Health TrialsbyHealthPanel

Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses

ConditionOrthotic Devices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorMagdalena Kolasińska

About this trial

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

This trial accepts healthy volunteers

Qualifiers

diagnosed with RA

diagnosed thumb deformity: butonier finger, type I or II

female

age 18 - 65 years

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thermoplastic orthosis

    Device

    The use of the author's orthosis is aimed at correcting the anatomical alignment of the MP (metacarpophalangeal) joints, IP (interphalangeal) by properly tensioning the central extensor band and the lateral bands of the thumb's extensor apparatus. It should significantly increase the mobility of the hand in connection with improving hand grip and reducing pain.

Treatment groups

60 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Grip strengthOther 1 intervention
Group B: DASH QuestionnaireOther 1 intervention
Group C: Likert scaleOther 1 intervention
Group D: Kapandji scoreOther 1 intervention
Group E: NRS scaleOther 1 intervention
Group F: Pinch strengthOther 1 intervention

Trial outcomes

Primary outcomes

1

Grip strength

Measurement of grip strength and of the right and left hands with a dynamometer in an orthosis and without an orthosis.

Time frame
6 month
2

DASH -Disabilities of the Arm, Shoulder and Hand

The DASH questionnaire assesses upper limb disability and consists of 30 questions in the general section and an additional work module with 4 questions and a sport/instrument playing module with 4 questions. In the DASH a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on test ranges from 0 (no disability) to 100 (most severe disability)

Time frame
6 month
3

Likert scale

Measurement strategy, used surveys through which knowledge about the degree of acceptance of the product can be obtained. Participants provide data using a four-point strongly disagree, disagree, agree, strongly agree

Time frame
6 month
4

Kapandji score

Is a tool useful for assessing the opposition of the thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.

Time frame
6 month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Magdalena Kolasińska

Lead sponsor

Józef Piłsudski University of Physical Education

Sponsor institution

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Collaborator

Source ClinicalTrials.gov
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