Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
Healthy Volunteers
NCT06267469

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

Age: 18Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here