NCT02990507

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 10, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2017

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

December 7, 2016

Last Update Submit

June 15, 2018

Conditions

Physically Disabled

Keywords

mobility impairmentvirtual environmentexercisephysical activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Exercise intensity

    2 days (approximately 48 hours) after enrolling

  • Body orientation

    2 days (approximately 48 hours) after enrolling

Study Arms (1)

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.

Other: AVEED: Arm rotation, video displayOther: AVEED: Arm rotation, without video displayOther: AVEED: Leg rotation, arm-energy input, video displayOther: AVEED: Leg rotation, arm-energy input, without video display

Interventions

AVEED: Arm rotation, video displayOTHER

Participants rotate arm cranks for 5 minutes then rest for 5 minutes.

AVEED
AVEED: Arm rotation, without video displayOTHER

Participants rotate arm cranks for 5 minutes then rest for 5 minutes.

AVEED
AVEED: Leg rotation, arm-energy input, video displayOTHER

Participants rotate leg cranks for 5 minutes then rest for 5 minutes.

AVEED
AVEED: Leg rotation, arm-energy input, without video displayOTHER

Participants rotate leg cranks for 5 minutes then rest for 5 minutes.

AVEED

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than 18 years old
  • Mobility impairment, able to push a manual wheelchair

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerisity of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sangeetha Padalabalanarayanan, MS

    University of Alabama at Birmingham

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 13, 2016

Study Start

February 10, 2017

Primary Completion

May 19, 2017

Study Completion

May 19, 2017

Last Updated

June 18, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)