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Completed

NCT Number: NCT02706912

Virtual Occupational Therapy Application

Virtual Occupational Therapy Application (VOTA) combines low-cost human motion tracking, commercial game engine technology, and evidence-based Occupational Therapy (OT) practice in a computer-based virtual world in which stroke patients practice activities of daily living (ADLs). The protocol investigates the efficacy of VOTA therapy for Upper Extremity (UE) motor recovery and assesses system usability and user acceptance.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UVA- HealthSouth Rehabilitation Hospital

Charlottesville, Virginia, 22901, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant is a hemiparetic stroke survivor;
  • Time since last stroke at least 3 months;
  • Participant has antigravity strength at the elbow to at least 45 degrees of active flexion in the stroke affected arm;
  • Participant has antigravity shoulder strength to at least 30 degrees each in active flexion, abduction/adduction, and 15 degrees in active rotation from an upright seated position in the stroke affected arm;
  • Participant has visual acuity with corrective lenses of 20/50 or better;

Exclusion criteria

  • Existing participation in an upper extremity stroke rehabilitation program or planned participation during the study period;
  • Inability to understand and follow verbal directions;
  • Determination that participation would result in over exertion or significant discomfort or pain;
  • Determination that participation would result in significant agitation or elevated stress;
  • Withholding or withdrawal of consent by the participant;
  • Visual field deficit in either eye that impairs the ability to view the computer monitor;
  • Hemispatial neglect that impairs the ability process and perceive visual stimuli provided through the computer monitor;

Treatment and study plan

VOTA Therapy

Behavioral

During sessions of approximately one hour in duration, participants practice performing virtual activities of daily living (ADLs) using the VOTA system. During this practice, the participant's real-world motion is replicated by an avatar's motion in the virtual world. To complete the activities, participant's must perform a wide range of functional arm movements while interacting with virtual objects. Individuals are asked to perform three such one-hour virtual ADL practice sessions per week over a participation period of approximately eight weeks.

Primary outcomes

  1. Fugl-Meyer upper extremity assessment

    Time frame: Pre-assessment and Post-assessment (8 weeks)

    Measure of upper extremity motor function

Secondary outcomes

  1. Wolf Motor Function Test

    Time frame: Pre-assessment and Post-assessment (8 weeks)

    Measure of upper extremity motor function

  2. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: Pre-assessment and Post-assessment (8 weeks)

    Cognitive assessment

  3. Trail Making Test

    Time frame: Pre-assessment and Post-assessment (8 weeks)

    Cognitive assessment

Sponsors and collaborators

Lead sponsor

Barron Associates, Inc.

Industry

Collaborators

  • University of Virginia

Registry information

Acronym: VOTA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 11, 2016
Registry last updated
Aug 14, 2017

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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