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临床试验/NCT03962582
NCT03962582已完成不适用

Clinical Evidence for Supported Spinal Curves in Wheelchair Seating: A Randomized Comparison

Shirley Ryan AbilityLab2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年12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
50
试验地点
2
主要终点
Seated Body Measurements performed.

研究概览

简要总结

This study tests using a wheelchair back that supports the spine in a neutral position and one that allows the spine and pelvis to fall into a posterior pelvic tilt.

详细描述

Individuals will randomly start with the supportive back vs the unsupportive back. Measurements of the spine and pelvis will be taken. Forward upward reach, one stroke push, times forward push and ramp skills will be assessed.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • complete spinal cord injury with levels
  • Full time wheelchair users
  • English speaking in order to understand the consent

排除标准

  • Over 250 pounds in body weight
  • Inability to grip a wheelchair push rim
  • Individual with pressure ulcer
  • Individual with shoulder pain

研究组 & 干预措施

Supportive Back Comparison

Experimental

Motion Concepts matrx back to be attached to individual's wheelchair in place of the individual's back. It will be adjusted for size and to support the spinal curves as compared to a fabric back

干预措施: Matrix back (Device)

结局指标

主要结局

Seated Body Measurements performed.

时间窗: 2 hour session (one visit)

Angle measurements will be taken when sitting. These include the pelvic angle (femur to pelvis) and Spinal Angle of Kyphosis (femur to acromion).

Vertical Forward Reach Test (VFRT):

时间窗: 2 hour session (one visit)

Assesses stability by measuring the maximum distance an individual can reach forward vertically (upward) while sitting in a fixed position.

Breathing status:

时间窗: 2 hour session (one visit)

An instrument called a spirometer is placed into the mouth with the nose clipped and the individual is instructed to take a deep breath and blow out. Peak effort flow, peak cough flow, and functional capacity will be recorded.

One stroke push:

时间窗: 2 hour session (one visit)

This measures how far the wheelchair moves forward with one stroke over carpet.

Timed forward Wheeling/Wheelchair Propulsion Test (WPT):

时间窗: 2 hour session (one visit)

The WPT is a brief test measuring the number of wheelchair pushes and time needed to cross a distance of 23 meters

Ramp Ascent (forward wheeling

时间窗: 2 hour session (one visit)

This is a timed test on a 10.3 meter ramp with a 1:13 grade slope

Pain Scale:

时间窗: 2 hour session (one visit)

The participant will rate any pain felt while sitting in the test wheelchairs after all activities using a numerical scale of 0-10, with 0 being no pain.

Survey

时间窗: 2 hour session (one visit)

The study team developed a survey for patients to fill out asking questions such as comfort of back support and opinions of practicality of back support.

次要结局

  • Breathing status:(2 hour session (one visit))

研究者

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

Jessica Pedersen

Research Scientist

Shirley Ryan AbilityLab

研究点 (2)

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