Virtual Occupational Therapy Application

NCT02706912 | Completed

• 1 other identifier: VOTA1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Hemiparesis

Keywords

Stroke; Hemiparesis; Activities of Daily Living; Virtual World; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer upper extremity assessment

  Measure of upper extremity motor function

  Pre-assessment and Post-assessment (8 weeks)

Secondary Outcomes (3)

• Wolf Motor Function Test

  Pre-assessment and Post-assessment (8 weeks)

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  Pre-assessment and Post-assessment (8 weeks)

• Trail Making Test

  Pre-assessment and Post-assessment (8 weeks)

Study Arms (1)

VOTA Group

EXPERIMENTAL

All enrolled subjects are in this arm. After pre-assessment subjects have an 8-week waiting period, after which a mid-assessment takes place. Subject then participate in VOTA therapy for 8 weeks, followed by a post-assessment . The pre-/mid-assessment difference is used to control for spontaneous recovery. The mid-/post-assessment difference is used to ascertain efficacy.

Behavioral: VOTA Therapy

Interventions

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.

VOTA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Barron Associates, Inc.: lead
• University of Virginia: collaborator

Study Sites (1)

UVA- HealthSouth Rehabilitation Hospital

Charlottesville, Virginia, 22901, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 11, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)