StrokeVOTANCT02706912
Virtual Occupational Therapy Application
A study testing VOTA Therapy in people with Stroke and Hemiparesis, run by Barron Associates, Inc. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- VOTA Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site
UVA- HealthSouth Rehabilitation Hospital
Charlottesville, Virginia, 22901
About this study
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
- Being tested
- VOTA Therapy
- Keywords
- Stroke, Hemiparesis, Activities of Daily Living, Virtual World, Occupational Therapy
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOTA TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: VOTA Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer upper extremity assessment
Measure of upper extremity motor function
Measured: Pre-assessment and Post-assessment (8 weeks)
Secondary outcomes (3)
Wolf Motor Function Test
Measure of upper extremity motor function
Measured: Pre-assessment and Post-assessment (8 weeks)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Cognitive assessment
Measured: Pre-assessment and Post-assessment (8 weeks)
Trail Making Test
Cognitive assessment
Measured: Pre-assessment and Post-assessment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barron Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706912
- Sponsor's protocol ID
- VOTA1
- Acronym
- VOTA
- Status last verified
- Aug 2017
- First submitted
- 3 Mar 2016
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Occupational Therapy Application
- ClinicalTrials.gov ID
- NCT02706912
- Acronym / sponsor ID
- VOTA / VOTA1
- Conditions
- Stroke, Hemiparesis
- Keywords
- Stroke, Hemiparesis, Activities of Daily Living, Virtual World, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Barron Associates, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VOTA Group | Experimental | Behavioral: VOTA TherapyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOTA TherapyDuring 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. | Behavioural | VOTA Group |
Primary outcome
Fugl-Meyer upper extremity assessment
Time frame: Pre-assessment and Post-assessment (8 weeks)
Measure of upper extremity motor function
3 secondary outcomes
Wolf Motor Function Test
Time frame: Pre-assessment and Post-assessment (8 weeks)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: Pre-assessment and Post-assessment (8 weeks)
Trail Making Test
Time frame: Pre-assessment and Post-assessment (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOTA Therapy in people with Stroke and Hemiparesis, run by Barron Associates, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer upper extremity assessment (time frame: Pre-assessment and Post-assessment (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.