Stroke AcuteIMVR StrokeNCT07086365
Feasibility of Using Immersive Virtual Functional Rehabilitation for Recovery of Upper Extremity Function in Patients With Early-stage Stroke: a Pilot Study
A study testing Immersive virtual reality in people with Stroke Acute, run by Clinica Alemana de Santiago at 1 site in Chile.
Trial summary
Feasibility of using immersive virtual functional rehabilitation for recovery of upper extremity function in patients with early-stage stroke: a pilot study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute
- What is being tested?
- Immersive virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChile
- Study dates
- 29 Mar 2023to 18 Mar 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 years old
- first episode of stroke (ischemic or hemorrhagic)
- time since stroke onset between 0 to 6 months
- upper limb motor impairment with the National Institutes of Health Stroke Scale arm motor sub-item score between 1 and 4
- medically stable parameters for rehabilitation initiation.
Who cannot join
- Delirium diagnosed using the Confusion Assessment Method
- Montreal Cognitive Assessment Scale <18
- Severe visual/perceptual deficits (spatial neglect affecting >70% of trials or visual acuity <20/200)
- previous participation in virtual reality-based rehabilitation
- inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Feasibility of using immersive virtual functional rehabilitation for recovery of upper extremity function in patients with early-stage stroke: a pilot study
Read the detailed description
Background: Immersive virtual reality (IVR)-based rehabilitation provides high-intensity, engaging, task-oriented training and motor exploration for upper limb (UL) recovery post-stroke. However, its feasibility and dose-response effects remain unclear.
Objective: To evaluate the feasibility and dose-response effects of IVR-based rehabilitation for UL recovery in early stroke patients.
Methods: A pilot trial included 12 early-stage stroke patients randomized into two groups: Group A (10 IVR sessions + conventional rehabilitation [CR]) and Group B (20 IVR sessions + CR). Feasibility outcomes included adherence, usability (User Satisfaction Evaluation Questionnaire [USEQ], System Usability Scale [SUS]), system operability, and adverse effects. Motor outcomes, categorized by the International Classification of Functioning, Disability, and Health (ICF), assessed UL impairment (Fugl-Meyer Assessment, Medical Research Council scale), activity (Box and Block Test), and participation (Motor Activity Log 30). Blinded therapists conducted assessments at baseline, post-intervention, and 4-week follow-up. Dose-response was analyzed using Probability of Superiority (PS).
- Conditions
- Stroke Acute
- Being tested
- Immersive virtual reality
- Keywords
- stroke, rehabilitation, neurorehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual realityDevice
Virtual reality with hand tracking and immersive environment
Immersive Virtual RealityDevice
Also called Extended reality., Digital therapeutics.
Immersive virtual reality is a digital therapeutic approach to enhance neuroplasticity using virtual environment and hand tracking for functional motion in upper extremity
| Study group | Role | What they receive |
|---|---|---|
| 10 session | Other | Participants receive 10 sessions of intervention with virtual inmersive reality.
Virtual reality with hand tracking and immersive environment Receives: Device: Immersive virtual reality |
| 20 sessions | Other | Participants receive 20 sessions of intervention with virtual inmersive reality. Virtual reality with hand tracking and immersive environment. Receives: Device: Immersive virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale [SUS]
Questionnaire completed by the handlers who administer the immersive virtual reality system
Measured: The treatment providers fill out the questionnaire at the end of treatment. It depends of the group patient: 10 or 20-session treatment.
User Satisfaction Evaluation Questionnaire [USEQ]
Questionnaire of 5 questions with 5 options based on likert rate. Is filled for the patient recruited
Measured: Administered within the first 7 days of using the immersive virtual reality device
Secondary outcomes (4)
Fugl-Meyer Assessment for Upper Extremity
Clinical assessment scale for upper extremity function. It evaluates various functional areas of the upper extremity: wrist, hand, coordination, and speed. This provides a total of 66 motor function points.
Measured: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.
Motor Activity Log
Questionnaire of 30 questions for quality of functional movement and 30 questions of quantity of functional movement of upper extremity. The maximal score is 150 for both quantity and quality.
Measured: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.
Box and block test
Patient must to pick up little boxes and carry on in a standarized box. Patient must perform the test with both hands, with paresis and without paresis in 1 minute per each upper extremity.
Measured: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.
Medical research council
Manual test muscle that use oxford graduation. M0 total weakness to M5 is normal strenght
Measured: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start29 Mar 2023
- Primary completion30 Dec 2024
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke AcuteStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Pilot study evaluating the feasibility of using an immersive virtual reality device in patients with stroke in the acute and sub-acute stages. Preliminary functional outcomes about upper extremity function are also assessed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Alemana de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margarita Venegas, Clinica Alemana de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086365
- Sponsor's protocol ID
- 1134 UIEC
- Acronym
- IMVR Stroke
- Status last verified
- Jul 2025
- First submitted
- 8 May 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demeco A, Zola L, Frizziero A, Martini C, Palumbo A, Foresti R, Buccino G, Costantino C. Immersive Virtual Reality in Post-Stroke Rehabilitation: A Systematic Review. Sensors (Basel). 2023 Feb 3;23(3):1712. doi: 10.3390/s23031712.
