Advanced Virtual Exercise Environment Device for Use by Persons With Physical Disabilities (AVEED)
June 15, 2018 updated by: Laurie A Malone, PhD, University of Alabama at Birmingham
Evaluation of an Advanced Virtual Exercise Environment Device (AVEED) for Use by Persons With Physical Disabilities
An Advanced Virtual Exercise Environment Device (AVEED) has been developed that incorporates arm and leg ergometers in conjunction with a virtual reality interface.
The purpose of this study is to examine participant perspectives regarding the virtual interface and exercise device combination with regard to usability, comfort, safety, rating of perceived exertion, and enjoyment.
Study Overview
Status
Completed
Conditions
Detailed Description
Individuals with physical disabilities show much lower rates of exercise participation than their able-bodied peers (Boslaugh et al. 2006, Preventing Chronic Disease). Much of the reason for the low rates of activity among this population come from the presence of barriers. Lack of motivation, lack of transportation, lack of accessible facilities and equipment, and cost are all factors that discourage exercise participation among those with disabilities (Rimmer et al. 2008, JRRD; Barfield and Malone 2013, JRRD). Based on these factors, there is a need for accessible enjoyable exercise options for people with physical disabilities. The AVEED is comprised of an ergometer with foot and hand pedals, and a visual display in front of the user that can show a variety of scenic pathways.
The AVEED builds on previous work that demonstrates the potential benefit of interactive exercise for those with physical disabilities. The present study will establish the potential of this device to provide an engaging moderate intensity exercise opportunity for persons with disabilities.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Univerisity of Alabama at Birmingham
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Greater than 18 years old
- Mobility impairment, able to push a manual wheelchair
Exclusion Criteria:
- Individuals without a disability
- Individuals with vision loss that prevents them from seeing video elements on the screen
- Individuals with unstable cardiovascular conditions
- Individuals unable to push a manual wheelchair
- Individuals unable to understand study directions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: AVEED
AVEED is composed of arm and leg cranks that can be used independently or together with a virtual exercise environment (VEE).
Participants rotate arm and/or leg cranks under 4 conditions for 5 min each with a 5 min rest between: 1) Arm rotation with VEE, while sitting or standing (AVEED: Arm rotation, video display); 2) Arm rotation without VEE, while sitting or standing (AVEED: Arm rotation, without video display); 3) Leg rotation with arm-energy input to assist the legs with VEE, while sitting (AVEED: Leg rotation, arm-energy input, video display); 4) Leg rotation with arm-energy input to assist the legs without VEE, while sitting (AVEED: Leg rotation, arm-energy input, without video display).
VEE controlled with voice commands, leaning, or keyboard buttons.
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Participants rotate arm cranks for 5 minutes then rest for 5 minutes.
Participants rotate arm cranks for 5 minutes then rest for 5 minutes.
Participants rotate leg cranks for 5 minutes then rest for 5 minutes.
Participants rotate leg cranks for 5 minutes then rest for 5 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Participant feedback
Time Frame: 2 days (approximately 48 hours) after enrolling
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Likert-style questions regarding ease of use, comfort, safety, and enjoyment related to using the device.
Other questions will ask participants to compare the device with virtual interface to the device without the interface, as well as the likelihood of using their using the device if they had access to one.
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2 days (approximately 48 hours) after enrolling
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise intensity
Time Frame: 2 days (approximately 48 hours) after enrolling
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Percent heart rate reserve (%HRR) is a measure of exercise intensity and is calculated as (HR - HRrest)/(HRmax - HRrest).
Maximum HR can be estimated using the Karvonen formula which states HRmax = 220 - age.
The participant's HR will be monitored in real time via a Bluetooth enabled device strapped to the chest.
The goal is for the participant to input energy into the AVEED system and maintain a rate that produces a HRR of approximately 60%.
Exercising at a rate of 60% of their age-predicted HRR, would establish them within the range of intensity for cardiovascular improvement.
Verbal cues will be provided to ensure participants stay between 50-70% of HRR.
If the participant is unable to sustain this intensity they will be allowed to rest for 1-2 minutes and then start again.
Data recorded by the system will include continuous HR and energy output (watts).
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2 days (approximately 48 hours) after enrolling
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Body orientation
Time Frame: 2 days (approximately 48 hours) after enrolling
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Video recordings will be used to assess how the participant's body is oriented in relation to the ergometer and their ease of use in rotating the cranks under the different conditions.
the video will be scored using a 3 point likert scale: 1 being very poor body orientation to 3 being excellent orientation.
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2 days (approximately 48 hours) after enrolling
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Sangeetha Padalabalanarayanan, MS, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2017
Primary Completion (Actual)
May 19, 2017
Study Completion (Actual)
May 19, 2017
Study Registration Dates
First Submitted
December 7, 2016
First Submitted That Met QC Criteria
December 8, 2016
First Posted (Estimate)
December 13, 2016
Study Record Updates
Last Update Posted (Actual)
June 18, 2018
Last Update Submitted That Met QC Criteria
June 15, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123UAB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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