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Completed

NCT Number: NCT05728866

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VR immersive therapy

Procedure

Participants will be asked to participate in 5 consecutive, 1-hour, 1:1 therapy sessions focused on rehabilitation of their weakened arm. Each session will involve use of a Virtual Reality (VR) system to deliver an immersive environment to encourage movement of the arm. The system also relies on 6 body-worn sensors that will detect movements of participant's arms and trunk. VR use will encompass 30-minutes of the therapy session, the remainder of the session will involve working with the therapist in addressing the functional tasks that are most meaningful for the participant and that involve the upper extremities.

Primary outcomes

  1. Change in hemiplegic arm movements

    Time frame: Baseline to approximately 12 days

    Arm movements will be measured using wrist-worn accelerometers. Amount of movement will be measured prior to and following the intervention

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Effectiveness of Immersive Virtual Reality (IVR) Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke: A Single Case Series Study.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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