Virtual Reality Based Rehabilitation After Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06401564
• Other study ID #: IRB2021-00237
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Stony Brook University
• Contact: Christine Pol, PhD
• Phone: (631) 444-9083
• Email: christiana.pol[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Good Samaritan Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility survey	The User Satisfaction Evaluation Questionnaire (USEQ) is a 14-item questionnaire evaluating satisfaction on a scale from 1 (not at all) to 5 (severely).	After each session up to 5 weeks
Primary	Simulator sickness questionnaire	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).	After each session up to 5 weeks
Secondary	Adverse events	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	After each session up to 5 weeks
Secondary	NIHSS	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).	Hospital discharge, an average of 7 days
Secondary	Modified Rankin Scale (mRS)	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.	Hospital discharge, an average of 7 days
Secondary	Duration of sessions	Actual time spent using the Virtual Reality (VR) system	After each session up to 1 week
Secondary	Time spent by therapist	Time spent by therapist assisting patient including set-up.	After each session up to 1 week