three days per week within four weeks. Before starting the rehabilitation, arm illusion with the Handbox is inducted to explore the ability of the patients to perceive the virtual arm as their own. During this task, patients sit on a chair with the injured arm inside the Handbox and are invited to perform slow movements with the hand, such as moving the fingers one at a time and moving the wrist up and down. Moreover, they are invited to keep their attention to the virtual arm project on the screen that follows their natural movements. The arm illusion lasts 3 minutes, and the embodiment questionnaire is administered. Then, the treatment starts with IVR and HB sessions, which are counterbalanced to avoid the learning effect
Traditional therapyBehavioural
Participants randomly assigned to the control group will receive rehabilitation treatment as per usual clinical practice. Specifically, patients will be directed to rehabilitation facilities according to standard clinical rehabilitation pathways. They will be assigned to a physiotherapist who will administer the rehabilitation treatment for the upper limb impairment. Patients in the control group will receive the same amount of rehabilitation for the recovery of upper limb impairment as the treatment group, which means 3 physiotherapy sessions lasting 1 hour 3 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Rehabilitation Therapy | Experimental | Experimental group. Receives: Device: Virtual Reality Rehabilitation System |
| Traditional Therapy | Active comparator | Control group. Receives: Behavioral: Traditional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fugl-Meyer Assessment (FMA)
The primary outcome measures will be the Fugl Meyer (Platz et al., 2005) for motor ability. The Fugl-Meyer includes 33 items to evaluate upper extremity motor impairment and is scored between 0 and 2 (0 = unable, 1 = partly able, and 2 = fully able to complete movement) with a total score range of 0-66. The assessment will be performed before treatment (T1), after the conclusion of the treatment (T2), and after 6 months as a follow-up (T3).
Measured: 2 years approximately.
Secondary outcomes (5)
"Limb ability"
The secondary outcome will include timed tests that measure the improvement in motor ability assessed by the Box and Blocks Test for the upper limb ability and motor coordination (the investigators count how many blocks the patients can move from one side of the box to the other within one minute).
Measured: 2 years approximately.
"Body's Proprioceptive ability"
The thirdly outcome will include timed tests that measure the proprioception dimension of the patient's body assessed by Multidimensional Assessment of Interoceptive Awareness test (MAIA; with a score from 0 = not at all, to 5 = totally).
Measured: 2 years approximately.
"Arm's Proprioceptive ability"
The fourth outcome will include timed tests that measure the proprioception dimension of the patient's injury arm assessed by the Rubber Hand Illusion (RHI; with a score from -3 = not at all to +3 = totally).
Measured: 2 years approximately.
"Autonomy level"
The fifth outcome will include timed tests that measure patient's autonomy level assessed by the Functional Independence Measure (FIM; Motor subscale with a score from 13 to 91, Cognitive subscale with a score from 5 to 35).
Measured: 2 years approximately.
"Self-efficacy"
The sixth outcome will include timed tests that measure the perceived and real ability in daily life activities assessed by the Stroke Self-Efficacy (with a score from 0 = not at all to 3 = totally).
Measured: 2 years approximately.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start8 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara Ventura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Ventura, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164054
- Sponsor's protocol ID
- IRCCS Bologna
- Status last verified
- Dec 2023
- First submitted
- 16 Nov 2023
- Last updated
- 11 Dec 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Virtual Reality Rehabilitation in Stroke Patients With Sensory-motor and Proprioception Upper Limb Deficit: a Study Protocol
- ClinicalTrials.gov ID
- NCT06164054
- Acronym / sponsor ID
- IRCCS Bologna
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sara VenturaUniversity, hospital or other
- Study start
- 8 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Dec 2023 (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.
Introduction: Stroke is the second leading cause of death in Europe. In the case of stroke survival (almost 70%), only 25% of patients recover completely, while the remaining 75% will undergo a rehabilitation phase that varying from months to years. The main consequences of a stroke include motor disability of the upper limbs, which involves a partial or complete inability to move the right or left limb, depending on the damaged hemisphere. Furthermore, the motor deficit distorts the proprioception of the body and the embodiment ability of the injured limb. This could be rehabilitated through the paradigm of body illusion that modulates the motor rehabilitation. The present protocol aims to investigate the effectiveness of a Virtual Reality system for sensorimotor and proprioception upper limb deficit compared to a traditional upper limb rehabilitation program.
