Actively Recruiting
Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
Led by Magdalena Kolasińska · Updated on 2025-09-03
60
Participants Needed
2
Research Sites
116 weeks
Total Duration
On this page
Sponsors
M
Magdalena Kolasińska
Lead Sponsor
N
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with rheumatoid arthritis
- Diagnosed thumb deformity: boutonniere finger, type I or II
- Female
- Age between 18 and 65 years
- Patient's consent to participate in the study
You will not qualify if you...
- Other deformity of the thumb
- Less than 1 year since surgical intervention in the hand
- Less than 6 months since injections within the thumb
- Change in treatment during the study or within 3 months before the study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Terapia Ręki Magda Kolasińska
Warsaw, Masovian Voivodeship, Poland, 01-494
Actively Recruiting
2
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, Masovian Voivodeship, Poland, 02-637
Actively Recruiting
Research Team
M
Magdalena Kolasińska, MSc
CONTACT
T
Teresa Sadura-Sieklucka, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
6
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