Virtual Reality in Stroke Rehabilitation

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04080791
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Montreal Cognitive Assessment (MoCA) [baseline]

   Scores range from 0 to 30 with higher scores denoting better outcomes.

2. Montreal Cognitive Assessment (MoCA) [Up to 8 days after baseline]

   Scores range from 0 to 30 with higher scores denoting better outcomes.

3. 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.

4. Modified Functional Reach Test (MFRT) [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) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Peggy Cromer, LRT, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

• Henderson A, Korner-Bitensky N, Levin M. Virtual reality in stroke rehabilitation: a systematic review of its effectiveness for upper limb motor recovery. Top Stroke Rehabil. 2007 Mar-Apr;14(2):52-61. Review.
• IBM Corp. (2012). IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp
• National Stroke Association, (2018) Stroke 101: Fast facts on stroke, accessed from url http://www.stroke.org/sites/default/files/resources/NSA_%20FactSheet_Strok e_101_2014.pdf
• Turolla A, Dam M, Ventura L, Tonin P, Agostini M, Zucconi C, Kiper P, Cagnin A, Piron L. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT04080791
• Other Study ID Numbers: IRB00052687
• First Posted: Sep 6, 2019
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• 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: Stroke; Ischemic Stroke

Study Results

No Results Posted as of Jun 30, 2022