Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2026-01-02 @ 7:04 AM
Study NCT ID:
NCT04914650
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2021-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TEleRehabilitation Nepal (TERN) to Improve Quality of Life of People With Spinal Cord Injury and Acquired Brain Injury
Sponsor:
University of Leeds
Organization:
Study Overview
Official Title:
TEleRehabilitation Nepal (TERN) to Improve Quality of Life of People With Spinal Cord Injury and Acquired Brain Injury. A Proof-of-concept Study
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TERN
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: