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临床试验/NCT04973059
NCT04973059已完成不适用

Determining Levels of Enhanced Function Associated With the Permobil SmartDrive Manual Wheelchair Power Assist

University of Alberta2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Wheelchair User's Shoulder Pain Index (WUSPI) change is being assessed

研究概览

简要总结

This study will determine whether a power assist accessory for manual wheelchairs increases participation in community activities. This study will determine whether the power assist device (SmartDrive) is effective by increase participating in both winter and summer conditions.

详细描述

The University of Alberta, Faculty of Rehabilitation Medicine Rehabilitation Robotics Laboratory undertakes a wide range of research relating to wheelchair propulsion. They have developed a sensor (Redliner ) that measures levels of exertion associated with wheelchair ambulation during everyday activities. The device is linked to the user's cell phone and records a wide range of clinically relevant parameters continuously linking them to the GPS (global positioning system) coordinates of the wheelchair user. This device has significant advantages over more sophisticated wheelchair propulsion force measuring devices such as SmartWheel which are heavy and intended for clinic-based measurements. Redliner fits onto the wheels of any manual wheelchair and its low cost lends itself to clinical studies that are fully powered statistically.

Permobil have developed a product, SmartDrive, that can be retrofitted to a manual wheelchair to provide assistance in propelling the wheelchair. It is paired to PushTracker E2 which communicates with the SmartDrive to record parameters such as location, distance travelled, speed and provides a convenient way to control the SmartDrive which is located between the rear wheels of the wheelchair.

The cost of the SmartDrive at US$6,500 exceeds that of most publicly funded manual wheelchairs but is much less than most powered wheelchairs. For manual wheelchair users the SmartDrive is intended to reduce the risk of upper extremity overuse injuries and enables wheelchair users who are marginally functional for community ambulation to achieve their goals, without substantial investment and the collateral costs of transportation and home modifications that a powered wheelchair entails.

One of the challenges of the SmartDrive technology is that the data that has been collected so far is not benchmarked against the performance of wheelchair users prior to acquiring the power assist capability. The "value added" by the device to the user is therefore primarily anecdotal. With the objective of ensuring this technology is widely available, including through public and employer funded benefits, criteria to indicate the level of benefit achieved with SmartDrive are needed. These in turn could be translated into eligibility criteria to be used by both wheelchair users and funders. Redliner could then be used routinely to collect baseline data for wheelchair users wishing to obtain a SmartDrive to determine this eligibility.

This study will compare the benefits of the SmartDrive in the challenging winter conditions in Edmonton and then in the Spring when snow cover has melted. Many wheelchair users in Canada report social isolation due to winter conditions, particularly associated with snow covered sidewalks and streets and this study could demonstrate a particular benefit of the SmartDrive.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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

  • Active wheelchair user using a wheelchair as their primary means of mobility (at least 4 hours each day)
  • Capable of giving signed informed consent which includes compliance with the requirements listed in the informed consent form (ICF) and in this protocol
  • 18 years of age inclusive, at the time of signing the informed consent.
  • If the participant has a spinal cord injury Motor level C6-L3 Spinal Cord Injury, American Spinal Injury Association Impairment Scale (AIS) A-C since at least six months
  • Full time manual wheelchair users, able to propel their own wheelchairs independently
  • Eligible reason for SmartDrive prescription (Self-reported shoulder pain, and/or decreased physical endurance for propulsion, limiting user from activity)

排除标准

  • Uncontrolled exercise-induced asthma
  • Heart condition or high blood pressure
  • Chest pain at rest, during physical activity, or during physical activity
  • Severe visual impairment that requires an attendant or guide dog
  • Cognitive impairment affecting the ability to operate the SmartDrive, indicated by participant's clinician
  • Weigh more than 150 Kg due to the technical specification of the SmartDrive
  • Currently participating in another clinical study anticipated to affect the outcome or ability to compete this study
  • Planned change from daily routines during the measurement periods, such as holiday, move, change jobs
  • For any other reason not suitable for participation in the study indicated by participant's clinician
  • Do not use a smart phone

结局指标

主要结局

Wheelchair User's Shoulder Pain Index (WUSPI) change is being assessed

时间窗: Arm 1: Applied after 7 days of Use. Arm 2: Applied after 7 days of Use. Arm 3: Applied after 7 days of Use. Arm 4: Applied after 7 days of Use.

Wheelchair Users' Pain Index Range 0 - 150 VAS high values indicate higher pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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