Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-07 @ 2:30 AM
Study NCT ID:
NCT07115693
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synchronous Tele-Resistance Training to Improve Upper Extremity Function in Patients With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in upper extremity muscle strength measured by hand-held dynamometer', 'timeFrame': 'Baseline and after 6 weeks of intervention', 'description': 'Muscle strength of the shoulder flexors, extensors, abductors, and wrist flexors and extensors will be measured bilaterally using a hand-held dynamometer. The outcome is reported in Newtons (N).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'This study investigated the effects of resistive exercises applied with synchronized telerehabilitation on upper extremity functions in patients with SCI who use wheelchairs. A randomized controlled trial included 21 patients with SCI between the ages of between18 and 60. Participants were divided into two groups: the Study Group (n=11) and the Control Group (n=10). Participants in the study group applied resistive exercise with a synchronized telerehabilitation method, while participants in the control group applied a home exercise program. The upper extremity muscle strength of the participants was evaluated with hand-held dynamometer before and after the treatment, physical performance with a 20-meter push test, and physical activity level with Physical Activity Scale for Disabled Individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 60 years\n* Diagnosed with spinal cord injury classified as ASIA A, B, or C\n* Cooperative and able to follow verbal instructions\n* Has access to online communication devices\n* Partially or fully dependent on a wheelchair\n* Sufficient upper extremity strength to operate a wheelchair\n* Has not undergone surgery in the past 6 months\n* Willing to participate and provided informed consent\n\nExclusion Criteria:\n\n* Unwilling or unmotivated to participate\n* Presence of a progressive disease\n* Fully bedridden\n* Significant cognitive impairment'}, 'identificationModule': {'nctId': 'NCT07115693', 'acronym': 'TELERES-SCI', 'briefTitle': 'Synchronous Tele-Resistance Training to Improve Upper Extremity Function in Patients With Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'Comparison of Upper Extremity Resistance Exercises as Synchronous Tele and Home Programs in Paraplegic Patients: a Randomized, Controlled, Double-blind Study', 'orgStudyIdInfo': {'id': 'IST-FTR-TELERES-SCI-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Synchronous Telerehabilitation with Resistance Exercises', 'description': 'Participants received live, video-based supervised resistance training 3x/week for 6 weeks.', 'interventionNames': ['Behavioral: Telerehabilitation-Based Resistance Exercise Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home-Based Exercise Program', 'description': 'Participants followed an unsupervised exercise program at home for 6 weeks.', 'interventionNames': ['Behavioral: Home Exercise Program']}], 'interventions': [{'name': 'Telerehabilitation-Based Resistance Exercise Program', 'type': 'BEHAVIORAL', 'description': 'Participants received synchronous telerehabilitation sessions three times per week for six weeks. Each session lasted 45 minutes and included supervised resistance exercises for upper extremity muscle groups. Exercise bands were chosen based on baseline strength. Pulse oximeters were used to monitor heart rate and oxygen saturation.', 'armGroupLabels': ['Synchronous Telerehabilitation with Resistance Exercises']}, {'name': 'Home Exercise Program', 'type': 'BEHAVIORAL', 'description': 'Participants were given a home-based, unsupervised exercise program to follow three times per week for six weeks. The exercises were taught at the beginning, and adherence was monitored using a physical activity diary. No tele-supervision was provided.', 'armGroupLabels': ['Home-Based Exercise Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21070', 'city': 'Diyarbakır', 'state': 'Kayapınar', 'country': 'Turkey (Türkiye)', 'facility': 'Turkish Spinal Cord Paralytics Association at Hüsnü Ayık Special Care Center', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacer Önen Tekin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'investigator', 'investigatorFullName': 'Hacer Önen Tekin', 'investigatorAffiliation': 'Istinye University'}}}}