Method: This study has a randomized and controlled design with control and experimental groups, a 1:1 allocation ratio, and 4 measurement times: pre-intervention, immediately after the intervention, and two follow-ups (at 6 and 12 months). The inclusion criteria are: (a) Being 18 to 85 years old, both males and females; (b) Suffering from ischemic or hemorrhagic stroke; (c) The stroke event must have occurred from two to eighteen months before recruitment; (d) Patients must have moderate to severe upper limb motor deficit, and the alteration of sensorimotor and proprioception abilities of the injury upper limb; (e) Patients must understand and sign the written consent for enrolment. The rehabilitation last four weeks with three sessions per week at Bellaria Hospital of Bologna (Italy). The VR protocol uses two types of technology: immersive and non-immersive, and the control group follow the traditional rehabilitation program.
Ethics and dissemination: The protocol was accepted by the Local Ethics Committee (ASL_BO n. 0115481) and the clinical trial was promoted.
Detailed description
Randomized control trial with active groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Rehabilitation Therapy | Experimental | Device: Virtual Reality Rehabilitation SystemExperimental group. |
| Traditional Therapy | Active comparator | Behavioral: Traditional therapyControl group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being 18 to 85 years old (both male and female)
- Suffering from ischemic or hemorrhagic stroke
- Time since the stroke from 2 to 18 months before recruitment
- Severe upper limb motor deficit established by a score of ≤ 80 on the Motricity Index
- Alteration of sensorimotor and proprioception abilities of the injury upper limb (failure in 3 proofs up to 4 of the Thumb Location Test)
Key exclusion criteria (4 listed)
- Severe cognitive and behavioral disorders or a state of confusion defined by temporal and/or spatial disorientation detected during an ordinary conversation (evaluate through 4AT)
- Severe upper limb motor deficit (score Motricity Index Scale: gripper <11, elbow flexion <14, shoulder abduction <14)
- Verbal comprehension ability (score <2 at Token Test)
- Severe spatial neglect ( score of >3 at Barrage test)
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 |
|---|---|---|
| Virtual Reality Rehabilitation SystemParticipants of the experimental group will undergo treatment with Virtual Reality, both IVR and HB. The intervention will consist of 12 sessions lasting about 1 hour each and carried out with a frequency of three days per week within four weeks. Before starting the rehabilitation, arm illusion with the Handbox is inducted to explore the ability of the patients to perceive the virtual arm as their own. During this task, patients sit on a chair with the injured arm inside the Handbox and are invited to perform slow movements with the hand, such as moving the fingers one at a time and moving the wrist up and down. Moreover, they are invited to keep their attention to the virtual arm project on the screen that follows their natural movements. The arm illusion lasts 3 minutes, and the embodiment questionnaire is administered. Then, the treatment starts with IVR and HB sessions, which are counterbalanced to avoid the learning effect | Device | Virtual Reality Rehabilitation Therapy |
| Traditional therapyParticipants randomly assigned to the control group will receive rehabilitation treatment as per usual clinical practice. Specifically, patients will be directed to rehabilitation facilities according to standard clinical rehabilitation pathways. They will be assigned to a physiotherapist who will administer the rehabilitation treatment for the upper limb impairment. Patients in the control group will receive the same amount of rehabilitation for the recovery of upper limb impairment as the treatment group, which means 3 physiotherapy sessions lasting 1 hour 3 times a week for 4 weeks. | Behavioural | Traditional Therapy |
Primary outcome
The Fugl-Meyer Assessment (FMA)
Time frame: 2 years approximately.
The primary outcome measures will be the Fugl Meyer (Platz et al., 2005) for motor ability. The Fugl-Meyer includes 33 items to evaluate upper extremity motor impairment and is scored between 0 and 2 (0 = unable, 1 = partly able, and 2 = fully able to complete movement) with a total score range of 0-66. The assessment will be performed before treatment (T1), after the conclusion of the treatment (T2), and after 6 months as a follow-up (T3).
5 secondary outcomes
"Limb ability"
Time frame: 2 years approximately.
"Body's Proprioceptive ability"
Time frame: 2 years approximately.
"Arm's Proprioceptive ability"
Time frame: 2 years approximately.
"Autonomy level"
Time frame: 2 years approximately.
"Self-efficacy"
Time frame: 2 years approximately.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Rehabilitation System and Traditional therapy in people with Stroke, run by Sara Ventura.
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 4 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 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The Fugl-Meyer Assessment (FMA) (time frame: 2 years approximately.). 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 11 Dec 2023.