PubMed 36772757Peralta-Wieland B, Vasquez-Torres R, Maldonado-Diaz M, Yoma M. Immersive Virtual Reality-Based Rehabilitation for Upper Limb Recovery in Acute and Subacute Stroke Patients: A Feasibility Study. Physiother Res Int. 2026 Jan;31(1):e70151. doi: 10.1002/pri.70151.
PubMed 41416487
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using Immersive Virtual Functional Rehabilitation for Recovery of Upper Extremity Function in Patients With Early-stage Stroke: a Pilot Study
- ClinicalTrials.gov ID
- NCT07086365
- Acronym / sponsor ID
- IMVR Stroke / 1134 UIEC
- Conditions
- Stroke Acute
- Keywords
- stroke, rehabilitation, neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Clinica Alemana de SantiagoUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 25 Jul 2025 (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.
Feasibility of using immersive virtual functional rehabilitation for recovery of upper extremity function in patients with early-stage stroke: a pilot study
Detailed description
Background: Immersive virtual reality (IVR)-based rehabilitation provides high-intensity, engaging, task-oriented training and motor exploration for upper limb (UL) recovery post-stroke. However, its feasibility and dose-response effects remain unclear.
Objective: To evaluate the feasibility and dose-response effects of IVR-based rehabilitation for UL recovery in early stroke patients.
Methods: A pilot trial included 12 early-stage stroke patients randomized into two groups: Group A (10 IVR sessions + conventional rehabilitation [CR]) and Group B (20 IVR sessions + CR). Feasibility outcomes included adherence, usability (User Satisfaction Evaluation Questionnaire [USEQ], System Usability Scale [SUS]), system operability, and adverse effects. Motor outcomes, categorized by the International Classification of Functioning, Disability, and Health (ICF), assessed UL impairment (Fugl-Meyer Assessment, Medical Research Council scale), activity (Box and Block Test), and participation (Motor Activity Log 30). Blinded therapists conducted assessments at baseline, post-intervention, and 4-week follow-up. Dose-response was analyzed using Probability of Superiority (PS).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot study evaluating the feasibility of using an immersive virtual reality device in patients with stroke in the acute and sub-acute stages. Preliminary functional outcomes about upper extremity function are also assessed.
| Arm | Type | Receives |
|---|---|---|
| 10 session | Other | Device: Immersive virtual realityParticipants receive 10 sessions of intervention with virtual inmersive reality. Virtual reality with hand tracking and immersive environment |
| 20 sessions | Other | Device: Immersive virtual realityParticipants receive 20 sessions of intervention with virtual inmersive reality. Virtual reality with hand tracking and immersive environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18 years old
- first episode of stroke (ischemic or hemorrhagic)
- time since stroke onset between 0 to 6 months
- upper limb motor impairment with the National Institutes of Health Stroke Scale arm motor sub-item score between 1 and 4
- medically stable parameters for rehabilitation initiation.
Key exclusion criteria (5 listed)
- Delirium diagnosed using the Confusion Assessment Method
- Montreal Cognitive Assessment Scale <18
- Severe visual/perceptual deficits (spatial neglect affecting >70% of trials or visual acuity <20/200)
- previous participation in virtual reality-based rehabilitation
- inability to provide informed consent.
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 |
|---|---|---|
| Immersive virtual realityVirtual reality with hand tracking and immersive environment | Device | 10 session, 20 sessions |
| Immersive Virtual RealityAlso: Extended reality., Digital therapeutics.Immersive virtual reality is a digital therapeutic approach to enhance neuroplasticity using virtual environment and hand tracking for functional motion in upper extremity | Device | 10 session, 20 sessions |
Primary outcome
System Usability Scale [SUS]
Time frame: The treatment providers fill out the questionnaire at the end of treatment. It depends of the group patient: 10 or 20-session treatment.
Questionnaire completed by the handlers who administer the immersive virtual reality system
User Satisfaction Evaluation Questionnaire [USEQ]
Time frame: Administered within the first 7 days of using the immersive virtual reality device
Questionnaire of 5 questions with 5 options based on likert rate. Is filled for the patient recruited
4 secondary outcomes
Fugl-Meyer Assessment for Upper Extremity
Time frame: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.
Motor Activity Log
Time frame: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.
Box and block test
Time frame: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.
Medical research council
Time frame: It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.
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 25 Jul 2025.
- Results publication: PubMed 36772757Demeco A, Zola L, Frizziero A, Martini C, Palumbo A, Foresti R, Buccino G, Costantino C. Immersive Virtual Reality in Post-Stroke Rehabilitation: A Systematic Review. Sensors (Basel). 2023 Feb 3;23(3):1712. doi: 10.3390/s23031712.
- Derived from this study: PubMed 41416487Peralta-Wieland B, Vasquez-Torres R, Maldonado-Diaz M, Yoma M. Immersive Virtual Reality-Based Rehabilitation for Upper Limb Recovery in Acute and Subacute Stroke Patients: A Feasibility Study. Physiother Res Int. 2026 Jan;31(1):e70151. doi: 10.1002/pri.70151.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive virtual reality in people with Stroke Acute, run by Clinica Alemana de Santiago at 1 site in Chile.
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 5 inclusion and 5 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 25 Jul 2025. 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 Chile. 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?
System Usability Scale [SUS] (time frame: The treatment providers fill out the questionnaire at the end of treatment. It depends of the group patient: 10 or 20-session treatment.). The study lists 2 primary outcomes in all. 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 NCT07086365, which also lists 2 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 25 Jul 2025.