Stroke
Conditions
Keywords
rehabilitation, upper limb, stroke survivor
Brief summary
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.
Interventions
DEVICEOculus VR
During the first visit, the Oculus headset will be placed on the stroke survivor's head and demonstrate how to use the headset. participant will be then allowed to play a game using the hand controllers for up to 30 minutes. Finally, a copy of exercises for their home rehabilitation program will be provided. During the next rehabilitation visits, a trained research assistant will guide the stroke survivor with using the gaming headset. The session will be stopped every 20 minutes to make sure that the stroke survivor is feeling well and to give them a break. The stroke survivor may stop the session at any time. This session will last for an hour.
Sponsors
IoT and Aging in Place Joint Seed Grant
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | Baseline | 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 Presence Questionnaire (PQ) | 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) | Baseline | Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome. |
| Limb Function as Assessed by the Action Research Arm Test (ARAT) | Baseline | Total score on the Action Research Arm Test (ARAT), ranging from 0 to 57, with higher scores indicating better upper limb function. |
| Arm Impairment as Assessed by Fugl Meyer - Upper Extremity Assessment | Baseline | Total score on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE), ranges from 0 to 66, with higher scores indicating better arm function. |
| Burden of Caregivers in Supporting the Stroke Survivor as Assessed by the Burden Scale for Family Caregivers - Short Version | Baseline | Total score on the Burden Scale for Family Caregivers - short version, ranges from 0 to 30, with a higher score indicating more burden |
| Feasibility as Assessed by the Number of Sessions Attended | 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 | 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) |
| Usability as Assessed by the Score on the System Usability Scale (SUS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | In-person, in-depth interviews will be conducted following completion of a virtual reality (VR) intervention using the Oculus Quest 2 headset for post-stroke rehabilitation. Interviews will be transcribed verbatim and a qualitative analytic process will be used to identify common themes. A codebook will be developed based on analysis of the transcripts. This outcome reflects the number of themes derived from the interviews. |
| Number of Subjects Who Have Received Occupational Therapy | Session 1 (week 1 day 1) | — |
| Number of Subjects Who Have Received Physical Therapy | Session 1 (week 1 day 1) | — |
| Number of Subjects Who Have Received Speech Therapy | Session 1 (week 1 day 1) | — |
| Impact of the Rehabilitation on the Participant as Assessed by the Number of Themes Derived From the Qualitative Interview | Baseline | In-person, in-depth interviews will be conducted following completion of a virtual reality (VR) intervention using the Oculus Quest 2 headset for post-stroke rehabilitation. Interviews will be transcribed verbatim and a qualitative analytic process will be used to identify common themes. A codebook will be developed based on analysis of the transcripts. This outcome reflects the number of themes derived from the interviews. |
Countries
United States
Participant flow
Pre-assignment details
32 individuals (16 dyads) were enrolled in total: 16 stroke survivor participants, each enrolled with a caregiver.
Participants by arm
| Arm | Count |
|---|---|
| Oculus VR Oculus VR: During the first visit, the Oculus headset will be placed on the stroke survivor's head and demonstrate how to use the headset. participant will be then allowed to play a game using the hand controllers for up to 30 minutes. Finally, a copy of exercises for their home rehabilitation program will be provided. During the next rehabilitation visits, a trained research assistant will guide the stroke survivor with using the gaming headset. The session will be stopped every 20 minutes to make sure that the stroke survivor is feeling well and to give them a break. The stroke survivor may stop the session at any time. This session will last for an hour. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Oculus VR |
|---|---|
| Age, Customized Caregiver | 52.12 years STANDARD_DEVIATION 10.81 |
| Age, Customized Stroke Survivor Participant | 50.31 years STANDARD_DEVIATION 15.15 |
| Daily use of electronics 3-4 hours | 3 Participants |
| Daily use of electronics 4-8 hours | 7 Participants |
| Daily use of electronics More than 8 hours | 6 Participants |
| Gaming Devices Used Previously Arcade | 11 Participants |
| Gaming Devices Used Previously Computer/Laptop | 9 Participants |
| Gaming Devices Used Previously Game Console | 14 Participants |
| Gaming Devices Used Previously Smart Phone | 13 Participants |
| Gaming Devices Used Previously Virtual Headset | 9 Participants |
| Level of Education Caregiver Associates | 2 Participants |
| Level of Education Caregiver Bachelors | 5 Participants |
| Level of Education Caregiver High School/GED | 0 Participants |
| Level of Education Caregiver Masters | 2 Participants |
| Level of Education Caregiver PhD | 1 Participants |
| Level of Education Caregiver Some College | 6 Participants |
| Level of Education Stroke Survivor Participant Associates | 1 Participants |
| Level of Education Stroke Survivor Participant Bachelors | 3 Participants |
