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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

5mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach

1 country

2 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.2 years study duration

Study Progress82%

Jul 2024Sep 2026

First Submitted

Initial submission to the registry

February 3, 2024

Completed

17 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed

5 months until next milestone

Study Start

First participant enrolled

July 6, 2024

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

February 3, 2024

Last Update Submit

August 26, 2025

Conditions

Orthotic Devices

Keywords

Boutonniere deformitythermoplastic orthosis

Outcome Measures

Primary Outcomes (6)

Grip strength
Measurement of grip strength and of the right and left hands with a dynamometer in an orthosis and without an orthosis.
6 month
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)
6 month
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
6 month
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.
6 month
NRS - Numerical Rating Scale
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.
6 month
pinch strength
pincer grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis.
6 month

Study Arms (6)

Grip strength

OTHER

Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength