Criticality Analysis of Diabetic Gait Within a Primary Care Pediatric Clinic for Obese Children (PAIDOS)
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      This feasibility study aims to the do the following:

        1. To evaluate the use of Criticality Analysis of Gait as means of Diabetes assessment.

        2. 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).

        3. To analyse the collected data and validate Gait data analysis as mechanism for
           identifying and monitoring pre-diabetic teenagers.

        4. 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.
    

Intervention name(s): Gait analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Gait recorded 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.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals attending the Primary Care Pediatric Clinic for Obese Children (PAIDOS) in the
        Hospital Infantil de Mexico Federico Gomez, living in the Major city area of Mexico City,
        Mexico.