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Sub-acute StrokeNCT06892886

Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects

A study testing Virtual Reality in people with Sub-acute Stroke, run by University Hospital of Ferrara at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Stroke produces brain damages that results in sensory, motor, and cognitive impairments which reduce the patient's quality of life and social participation. Upper limb recovery is a complex process whose goal is to allow the patients to gain, in part or completely, independence in daily living activities, for that it… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Sub-acute Stroke
What is being tested?
Virtual Reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteItaly
Study dates
1 Mar 2023to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • diagnosis of first, ischemic or hemorrhagic, stroke verified by brain imaging within 4 week
  • upper limb motor impairment defined by an upper extremity score <55 on the Fugl-Meyer Assessment

Who cannot join

  • neurological conditions in addition to stroke that may affect motor function
  • other medical conditions likely to interfere with the ability to safely complete the study protocol
  • impaired cognitive functioning that influences the ability to give informed consent
  • severe neuropsychological disorders
  • visual impairment
  • severe upper-limb pain defined as > 7 on the Visual Analogue Scale

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sofia Straudi, MD, PhD contact

+390532238720

sofia.straudi@unife.it

Italy1 site, 1 recruiting

  • Ferrara University Hospital

    Ferrara, 44124

    Sofia Straudi, MD, PhD, 0532238720, sofia.straudi@unife.it

    Sofia Straudi, MD, PhD

    Recruiting

Other trials in Italy

About this study

Official title: Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects: a Multicenter Randomized Control Trial

Stroke produces brain damages that results in sensory, motor, and cognitive impairments which reduce the patient's quality of life and social participation. Upper limb recovery is a complex process whose goal is to allow the patients to gain, in part or completely, independence in daily living activities, for that it represents one of the most important rehabilitation focus. Virtual reality is a fairly recent approach able to simulate concrete movements and functional tasks in a higher dosage compared to other therapies. It seems that the use of VR could improve limb function, however, the amount of this gain is still unclear because of insufficient evidence. This study aims at quantitatively investigating the effectiveness of an HMD immersive virtual reality system on the upper limb functioning in subacute stroke survivors.

Being tested
Virtual Reality
Keywords
stroke, rehabilitation, upper limb, immersive virtual reality, head-mounted display, subacute stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RealityDevice

    Also called Head-mounted display

    Four tasks, uni and bi-manuals, will be proposed for the treatment of the patient's paretic upper limb in virtual-apartment for improving the relevance and the transferability of the movements requested.

Study groups in NCT06892886
Study groupRoleWhat they receive
VR groupExperimentalAll participants will receive an hour of VR training 5 times/week for 4 weeks within the daily rehab routine.
Receives: Device: Virtual Reality
Control groupNo interventionParticipants will receive the usual rehabilitation activities due to their clinical needs (physical therapy, speech therapy, etc) for 5 times/week over 4 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in upper limb impairment

    Motor recovery will be assessed through the Fugl Meyer Assessment - Upper Extremity

    Measured: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)

Secondary outcomes (8)

  1. Change in Spasticity

    Spasticity grade at the paretic upper limb will be measured with the Ashworth Scale (0-5), in which higher scores are related to more severe muscle hypertonia

    Measured: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)

  2. Change in Activities of Daily Living

    Patient's independence will be quantified with the Barthel Index

    Measured: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)

  3. Change in perceived quality of life

    Stroke Impact Scale 2.0 will be performed for investigating the perceived quality of life, higher scores indicate better quality of life perceived

    Measured: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)

  4. Kinematic data

    Instrumental data of hand movements registered during the sessions (relevant kinematic indexes will be recorded and offline analyzed such as hand trajectories and peak velocity)

    Measured: Parameters changes (e.g. hand peak velocities) before (T0) and after (T1) the 4 weeks of treatment

  5. Electroencephalogram

    The EEG signals will be measured by means of a 32-channel cap, according to the International 10-20 system, recorded and monitored by computerized devices.

    Measured: Data changes before (T0) and after (T1) the 4 weeks of treatment (4 weeks) and at 6-month follow-up (T2)

  6. Treatment satisfaction

    The satisfaction related to the virtual training will be investigated through a specific questionnaire

    Measured: After 4 weeks

  7. Embodiment

    The embodiment feeling will be analyzed with the Gonzalez-Franco questionnaire

    Measured: After 4 weeks

  8. Cybersickness

    For monitoring undesirable events the Simulator Sickness Questionnaire will be used

    Measured: After 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2025
  2. Study start1 Mar 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Randomized Controlled Trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06892886
Sponsor's protocol ID
VR_STROKE_MULTICENTER
Status last verified
Nov 2024
First submitted
30 Jan 2023
Last updated
25 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality in people with Sub-acute Stroke, run by University Hospital of Ferrara 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 2 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: looking for participants now, as of the sponsor's last update on 25 Mar 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 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sofia Straudi, MD, PhD (+390532238720, sofia.straudi@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in upper limb impairment (time frame: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)). 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 NCT06892886.

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 Mar 2025.

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