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NCT Number: NCT06892886

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

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.

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Key information

Conditions

Sub-acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ferrara University Hospital

Ferrara, 44124, Italy

Location status: Recruiting

Location contact

Andrea Baroni, PT, PhD

SUB_INVESTIGATOR

Antonino Casile, PhD

SUB_INVESTIGATOR

Giulia Fregna, PT, MSc, PhD student

SUB_INVESTIGATOR

Sofia Straudi, MD, PhD

CONTACT

[email protected]

0532238720

Sofia Straudi, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Virtual reality

Device

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.

Other names: Head-mounted display

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. Change in Spasticity

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

    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

  2. Change in Activities of Daily Living

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

    Patient's independence will be quantified with the Barthel Index

  3. Change in perceived quality of life

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

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

  4. Kinematic data

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

    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)

  5. Electroencephalogram

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

    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.

  6. Treatment satisfaction

    Time frame: After 4 weeks

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

  7. Embodiment

    Time frame: After 4 weeks

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

  8. Cybersickness

    Time frame: After 4 weeks

    For monitoring undesirable events the Simulator Sickness Questionnaire will be used

Study contacts

Contact information is provided by the study sponsor or research team.

Sofia Straudi, MD, PhD

CONTACT

[email protected]

+390532238720

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Collaborators

  • Casa di Cura Città di Rovigo
  • IRCCS Centro Neurolesi Bonino Pulejo
  • Ospedale Accreditato Villa Bellombra

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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