Prevalence of Foot and Musculoskeletal Complications and Effect of Structured Foot Health Program on Foot Biomechanics and Quality of Life in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 2)WHOQOL-BREFF
研究概览
简要总结
This study is a Randomized, participant blinded,parallel group trial comparing the effect of structured foot health program on foot biomechanics and Quality of Life in Type 2 Diabetes Mellitus. This study consists control group and study group with 70 subjects in each group where control group will recieve physician prescribed management and study group will recieve physician prescribed management and structured foot health program .The outcome measures will be Foot Biomechanics using static and dynamic plantar pressure analysis, quality of life using WHOQOL-BREFF questionnaire, plantar intrinsic foot muscle thickness and plantar tissue thickness using musculoskeletal ultrasound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed Type 2 diabetic patients With duration of 1 year and above Age between 30 to 65 years.
排除标准
- •Cerebero Vascular Accident (CVA) Ischemic heart diseases Cardiac arrhythmias Previous history of lower extremity fractures Arthritic conditions Congenital and acquired foot deformities.
结局指标
主要结局
2)WHOQOL-BREFF
时间窗: 70 Subjects in each group
1)Foot bio-mechanics - static and dynamic gait parameters.
时间窗: 70 Subjects in each group
次要结局
- 1.Plantar skin thickness, fascia thickness and intrinsic muscle thickness using musculoskeletal Ultrasound(70 subjects in each group)