Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-02 @ 3:47 AM
Study NCT ID:
NCT05625451
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2022-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Doses of Total End Range Time Offer Better Results Than Low Doses Treating Proximal Interphalangeal Joint Stiffness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-27', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-11-20', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the proximal interphalangeal joint extension', 'timeFrame': '7 days', 'description': 'difference in passive finger extension between the first day and the seventh day'}, {'measure': 'Change in the proximal interphalangeal joint extension', 'timeFrame': '21 days', 'description': 'difference in passive finger extension between the first day and the twenty first day'}, {'measure': '- Modified Weeks Test', 'timeFrame': 'fifteen minutes', 'description': 'Difference in finger extension at the beginning of te session and after a 15 min passive assisted extension exercise with a force of 500g'}, {'measure': '- Contraction Test', 'timeFrame': '21 days', 'description': 'Finger reaction at release of the orthosis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proximal Interphalangeal Finger Joint Contractures']}, 'descriptionModule': {'briefSummary': 'Elastic Tension Digital Neoprene Orthosis is a new device that can increase the dose of treatment of the proximal interphalangeal flexion contractures. This treatment improved the results in extension and also reducing the time to obtain it.', 'detailedDescription': 'Question: In fingers with proximal interphalangeal joint flexion contractures, do significant differences exist between the passive range of motion improvement achieved in joints that receive higher doses of daily total end range time compared to those that receive lower doses of daily total end range time?\n\nDesign: Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat\n\nParticipants: Fifty-seven fingers in fifty patients suffering a proximal interphalangeal joint flexion contracture\n\nIntervention: The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate extension. Researchers applied two different daily total end range time doses. Group A patients used the orthosis with a dose of twenty to twenty-two hours of daily total end range time while group B patients used the elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours. The exercise program was the same for both groups.\n\nOutcome measures: The researchers performed the goniometric measurements manually twice at the beginning of every session during the three-week period. The first measurement was at the patient arrival after a preconditioning and the second was after twenty minutes. This measurement at the first session was included as a Modified weeks test while at the second, third and forth session was recorded as a contraction test. Patient report of orthosis wear time and'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* Patients with flexion contractures of the proximal interphalangeal joint after trauma or post-surgical complications.\n* Patients with long standing flexion contractures\n* Patients with contractures greater than 45º.\n\nExclusion Criteria:\n\n* Patients with acute tendon injuries or fractures\n* Patients with inflammatory conditions,\n* Patients with proximal interphalangeal joint replacements,\n* Patients with Dupuytren conservative treatments\n* Patients lacking active proximal interphalangeal joint extension'}, 'identificationModule': {'nctId': 'NCT05625451', 'briefTitle': 'High Doses of Total End Range Time Offer Better Results Than Low Doses Treating Proximal Interphalangeal Joint Stiffness', 'organization': {'class': 'OTHER', 'fullName': 'Hand Therapy Barcelona'}, 'officialTitle': 'A Comparison Between Two Intervals of Daily Total End Range Time for Treatment of Proximal Interphalangeal Joint Flexion Contracture Using an Elastic Tension Digital Neoprene Orthosis', 'orgStudyIdInfo': {'id': '002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20-22 hours of daily total end range time intervention', 'description': 'used the elastic tension digital neoprene orthosis from twenty to twenty-two hours', 'interventionNames': ['Device: Elastic Tension Digital Neoprene Orthosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '11-13 hours daily total end range time intervention', 'description': 'used the elastic tension digital neoprene orthosis from eleven to thirteen hours', 'interventionNames': ['Device: Elastic Tension Digital Neoprene Orthosis']}], 'interventions': [{'name': 'Elastic Tension Digital Neoprene Orthosis', 'type': 'DEVICE', 'description': 'The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate two different daily total end range time doses. Group A patients used a dose of twenty to twenty-two hours of daily total end range time while group B patients used the extension elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours for a mean of twenty hours a day. The exercise program was the same for both groups.', 'armGroupLabels': ['11-13 hours daily total end range time intervention', '20-22 hours of daily total end range time intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08010', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hand Therapy Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vicenç Punsola Izard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physical Therapist, Certified Hand Therapist in Hand Therapy Barcelona, MSc Gimbernat Universiy , Assistant lecturer at Gimbernat University, PhD Candidate at University of Barcelona', 'investigatorFullName': 'Vicenç Punsola Izard', 'investigatorAffiliation': 'Hand Therapy Barcelona'}}}}