Validation of Manual Muscle Testing and the Myositis Activity Profile Assessments in Patients With Inflammatory Myositis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Manual Muscle Testing 8 (MMT8)
研究概览
简要总结
The aim of the study is to evaluate the psychometric properties (content and construct validity, reliability, measurements error, as well as possible floor and ceiling effects) of both the assessments MMT8 and the myositis activity profile in patients with IM.
详细描述
This study evaluates the validity and reliability of two health related instruments that assess disease relevant functions and disabilities in patients with IM: the manual muscle testing 8 (MMT8) and the myositis activity profile (MAP). This study is needed to determine the psychometric properties of these two assessments. Provided that both the MMT8 and the MAP show good psychometric properties, these assessments could be used in the rehabilitation process and intervention programs of patients with IM to determine progress in muscle strength and activity in daily life.
Methodology: Reliability (Test re-test study and validity (cross sectional study) of a short form of MMT 8 and a questionnaire to assess difficulties in activities of daily life (MAP) in myositis patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of polymyositis or dermatomyositis or inflammatory myositis associated disorders (e.g. Scleroderma, Systematic lupus erythematosus, Sjögren's syndrome)
- •Age over 18
- •Sufficiently understanding of German language
- •able to understand and follow verbal and written instructions
- •signed informed consent to participate in the study
排除标准
- •Diagnosis of inclusion body myositis
- •Pulmonary hypertension
- •Osteoporosis
- •Severe cardiovascular and/or pulmonary disease
- •Pain syndrome
- •Inclusion Criteria aged and gender matched healthy controls (Systematic lupus erythematosus, Sjögren's syndrome)
- •Age over 18
- •Sufficiently understanding of German language
- •able to understand and follow verbal and written instructions
- •signed informed consent to participate in the study
结局指标
主要结局
Manual Muscle Testing 8 (MMT8)
时间窗: 15 minutes
The strength of 8 Muscle groups is tested in a defined position and rewarded with a score varying from 0 (No visible movement) to 10 (holds test position against strong pressure) and summed for a potential score from 0-80.
次要结局
- Functional Index 2(30 minutes)
- Functional Test Battery (FTB): Test 1 Self-Performed Physical Performance Test.(Total FTB: 1 1/4 hours)
- Functional Test Battery (FTB): Balance Test(Total FTB: 1 1/4 hours)
- Quantitative Muscle Testing(15 Minutes)
- Functional Test Battery ( FTB): Walk test ( 4 m)(Total FTB: 1 1/4 hours)
- Functional Test Battery ( FTB): 6 Minute walk-test(Total FTB: 1 1/4 hours)
- Modified Myositis Activity Profile(30 Minutes)
- Functional Test Battery ( FTB): 1 leg stand(Total FTB: 1 1/4 hours)
- Functional Test Battery ( FTB): Grip ability Test(Total FTB: 1 1/4 hours)
- Functional Test Battery ( FTB): Jamar grip test(Total FTB: 1 1/4 hours)
- Functional Test Battery ( FTB): Pile Test(Total FTB: 1 1/4 hours)