| Level of Education Stroke Survivor Participant High School/GED | 3 Participants |
| Level of Education Stroke Survivor Participant Masters | 2 Participants |
| Level of Education Stroke Survivor Participant PhD | 1 Participants |
| Level of Education Stroke Survivor Participant Some College | 6 Participants |
| Number of Participants with a history of previous stroke | 6 Participants |
| Number of Participants with a right sided stroke | 10 Participants |
| Race/Ethnicity, Customized Caregiver Black or African American | 8 Participants |
| Race/Ethnicity, Customized Caregiver Hispanic/Latino | 1 Participants |
| Race/Ethnicity, Customized Caregiver White | 7 Participants |
| Race/Ethnicity, Customized Stroke Survivor Participant Black or African American | 8 Participants |
| Race/Ethnicity, Customized Stroke Survivor Participant Hispanic/Latino | 2 Participants |
| Race/Ethnicity, Customized Stroke Survivor Participant White | 6 Participants |
| Region of Enrollment United States | 32 participants |
| Relationship of Stroke Survivor to Caregiver Child of Caregiver | 1 Participants |
| Relationship of Stroke Survivor to Caregiver Friend of Caregiver | 1 Participants |
| Relationship of Stroke Survivor to Caregiver Parent of Caregiver | 3 Participants |
| Relationship of Stroke Survivor to Caregiver Sibling of Caregiver | 3 Participants |
| Relationship of Stroke Survivor to Caregiver Spouse of Caregiver | 8 Participants |
| Sex/Gender, Customized Caregiver Female | 13 Participants |
| Sex/Gender, Customized Caregiver Male | 3 Participants |
| Sex/Gender, Customized Stroke Survivor Participant Female | 5 Participants |
| Sex/Gender, Customized Stroke Survivor Participant Male | 11 Participants |
| Stroke Type Intracerebral hemorrhage | 6 Participants |
| Stroke Type Ischemic | 9 Participants |
| Stroke Type Subarachnoid hemorrhage | 1 Participants |
| Type of Internet DSL | 3 Participants |
| Type of Internet Wi-fi | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 6 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 12 (week 4 day 3)
Population: Includes data for 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16 score on a scale | Standard Deviation 0 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 1 (week 1 day 1)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16.38 score on a scale | Standard Deviation 0.72 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 11 (week 4 day 2)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16.25 score on a scale | Standard Deviation 0.5 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 10 (week 4 day 1)
Population: Includes data for 14 stroke survivor participants. 2 participants did not attend the session therefore, data were not collected for 2 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16.33 score on a scale | Standard Deviation 0.58 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 9 (week 3 day 3)
Population: Includes data for 12 stroke survivor participants. 4 participants did not attend the session therefore, data were not collected for 4 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16.17 score on a scale | Standard Deviation 0.41 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 8 (week 3 day 2)
Population: Includes data for 12 stroke survivor participants. 4 participants did not attend the session therefore, data were not collected for 4 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16.14 score on a scale | Standard Deviation 0.38 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 7 (week 3 day 1)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16 score on a scale | Standard Deviation 0 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 5 (week 2 day 2)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16.11 score on a scale | Standard Deviation 0.33 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 6 (week 2 day 3)
Population: Includes data for 14 stroke survivor participants. 2 participants did not attend the session therefore, data were not collected for 2 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16.33 score on a scale | Standard Deviation 0.71 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 4(week 2 day 1)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16.17 score on a scale | Standard Deviation 0.72 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 3 (week 1 day 3)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16.25 score on a scale | Standard Deviation 0.62 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Session 2 (week 1 day 2)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16.33 score on a scale | Standard Deviation 0.72 |
Primary
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire
Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness
Time frame: Baseline
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire | 16.69 score on a scale | Standard Deviation 1.35 |
Primary
Arm Impairment as Assessed by Fugl Meyer - Upper Extremity Assessment
Total score on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE), ranges from 0 to 66, with higher scores indicating better arm function.
Time frame: Baseline
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Arm Impairment as Assessed by Fugl Meyer - Upper Extremity Assessment | 30.56 score on a scale | Standard Deviation 14.99 |
Primary
Arm Impairment as Assessed by Fugl Meyer - Upper Extremity Assessment
Total score on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE), ranges from 0 to 66, with higher scores indicating better arm function.
