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Effectiveness of IVR Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Enrolling

Conditions

Stroke

Treatments

Procedure: VR immersive therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05728866
HM20025720

Details and patient eligibility

About

The purpose of this research study is to understand the efficacy of using an immersive Virtual Reality (VR) environment, with task-specific training, to encourage arm movement following stroke.

Full description

The study will investigate how people who have had a stroke use their weakened arm in everyday tasks, and how this relates to measurements of movement ability from standardized clinic tests. Results of this research will ultimately help develop more effective training approaches to be used with stroke survivors.

Enrollment

13 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18 or older.
  • Diagnosed as having an ischemic or hemorrhagic stroke (with documented confirmatory neuroimaging in the medical record) that occurred at least 6-months prior to study enrollment.
  • Lack of full active range of motion in the involved shoulder, elbow, and wrist as the result of the injury.
  • At the time of study enrollment, participant completed structured therapeutic interventions at least 2-months prior.
  • Participants will not participate in Yoga, Tai-Chi, or other wellness lifestyle classes while participating in the study.
  • Absence of significant cognitive impairment as determined by a Mini-Mental Status Examination score of greater than or equal to 24.
  • The absence of upper extremity injury limiting functional use of the arm prior to the incident stroke.

Exclusion criteria

  • Unable to provide informed consent.
  • Sensory loss as determined by a score of 2 on the sensory item of the NIH Stroke Scale.
  • Pain in the involved upper limb that could interfere with daily activities as evidenced by a pain score of 5 or greater on the Numeric Pain Rating Scale.
  • History of greater than two strokes.
  • Suffered a stroke less than 6-months prior to participating in the study.
  • A history of, or being susceptible to, cyber-sickness (i.e., motion sickness).
  • Unable to don/doff accelerometer independently, or the lack of support in the home to assist with donning/doffing device; and
  • A history of seizures.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Virtual reality (VR) therapy
Experimental group
Treatment:
Procedure: VR immersive therapy

Trial contacts and locations

1

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Central trial contact

Rahsaan Holley; Virginia Chu, PhD

Data sourced from clinicaltrials.gov

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