Criticality Analysis of Diabetic Gait Within the PAIDOS Pediatric Clinic for Obese Children (PAIDOS: Pediatric Attention Integral and Dynamic for Obese Children Program)- A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Gait
研究概览
简要总结
One of the difficulties with diabetes care is the problem of predicting progression to more severe stages using current measures (for example blood glucose, HbA1c). This feasibility study aims to use Criticality Analysis (CA) of gait to monitor the progression of the condition as well as identifying individuals at risk of developing diabetes among children in Mexico.The study will investigate whether gait analysis can be used as a fast, reliable and cost effective way to detect individuals at risk of developing Type 2 Diabetes (T2DM) as early treatment could reduce the number of cases that develop into full T2DM.
详细描述
This feasibility study aims to the do the following:
- To evaluate the use of Criticality Analysis of Gait as means of Diabetes assessment.
- To design and set up a clinical feasibility study in a hospital (Hospital Infantil de Mexico) with adolescent patients on different clinical stages of type 2 Diabetes mellitus (DM).
- To analyse the collected data and validate Gait data analysis as mechanism for identifying and monitoring pre-diabetic teenagers.
- To use the feasibility study conducted in Mexico to develop a robust method using Gait analysis for diabetes prevention and management.
Participants will be selected from the Primary Care Pediatric Clinic for Obese Children (PAIDOS) in the Hospital Infantil de México Federico Gómez, Mexico City, Mexico. Sixty participants will be selected and divided into three groups: 40 obese non-diabetic subjects, 10 with Type 2 Diabetes and 10 healthy subjects as controls. Obese participants within the Paidos clinic will undergo standard clinical care that includes dietary prescription of caloric intake according to height, 150 min weekly physical activity, group cognitive-behavioural intervention, 6 session of obesity awareness and educational program.
Gait will be recorded in all groups using a sensor on the 4th vertebrae of the lumbar spine, once a week across 6 weeks during the routine PAIDOS clinic. Critical changes in walking control, stride frequency and length will be observed as individuals change speed; effectively stressing their mobility. The study will be repeated after 3-6 months as a follow up.
Data analysis will be performed in a semi-blind manner in order to test the efficacy of the criticality analysis Rate control of Chaos (RCC) model. In order to provide an objective measure of analysis, the anonymised data will be presented to the nonlinear RCC models, where results can be extracted and compared afterwards to known states.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI over 95 th percentile for age
- •Living in Major Mexico City area
排除标准
- •Diabetic patients
- •major physical disability
结局指标
主要结局
Gait
时间窗: 6 weeks, 3 and 6 month post-baseline follow-up
Critical changes in walking control, stride frequency and length observed as individuals change speed using a movement sensor (Inertial Measurement Units (IMU) on the 4th vertebrae of the lumbar spine). Recorded during a 10 metre walk and 6 minute walk test
次要结局
- O2 saturation (mmHg) using a pulse Oximeter(6 weeks, 3 and 6 month post-baseline follow-up)
- 6 Minute Walk test (6MWT)(6 weeks, 3 and 6 month post-baseline follow-up)
- Respiratory rate(6 weeks, 3 and 6 month post-baseline follow-up)
- Borg scale of perceived exertion(6 weeks, 3 and 6 month post-baseline follow-up)
- Fasting blood Glucose(6 weeks, 3 and 6 month post-baseline follow-up)
- Heart rate(6 weeks, 3 and 6 month post-baseline follow-up)
- Blood Pressure (mmHg) using a baumanometer(6 weeks, 3 and 6 month post-baseline follow-up)
- Insulin(6 weeks, 3 and 6 month post-baseline follow-up)
- Hemoglobin A1C(6 weeks, 3 and 6 month post-baseline follow-up)
- Total cholesterol(6 weeks, 3 and 6 month post-baseline follow-up)
- Level of High-density lipoprotein (HDL) in blood(6 weeks, 3 and 6 month post-baseline follow-up)
- Low-density lipoprotein (LDL)(6 weeks, 3 and 6 month post-baseline follow-up)
- Alanine aminotransferase (ALT)(6 weeks, 3 and 6 month post-baseline follow-up)
- Homeostatic model assessment (HOMA) Index(6 weeks, 3 and 6 month post-baseline follow-up)
- Weight(6 weeks, 3 and 6 month post-baseline follow-up)
- Leg Length(Baseline- Week 1)
- Shoe Size(Baseline- Week 1)
- Physical Activity- Accelerometer(6 weeks)
- Health Behaviour in School Aged Children (HSBC)- Eating Habits Questionnaire(6 weeks)
- Aspartate aminotransferase (AST)(6 weeks, 3 and 6 month post-baseline follow-up)
- Hip Circumference(6 weeks, 3 and 6 month post-baseline follow-up)
- Waist Circumference(6 weeks, 3 and 6 month post-baseline follow-up)
- Triglycerides(6 weeks, 3 and 6 month post-baseline follow-up)
- Body Mass Index (BMI)- Kg/m2(6 weeks, 3 and 6 month post-baseline follow-up)
- Height(Baseline- Week 1)
研究者
Dr Salvador Villalpando-Carrion
Head of Pediatric Gastroenterology and Nutrition
Hospital Infantil de Mexico Federico Gomez