Time frame: end of intervention( about 4 weeks from baseline)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Arm Impairment as Assessed by Fugl Meyer - Upper Extremity Assessment | 31.25 score on a scale | Standard Deviation 19.26 |
Primary
Burden of Caregivers in Supporting the Stroke Survivor as Assessed by the Burden Scale for Family Caregivers - Short Version
Total score on the Burden Scale for Family Caregivers - short version, ranges from 0 to 30, with a higher score indicating more burden
Time frame: Baseline
Population: Includes data for all 16 caregivers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Burden of Caregivers in Supporting the Stroke Survivor as Assessed by the Burden Scale for Family Caregivers - Short Version | 13 score on a scale | Standard Deviation 8.53 |
Primary
Burden of Caregivers in Supporting the Stroke Survivor as Assessed by the Burden Scale for Family Caregivers - Short Version
Total score on the Burden Scale for Family Caregivers - short version, ranges from 0 to 30, with a higher score indicating more burden
Time frame: end of intervention( about 4 weeks from baseline)
Population: Includes data for 14 caregivers. Data were not collected for 2 caregivers because they did not fill out the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Burden of Caregivers in Supporting the Stroke Survivor as Assessed by the Burden Scale for Family Caregivers - Short Version | 13.83 score on a scale | Standard Deviation 7.55 |
Primary
Cognition as Assessed by the Montreal Cognitive Assessment (MoCA)
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Time frame: Baseline
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Cognition as Assessed by the Montreal Cognitive Assessment (MoCA) | 23.21 score on a scale | Standard Deviation 4.88 |
Primary
Cognition as Assessed by the Montreal Cognitive Assessment (MoCA)
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Time frame: end of intervention (about 4 weeks from baseline)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Cognition as Assessed by the Montreal Cognitive Assessment (MoCA) | 23.25 score on a scale | Standard Deviation 3.59 |
Primary
Feasibility as Assessed by the Number of Sessions Attended
The minimum number of sessions expected for a user are 2 per week (8 sessions)
Time frame: end of intervention( about 4 weeks from baseline)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Feasibility as Assessed by the Number of Sessions Attended | 11.06 sessions | Standard Deviation 1.12 |
Primary
Feasibility as Assessed by the Time Spent Using the Oculus VR
the minimum time spent playing Job Simulator is 1 hour (60 minutes) per week. (240 minutes through the end of the study)
Time frame: end of intervention( about 4 weeks from baseline)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Feasibility as Assessed by the Time Spent Using the Oculus VR | 785 minutes | Standard Deviation 98.83 |
Primary
Limb Function as Assessed by the Action Research Arm Test (ARAT)
Total score on the Action Research Arm Test (ARAT), ranging from 0 to 57, with higher scores indicating better upper limb function.
Time frame: end of intervention( about 4 weeks from baseline)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Limb Function as Assessed by the Action Research Arm Test (ARAT) | 20.68 score on a scale | Standard Deviation 21.13 |
Primary
Limb Function as Assessed by the Action Research Arm Test (ARAT)
Total score on the Action Research Arm Test (ARAT), ranging from 0 to 57, with higher scores indicating better upper limb function.
Time frame: Baseline
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Limb Function as Assessed by the Action Research Arm Test (ARAT) | 19.37 score on a scale | Standard Deviation 21.59 |
Primary
Usability as Assessed by the Score on the Presence Questionnaire (PQ)
The Presence Questionnaire (PQ), total score ranges from 29 to 87, with a higher score indicating greater usability.
Time frame: end of intervention( about 4 weeks from baseline)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Usability as Assessed by the Score on the Presence Questionnaire (PQ) | 75.86 score on a scale | Standard Deviation 6.8 |
Primary
Usability as Assessed by the Score on the System Usability Scale (SUS)
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.
Time frame: end of intervention( about 4 weeks from baseline)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculus VR | Usability as Assessed by the Score on the System Usability Scale (SUS) | 32 score on a scale | Standard Deviation 1.75 |
Secondary
Impact of the Rehabilitation on the Caregiver as Assessed by Number of Themes Derived From the Qualitative Interview
In-person, in-depth interviews will be conducted following completion of a virtual reality (VR) intervention using the Oculus Quest 2 headset for post-stroke rehabilitation. Interviews will be transcribed verbatim and a qualitative analytic process will be used to identify common themes. A codebook will be developed based on analysis of the transcripts. This outcome reflects the number of themes derived from the interviews.
