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The purpose of this research study is to investigate the effects of Virtual Reality (VR) as a treatment intervention to increase physical and cognitive function in stroke survivors.
In this pilot study, the objective is to determine if there is an increase in MoCA (Montreal Cognitive Assessment), MFRT (Modified Functional Reach Test), and FMA-UA (Fugl-Meyer Assessment Upper Extremity) scores of participants who receive the VR intervention in addition to traditional inpatient rehabilitation standard of care (experimental group) versus participants who receive the traditional standard of care (control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group- Virtual Reality (VR) Treatment | Experimental | The participants in the experimental group will complete the educational/training session on how to use the VR equipment and programs (30 minutes). The following day, participants will begin the VR intervention attending a daily 30-minute sessions for 8 days or until a discharge date has been set, whichever comes first. |
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| Standard of care group | Active Comparator | The control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol. Prior to discharge, control group participants will meet with a licensed clinical therapist to complete the cognitive and physical assessments for the posttest evaluation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality (VR) System | Device | The participants will undergo daily 30-minute sessions for 8 days of Virtual Reality (VR) with a VR system using commercially available default programs in addition to traditional intensive therapy regimen provided during inpatient rehab. |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | Scores range from 0 to 30 with higher scores denoting better outcomes. | baseline |
| Montreal Cognitive Assessment (MoCA) | Scores range from 0 to 30 with higher scores denoting better outcomes. | Up to 8 days after baseline |
| Modified Functional Reach Test (MFRT) | The Modified Functional Reach Test will be used to measure physical functioning. Measurements are the maximum distance the patient can reach forward while sitting in a fixed position. A score of 6 or less indicates a significant increased risk of falls. A score between 6-10 inches indicates a moderate risk for falls. | baseline |
| Modified Functional Reach Test (MFRT) | The Modified Functional Reach Test will be used to measure physical functioning. Measurements are the maximum distance the patient can reach forward while sitting in a fixed position. A score of 6 or less indicates a significant increased risk of falls. A score between 6-10 inches indicates a moderate risk for falls. | Up to 8 days after baseline |
| FMA-UE (Fugl-Meyer Assessment for Upper Extremity) | Fugl-Meyer Assessment for Upper Extremity will be used to measure upper extremity motor function. Scores range from 0 (unable to do the task) to 66 (task performed fully). Higher scores denote better outcome. | baseline |
| FMA-UE (Fugl-Meyer Assessment for Upper Extremity) | Fugl-Meyer Assessment for Upper Extremity will be used to measure upper extremity motor function. Scores range from 0 (unable to do the task) to 66 (task performed fully). Higher scores denote better outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity self-report ratings | For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity. | prior to VR treatment, day 1, and days 2, 3, 4, 5, 6, 7, and 8 after baseline |
| Pain intensity self-report ratings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peggy Cromer, LRT | Wake Forest University Health Sciences | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17517575 | Background | Henderson A, Korner-Bitensky N, Levin M. Virtual reality in stroke rehabilitation: a systematic review of its effectiveness for upper limb motor recovery. Top Stroke Rehabil. 2007 Mar-Apr;14(2):52-61. doi: 10.1310/tsr1402-52. | |
| Background | National Stroke Association, (2018) Stroke 101: Fast facts on stroke, accessed from url http://www.stroke.org/sites/default/files/resources/NSA_%20FactSheet_Strok e_101_2014.pdf | ||
| 23914733 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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| Standard of care | Procedure | Control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol. |
|
| Up to 8 days after baseline |
For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity. |
| immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline |
| Wong-Baker FACES scale | For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity. | prior to VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline |
| Wong-Baker FACES scale | For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity. | immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline |
| Background |
| Turolla A, Dam M, Ventura L, Tonin P, Agostini M, Zucconi C, Kiper P, Cagnin A, Piron L. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85. |
| Background | IBM Corp. (2012). IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006298 |
| Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |