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

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

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

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Traumatic Brain Injury; Acquired Brain Injury, Stroke
• Intervention / Treatment: Other: Telerehabilitation

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Kavre
    • Bhainsepati, Kavre, Nepal
      • Spinal Injury Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Telerehabilitation intervention	Other: Telerehabilitation; Providing multidisciplinary rehabilitation to individuals with spinal cord injury or brain injury using virtual conference methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Barthel Index	Modified Barthel Index	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Anxiety Stress Scale	Depression Anxiety Stress Scale	6 months
EuroQoL	EuroQoL	6 months

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: Spinal Injury Rehabilitation Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): July 31, 2021

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (ACTUAL): June 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Spinal Cord Injuries
• Other Study ID Numbers: MREC 19-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No