Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-02-23 @ 10:54 PM
Study NCT ID:
NCT06905418
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Design and Validation of a Mobile Health Application for Home-Based Musculoskeletal Therapy in Ankle Sprain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foot and Ankle Ability Measure (FAAM)', 'timeFrame': '12 Months', 'description': 'FAAM. Each item of the FAAM is scored on a 5-point Likert scale with 4 points representing no difficulty at all; 3 points, slight difficulty; 2 points, moderate difficulty; 1 point, extreme difficulty; and 0 points, unable to do'}, {'measure': 'Numeric pain rating scale (NPRS)', 'timeFrame': '12 months', 'description': 'The Numeric Pain Rating Scale (NPRS) is perhaps the most frequently applied scale used to quantify pain intensity in the clinical setting. It is an 11-point numeric scale, ranging from 0 indicating no pain to 10 indicating worst pain imaginable'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Sprains']}, 'descriptionModule': {'briefSummary': '"Ankle sprain is a common musculoskeletal injury that can pointedly influence the quality of life of an indivual. Old rehabilitation approaches often require recurrent clinic visits, which can be time-consuming, costly, and unreachable to many. This study aims to design and validate a mobile health application for home-based musculoskeletal therapy in ankle sprain.', 'detailedDescription': 'The study will employ a randomized controlled trial design, involving patients with ankle sprains, healthcare professionals, and healthy volunteers. The mobile health application will be designed to provide personalized exercises, education, and monitoring to improve rehabilitation outcomes. The study will evaluate the effects of the mobile health application (m Health) in reducing pain, improving functional ability, and ornamental quality of life. The study will also assess the usability and acceptability of the application among patients and healthcare professionals.\n\nOutcome measurement tools will contain the Foot and Ankle Ability Measure (FAAM), Numeric Pain Rating Scale (NPRS) and System Usability Scale (SUS) The study will contribute to the development of an innovative, home-based rehabilitation solution for individuals with ankle sprains, improving accessibility and adherence to rehabilitation programs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, 18-65 years, both gender(male and female) will be included.\n* Include participants clinically diagnosed with a lateral ankle sprain confirmed by a healthcare professional, with a clear timeframe such as within the last 4-6 weeks.\n* Grade I and II sprains (mild to moderate) will be included using NPRS tool range from 0 to 6.\n* Participants must own and be able to use a smartphone or tablet that is compatible with the mobile health application.\n* Specify that participants must be able to read and understand the application interface language.\n* Ensure participants can safely perform the exercises prescribed in the app without additional risk of injury\n\nExclusion Criteria:\n\n* Concurrent fractures of the leg or foot.\n* Previous surgery in the affected ankle or surgery resulting from the current ankle sprain.\n* Serious systemic illnesses (e.g. rheumatoid arthritis, or fibromyalgia).\n* Neurological impairments or other conditions that may affect rehabilitation outcomes'}, 'identificationModule': {'nctId': 'NCT06905418', 'briefTitle': 'Design and Validation of a Mobile Health Application for Home-Based Musculoskeletal Therapy in Ankle Sprain', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Design and Validation of a Mobile Health Application for Home-Based Musculoskeletal Therapy in Ankle Sprain', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall23/782'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinic', 'interventionNames': ['Diagnostic Test: Clinic']}, {'type': 'EXPERIMENTAL', 'label': 'Mobile App', 'interventionNames': ['Combination Product: Mobile App']}], 'interventions': [{'name': 'Clinic', 'type': 'DIAGNOSTIC_TEST', 'description': 'group A will get treatment in clinic', 'armGroupLabels': ['Clinic']}, {'name': 'Mobile App', 'type': 'COMBINATION_PRODUCT', 'description': 'group B will use mobile application for treatment', 'armGroupLabels': ['Mobile App']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Superior University', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}