跳至主要内容
临床试验/NCT00283296
NCT00283296已完成2 期

Development of a Collapsible Folding Manual Wheelchair

VA Pittsburgh Healthcare System2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
14
试验地点
2
主要终点
Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Use a manual wheelchair as a primary means of mobility.
  • Male and females over the age of
  • The ability to adequately fit in a wheelchair with a 16" seat width.
  • A minimum of 6 months experience using a manual wheelchair as primary means of mobility.
  • Able to transfer independently.
  • Drive own vehicle from vehicle seat.

排除标准

  • Active pressure sores as reported by subject.
  • History of traumatic upper extremity injury that would prevent you from folding, lifting and storing a manual wheelchair.

结局指标

主要结局

Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)

时间窗: 2 week in-home trial

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

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

时间窗: 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.

Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)

时间窗: 2 week in-home trial

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

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Rory Cooper

Director; Pittsburgh VA Rehabilitation Research & Development Center

VA Pittsburgh Healthcare System

研究点 (2)

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