Trial Outcomes & Findings for Development of a Collapsible Folding Manual Wheelchair (NCT NCT00283296)

Results Overview

Participants completed an Activities of Daily Living Course in their own personal w/c and the Endeavor. Then participants were asked to rate their level of difficulty to complete based on a 5 point likert scale: very difficult, difficult, moderate, easy, very easy. Number of participants reported the Endeavor w/c to be the same as their current w/c or better with regards to transporting in a vehicle.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

immediately following course completion

Results posted on

2015-01-06

Participant Flow

All recruitment and data collection occured in 2008 at the Human Engineering Research Laboratories.

Participant milestones

Participant milestones
Measure	Endeavor Wheelchair All participants completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair three times each. Testing was completed during a one-day visit that did not exceed 2 1/2 hours. For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
Overall Study STARTED	14
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Endeavor Wheelchair All participants completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair three times each. Testing was completed during a one-day visit that did not exceed 2 1/2 hours. For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
Overall Study in-home trial not completed	5

Baseline Characteristics

Development of a Collapsible Folding Manual Wheelchair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endeavor Wheelchair n=14 Participants Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45.2 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: immediately following course completion

Participants completed an Activities of Daily Living Course in their own personal w/c and the Endeavor. Then participants were asked to rate their level of difficulty to complete based on a 5 point likert scale: very difficult, difficult, moderate, easy, very easy. Number of participants reported the Endeavor w/c to be the same as their current w/c or better with regards to transporting in a vehicle.

Outcome measures

Outcome measures
Measure	Endeavor Wheelchair n=14 Participants All participants received an introduction to the Endeavor wheelchair, and completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle	10 participants

PRIMARY outcome

Timeframe: 2 week in-home trial

Population: personal w/c

Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger.

Outcome measures

Outcome measures
Measure	Endeavor Wheelchair n=10 Participants All participants received an introduction to the Endeavor wheelchair, and completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)	1726 meters/day Standard Deviation 716

PRIMARY outcome

Timeframe: 2 week in-home trial

Population: Endeavor w/c

Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger.

Outcome measures

Outcome measures
Measure	Endeavor Wheelchair n=10 Participants All participants received an introduction to the Endeavor wheelchair, and completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)	1688 meters/day Standard Deviation 822

Adverse Events

Endeavor Wheelchair

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Endeavor Wheelchair n=14 participants at risk Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
Musculoskeletal and connective tissue disorders ankle/foot injury	7.1% 1/14

Additional Information

Rory Cooper, PhD

Human Engineering Research Laboratories

Phone: 412-822-3700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place