Virtual Occupational Therapy Application

Stroke Clinical Trial

— VOTA  

Official title:

Virtual Occupational Therapy Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706912
• Other study ID #: VOTA1
• Status: Completed
• Phase: N/A
• First received: March 3, 2016
• Last updated: August 11, 2017
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: August 2017
• Source: Barron Associates, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UVA- HealthSouth Rehabilitation Hospital	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Barron Associates, Inc.	University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer upper extremity assessment	Measure of upper extremity motor function	Pre-assessment and Post-assessment (8 weeks)
Secondary	Wolf Motor Function Test	Measure of upper extremity motor function	Pre-assessment and Post-assessment (8 weeks)
Secondary	Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Cognitive assessment	Pre-assessment and Post-assessment (8 weeks)
Secondary	Trail Making Test	Cognitive assessment	Pre-assessment and Post-assessment (8 weeks)