Virtual Occupational Therapy Application

NCT ID: NCT02706912

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VOTA Group

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.

Group Type: EXPERIMENTAL

VOTA Therapy

Intervention Type: 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.

Interventions

VOTA Therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

Barron Associates, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UVA- HealthSouth Rehabilitation Hospital

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

VOTA1

Identifier Type: -

Identifier Source: org_study_id