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| Name | Class |
|---|---|
| Good Samaritan Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| NIHSS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Pol, PhD | Contact | (631) 444-9083 | christiana.pol@stonybrookmedicine.edu | |
| Ruth Reinsel, PhD | Contact | (631) 638-2087 | ruth.reinsel@stonybrookmedicine.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason Mathew, DO | Stony Brook University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Hospital | Recruiting | Stony Brook | New York | 11794-8121 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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 |
| 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 |
| Duration of sessions | Actual time spent using the Virtual Reality (VR) system | After each session up to 1 week |
| Time spent by therapist | Time spent by therapist assisting patient including set-up. | After each session up to 1 week |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |