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Recruiting NCT06401564

Virtual Reality Based Rehabilitation After Ischemic Stroke

No phase Interventional Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Therapy.
Who it may be relevant to
Registry conditions: Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

Use the template below as a guide to write a brief study description in plain language. Tailor the text that appears in brackets and yellow to your research study. To finalize, delete the text in italics. 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.

Interventions

  • Device Virtual Reality Therapy
    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 outcome measures

  • Feasibility survey [Time frame: After each session up to 5 weeks]
  • Simulator sickness questionnaire [Time frame: After each session up to 5 weeks]
Secondary outcome measures (5)
  • Adverse events [Time frame: After each session up to 5 weeks]
  • NIHSS [Time frame: Hospital discharge, an average of 7 days]
  • Modified Rankin Scale (mRS) [Time frame: Hospital discharge, an average of 7 days]
  • Duration of sessions [Time frame: After each session up to 1 week]
  • Time spent by therapist [Time frame: After each session up to 1 week]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stony Brook University Hospital — Stony Brook

Identifiers

NCT: NCT06401564 · IRB2021-00237

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