Development of an Ergonomic Manual Wheelchair Pushrim- Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in Functional Status Score
研究概览
简要总结
The purpose of this study is to test the effectiveness of newly designed ergonomic manual wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard handrim. It is our hope that the new design of the handrims will help reduce upper extremity pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim was designed to directly address the shortcomings of standard handrims and to improve the standard-round tube handrims which were designed over 50 years ago. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.
详细描述
This research will have three parts.
The first part will include completing propulsion and braking tasks with the subject's original handrims. After the initial testing, new handrims (NaturalFit, PalmRim, and a new standard handrim) will be installed on the subject's wheelchair and subjects will again be asked to complete another set of propulsion and braking tasks. Subjects will also be asked to complete a questionnaire to assess wrist and shoulder pain and undergo an examination of the condition of the palm of their hand.
For the second part of the study, subjects will be asked to participate in a 4-month trial use period of the new handrims on their wheelchair.
In the third part of the study, subjects will complete the final set of propulsion and braking tasks and complete a follow-up questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)
- •Use a standard handrim
- •Between the ages of 18 and 55
- •Has normal hand function
排除标准
- •Pressure Sores
- •Inclusion Criteria:
- •Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)
- •Use a vinyl-coated handrim
- •Between ages 18 and 55
- •Has impaired hand function
- •Exclusion Criteria:
- •Pressure sores
结局指标
主要结局
Change in Functional Status Score
时间窗: Baseline, 4 Months
The Functional Status Scale, which measures hand and wrist symptoms.
次要结局
未报告次要终点
研究者
Michael Boninger
Chair, Department of Physical Medicine and Rehabilitation
University of Pittsburgh