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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-04', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Barthel Index', 'timeFrame': '6 months', 'description': 'Modified Barthel Index'}], 'secondaryOutcomes': [{'measure': 'Depression Anxiety Stress Scale', 'timeFrame': '6 months', 'description': 'Depression Anxiety Stress Scale'}, {'measure': 'EuroQoL', 'timeFrame': '6 months', 'description': 'EuroQoL'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries; Traumatic Brain Injury; Acquired Brain Injury, Stroke']}, 'referencesModule': {'references': [{'pmid': '36278119', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': '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:\n\n1. estimate the rehabilitation needs in individuals after stroke, brain injury and spinal cord injury in rural communities after discharge from SIRC\n2. hold user and stakeholder workshops to explore the role of multidisciplinary teleconferencing methods for remote assessment and management and agree systems for piloting\n3. deploy and pilot a novel telerehabilitation system to improve the lives of these individuals, and evaluate it in terms of feasibility and acceptability', 'detailedDescription': 'The methods to be used in each of the three work packages of this study are:\n\nWork Package 1: Identifying baseline and context\n\nIndividuals 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.\n\nWork Package 2: Assessing utility of telerehabilitation to address needs\n\nInformed 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.\n\nWork Package 3: Pilot and rapid evaluation\n\nThe 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.).\n\nThis is followed by a rapid, mixed-methods evaluation which will assess of the feasibility and acceptability of telerehabilitation interventions by incorporating:\n\n* analysis of routinely collected clinical caseload data\n* standardised quantitative outcome measures\n* semi-structured interviews with service user participants and focus group discussions with staff\n* case studies of exemplar cases including video recording'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 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.\n\nExclusion Criteria:\n\nIndividuals who do not report any ongoing rehabilitation needs'}, 'identificationModule': {'nctId': 'NCT04914650', 'acronym': 'TERN', 'briefTitle': 'TEleRehabilitation Nepal (TERN) to Improve Quality of Life of People With Spinal Cord Injury and Acquired Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'TEleRehabilitation Nepal (TERN) to Improve Quality of Life of People With Spinal Cord Injury and Acquired Brain Injury. A Proof-of-concept Study', 'orgStudyIdInfo': {'id': 'MREC 19-031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation intervention', 'interventionNames': ['Other: Telerehabilitation']}], 'interventions': [{'name': 'Telerehabilitation', 'type': 'OTHER', 'description': 'Providing multidisciplinary rehabilitation to individuals with spinal cord injury or brain injury using virtual conference methods', 'armGroupLabels': ['Telerehabilitation intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bhainsepati', 'state': 'Kavre', 'country': 'Nepal', 'facility': 'Spinal Injury Rehabilitation Centre', 'geoPoint': {'lat': 27.65424, 'lon': 85.30903}}], 'overallOfficials': [{'name': 'Manoj Sivan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leeds'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spinal Injury Rehabilitation Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr Manoj Sivan', 'investigatorAffiliation': 'University of Leeds'}}}}