Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Grip strength
研究概览
简要总结
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
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •diagnosed with RA
- •diagnosed thumb deformity: butonier finger, type I or II
- •age 18 - 65 years
- •patient's consent to the study
排除标准
- •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
研究组 & 干预措施
Grip strength
Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength
干预措施: Thermoplastic orthosis (Device)
DASH Questionnaire
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. Assess symptoms and the inability to perform certain activities based on health status.
干预措施: Thermoplastic orthosis (Device)
Likert scale
Measurement strategy, used in surveys to gain knowledge about the degree of acceptance of the orthosis
干预措施: Thermoplastic orthosis (Device)
Kapandji score
Is a tool useful for assessing the opposition of the thumb
干预措施: Thermoplastic orthosis (Device)
NRS scale
Requires the patient to rate their pain on a defined scale
干预措施: Thermoplastic orthosis (Device)
Pinch strength
Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength
干预措施: Thermoplastic orthosis (Device)
结局指标
主要结局
Grip strength
时间窗: 6 month
Measurement of grip strength and of the right and left hands with a dynamometer in an orthosis and without an orthosis.
Likert scale
时间窗: 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
时间窗: 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
时间窗: 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.
DASH -Disabilities of the Arm, Shoulder and Hand
时间窗: 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)
pinch strength
时间窗: 6 month
pincer grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis.
次要结局
未报告次要终点
研究者
Magdalena Kolasińska
Principal Investigator
Józef Piłsudski University of Physical Education