TEleRehabilitation Nepal (TERN) to Improve Quality of Life of People With Spinal Cord Injury and Acquired Brain Injury (TERN)
Primary Purpose
Spinal Cord Injuries; Traumatic Brain Injury; Acquired Brain Injury, Stroke
Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries; Traumatic Brain Injury; Acquired Brain Injury, Stroke
Eligibility Criteria
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
Sites / Locations
- Spinal Injury Rehabilitation Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telerehabilitation intervention
Arm Description
Outcomes
Primary Outcome Measures
Modified Barthel Index
Modified Barthel Index
Secondary Outcome Measures
Depression Anxiety Stress Scale
Depression Anxiety Stress Scale
EuroQoL
EuroQoL
Full Information
NCT ID
NCT04914650
First Posted
June 3, 2021
Last Updated
November 4, 2021
Sponsor
University of Leeds
Collaborators
Spinal Injury Rehabilitation Center
1. Study Identification
Unique Protocol Identification Number
NCT04914650
Brief Title
TEleRehabilitation Nepal (TERN) to Improve Quality of Life of People With Spinal Cord Injury and Acquired Brain Injury
Acronym
TERN
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
Collaborators
Spinal Injury Rehabilitation Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
estimate the rehabilitation needs in individuals after stroke, brain injury and spinal cord injury in rural communities after discharge from SIRC
hold user and stakeholder workshops to explore the role of multidisciplinary teleconferencing methods for remote assessment and management and agree systems for piloting
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries; Traumatic Brain Injury; Acquired Brain Injury, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
Providing multidisciplinary rehabilitation to individuals with spinal cord injury or brain injury using virtual conference methods
Primary Outcome Measure Information:
Title
Modified Barthel Index
Description
Modified Barthel Index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depression Anxiety Stress Scale
Description
Depression Anxiety Stress Scale
Time Frame
6 months
Title
EuroQoL
Description
EuroQoL
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Sivan, MD
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spinal Injury Rehabilitation Centre
City
Bhainsepati
State/Province
Kavre
Country
Nepal
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36278119
Citation
Dhakal R, Baniya M, Solomon RM, Rana C, Ghimire P, Hariharan R, Makower SG, Meng W, Halpin S, Xie SQ, O'Connor RJ, Allsop MJ, Sivan M. TEleRehabilitation Nepal (TERN) for People With Spinal Cord Injury and Acquired Brain Injury: A Feasibility Study. Rehabil Process Outcome. 2022 Oct 18;11:11795727221126070. doi: 10.1177/11795727221126070. eCollection 2022.
Results Reference
derived
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TEleRehabilitation Nepal (TERN) to Improve Quality of Life of People With Spinal Cord Injury and Acquired Brain Injury
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