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临床试验/NCT04668326
NCT04668326已完成不适用

Impact of Mobile Manual Standing Wheelchair on Standing Dosage and Utility

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
4
主要终点
Utility - Measured using the Wheelchair Outcome Measure

研究概览

简要总结

People with spinal cord injuries (SCI) are particularly prone to complications from excessive sitting, because many are not able to stand without support. Excessive sitting after SCI is believed to contribute to pressure injuries, pain, osteoporosis, joint stiffness, spasticity, and worsening bowel and bladder function. The VA has developed, patented, and licensed a mobile manual standing wheelchair (MMSW), and the investigators believe the key feature of being able to wheel around while in a standing position will dramatically change how paralyzed Veterans function in their home and community. If this expanded utility is realized, persons with SCI may naturally spend more time standing and less time sitting. To test these ideas, Veterans with SCI will be randomized to using one of two manual standing wheelchairs at home and in the community for two months.

详细描述

Background - The investigators contend that for Veterans with SCI to stand enough to impact health outcomes, the standing device must enhance utility while integrating into their everyday life; at home, at work, and in the community. For this integration to occur, the investigators believe the standing device must fulfill the following criteria: 1. Easy access, 2. Straightforward standing mechanism, 3. Mobility in both seated and standing positions, 4. Natural intuitive propulsion, 5. Stability, and 6. Independent operability. The Minneapolis Adaptive Design & Engineering (MADE) Program has recently developed a mobile manual standing wheelchair (MMSW) with all these features. Based on initial in-lab pilot testing, Veterans who trialed the device demonstrated excellent functional mobility and stability in both seated and standing postures. User feedback received during this initial testing also indicated these unique mobility and stability features offer potential new utility for Veterans with SCI.

Research Questions (Objectives) - The purpose of this project is to extend testing of the MMSW to home and community environments of 48 Veterans with SCI to see if mobility in standing affects utility and standing time.

Relevance to VA - There is a mounting body of literature showing significant adverse health consequences associated with excessive time spent in a seated position. Any person who has an underlying condition which impairs their ability to stand or walk is at increased risk for seating related adverse health consequences. There are an estimated 1.7 million people in the United States who have enough impairment that they use seated mobility devices (wheelchairs and scooters). Specifically, people with spinal cord injuries (SCI) are particularly prone to complications from excessive sitting, because many are unable to stand without some type of support. According to the VA's Corporate Data Warehouse, the VA provides care to 17,886 Veterans with SCI/D each year and estimate that over 7,000 of these Veterans have paraplegia. Excessive sitting after SCI is believed to contribute to pressure injuries, worsening pain, osteoporosis, joint stiffness, spasticity, and worsening bowel and bladder function. Until recently, there have been few practical options for safely supporting these individuals while standing or walking. Although there is now a growing list of assistive devices available to support standing and walking in SCI, relatively little attention has been given to determining how often such devices are used or how often they would need to be used to optimally promote the various potential health-related outcomes, nor which devices are most likely to achieve these changes.

Number of Research Participants (Sample Size) - Forty-eight participants (24/group) will be randomized. Each of the two study sites will be expected to screen up to 390 participants to reach the target of 48 randomized over both sites.

Participating Sites - Minneapolis VA Health Care System, VA Palo Alto Health Care System

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • United States Veteran
  • SCI or stable disorder/dysfunction of the spinal cord
  • Tolerates manual wheelchair use on a regular basis
  • Sufficient hand & arm function to operate manual standing wheelchair
  • Unable to stand independently without support
  • Greater than 6 months post-injury (SCI), or 6 months post diagnosis (disorder/dysfunction)
  • Weight less than 125 kg (275 lbs)
  • Age 18 or older
  • Decisional competency to provide consent and cognitive ability to participate fully in study procedures
  • Body size appropriate to fit the devices
  • Not involved in another study related to mobility
  • Identify an appropriate location for use of the study wheelchair

排除标准

  • Contraindication for standing including lower limb contractures, uncontrolled hypertension, uncontrolled spasticity, etc.
  • Unhealed lower-limb fractures
  • Unstable lower-limb joints
  • An active grade 2 or greater pressure injury that can be worsened by standing in the device
  • Flap procedure to address pressure injury less than one year earlier
  • Not able to propel a manual wheelchair or operate the sit-to-stand mechanism (e.g. weakness, or discomfort)
  • Low bone mineral density (BMD), defined by total hip DXA more than 3.5 SD below peak and/or distal femur/proximal tibia BMD below 0.6 g/cm
  • (Low BMD at any site will be ineligible).
  • Unable to obtain clinically acceptable seating system for study wheelchairs
  • Unable to build up standing tolerance within the first eight visits
  • Individual deemed not appropriate for participation in the study as determined by study team

研究组 & 干预措施

Manual Standing Wheelchair

Active Comparator

Mobile in seated position; Not mobile in standing position

干预措施: Manual Standing Wheelchair (Device)

Mobile Manual Standing Wheelchair

Experimental

Mobile in BOTH seated and standing positions

干预措施: Mobile Manual Standing Wheelchair (Device)

结局指标

主要结局

Utility - Measured using the Wheelchair Outcome Measure

时间窗: Two months

The Wheelchair Outcome Measure (WhOM) will be slightly modified to ask users to provide participation goals in the home and community in the context of standing devices/wheelchairs as opposed to wheelchairs alone. The WhOM collects activities that are goals for participation and then has the participant rank the importance and satisfaction with each activity. The rankings allow a quantitative score to be calculated for comparison. The WhOM was chosen to represent the concept of "utility" because it captures what is meaningful and important to each participant, while also allowing a quantitative scoring. The investigators will specifically calculate Mean satisfaction x importance = the sum of the individual importance x satisfaction of all goals divided number of goals Higher scores indicate higher satisfaction with specific goals, using importance of the task to help scale the effect of each goal. Thus higher scores will be considered higher utility.

Standing Dose - Total time standing - Study Wheelchair

时间窗: Two months

An accelerometer will be placed on part of the study standing wheelchair that rotates upward during standing. The gravitational acceleration will indicate standing versus sitting. A custom algorithm will be used to determine when the wheelchair is in the standing position.

Standing Dose - Total time standing - Existing Standing Device

时间窗: Two months

An accelerometer will be placed on part of the existing standing device (when applicable) that rotates upward during standing. The gravitational acceleration will indicate standing versus sitting. A custom algorithm will be used to determine when the standing device is in the standing position.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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