None listed
Conditions
Brief summary
This study is based on the assumption that the presence of foot ulcers in the clinical history of a diabetic subject is a sign of worsening neuropathy, because developing ulceration has been considered the probable result of progressive neurological, vascular and autonomic damage that denote the advancement of the disease over time. For this reason, the purpose of this study was to investigate and compare the influence of the progression of diabetic neuropathy and a previous history of foot ulcers on plantar pressure variables during gait. We hypothesized that, even with healed ulcers, diabetic neuropathy patients with history of ulceration would still show an altered distribution pattern of plantar pressure during gait when compared to patients who had not yet developed ulceration.
Interventions
The subjects involved on this research have their gait analyzed in a Laboratory of Biomechanics and they preform a natural gait wearing sensored insoles which register the plantar pressure distribution during walking in a 10mt flat walkway. The subjects will undergo 1 session in which they will walk the 10 metre walkway twice. There is not a repeated session. the data collection has last in average 30 minutes. During this time, the apparatus are calibrated, positioned on the subjects, there is
The subjects involved on this research have their gait analyzed in a Laboratory of Biomechanics and they preform a natural gait wearing sensored insoles which register the plantar pressure distribution during walking in a 10mt flat walkway. The subjects will undergo 1 session in which they will walk the 10 metre walkway twice. There is not a repeated session. the data collection has last in average 30 minutes. During this time, the apparatus are calibrated, positioned on the subjects, there is a time to allow each subject to get used to the equipement and also to the laboratory and finally, time to perform the trials. the subjects perform the gait wearing the Pedar insoles from the fabricant NOVEL (Germany). As there is no intervention, the subjects are called just once to participate of this study.
Sponsors
FAPESP - Fundacao de amparo a Pesquisa do Estado de Sao Paulo
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
39 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for both neuropathic groups were: Diabetes Type 1 or 2 with more than five years since onset, and a score higher than six on the Michigan Neuropathy Screening Instrument questionnaire (MNSI-q) for symptoms related to the diabetic neuropathy (Feldman et al., 1994). Additionally, subjects were required to have a minimum of two areas where they did not recognize or feel the touch of a 10-g monofilament during tactile perception testing (Frykberg et al., 1998). For inclusion in the neuropathic group with previous ulceration on the plantar surface, the patients were required to present a history of a foot ulceration within the last year that at the time of the evaluation was healed.
Exclusion criteria
Subjects were excluded if they were over 65 years of age; presented hallux amputation or partial amputation of the foot, except toes; major foot shape alterations by visual inspection, orthopedic disorders of the lower limbs; pain during the data acquisition; used any assistive devices for walking (walking sticks/canes); presented traumatic ulceration that could be immediately recognized by the subject; Charcot arthropathy had been confirmed by radiography, or had foot ulcers at the moment of the evaluation.
Outcome results
None listed