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

Physically Disabled Clinical Trial

— AVEED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990507
• Other study ID #: 123UAB
• Status: Completed
• Phase: N/A
• Start date: February 10, 2017
• Est. completion date: May 19, 2017

Study information

• Verified date: June 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 19, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Physically Disabled

Intervention

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

Locations

Country	Name	City	State
United States	Univerisity of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant feedback	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.	2 days (approximately 48 hours) after enrolling
Secondary	Exercise intensity	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 days (approximately 48 hours) after enrolling
Secondary	Body orientation	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.	2 days (approximately 48 hours) after enrolling