Ischemic Stroke
Conditions
Keywords
Virtual Reality, Stroke, National Stroke Association, Stroke Rehabilitation
Brief summary
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.
Detailed description
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).
Interventions
DEVICEVirtual Reality (VR) System
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.
PROCEDUREStandard of care
Control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients Age 18 and older admitted to inpatient rehabilitation with a projected LOS (length of stay) of 10 days or more within the open data collection period for treatment of ischemic stroke and agree to participate in the study in addition to traditional intensive rehabilitation therapy.
Exclusion criteria
* Individual patients who exhibit the following symptoms or medical history or are not medically cleared for participation will be excluded: * History of, or high risk for, seizures * Feed tube, tracheotomy, or other medical devices that would preclude the use or wear of the VR headset as it covers the face and head * Blindness * History of mental health issues such as schizophrenia, manic episodes, active psychosis, or other mental health issues that may be exacerbated by exposure to VR * Open wounds that would preclude use for the VR headset
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | baseline | Scores range from 0 to 30 with higher scores denoting better outcomes. |
| Modified Functional Reach Test (MFRT) | baseline | 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. |
| FMA-UE (Fugl-Meyer Assessment for Upper Extremity) | baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity self-report ratings | prior to VR treatment, day 1, and days 2, 3, 4, 5, 6, 7, and 8 after baseline | For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity. |
| Wong-Baker FACES scale | prior to VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline | For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity. |
Outcome results
None listed