Clinical trial NCT04080791: Virtual Reality in Stroke Rehabilitation
Official title: Efficacy of Virtual Reality in Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: Virtual Reality
Stroke
National Stroke Association
Stroke Rehabilitation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: baseline
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Up to 8 days after baseline
measure: Modified Functional Reach Test (MFRT)
timeFrame: baseline
measure: Modified Functional Reach Test (MFRT)
timeFrame: Up to 8 days after baseline
measure: FMA-UE (Fugl-Meyer Assessment for Upper Extremity)
timeFrame: baseline
measure: FMA-UE (Fugl-Meyer Assessment for Upper Extremity)
timeFrame: Up to 8 days after baseline
Secondary outcomes:
measure: Pain intensity self-report ratings
timeFrame: prior to VR treatment, day 1, and days 2, 3, 4, 5, 6, 7, and 8 after baseline
measure: Pain intensity self-report ratings
timeFrame: immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline
measure: Wong-Baker FACES scale
timeFrame: prior to VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline
measure: Wong-Baker FACES scale
timeFrame: immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Peggy Cromer, LRT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: IBM Corp. (2012). IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp