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NCT Number: NCT06401564

Virtual Reality Based Rehabilitation After Ischemic Stroke

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The goal of this single-arm study is to explore the use of early virtual reality-based rehabilitation as an adjunct to conventional physical/occupational therapy in adult patients with acute ischemic stroke. The main question it aims to answer is:

Feasibility and tolerability of using immersive Virtual Reality technology-based therapy for patients suffering from acute ischemic stroke in an inpatient hospital setting Participants will receive 1 or 2 virtual reality therapy sessions and complete surveys at the end of each session.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University Hospital

Stony Brook, New York, 11794-8121, United States

Location status: Recruiting

Location contact

Christine Pol

CONTACT

[email protected]

631-444-9083

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18
  • MRI or CT imaging confirmed ischemic stroke
  • Able to follow multistep commands

Exclusion criteria

  • Plegia in both arms
  • Previous reported history of vertigo or inner ear dysfunction
  • Patients with epilepsy
  • Patients who cannot begin therapy during admission
  • Patients who are pregnant
  • Patients with a pre-existing condition that interferes with virtual reality usage (e.g., visual impairment, limitation of either upper extremity or neck).

Treatment and study plan

Virtual reality therapy

Device

Each participant will receive one or two 20 minute VR sessions during their admission. Participants are able to pause or discontinue at any time. During each VR session, participants will use the REAL Immersive VR system and be equipped with a VR headset and 6 sensors attached to the torso, waist, and upper extremities. Patient will then undergo various virtual challenges guided by the physical or occupational therapist facilitating movements of the upper extremity, core, head, and neck.

Primary outcomes

  1. Feasibility survey

    Time frame: After each session up to 5 weeks

    The User Satisfaction Evaluation Questionnaire (USEQ) is a 14-item questionnaire evaluating satisfaction on a scale from 1 (not at all) to 5 (severely).

  2. Simulator sickness questionnaire

    Time frame: After each session up to 5 weeks

    An evaluation tool for assessing the subjective severity of simulator sickness symptoms. A 16-item questionnaire evaluating different symptoms on a scale from 0 (not at all) to 4 (severe).

Secondary outcomes

  1. Adverse events

    Time frame: After each session up to 5 weeks

    Frequency of adverse events such as dizziness, lightheadedness, nausea, headache, falls, fatigue, or other symptoms prompting program termination prior to end of a single 20-minute session

  2. NIHSS

    Time frame: Hospital discharge, an average of 7 days

    NIHSS is a standardized method that uses a 42-point scale to measure the level of impairment caused by a stroke. The 42-point scale measures several aspects of brain function, including consciousness, vision, sensation, movement, speech, and language (0 = no stroke and 42 = severe stroke).

  3. Modified Rankin Scale (mRS)

    Time frame: Hospital discharge, an average of 7 days

    The mRS incorporates mental as well as physical adaptations to the neurological deficits. It measures independence rather than performance of specific tasks. The mRS includes 15 items and takes approximately six minutes to complete. Scales consists of seven grades, from zero to six, with zero corresponding to no symptoms and six corresponding to death.

  4. Duration of sessions

    Time frame: After each session up to 1 week

    Actual time spent using the Virtual Reality (VR) system

  5. Time spent by therapist

    Time frame: After each session up to 1 week

    Time spent by therapist assisting patient including set-up.

Study contacts

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

Christine Pol, PhD

CONTACT

[email protected]

(631) 444-9083

Ruth Reinsel, PhD

CONTACT

[email protected]

(631) 638-2087

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • Good Samaritan Hospital

Registry information

Official study title

Improving Functional and Cognitive Outcomes After Ischemic Stroke Using Virtual Reality Based Rehabilitation

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 6, 2024
Registry last updated
May 6, 2024

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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