Virtual Reality in Stroke Rehabilitation

Ischemic Stroke Clinical Trial

Official title:

Efficacy of Virtual Reality in Stroke Rehabilitation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04080791
• Other study ID #: IRB00052687
• Status: Withdrawn
• Phase: N/A
• Start date: March 2023
• Est. completion date: January 2024

Study information

• Verified date: March 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

References & Publications (4)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment (MoCA)	Scores range from 0 to 30 with higher scores denoting better outcomes.	baseline
Primary	Montreal Cognitive Assessment (MoCA)	Scores range from 0 to 30 with higher scores denoting better outcomes.	Up to 8 days after baseline
Primary	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.	baseline
Primary	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.	Up to 8 days after baseline
Primary	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.	baseline
Primary	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.	Up to 8 days after baseline
Secondary	Pain intensity self-report ratings	For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.	prior to VR treatment, day 1, and days 2, 3, 4, 5, 6, 7, and 8 after baseline
Secondary	Pain intensity self-report ratings	For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.	immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline
Secondary	Wong-Baker FACES scale	For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.	prior to VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline
Secondary	Wong-Baker FACES scale	For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.	immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline