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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04914650
Recruitment Status : Completed
First Posted : June 4, 2021
Last Update Posted : November 8, 2021
Sponsor:
Collaborator:
Spinal Injury Rehabilitation Center
Information provided by (Responsible Party):
Dr Manoj Sivan, University of Leeds

Study Description
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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

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries; Traumatic Brain Injury; Acquired Brain Injury, Stroke Other: Telerehabilitation Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2019
Actual Primary Completion Date : June 1, 2021
Actual Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Telerehabilitation intervention Other: Telerehabilitation
Providing multidisciplinary rehabilitation to individuals with spinal cord injury or brain injury using virtual conference methods


Outcome Measures
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Primary Outcome Measures :
  1. Modified Barthel Index [ Time Frame: 6 months ]
    Modified Barthel Index


Secondary Outcome Measures :
  1. Depression Anxiety Stress Scale [ Time Frame: 6 months ]
    Depression Anxiety Stress Scale

  2. EuroQoL [ Time Frame: 6 months ]
    EuroQoL


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04914650


Locations
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Nepal
Spinal Injury Rehabilitation Centre
Bhainsepati, Kavre, Nepal
Sponsors and Collaborators
University of Leeds
Spinal Injury Rehabilitation Center
Investigators
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Principal Investigator: Manoj Sivan, MD University of Leeds
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Manoj Sivan, Dr, University of Leeds
ClinicalTrials.gov Identifier: NCT04914650    
Other Study ID Numbers: MREC 19-031
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Spinal Cord Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases