Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Reality in Stroke Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04080791
Recruitment Status : Not yet recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: Virtual Reality (VR) System Procedure: Standard of care Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Virtual Reality in Stroke Rehabilitation
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: Virtual 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.

Procedure: Standard of care
Control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol.

Active Comparator: 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.
Procedure: Standard of care
Control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol.




Primary Outcome Measures :
  1. Montreal Cognitive Assessment (MoCA) [ Time Frame: baseline ]
    Scores range from 0 to 30 with higher scores denoting better outcomes.

  2. Montreal Cognitive Assessment (MoCA) [ Time Frame: Up to 8 days after baseline ]
    Scores range from 0 to 30 with higher scores denoting better outcomes.

  3. Modified Functional Reach Test (MFRT) [ Time Frame: 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.

  4. Modified Functional Reach Test (MFRT) [ Time Frame: 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.

  5. FMA-UE (Fugl-Meyer Assessment for Upper Extremity) [ Time Frame: 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.

  6. FMA-UE (Fugl-Meyer Assessment for Upper Extremity) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Pain intensity self-report ratings [ Time Frame: prior to VR treatment 1 day after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  2. Pain intensity self-report ratings [ Time Frame: prior to VR treatment 2 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  3. Pain intensity self-report ratings [ Time Frame: prior to VR treatment 3 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  4. Pain intensity self-report ratings [ Time Frame: prior to VR treatment 4 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  5. Pain intensity self-report ratings [ Time Frame: prior to VR treatment 5 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  6. Pain intensity self-report ratings [ Time Frame: prior to VR treatment 6 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  7. Pain intensity self-report ratings [ Time Frame: prior to VR treatment 7 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  8. Pain intensity self-report ratings [ Time Frame: prior to VR treatment 8 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  9. Pain intensity self-report ratings [ Time Frame: immediately after VR treatment 1 day after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  10. Pain intensity self-report ratings [ Time Frame: immediately after VR treatment 2 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  11. Pain intensity self-report ratings [ Time Frame: immediately after VR treatment 3 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  12. Pain intensity self-report ratings [ Time Frame: immediately after VR treatment 4 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  13. Pain intensity self-report ratings [ Time Frame: immediately after VR treatment 5 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  14. Pain intensity self-report ratings [ Time Frame: immediately after VR treatment 6 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  15. Pain intensity self-report ratings [ Time Frame: immediately after VR treatment 7 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  16. Pain intensity self-report ratings [ Time Frame: immediately after VR treatment 8 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  17. Wong-Baker FACES scale [ Time Frame: prior to VR treatment 1 day after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  18. Wong-Baker FACES scale [ Time Frame: prior to VR treatment 2 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  19. Wong-Baker FACES scale [ Time Frame: prior to VR treatment 3 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  20. Wong-Baker FACES scale [ Time Frame: prior to VR treatment 4 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  21. Wong-Baker FACES scale [ Time Frame: prior to VR treatment 5 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  22. Wong-Baker FACES scale [ Time Frame: prior to VR treatment 6 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  23. Wong-Baker FACES scale [ Time Frame: prior to VR treatment 7 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  24. Wong-Baker FACES scale [ Time Frame: prior to VR treatment 8 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  25. Wong-Baker FACES scale [ Time Frame: immediately after VR treatment 1 day after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  26. Wong-Baker FACES scale [ Time Frame: immediately after VR treatment 2 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  27. Wong-Baker FACES scale [ Time Frame: immediately after VR treatment 3 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  28. Wong-Baker FACES scale [ Time Frame: immediately after VR treatment 4 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  29. Wong-Baker FACES scale [ Time Frame: immediately after VR treatment 5 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  30. Wong-Baker FACES scale [ Time Frame: immediately after VR treatment 6 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  31. Wong-Baker FACES scale [ Time Frame: immediately after VR treatment 7 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

  32. Wong-Baker FACES scale [ Time Frame: immediately after VR treatment 8 days after baseline ]
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080791


Contacts
Layout table for location contacts
Contact: Peggy Cromer, LRT 336-713-8391 pcromer@wakehealth.edu

Locations
Layout table for location information
United States, North Carolina
Wake Forest University Health Sciences Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Carolyn Austin    336-713-8393    caaustin@wakehealth.edu   
Contact: Pamela Wilson    336-716-6778    pwilson@wakehealth.edu   
Principal Investigator: Peggy Comer, LRT         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: Peggy Cromer, LRT Wake Forest University Health Sciences

Publications:
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04080791     History of Changes
Other Study ID Numbers: IRB00052687
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
Virtual Reality
Stroke
National Stroke Association
Stroke Rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases