Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 10:43 AM
Study NCT ID:
NCT06267469
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2024-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2024-02-03', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grip strength', 'timeFrame': '6 month', 'description': 'Measurement of grip strength and of the right and left hands with a dynamometer in an orthosis and without an orthosis.'}, {'measure': 'DASH -Disabilities of the Arm, Shoulder and Hand', 'timeFrame': '6 month', 'description': 'The DASH questionnaire assesses upper limb disability and consists of 30 questions in the general section and an additional work module with 4 questions and a sport/instrument playing module with 4 questions. In the DASH a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on test ranges from 0 (no disability) to 100 (most severe disability)'}, {'measure': 'Likert scale', 'timeFrame': '6 month', 'description': 'Measurement strategy, used surveys through which knowledge about the degree of acceptance of the product can be obtained. Participants provide data using a four-point strongly disagree, disagree, agree, strongly agree'}, {'measure': 'Kapandji score', 'timeFrame': '6 month', 'description': 'Is a tool useful for assessing the opposition of the thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.'}, {'measure': 'NRS - Numerical Rating Scale', 'timeFrame': '6 month', 'description': 'Requires the patient to rate their pain on a defined scale. Ranges from 0 to 10. zero being an example of someone with no pain and ten being the worst pain possible.'}, {'measure': 'pinch strength', 'timeFrame': '6 month', 'description': 'pincer grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Boutonniere deformity', 'thermoplastic orthosis'], 'conditions': ['Orthotic Devices']}, 'descriptionModule': {'briefSummary': "The goal of this study is to present the author's thumb orthosis with a butonier deformity and its effect on hand function, strength, dexterity and pain levels in relation to patients wearing factory-made orthopedic supplies. It is planned to include about 60 people in the study (30 people each in the group with thermoplastic orthoses and 30 participants with factory-made orthoses)\n\nThe main questions it aims to answer are:\n\n1\\. How much improvement in dexterity will the patient wearing the orthosis get? 2. By how much will the grip strength of the whole hand and pincer grip strength improve with the orthosis? 3. How will wearing the orthosis affect the pain associated with the disease? Participants will\n\n1. measurement of grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the appointed times.\n2. measurement of pincer grip strength with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the designated times.\n\n4\\. completion of the DASH questionnaire 6. assessment of the NRS pain scale in relation to the period of 6 months before the start of the study 7. Likert scale - evaluation of satisfaction with the use of the orthosis 8. the Kapandji scale Researchers will compare patients with thermoplastic orthosis and patients with fabric orthosis to see which is more functional."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosed with RA\n* diagnosed thumb deformity: butonier finger, type I or II\n* female\n* age 18 - 65 years\n* patient's consent to the study\n\nExclusion Criteria:\n\n* other deformity of the thumb\n* less than 1 year since surgical intervention in the hand\n* less than 6 months since delivery injections within the thumb\n* change in treatment during the study and 3 months before the study"}, 'identificationModule': {'nctId': 'NCT06267469', 'briefTitle': 'Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses', 'organization': {'class': 'OTHER', 'fullName': 'Józef Piłsudski University of Physical Education'}, 'officialTitle': 'Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses', 'orgStudyIdInfo': {'id': 'Boutonniere deformity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Grip strength', 'description': 'Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength', 'interventionNames': ['Device: Thermoplastic orthosis']}, {'type': 'OTHER', 'label': 'DASH Questionnaire', 'description': 'The DASH questionnaire assesses upper limb disability and consists of 30 questions in the general section and an additional work module with 4 questions and a sport/instrument playing module with 4 questions. Assess symptoms and the inability to perform certain activities based on health status.', 'interventionNames': ['Device: Thermoplastic orthosis']}, {'type': 'OTHER', 'label': 'Likert scale', 'description': 'Measurement strategy, used in surveys to gain knowledge about the degree of acceptance of the orthosis', 'interventionNames': ['Device: Thermoplastic orthosis']}, {'type': 'OTHER', 'label': 'Kapandji score', 'description': 'Is a tool useful for assessing the opposition of the thumb', 'interventionNames': ['Device: Thermoplastic orthosis']}, {'type': 'OTHER', 'label': 'NRS scale', 'description': 'Requires the patient to rate their pain on a defined scale', 'interventionNames': ['Device: Thermoplastic orthosis']}, {'type': 'OTHER', 'label': 'Pinch strength', 'description': 'Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength', 'interventionNames': ['Device: Thermoplastic orthosis']}], 'interventions': [{'name': 'Thermoplastic orthosis', 'type': 'DEVICE', 'description': "The use of the author's orthosis is aimed at correcting the anatomical alignment of the MP (metacarpophalangeal) joints, IP (interphalangeal) by properly tensioning the central extensor band and the lateral bands of the thumb's extensor apparatus. It should significantly increase the mobility of the hand in connection with improving hand grip and reducing pain.", 'armGroupLabels': ['DASH Questionnaire', 'Grip strength', 'Kapandji score', 'Likert scale', 'NRS scale', 'Pinch strength']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-494', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Magdalena Kolasińska, Msc', 'role': 'CONTACT', 'email': 'magdalena.kolasinska@awf.edu.pl', 'phone': '+48609219822'}], 'facility': 'Terapia Ręki Magda Kolasińska', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-637', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Magdalena Kolasińska, Msc', 'role': 'CONTACT', 'email': 'magdalena.kolasinska@awf.edu.pl', 'phone': '+48609219822'}, {'name': 'Teresa Sadura-Sieklucka, Phd', 'role': 'CONTACT', 'email': 'teresa.sadura@awf.edu.pl'}], 'facility': 'Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Magdalena Kolasińska, MSc', 'role': 'CONTACT', 'email': 'magdalena.kolasinska@awf.edu.pl', 'phone': '+48609219822'}, {'name': 'Teresa Sadura-Sieklucka, Phd', 'role': 'CONTACT', 'email': 'teresa.sadura@awf.edu.pl'}], 'overallOfficials': [{'name': 'Magdalena Kolasińska, Msc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Physical Education in Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Magdalena Kolasińska', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Magdalena Kolasińska', 'investigatorAffiliation': 'Józef Piłsudski University of Physical Education'}}}}