Viewing Study NCT06267469



Ignite Creation Date: 2024-05-06 @ 8:07 PM
Last Modification Date: 2024-10-26 @ 3:21 PM
Study NCT ID: NCT06267469
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-02-20
First Post: 2024-02-03

Brief Title: Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
Sponsor: Magdalena Kolasińska
Organization: Józef Piłsudski University of Physical Education

Study Overview

Official Title: Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this study is to present the authors 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None