Efficacy of Virtual Reality in Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Experimental Group- Virtual Reality (VR) Treatment
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.
干预措施: Virtual Reality (VR) System (Device)
Experimental Group- Virtual Reality (VR) Treatment
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.
干预措施: Standard of care (Procedure)
Standard of care group
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.
干预措施: Standard of care (Procedure)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: Up to 8 days after baseline
Scores range from 0 to 30 with higher scores denoting better outcomes.
Modified Functional Reach Test (MFRT)
时间窗: Up to 8 days after 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)
时间窗: Up to 8 days after 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.
Montreal Cognitive Assessment (MoCA)
时间窗: baseline
Scores range from 0 to 30 with higher scores denoting better outcomes.
Modified Functional Reach Test (MFRT)
时间窗: 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)
时间窗: 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.
次要结局
- Wong-Baker FACES scale(immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline)
- Pain intensity self-report ratings(immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline)
- Pain intensity self-report ratings(prior to VR treatment, day 1, and days 2, 3, 4, 5, 6, 7, and 8 after baseline)
- Wong-Baker FACES scale(prior to VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline)