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临床试验/NCT03987243
NCT03987243已完成不适用

Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年2月14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
发起方
Mayo Clinic
入组人数
19
试验地点
2
主要终点
Trunk Movement

研究概览

简要总结

This study will examine two interventions to increase weight shifts, overall trunk movement, and self-efficacy related to pressure ulcer prevention in wheelchair users with a spinal cord injury (SCI).

详细描述

Participants will use a mobile seat interface pressure mapping system that gives them live, real-time, visual feedback on the distribution of pressure between them and their seat cushion. This type of feedback works as a compensatory strategy for lack of sensation and allows the individual to visually observe pressure distribution they are not able to feel. Additionally, the participants will be provided with structured pressure ulcer prevention education, grounded in the principles of social cognitive theory, regarding pressure ulcer risk and use of weight shifts.

The pressure mapping system, which will be used during training, provides virtual modeling of the desired outcome (reduced pressure) and is an important part of the education module.

The findings of this study will inform clinicians and investigators of whether use of mobile seat interface pressure mapping as a compensatory-based intervention has a positive impact on trunk movement and self-efficacy for completing weight shifts in wheelchair users who lack sensation. Another contribution of this work is an exploration of the relationship between self-efficacy and movement in wheelchair users.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with a spinal cord injury (C4 and below, traumatic or non-traumatic, with onset greater than 12 months at enrollment)
  • Individuals who use a wheelchair as their primary form of mobility
  • Individuals who are willing to participate and able to make 2 visits to the Mayo Clinic in Rochester, MN

排除标准

  • Documented active pressure ulcer of any stage at initiation of study

研究组 & 干预措施

Intervention

Other

Two interventions will be provided. The first intervention is a structured education regarding pressure ulcer prevention through weight shifts at start of study. The second intervention is the use of a mobile seat interface pressure map (IPM), which will occur during two intervention phases.

干预措施: Structured Pressure Ulcer Prevention Education (Behavioral)

Intervention

Other

Two interventions will be provided. The first intervention is a structured education regarding pressure ulcer prevention through weight shifts at start of study. The second intervention is the use of a mobile seat interface pressure map (IPM), which will occur during two intervention phases.

干预措施: Mobile Seat Interface Pressure Mapping System (IPM) (Other)

结局指标

主要结局

Trunk Movement

时间窗: For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.

The primary outcome variable, trunk movement, will be defined by the percentage of the day with active trunk movement.

次要结局

  • Total Vector Magnitude of Movement(For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.)
  • Forward and Lateral Tilt(For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa M. Morrow, Ph.D.

Associate Professor

Mayo Clinic

研究点 (2)

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