Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial
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Citações na Scopus
9
Tipo de produção
article
Data de publicação
2020
Título da Revista
ISSN da Revista
Título do Volume
Editora
BMC
Autores
SANTOS, D. P.
MONTEIRO, R. L.
SARTOR, C. D.
Citação
TRIALS, v.21, n.1, article ID 180, 13p, 2020
Resumo
Background This study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals' foot health and quality of life. Based on the current trends of self-monitoring and self-care, providing a tool with foot-related exercises and educational care may help patients to avoid or reduce the musculoskeletal complications resulting from DPN, improving autonomous performance in daily living tasks. The aim of this trial is to evaluate the effects of an educational booklet for foot care and foot muscle strengthening on DPN symptoms and severity, clinical outcomes, and gait biomechanics in patients with DPN. Methods/design The FOotCAre (FOCA) trial II study has been designed as a single-blind, two-parallel-arm randomized controlled trial. It will include 48 patients with DPN who will be randomly allocated to a control (recommended foot care by international consensus with no foot exercises) group or an intervention (foot-related exercises using an educational booklet three times/week at home for 8 weeks) group. Participants from both groups will be assessed at baseline, after 8 weeks, and at 16 weeks for follow-up. The primary outcomes are the DPN symptoms and severity, and the secondary outcomes are foot-ankle kinematics, gait kinetics, plantar pressure distribution during gait, tactile and vibratory sensitivities, foot strength, functional balance, and foot health and functionality. Discussion The booklet is a management tool that allows users to be autonomous in their treatment by choosing how and where to perform the exercises. This allows the patients to perform the exercises regularly as a continuous habit for foot care and health, which is an important element in the management of the diabetic foot. As the booklet focuses on specific foot-ankle exercises, we expect that it will improve the clinical aspects of DPN and produce beneficial biomechanical changes during gait, becoming a powerful self-management tool that can be easily implemented to improve the performance of daily living tasks.
Palavras-chave
Diabetic neuropathies, Exercise, Preventive care, Diabetic foot, Foot ulcer, Clinical trial, Physical therapy
Referências
- Akashi PMH, 2008, CLIN BIOMECH, V23, P584, DOI 10.1016/j.clinbiomech.2007.11.015
- Allen MD, 2015, CLIN NEUROPHYSIOL, V126, P794, DOI 10.1016/j.clinph.2014.07.018
- Allen MD, 2014, CLIN NEUROPHYSIOL, V125, P836, DOI 10.1016/j.clinph.2013.09.037
- Allen MD, 2013, MUSCLE NERVE, V48, P298, DOI 10.1002/mus.23792
- Allet L, 2010, GAIT POSTURE, V32, P185, DOI 10.1016/j.gaitpost.2010.04.013
- Allet L, 2010, DIABETOLOGIA, V53, P458, DOI 10.1007/s00125-009-1592-4
- Altman DG, 1999, BRIT MED J, V319, P703, DOI 10.1136/bmj.319.7211.703
- Bakker K, 2012, DIABETES-METAB RES, V28, P225, DOI 10.1002/dmrr.2253
- BARTLETT EE, 1985, PATIENT EDUC COUNS, V7, P323, DOI 10.1016/0738-3991(85)90041-2
