跳至主要内容
临床试验/CTRI/2025/06/089008
CTRI/2025/06/089008已完成不适用

An observational study on user’s feedback to an innovative multifunctional mobility assistive wheelchair

Sanjay Gandhi Post Graduate Institute of medical sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
satisfaction score for the usability of this innovative wheelchair

研究概览

简要总结

Improving participation in various activities of life is a central goal of rehabilitation among people with spinal cord injury (SCI). It is observed that wheel chair users reported positive changes in daily activities and improved participation. Clinically, it is important to carefully document the perceived impact of wheelchair on the user’s daily life. There is lack of information regarding the impact of wheelchair on participation and satisfaction level in wheel chair users with SCI. This study is being done to find out the association between assistive device user perceived satisfaction and participation and community integration in people with chronic SCI. The study results may be critical in identifying the extent of association of user satisfaction with participation and community integration in wheelchair bound people with SCI. After using the wheel chair for minimum 4 hours a day for at least 2 weeks, patient, their care givers and medical staff will be given a pre designed and pre tested questionnaire to assess their feedback for the usability of this innovative wheelchair. The questionnaire has 12 items and each item is scored on a 5 point scale [ranging from not satisfied at all (0) to very satisfied (5). Items in the satisfaction with the device domain include dimensions, weight, adjustments, safety, durability, simplicity of use, comfort and effectiveness. The total score was calculated by adding the ratings of the valid responses and divided this sum by number of valid items. The same procedure is followed for device subscale and services subscale scoring.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Spinal cord injury patients Inclusion Criteria: Participants must meet the following criteria to be included in the study Age: 18 years and older Diagnosed with spinal cord injury Limited mobility as assessed by a Physiatrist.
  • Willing and able to provide informed consent.

排除标准

  • Participants will be excluded from the study if they meet any of the following criteria: Severe cognitive impairment that may impact the ability to use the assistive device safely.
  • Uncontrolled medical conditions that may pose a risk during the study.
  • Known allergies to materials used in the assistive device.
  • Pregnancy, as the effects of the device on pregnant individuals have not been studied.

结局指标

主要结局

satisfaction score for the usability of this innovative wheelchair

时间窗: 0 and 2 week

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Siddharth Rai

SGPGIMS

研究点 (1)

Loading locations...

相似试验

study on user’s feedback to an innovative... | 临床试验