Study of gait and balance of subjects suffering from diabetic foot complications.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-9fwv27
• Date of registration: 04/01/2012
• Primary sponsor: Faculdade de Ciência e Tecnologia - Universidade Estadual Paulista - Brazil
• Public title: Study of gait and balance of subjects suffering from diabetic foot complications.
• Scientific title: Gait parameters, plantar pressures and body balance of diabetics with neuropathy and vasculopathy that use insoles
• Date of first enrolment: 10/11/2011
• Target sample size: 40
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-9fwv27/
• Study design: Clinical trial,factorial, controlled non-random, open.

Countries of recruitment

Brazil

Contacts

• Name: Alessandra Mantovani
• Affiliation: Faculdade de Ciência e Tecnologia - Universidade Estadual Paulista

• Name: Cristina Elena Fregonesi
• Affiliation: Faculdade de Ciência e Tecnologia - Universidade Estadual Paulista

Key inclusion & exclusion 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: 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.

Age minimum: 55Y
Age maximum: 70Y
Gender: -

Health Condition(s) or Problem(s) studied

Subjects suffering from diabetic neuropathic and vascular complications in the feet.
C10.668.829.300

Intervention(s)

Initially all methodological procedures will be performed for two groups: control (CG) and diabetic (GD), followed by periodic reassessments of the GD, ending with a comparison of data.
Stage I - At this stage all subjects in both groups (GC and GD) will be submitted to the methodological procedures of the study (detection of vasculopathy and neuropathy, plantar pressure analysis of static and dynamic equilibrium analysis).
Stage II - The GD participants will receive customized insoles and will be reviewed at regular intervals: a) one minute after placing the insole b) two days after use; c) fifteen days after use; d) thirty days of use, and Finally, e) forty-five days of use. So, you can show, within forty-five days, how long it takes to act effectively insole (if effective) and prolonged use causes hipercorreções or, ultimately, see if this time the gains and losses arising from the use insole follow, or not, temporal rules.
The frequency of use of the insole will be at least five days a week and eight hours a day, comfortable shoes pre-assessed by the researcher. The subject will receive control chips to record the use of insoles.

Primary Outcome(s)

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).

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%.

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.

Secondary Outcome(s)

Still, we seek to propose an effective tool in the prevention of ulcers and amputation in the diabetic population.

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.

Secondary ID(s)

10/2011

Source(s) of Monetary Support

Faculdade de Ciência e Tecnologia - Universidade Estadual Paulista - Brazil

Secondary Sponsor(s)

Faculdade de Ciência e Tecnologia - Universidade Estadual Paulista - Brazil