Time frame: end of intervention( about 4 weeks from baseline)
Population: includes data for all 16 caregivers.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oculus VR | Impact of the Rehabilitation on the Caregiver as Assessed by Number of Themes Derived From the Qualitative Interview | 5 themes |
Secondary
Impact of the Rehabilitation on the Participant as Assessed by the Number of Themes Derived From the Qualitative Interview
In-person, in-depth interviews will be conducted following completion of a virtual reality (VR) intervention using the Oculus Quest 2 headset for post-stroke rehabilitation. Interviews will be transcribed verbatim and a qualitative analytic process will be used to identify common themes. A codebook will be developed based on analysis of the transcripts. This outcome reflects the number of themes derived from the interviews.
Time frame: Baseline
Population: Includes data from all 16 stroke survivor participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oculus VR | Impact of the Rehabilitation on the Participant as Assessed by the Number of Themes Derived From the Qualitative Interview | 5 themes |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 10 (week 4 day 1)
Population: Includes data for 14 stroke survivor participants. 2 participants did not attend the session therefore, data were not collected for 2 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 2 Participants |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 1 (week 1 day 1)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 14 Participants |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 2 (week 1 day 2)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 8 Participants |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 3 (week 1 day 3)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 5 Participants |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 4(week 2 day 1)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 8 Participants |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 5 (week 2 day 2)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 5 Participants |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 6 (week 2 day 3)
Population: Includes data for 14 stroke survivor participants. 2 participants did not attend the session therefore, data were not collected for 2 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 6 Participants |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 7 (week 3 day 1)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 4 Participants |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 8 (week 3 day 2)
Population: Includes data for 12 stroke survivor participants. 4 participants did not attend the session therefore, data were not collected for 4 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 2 Participants |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 9 (week 3 day 3)
Population: Includes data for 12 stroke survivor participants. 4 participants did not attend the session therefore, data were not collected for 4 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 3 Participants |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 11 (week 4 day 2)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 2 Participants |
Secondary
Number of Subjects Who Have Received Occupational Therapy
Time frame: Session 12 (week 4 day3 )
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Occupational Therapy | 1 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 11 (week 4 day 2)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 2 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 1 (week 1 day 1)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 13 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 2 (week 1 day 2)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 7 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 3 (week 1 day 3)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 3 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 4(week 2 day 1)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 7 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 5 (week 2 day 2)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 3 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 6 (week 2 day 3)
Population: Includes data for 14 stroke survivor participants. 2 participants did not attend the session therefore, data were not collected for 2 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 6 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 7 (week 3 day 1)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 3 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 8 (week 3 day 2)
Population: Includes data for 12 stroke survivor participants. 4 participants did not attend the session therefore, data were not collected for 4 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 2 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 12 (week 4 day3 )
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 1 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 10 (week 4 day 1)
Population: Includes data for 14 stroke survivor participants. 2 participants did not attend the session therefore, data were not collected for 2 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 2 Participants |
Secondary
Number of Subjects Who Have Received Physical Therapy
Time frame: Session 9 (week 3 day 3)
Population: Includes data for 12 stroke survivor participants. 4 participants did not attend the session therefore, data were not collected for 4 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Physical Therapy | 3 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 1 (week 1 day 1)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 11 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 11 (week 4 day 2)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 1 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 12 (week 4 day 3)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 1 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 10 (week 4 day 1)
Population: Includes data for 14 stroke survivor participants. 2 participants did not attend the session therefore, data were not collected for 2 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 1 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 2 (week 1 day 2)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 2 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 3 (week 1 day 3)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 2 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 4(week 2 day 1)
Population: Includes data for all 16 stroke survivor participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 3 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 5 (week 2 day2)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 1 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 6 (week 2 day 3)
Population: Includes data for 14 stroke survivor participants. 2 participants did not attend the session therefore, data were not collected for 2 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 2 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 7 (week 3 day 1)
Population: Includes data for 15 stroke survivor participants. 1 participant did not attend the session therefore, data were not collected for 1 participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 1 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 8 (week 3 day 2)
Population: Includes data for 12 stroke survivor participants. 4 participants did not attend the session therefore, data were not collected for 4 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 0 Participants |
Secondary
Number of Subjects Who Have Received Speech Therapy
Time frame: Session 9 (week 3 day 3)
Population: Includes data for 12 stroke survivor participants. 4 participants did not attend the session therefore, data were not collected for 4 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oculus VR | Number of Subjects Who Have Received Speech Therapy | 1 Participants |