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Ischemic StrokeNCT04080791

Virtual Reality in Stroke Rehabilitation

A study testing Virtual Reality (VR) System in people with Ischemic Stroke, run by Wake Forest University Health Sciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Virtual Reality (VR) System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2023to Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

Official title: Efficacy of Virtual Reality in Stroke Rehabilitation

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.

Read the 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).

Conditions
Ischemic Stroke
Being tested
Virtual Reality (VR) System, Standard of care
Keywords
Virtual Reality, Stroke, National Stroke Association, Stroke Rehabilitation
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality (VR) SystemDevice

    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.

  • Standard of careProcedure or surgery

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

Study groups in NCT04080791
Study groupRoleWhat they receive
Experimental Group- Virtual Reality (VR) TreatmentExperimentalThe 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.
Receives: Device: Virtual Reality (VR) System; Procedure: Standard of care
Standard of care groupActive comparatorThe 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.
Receives: Procedure: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montreal Cognitive Assessment (MoCA)

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

    Measured: baseline

  2. Montreal Cognitive Assessment (MoCA)

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

    Measured: Up to 8 days after baseline

  3. Modified Functional Reach Test (MFRT)

    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.

    Measured: baseline

  4. Modified Functional Reach Test (MFRT)

    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.

    Measured: Up to 8 days after baseline

  5. FMA-UE (Fugl-Meyer Assessment for Upper Extremity)

    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.

    Measured: baseline

  6. FMA-UE (Fugl-Meyer Assessment for Upper Extremity)

    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.

    Measured: Up to 8 days after baseline

Secondary outcomes (4)

  1. Pain intensity self-report ratings

    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

    Measured: prior to VR treatment, day 1, and days 2, 3, 4, 5, 6, 7, and 8 after baseline

  2. Pain intensity self-report ratings

    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

    Measured: immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline

  3. Wong-Baker FACES scale

    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

    Measured: prior to VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline

  4. Wong-Baker FACES scale

    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

    Measured: immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study startMar 2023 (estimated)
  3. Primary completionJan 2024 (estimated)
  4. Study completionJan 2024 (estimated)

Why it stopped: Unable to enroll

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04080791
Sponsor's protocol ID
IRB00052687
Status last verified
Mar 2023
First submitted
3 Sep 2019
Last updated
31 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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. doi: 10.1310/tsr1402-52.

    PubMed 17517575

  • 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.

    PubMed 23914733

  • IBM Corp. (2012). IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality (VR) System in people with Ischemic Stroke, run by Wake Forest University Health Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment (MoCA) (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04080791, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.

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