protocolSection identificationModule nctId: NCT06267469, orgStudyIdInfo id: Boutonniere deformity, briefTitle: Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Magdalena Kolasińska, class: OTHER, collaborators name: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland, 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)The main questions it aims to answer are:1. 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 will1. 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.2. 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.4. 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., conditionsModule conditions: Orthotic Devices, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Thermoplastic orthosis, outcomesModule primaryOutcomes measure: Grip strength, primaryOutcomes measure: DASH -Disabilities of the Arm, Shoulder and Hand, primaryOutcomes measure: Likert scale, primaryOutcomes measure: Kapandji score, primaryOutcomes measure: NRS - Numerical Rating Scale, primaryOutcomes measure: pinch strength, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, city: Warsaw, state: Mazowieckie, zip: 02-637, country: Poland, contacts name: Magdalena Kolasińska, Msc, role: CONTACT, phone: +48609219822, email: magdalena.kolasinska@awf.edu.pl, contacts name: Teresa Sadura-Sieklucka, Phd, role: CONTACT, email: teresa.sadura@awf.edu.pl, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Terapia Ręki Magda Kolasińska, city: Warszawa, state: Mazowieckie, zip: 01-494, country: Poland, contacts name: Magdalena Kolasińska, Msc, role: CONTACT, phone: +48609219822, email: magdalena.kolasinska@awf.edu.pl, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False