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Influence of physical therapy intervention on foot and ankle biomechanics of gait in diabetic neuropatic individuals: a randomized controlled trial

Grant number: 11/19304-4
Support Opportunities:Scholarships in Brazil - Doctorate (Direct)
Effective date (Start): March 01, 2012
Effective date (End): May 31, 2013
Field of knowledge:Health Sciences - Physiotherapy and Occupational Therapy
Principal Investigator:Isabel de Camargo Neves Sacco
Grantee:Cristina Dallemole Sartor
Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil


Polineuropathy is a complication from Diabetes Mellitus that have been very challenging for clinicians. It brings high costs for public health and huge impact on patients'quality of life. Prevention actions are still the most important stages to avoid plantar ulceration and amputations that are the most devastating endpoint of the disease. There are some interventions that show an improvement in gait quality, confidence and quality of life, but there is not yet evidence of an effective therapeutic intervention for recovering musculoskeletal functions and foot rollover during gait that can potentially reduce ulcer incidence or its recurrence. We present an intervention protocol with simple tasks that allow the patient to practice the exercises at home, without the need for professional supervision, aiming at recovering the most impaired segments due to polineuropathy. If these exercises show any benefit, they could be indicated as a complementary treatment for the disease. Methods/Design: a randomized controlled trial, blind assessment, was designed to study the effect of a physiotherapy intervention on foot rollover during gait, range of motion, muscle strength and function of the foot and ankle, and balance confidence. The main outcome is plantar pressure during foot rollover and secondary outcomes are kinetic and kinematic parameters of gait, neuropathy signs and symptoms, foot and ankle range of motion and function, muscle strength and balance confidence. The intervention is carried out for 12 weeks, twice a week, for 40-60 minutes each session. The follow-up period is 24 weeks of baseline condition. We calculatied the effect size of 0,36 (moderate effect size) to detect differences on the primary outcome. A sample size of 46 subjects is needed to provide 81% power, assuming an alpha level of 0.05 and an statistical design of F test of repeated measures (between and within effects). The statistical analysis will be based on intention-to-treat analysis and general linear models of analysis of variance and repeated measure will be used to detect treatment-time interactions. This trial is currently recruiting patients since August 2011. Trial registration: identifier: NCT01207284. (AU)

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Scientific publications (9)
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
SACCO, ISABEL C. N.; SUDA, ENEIDA YURI; VIGNERON, VINCENT; SARTOR, CRISTINA DALLEMOLE. An `Importance' Map of Signs and Symptoms to Classify Diabetic Polyneuropathy: An Exploratory Data Analysis. PLoS One, v. 10, n. 6, . (13/06123-7, 11/19304-4)
BUTUGAN, MARCO K.; SARTOR, CRISTINA D.; WATARI, RICKY; MARTINS, MARIA CECILIA S.; ORTEGA, NELI R. S.; VIGNERON, VINCENT A. M.; SACCO, ISABEL C. N.. Multichannel EMG-based estimation of fiber conduction velocity during isometric contraction of patients with different stages of diabetic neuropathy. JOURNAL OF ELECTROMYOGRAPHY AND KINESIOLOGY, v. 24, n. 4, p. 465-472, . (11/15770-0, 11/19304-4)
SACCO, ISABEL C. N.; PICON, ANDREJA P.; MACEDO, DIEGO OLIVEIRA; BUTUGAN, MARCOS KENJI; WATARI, RICKY; SARTOR, CRISTINA D.. Alterations in the Lower Limb Joint Moments Precede the Peripheral Neuropathy Diagnosis in Diabetes Patients. DIABETES TECHNOLOGY & THERAPEUTICS, v. 17, n. 6, p. 405-412, . (11/15770-0, 11/19304-4, 10/07921-6)
SACCO, ISABEL C. N.; SARTOR, CRISTINA D.. From treatment to preventive actions: improving function in patients with diabetic polyneuropathy. DIABETES-METABOLISM RESEARCH AND REVIEWS, v. 32, n. 1, p. 206-212, . (13/05580-5, 11/19304-4)
SACCO, ISABEL C. N.; HAMAMOTO, ADRIANA N.; TONICELLI, LUCAS M. G.; WATARI, RICKY; ORTEGA, NELI R. S.; SARTOR, CRISTINA D.. Abnormalities of plantar pressure distribution in early, intermediate, and late stages of diabetic neuropathy. GAIT & POSTURE, v. 40, n. 4, p. 570-574, . (11/19304-4)
WATARI, RICKY; SARTOR, CRISTINA D.; PICON, ANDREJA P.; BUTUGAN, MARCO K.; AMORIM, CESAR F.; ORTEGA, NELI R. S.; SACCO, ISABEL C. N.. Effect of diabetic neuropathy severity classified by a fuzzy model in muscle dynamics during gait. JOURNAL OF NEUROENGINEERING AND REHABILITATION, v. 11, . (13/05580-5, 11/15770-0, 11/19304-4)
PICON, ANDREJA P.; SARTOR, CRISTINA D.; ROVERI, MARIA I.; PASSARO, ANICE C.; ORTEGA, NELI R.; SACCO, ISABEL C. N.. Diabetic patients with and without peripheral neuropathy reveal different hip and ankle biomechanical strategies during stair descent. BRAZILIAN JOURNAL OF PHYSICAL THERAPY, v. 16, n. 6, p. 528-534, . (11/19304-4)
SARTOR, CRISTINA DALLEMOLE; WATARI, RICKY; PASSARO, ANICE CAMPOS; PICON, ANDREJA PALEY; HASUE, RENATA HAYDEE; SACCO, ISABEL C. N.. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial. BMC MUSCULOSKELETAL DISORDERS, v. 13, . (11/19304-4)
GIACOMOZZI, CLAUDIA; SARTOR, CRISTINA D.; TELLES, RAFAEL; UCCIOLI, LUIGI; SACCO, ISABEL C. N.. Ulcer-risk classification and plantar pressure distribution in patients with diabetic polyneuropathy: exploring the factors that can lead to foot ulceration. ANNALI DELL ISTITUTO SUPERIORE DI SANITA, v. 54, n. 4, p. 284-293, . (14/09477-7, 11/19304-4)
Academic Publications
(References retrieved automatically from State of São Paulo Research Institutions)
SARTOR, Cristina Dallemole. Influence of a Physical Therapy intervention for foot and ankle on gait biomechanics of patients with diabetic polineuropathiy: a randomized controlled trial. 2013. Doctoral Thesis - Universidade de São Paulo (USP). Faculdade de Medicina (FM/SBD) São Paulo.

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