Diabetic Upper Extremity Pathophysiology, Limited Joint Mobility and Disability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Arm elevation.
研究概览
简要总结
The primary goal of this project is to determine how advanced glycation end-product (AGEs) accumulation and shoulder movement (humeral thoracic range of motion and "activity count") interact to contribute to shoulder limited joint mobility (LJM), pain and disability, and if an intervention consisting of a tailored dose of stretching and active shoulder movement can reduce these problems in people with diabetes mellitus (DM). The investigators will focus on the following measures that span health domains; Skin intrinsic fluorescence to measure AGEs; Ultrasound to measure supraspinatus tendon thickness; 3 dimensional joint range of motion and "activity counts" to measure shoulder movements; and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire to measure patient reported pain and disability. The investigators will test the innovative hypothesis that metabolic and movement factors interact to cause severe shoulder problems in people with DM and that an optimized shoulder movement intervention can have an important impact on reducing the development of limited joint mobility, pain and disability in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals with type 2 DM and duration of diagnosed diabetes more than 10 years OR type 2 DM and presence of a 'positive prayer sign' OR shoulder flexion < 150 degrees; disability of arm, shoulder and hand (DASH) scores in the range of <70%; between the age of 40-70 will be recruited.
排除标准
- •currently diagnosed adhesive capsulitis
- •diagnosed rotator cuff tear
- •recent (6 months) upper extremity injury and/or fractures
- •surgery in the upper extremity or thorax
- •cervical radiculopathy
- •thoracic outlet syndrome
- •stroke with residual upper extremity involvement
- •severe skin allergies in area to be tested
- •rheumatic conditions
- •known connective tissue diseases
- •carpal tunnel syndrome
- •use of a cane
- •individuals who engage in heavy upper extremity/ overhead use (ie, painters, tennis players) because they likely have a different mechanism of injury than those with low shoulder activity.
研究组 & 干预措施
ADA guideline Instructed
The control intervention will be instruction in basic wellness activities according to the American Diabetes Association guidelines
干预措施: ADA Guideline Instructed (Other)
Optimized Shoulder Movement Program
The experimental intervention is the Optimized Shoulder Movement Program. Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation, and active shoulder motion based on the participant's baseline "activity count" .
干预措施: Optimized Shoulder Movement Program (Other)
结局指标
主要结局
Arm elevation.
时间窗: One year
Arm elevation is a composite of shoulder (glenohumeral) and scapular motion and will be measured using goniometry and computer assisted kinematics. Glenohumeral elevation and external rotation motions are the main focus.
次要结局
- Disability of the Arm, Shoulder, and Hand (DASH) questionnaire(One year)