Orthotic Devices
Conditions
Keywords
Boutonniere deformity, thermoplastic orthosis
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.
Interventions
DEVICEThermoplastic orthosis
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.
Sponsors
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Magdalena Kolasińska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grip strength | 6 month | Measurement of grip strength and of the right and left hands with a dynamometer in an orthosis and without an orthosis. |
| DASH -Disabilities of the Arm, Shoulder and Hand | 6 month | 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) |
| Likert scale | 6 month | 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 |
| Kapandji score | 6 month | 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. |
| NRS - Numerical Rating Scale | 6 month | Requires the patient to rate their pain on a defined scale. Ranges from 0 to 10. zero being an example of someone with no pain and ten being the worst pain possible. |
| pinch strength | 6 month | pincer grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis. |
Countries
Poland
Contacts
Primary ContactMagdalena Kolasińska, MSc
Backup ContactTeresa Sadura-Sieklucka, Phd
Outcome results
None listed