The Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Feasibility as Assessed by the Number of Sessions Attended
研究概览
简要总结
The purpose of this study is to test the (a) feasibility, (b) usability, and (c) acceptability of using the Oculus Virtual Reality (VR) for chronic stroke survivors who have mild-moderate cognitive and unilateral arm impairment to administer upper extremity and cognitive rehabilitation, to calculate the change in upper extremity and cognition scores on standardized measurements per standard of care and to qualitatively explore the impact of engaging caregivers in supporting the stroke survivor's rehabilitation and the impact of this engagement on the stroke survivor and caregiver dyad using semi-structured interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Ischemic or hemorrhagic stroke diagnosis within 6 months to 2 years of enrollment
- •can read, write, comprehend, speak English
- •willing and able to provide informed consent
- •Caregivers must live in the home with the stroke survivor
排除标准
- •do not have score ranges that indicate mild to moderate severity on the Montreal Cognitive Assessment (MoCA )(15-25) or other appropriate cognitive screening test selected by the speech language pathologist
- •has aphasia, hemiopsia, and other neurological deficits that prevents the participant from being examined using MoCA or a modified MoCA, Fugl-Meyer Assessment - Upper Extremity (FM) (20-50)
- •unstable while standing unassisted
- •have a history of motion sickness/ vertigo/ dizziness/seizures, claustrophobia, blind/deaf, and cannot hold the controller in their affected arm.
结局指标
主要结局
Feasibility as Assessed by the Number of Sessions Attended
时间窗: end of intervention( about 4 weeks from baseline)
The minimum number of sessions expected for a user are 2 per week (8 sessions)
Feasibility as Assessed by the Time Spent Using the Oculus VR
时间窗: end of intervention( about 4 weeks from baseline)
the minimum time spent playing Job Simulator is 1 hour (60 minutes) per week. (240 minutes through the end of the study)
Limb Function as Assessed by the Action Research Arm Test (ARAT)
时间窗: end of intervention( about 4 weeks from baseline)
Total score on the Action Research Arm Test (ARAT), ranging from 0 to 57, with higher scores indicating better upper limb function.
Burden of Caregivers in Supporting the Stroke Survivor as Assessed by the Burden Scale for Family Caregivers - Short Version
时间窗: end of intervention( about 4 weeks from baseline)
Total score on the Burden Scale for Family Caregivers - short version, ranges from 0 to 30, with a higher score indicating more burden
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
时间窗: Session 12 (week 4 day 3)
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Usability as Assessed by the Score on the System Usability Scale (SUS)
时间窗: end of intervention( about 4 weeks from baseline)
The System Usability Scale (SUS) was used to assess the usability of the technology. Total score ranges from 10 to 50, with a higher score indicating greater usability.
Usability as Assessed by the Score on the Presence Questionnaire (PQ)
时间窗: end of intervention( about 4 weeks from baseline)
The Presence Questionnaire (PQ), total score ranges from 29 to 87, with a higher score indicating greater usability.
Cognition as Assessed by the Montreal Cognitive Assessment (MoCA)
时间窗: end of intervention (about 4 weeks from baseline)
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Arm Impairment as Assessed by Fugl Meyer - Upper Extremity Assessment
时间窗: end of intervention( about 4 weeks from baseline)
Total score on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE), ranges from 0 to 66, with higher scores indicating better arm function.
次要结局
- Impact of the Rehabilitation on the Caregiver as Assessed by Number of Themes Derived From the Qualitative Interview(end of intervention( about 4 weeks from baseline))
- Number of Subjects Who Have Received Physical Therapy(Session 12 (week 4 day3 ))
- Impact of the Rehabilitation on the Participant as Assessed by the Number of Themes Derived From the Qualitative Interview(Baseline)
- Number of Subjects Who Have Received Occupational Therapy(Session 12 (week 4 day3 ))
- Number of Subjects Who Have Received Speech Therapy(Session 12 (week 4 day 3))
研究者
Seema S Aggarwal
Assistant Professor
The University of Texas Health Science Center, Houston