Development of a Collapsible Folding Manual Wheelchair

• Sponsor: VA Pittsburgh Healthcare System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00283296
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 87
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding, ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in confined areas. This enables access to narrow environments such as those encountered in offices, restrooms, and transportation settings. When using the small access wheels, the wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead compartment. It is anticipated that the Endeavor will maximize mobility; increase access to confined areas; and ease the demands of travel for people with disabilities.

Condition or Disease	Intervention/Treatment	Phase
Wheelchair Users	Device: Endeavor	Phase 2

Detailed Description

The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding, ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in confined areas. This enables access to narrow environments such as those encountered in offices, restrooms, and transportation settings. When using the small access wheels, the wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead compartment. It is anticipated that the Endeavor will maximize mobility; increase access to confined areas; and ease the demands of travel for people with disabilities.

There are two stages to this research project: an Activities of Daily Living Course and an In-Home trial. The activities of daily living course is located at the Human Engineering Research Laboratories and simulates daily barriers encountered by wheelchair users. Subjects will be asked to complete the course in their personal wheelchair and in the Endeavor three times each. Testing will be completed during a one-day visit that will not exceed 2 1/2 hours.

For the in-home trial, subjects will be asked to use the Endeavor as their primary means of mobility for two weeks, which will be compared to using their own wheelchair for two weeks. During this four-week period a datalogger will be mounted to the subject's wheelchair(s), which will give information about distance traveled, average speed, and time used. In addition to the data-logger, subjects will also be asked to keep a brief, daily, written log of the activities they performed while in the chair. At the end of the Endeavor trial-use period, subjects will be asked to complete a questionnaire. There is an 8-week follow-up period where subjects will be allowed to keep the Endeavor. We will make three calls during this period to conduct interviews on usage of the Endeavor.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Development of a Collapsible Folding Manual Wheelchair
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endeavor Wheelchair 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.	Device: Endeavor; Collapsible, forward folding manual wheelchair

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle [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.

2. Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c) [2 week in-home trial]

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

3. Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c) [2 week in-home trial]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Use a manual wheelchair as a primary means of mobility.

2. Male and females over the age of 18.

3. The ability to adequately fit in a wheelchair with a 16" seat width.

4. A minimum of 6 months experience using a manual wheelchair as primary means of mobility.

5. Able to transfer independently.

6. Drive own vehicle from vehicle seat.

Exclusion Criteria:

1. Active pressure sores as reported by subject.

2. History of traumatic upper extremity injury that would prevent you from folding, lifting and storing a manual wheelchair.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Human Engineering Research Laboratories	Pittsburgh	Pennsylvania	United States	15206

Sponsors and Collaborators

• VA Pittsburgh Healthcare System

Investigators

• Principal Investigator: Rory A Cooper, PhD, Human Engineering Research Laboratories

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rory Cooper, Director; Pittsburgh VA Rehabilitation Research & Development Center, VA Pittsburgh Healthcare System
• ClinicalTrials.gov Identifier: NCT00283296
• Other Study ID Numbers: 02331, 0408063; H133S030016
• First Posted: Jan 27, 2006
• Last Update Posted: Jan 6, 2015
• Last Verified: Dec 1, 2014

• Keywords provided by Rory Cooper, Director; Pittsburgh VA Rehabilitation Research & Development Center, VA Pittsburgh Healthcare System: manual wheelchair; assistive technology; travel wheelchair

Study Results

Participant Flow

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

Arm/Group Title	Endeavor Wheelchair
Arm/Group Description	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.
Period Title: Overall Study
STARTED	14
COMPLETED	9
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Endeavor Wheelchair
Arm/Group Description	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.
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.2 (10.8)
Sex: Female, Male (Count of Participants)
Female	2 14.3%
Male	12 85.7%
Region of Enrollment (participants) [Number]
United States	14 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle
Description	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.
Time Frame	immediately following course completion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endeavor Wheelchair
Arm/Group Description	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.
Measure Participants	14
Number [participants]	10 71.4%

2. Primary Outcome

Title	Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)
Description	Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger.
Time Frame	2 week in-home trial

Outcome Measure Data

Analysis Population Description

personal w/c

Arm/Group Title	Endeavor Wheelchair
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [meters/day]	1726 (716)

3. Primary Outcome

Title	Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)
Description	Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger.
Time Frame	2 week in-home trial

Outcome Measure Data

Analysis Population Description

Endeavor w/c

Arm/Group Title	Endeavor Wheelchair
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [meters/day]	1688 (822)

Adverse Events

Arm/Group Title	Endeavor Wheelchair
Arm/Group Description	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.
All Cause Mortality
	Endeavor Wheelchair
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Endeavor Wheelchair
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	Endeavor Wheelchair
	Affected / at Risk (%)	# Events
Total	1/14 (7.1%)
Musculoskeletal and connective tissue disorders
ankle/foot injury	1/14 (7.1%)

Limitations/Caveats

Limited number of Endeavor prototypes.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.