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临床试验/NCT04914650
NCT04914650已完成不适用

TEleRehabilitation Nepal (TERN) to Improve Quality of Life of People With Spinal Cord Injury and Acquired Brain Injury. A Proof-of-concept Study

University of Leeds1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019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
100
试验地点
1
主要终点
Modified Barthel Index

研究概览

简要总结

Nepal is a low-income country with over 3 million individuals with physical disabilities and currently no government-run specialist rehabilitation services. The aim of this research proposal is to work in partnership with a Nepal Non-Governmental Organisation (NGO), the Spinal Injury Rehabilitation Centre (SIRC, Nepal) to achieve the following:

  1. estimate the rehabilitation needs in individuals after stroke, brain injury and spinal cord injury in rural communities after discharge from SIRC
  2. hold user and stakeholder workshops to explore the role of multidisciplinary teleconferencing methods for remote assessment and management and agree systems for piloting
  3. deploy and pilot a novel telerehabilitation system to improve the lives of these individuals, and evaluate it in terms of feasibility and acceptability

详细描述

The methods to be used in each of the three work packages of this study are:

Work Package 1: Identifying baseline and context

Individuals discharged from SIRC between January 2018 and December 2019 will be identified and recruited to the study. Initially, a cross sectional study will capture their experiences and baseline community outcomes using both standardised quantitative outcome measures and qualitative data from semi-structured interviews. Recruitment and data collection for this part of the study will be conducted by partners in Nepal. Analysis and management of this data will be joint between Nepal and Leeds teams.

Work Package 2: Assessing utility of telerehabilitation to address needs

Informed by previous work package, user and stakeholder workshops will be used to explore the role of multidisciplinary video teleconferencing, telemedicine follow-up clinics, remote management using mobile phone camera monitoring and other methods identified to reach consensus on interventions to address the most pressing clinical challenges. These workshops will be facilitated by all the researchers and will involve service users, family members, clinicians, hospital managers, community health providers, NGO representatives and national policy makers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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
否

入选标准

  • •Age 18 years or above Diagnosis of spinal cord injury or acquired brain injury and received inpatient care in SIRC Discharged from SIRC between February 2018 and August 2019.

排除标准

  • •Individuals who do not report any ongoing rehabilitation needs

研究组 & 干预措施

Telerehabilitation intervention

Experimental

干预措施: Telerehabilitation (Other)

结局指标

主要结局

Modified Barthel Index

时间窗: 6 months

Modified Barthel Index

次要结局

  • Depression Anxiety Stress Scale(6 months)
  • EuroQoL(6 months)

研究者

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

Dr Manoj Sivan

Dr

University of Leeds

研究点 (1)

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