Study in healthy subjects
Conditions
Interventions
The saccharin test is performed by measuring the time elapsed between placement of a particle of sodium saccharin into one of the nostrils and the perception of its taste. 18 patients did the test in
other
E02.779
Sponsors
Faculdade de Medicina de Ribeirão Preto
Faculdade de Ciência e Tecnologia - Universidade Estadual Paulista
Eligibility
Age
55 Years to 70 Years
Inclusion criteria
Inclusion criteria: In the diabetic group, will need medical confirmation of diabetes mellitus, changes in the circulation and peripheral perfusion, detected respectively by the ankle/ brachial index and pulse oximetry, and diabetic neuropathy confirmed by insensitivity to the Semmes-Weinstein monofilament 10g and the scale for the diagnosis of diabetic distal polyneuropathy. For the control group, it is mandatory sensitivity to monofilament 2g, confirming the normality of somatosensory sensitivity of the feet.
Exclusion criteria
Exclusion criteria: Will be excluded from the study who were diagnosed with other neurological disease or neuropathic; to have visual impairment or vestibular important and uncorrected, inability to understand for testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the phase of data management will be comparing the results obtained in all evaluations of Phase II with data from the Phase I of GD (to test whether the subjects showed improvement on its initial situation) and GC (to observe if, by the use of insoles, reached values ??closer to those obtained in the GC).;We hope to find more abnormal gait, body balance and plantar pressure points on the feet of the individual components of the DG compared to CG. ;The statistical analysis consists of, initially to check the distribution as to normality by the Shapiro-Wilk. Comparisons between different time points (before use of sock = T1, one minute after placing the insole (T2), two days after its use = T3; after fifteen days of use = T4; thirty days of use = T5, and Finally, forty-five days of use = T6) will be done using analysis of variance for repeated measures, supplemented by post-hoc Tukey. In this study, analysis of covariance (ANCOVA) will also be used for the same comparisons, but using the body mass, height, gender, speed, leg length and duration of disease as covariates. All tests will be performed using the SPSS 17.0 software and the level of significance is 5%. | — |
Secondary
| Measure | Time frame |
|---|---|
| We believe that with the use of insoles, better distribution of plantar pressure, decrease in body movements and better performance on spatial-temporal parameters of gait. ;Still, we seek to propose an effective tool in the prevention of ulcers and amputation in the diabetic population. | — |
Countries
Brazil
Contacts
Public ContactAlessandra Mantovani
Faculdade de Ciência e Tecnologia - Universidade Estadual Paulista
Outcome results
None listed