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Advanced Virtual Exercise Environment Device for Use by Persons With Physical Disabilities (AVEED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990507
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Laurie A Malone, PhD, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Physically Disabled Other: AVEED: Arm rotation, video display Other: AVEED: Arm rotation, without video display Other: AVEED: Leg rotation, arm-energy input, video display Other: AVEED: Leg rotation, arm-energy input, without video display Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of an Advanced Virtual Exercise Environment Device (AVEED) for Use by Persons With Physical Disabilities
Actual Study Start Date : February 10, 2017
Actual Primary Completion Date : May 19, 2017
Actual Study Completion Date : May 19, 2017


Arm Intervention/treatment
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.
Other: AVEED: Arm rotation, video display
Participants rotate arm cranks for 5 minutes then rest for 5 minutes.

Other: AVEED: Arm rotation, without video display
Participants rotate arm cranks for 5 minutes then rest for 5 minutes.

Other: AVEED: Leg rotation, arm-energy input, video display
Participants rotate leg cranks for 5 minutes then rest for 5 minutes.

Other: AVEED: Leg rotation, arm-energy input, without video display
Participants rotate leg cranks for 5 minutes then rest for 5 minutes.




Primary Outcome Measures :
  1. Participant feedback [ Time Frame: 2 days (approximately 48 hours) after enrolling ]
    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.


Secondary Outcome Measures :
  1. Exercise intensity [ Time Frame: 2 days (approximately 48 hours) after enrolling ]
    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).

  2. Body orientation [ Time Frame: 2 days (approximately 48 hours) after enrolling ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990507


Locations
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United States, Alabama
Univerisity of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
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Study Director: Sangeetha Padalabalanarayanan, MS University of Alabama at Birmingham
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Responsible Party: Laurie A Malone, PhD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02990507    
Other Study ID Numbers: 123UAB
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laurie A Malone, PhD, University of Alabama at Birmingham:
mobility impairment
virtual environment
exercise
physical activity
Additional relevant MeSH terms:
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Methyltestosterone
Testosterone 17 beta-cypionate
Testosterone
Testosterone undecanoate
Testosterone enanthate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens