Criticality Analysis of Diabetic Gait Within a Primary Care Pediatric Clinic for Obese Children (PAIDOS)

Dr Salvador Villalpando-Carrion

Status: Completed

Conditions: Childhood Obesity

Treatments: Diagnostic Test: Gait analysis

Study type: Observational

Funder types: Other

Identifiers

NCT03943108

HIM-060-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI over 95 th percentile for age
• Living in Major Mexico City area

Exclusion criteria

• Diabetic patients
• major physical disability

Trial design

48 participants in 3 patient groups

Obese teenagers within the PAIDOS clinic

Description:

Obese children within the PAIDOS clinic, Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico.

Treatment:

Diagnostic Test: Gait analysis

Healthy children

Description:

Healthy children living in Mexico City, Mexico.

Treatment:

Diagnostic Test: Gait analysis

Children with Type 2 Diabetes

Description:

Chjildren with Type 2 Diabetes attending the Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico.

Treatment:

Diagnostic Test: Gait analysis