Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-29 @ 1:25 PM
Study NCT ID:
NCT06913933
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Static vs. Dynamic Progressive Splinting for Persistent Wrist Stiffness After DRF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013165', 'term': 'Splints'}], 'ancestors': [{'id': 'D016267', 'term': 'External Fixators'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into two parallel arms. One arm will receive a static progressive splint, and the other a dynamic splint, each used in addition to a weekly supervised therapy session. The splints are used to address persistent ROM limitations after conventional therapy has plateaued.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wrist Active and Passive Range of Motion (AROM/PROM)', 'timeFrame': 'Assessed at baseline, 6 weeks (post-intervention), and 3 months follow-up.', 'description': 'Measured using a standard goniometer, improvements in wrist flexion and extension (in degrees) are the primary indicators of treatment efficacy.'}], 'secondaryOutcomes': [{'measure': 'Patient-Rated Wrist Evaluation (PRWE)', 'timeFrame': 'Assessed at baseline and at 6 weeks post-intervention.', 'description': 'The PRWE questionnaire assesses wrist pain and disability, with lower scores indicating better functional status.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Collected at 6 weeks and 3 months post-intervention.', 'description': "A standardized satisfaction survey measuring patients' perceived improvement and overall satisfaction with the orthotic intervention."}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'Continuously monitored from baseline to the 3-month follow-up.', 'description': 'Incidence and severity of adverse events such as skin breakdown, discomfort, or pain (≥4/10) associated with splint usage.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distal Radius Fractures']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will compare the effectiveness of static progressive splinting versus dynamic splinting for treating persistent wrist stiffness in adults ≥18 years old at least 8 weeks post distal radius fracture (DRF) injury. Both splinting modalities are provided as an adjunct to one weekly supervised therapy session over a 6-week period. The primary outcomes are wrist active and passive range of motion (AROM/PROM) measured using goniometry, with secondary outcomes including patient-reported wrist function (PRWE), overall satisfaction, and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18 years or older. At least 8 weeks post distal radius fracture (operative or nonoperative) who have completed standard rehabilitation.\n\nDemonstrated persistent wrist stiffness with ≤50% of contralateral wrist extension or flexion.\n\nCapable of providing written informed consent and complying with study procedures\n\nExclusion Criteria:\n\nPresence of complex regional pain syndrome (CRPS) or active fracture healing issues.\n\nHistory of significant wrist pathology unrelated to the DRF. Uncontrolled medical conditions that would interfere with splint application or therapy.\n\nKnown skin conditions or allergies that preclude orthosis use. Inability or unwillingness to adhere to the intervention protocol or follow-up schedule.\n\nPregnant or breastfeeding individuals.'}, 'identificationModule': {'nctId': 'NCT06913933', 'briefTitle': 'Static vs. Dynamic Progressive Splinting for Persistent Wrist Stiffness After DRF', 'organization': {'class': 'OTHER', 'fullName': 'Al Hayah University In Cairo'}, 'officialTitle': 'A Two-Arm, Parallel-Group Randomized Controlled Trial Comparing Static Progressive Splinting Versus Dynamic Splinting for Improving Wrist PROM/AROM in Patients With Persistent Post-DRF Stiffness', 'orgStudyIdInfo': {'id': 'SPDS2025-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Static Progressive Splinting Group (SPSG)', 'description': "Participants in this group receive static progressive splinting using a commercial splint that allows incremental adjustment through a turnbuckle design. This splint is used to gradually increase wrist extension and/or flexion, tailored to the patient's stiffness pattern, alongside a once-weekly supervised therapy session.", 'interventionNames': ['Behavioral: Static Progressive Splinting for Persistent Wrist Stiffness']}, {'type': 'EXPERIMENTAL', 'label': 'Dynamic Splinting Group (DSG)', 'description': 'Participants in this group receive dynamic splinting using a commercial device equipped with elastic tension (spring-loaded) that provides a constant dynamic stretch to the wrist. This intervention is delivered alongside a weekly supervised therapy session.', 'interventionNames': ['Behavioral: Dynamic Splinting for Persistent Wrist Stiffness']}], 'interventions': [{'name': 'Static Progressive Splinting for Persistent Wrist Stiffness', 'type': 'BEHAVIORAL', 'description': 'A commercially available static progressive splint with a turnbuckle mechanism allowing fine-tuned adjustments in wrist flexion and extension.\n\nInstructional materials for home use including written guidelines and an adjustment log.', 'armGroupLabels': ['Static Progressive Splinting Group (SPSG)']}, {'name': 'Dynamic Splinting for Persistent Wrist Stiffness', 'type': 'BEHAVIORAL', 'description': 'Materials:\n\nA commercially available dynamic (spring-loaded) splint designed for the wrist. An instructional manual and daily usage log for participants.', 'armGroupLabels': ['Dynamic Splinting Group (DSG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed ElMeligie, Ph.D', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@ahuc.edu.eg', 'phone': '01159880001', 'phoneExt': '+20'}], 'facility': 'Faculty of Physical Therapy, Al Hayah University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al Hayah University In Cairo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}