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Completed

NCT Number: NCT04914650

TEleRehabilitation Nepal (TERN) to Improve Quality of Life of People With Spinal Cord Injury and Acquired Brain Injury

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

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Key information

About this study

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.

Work Package 3: Pilot and rapid evaluation

The telerehabilitation interventions agreed in work package 2 will then be piloted by the clinical team at SIRC and the participants recruited in work package 1. This will involve post discharge follow up facilitated by the telerehabilitation system, and may result in further clinical rehabilitation care as appropriate (advice, provision of equipment, etc.).

This is followed by a rapid, mixed-methods evaluation which will assess of the feasibility and acceptability of telerehabilitation interventions by incorporating:

  • analysis of routinely collected clinical caseload data
  • standardised quantitative outcome measures
  • semi-structured interviews with service user participants and focus group discussions with staff
  • case studies of exemplar cases including video recording

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Individuals who do not report any ongoing rehabilitation needs

Treatment and study plan

telerehabilitation

Other

Providing multidisciplinary rehabilitation to individuals with spinal cord injury or brain injury using virtual conference methods

Primary outcomes

  1. Modified Barthel Index

    Time frame: 6 months

    Modified Barthel Index

Secondary outcomes

  1. Depression Anxiety Stress Scale

    Time frame: 6 months

    Depression Anxiety Stress Scale

  2. EuroQoL

    Time frame: 6 months

    EuroQoL

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • Spinal Injury Rehabilitation Center

Registry information

Official study title

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

Acronym: TERN

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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