NCT06267469 Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
| NCT ID | NCT06267469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Magdalena Kolasińska |
| Condition | Orthotic Devices |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-06 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-07-06 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 will 1. 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.
Eligibility Criteria
Inclusion Criteria: * diagnosed with RA * diagnosed thumb deformity: butonier finger, type I or II * female * age 18 - 65 years * patient's consent to the study Exclusion Criteria: * other deformity of the thumb * less than 1 year since surgical intervention in the hand * less than 6 months since delivery injections within the thumb * change in treatment during the study and 3 months before the study
Contact & Investigator
Magdalena Kolasińska, Msc
STUDY DIRECTOR
University of Physical Education in Warsaw
Frequently Asked Questions
Who can join the NCT06267469 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Orthotic Devices. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06267469 currently recruiting?
Yes, NCT06267469 is actively recruiting participants. Contact the research team at magdalena.kolasinska@awf.edu.pl for enrollment information.
Where is the NCT06267469 trial being conducted?
This trial is being conducted at Warsaw, Poland, Warsaw, Poland.
Who is sponsoring the NCT06267469 clinical trial?
NCT06267469 is sponsored by Magdalena Kolasińska. The principal investigator is Magdalena Kolasińska, Msc at University of Physical Education in Warsaw. The trial plans to enroll 60 participants.