Physically DisabledAVEEDNCT02990507
Advanced Virtual Exercise Environment Device for Use by Persons With Physical Disabilities
A study testing AVEED: Arm rotation, video display, AVEED: Arm rotation, without video display and AVEED: Leg rotation, arm-energy input, video display in people with Physically Disabled, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physically Disabled
- What is being tested?
- AVEED: Arm rotation, video display, AVEED: Arm rotation, without video display and AVEED: Leg rotation, arm-energy input, video display
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2017to 19 May 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
- Greater than 18 years old
- Mobility impairment, able to push a manual wheelchair
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerisity of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: 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.
Read the 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.
- Conditions
- Physically Disabled
- Being tested
- AVEED: Arm rotation, video display, AVEED: Arm rotation, without video display, AVEED: Leg rotation, arm-energy input, video display, AVEED: Leg rotation, arm-energy input, without video display
- Keywords
- mobility impairment, virtual environment, exercise, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVEED: Arm rotation, video displayOther
Participants rotate arm cranks for 5 minutes then rest for 5 minutes.
AVEED: Arm rotation, without video displayOther
Participants rotate arm cranks for 5 minutes then rest for 5 minutes.
AVEED: Leg rotation, arm-energy input, video displayOther
Participants rotate leg cranks for 5 minutes then rest for 5 minutes.
AVEED: Leg rotation, arm-energy input, without video displayOther
Participants rotate leg cranks for 5 minutes then rest for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| AVEED | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days (approximately 48 hours) after enrolling
Secondary outcomes (2)
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).
Measured: 2 days (approximately 48 hours) after enrolling
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.
Measured: 2 days (approximately 48 hours) after enrolling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start10 Feb 2017
- Primary completion19 May 2017
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physically DisabledStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Laurie A Malone, PhD, University of Alabama at Birmingham
- Investigators
- Sangeetha Padalabalanarayanan, MS, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990507
- Sponsor's protocol ID
- 123UAB
- Acronym
- AVEED
- Status last verified
- Jun 2018
- First submitted
- 7 Dec 2016
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Advanced Virtual Exercise Environment Device (AVEED) for Use by Persons With Physical Disabilities
- ClinicalTrials.gov ID
- NCT02990507
- Acronym / sponsor ID
- AVEED / 123UAB
- Conditions
- Physically Disabled
- Keywords
- mobility impairment, virtual environment, exercise, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 13 Dec 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVEED | Experimental | 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 displayAVEED 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Greater than 18 years old
- Mobility impairment, able to push a manual wheelchair
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| AVEED: Arm rotation, video displayParticipants rotate arm cranks for 5 minutes then rest for 5 minutes. | Other | AVEED |
| AVEED: Arm rotation, without video displayParticipants rotate arm cranks for 5 minutes then rest for 5 minutes. | Other | AVEED |
| AVEED: Leg rotation, arm-energy input, video displayParticipants rotate leg cranks for 5 minutes then rest for 5 minutes. | Other | AVEED |
| AVEED: Leg rotation, arm-energy input, without video displayParticipants rotate leg cranks for 5 minutes then rest for 5 minutes. | Other | AVEED |
Primary outcome
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.
2 secondary outcomes
Exercise intensity
Time frame: 2 days (approximately 48 hours) after enrolling
Body orientation
Time frame: 2 days (approximately 48 hours) after enrolling
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 18 Jun 2018.
- Individual participant dataSharing planned: No
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.
Sangeetha Padalabalanarayanan, MS study director
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVEED: Arm rotation, video display, AVEED: Arm rotation, without video display and AVEED: Leg rotation, arm-energy input, video display in people with Physically Disabled, run by University of Alabama at Birmingham 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 2 inclusion and 5 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 18 Jun 2018. 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?
Participant feedback (time frame: 2 days (approximately 48 hours) after enrolling). 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 18 Jun 2018.