Ischemic Stroke
Conditions
Keywords
virtual reality, stroke rehabilitation, quality of life, upper extremity
Brief summary
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
DEVICEVirtual 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.
Sponsors
Good Samaritan Hospital
Stony Brook University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility survey | 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). |
| Simulator sickness questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 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. |
| Adverse events | 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 |
| Time spent by therapist | After each session up to 1 week | Time spent by therapist assisting patient including set-up. |
| Duration of sessions | After each session up to 1 week | Actual time spent using the Virtual Reality (VR) system |
| NIHSS | 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). |
Countries
United States
Contacts
Primary ContactChristine Pol, PhD
Backup ContactRuth Reinsel, PhD
Outcome results
None listed