- Botega NJ, 1995, REV SAUDE PUBL, V29, P355, DOI 10.1590/S0034-89101995000500004
- Boulton AJM, 2004, DIABETOLOGIA, V47, P1343, DOI 10.1007/s00125-004-1463-y
- Bruun C, 2013, DIABETIC MED, V30, P964, DOI 10.1111/dme.12196
- Bus SA, 2016, DIABETES-METAB RES, V32, P16, DOI 10.1002/dmrr.2696
- Bus SA, 2002, DIABETES CARE, V25, P1444, DOI 10.2337/diacare.25.8.1444
- Cerrahoglu L, 2016, J AM PODIAT MED ASSN, V106, P189, DOI 10.7547/14-095
- Chan AW, 2015, REV PANAM SALUD PUBL, V38, P506
- Chang CF, 2015, WORLDV EVID-BASED NU, V12, P145, DOI 10.1111/wvn.12091
- Chatterjee S, 2018, LANCET DIABETES ENDO, V6, P130, DOI 10.1016/S2213-8587(17)30239-5
- Cheuy VA, 2013, CLIN BIOMECH, V28, P1055, DOI 10.1016/j.clinbiomech.2013.10.006
- Crawford F, 2007, QJM-INT J MED, V100, P65
- Dijs HM, 2000, J AM PODIAT MED ASSN, V90, P126, DOI 10.7547/87507315-90-3-126
- DUNCAN PW, 1990, J GERONTOL, V45, pM192, DOI 10.1093/geronj/45.6.M192
- Faul F, 2007, BEHAV RES METHODS, V39, P175, DOI 10.3758/BF03193146
- Fayed EE, 2016, INT J PHARMTECH RES, V9, P151
- Ferreira AFB, 2008, CLINICS, V63, P595, DOI 10.1590/S1807-59322008000500005
- Francia Piergiorgio, 2015, Italian Journal of Anatomy and Embryology, V120, P21, DOI 10.13128/IJAE-16470
- Giacomozzi C, 2000, MED BIOL ENG COMPUT, V38, P156, DOI 10.1007/BF02344770
- Goldsmith JR, 2002, J AM PODIAT MED ASSN, V92, P483, DOI 10.7547/87507315-92-9-483
- Gomes AA, 2011, MUSCLE NERVE, V44, P258, DOI 10.1002/mus.22051
- Guney A, 2015, EXP CLIN ENDOCR DIAB, V123, P428, DOI 10.1055/s-0035-1549889
- Halawa MR, 2018, DIABETES METAB SYND, V12, P99, DOI 10.1016/j.dsx.2017.09.010
- Haukoos JS, 2007, ACAD EMERG MED, V14, P662, DOI 10.1197/j.aem.2006.11.037
- IJzerman TH, 2012, DIABETES RES CLIN PR, V95, P345, DOI 10.1016/j.diabres.2011.10.026
- International Diabetes Federation, 2017, IDF DIABETES ATLAS
- Iunes DH, 2014, PLOS ONE, V9, DOI 10.1371/journal.pone.0114151
- Kanchanasamut W, 2017, DIABET FOOT ANKLE, V8, DOI 10.1080/2000625X.2017.1287239
- KITCHING JB, 1990, J ROY SOC MED, V83, P298
- Kruse RL, 2010, PHYS THER, V90, P1568, DOI 10.2522/ptj.20090362
- Leenders M, 2013, J AM MED DIR ASSOC, V14, P585, DOI 10.1016/j.jamda.2013.02.006
- Liang R, 2012, CAN J DIABETES, V36, P15, DOI 10.1016/j.jcjd.2011.08.002
- Lincoln NB, 2008, DIABETOLOGIA, V51, P1954, DOI 10.1007/s00125-008-1110-0
- Martinelli Alessandra Rezende, 2013, Foot (Edinb), V23, P17, DOI 10.1016/j.foot.2012.11.001
- Melai T, 2013, J FOOT ANKLE RES, V6, DOI 10.1186/1757-1146-6-41
- Mickle KJ, 2009, CLIN BIOMECH, V24, P787, DOI 10.1016/j.clinbiomech.2009.08.011
- Moher D, 2001, LANCET, V357, P1191, DOI 10.1016/S0140-6736(00)04337-3
- Mueller MJ, 2013, ARCH PHYS MED REHAB, V94, P829, DOI 10.1016/j.apmr.2012.12.015
- Mueller MJ, 2003, J BIOMECH, V36, P1009, DOI 10.1016/S0021-9290(03)00078-2
- MUELLER MJ, 1994, ARCH PHYS MED REHAB, V75, P1196, DOI 10.1016/0003-9993(94)90004-3
- Onodera AN, 2011, MUSCLE NERVE, V44, P269, DOI 10.1002/mus.22072
- Pataky Z, 2010, DIABETIC MED, V27, P61, DOI 10.1111/j.1464-5491.2009.02875.x
- Perkins BA, 2001, DIABETES CARE, V24, P250, DOI 10.2337/diacare.24.2.250
- Pham H, 2000, DIABETES CARE, V23, P606, DOI 10.2337/diacare.23.5.606
- Picon AP, 2012, CLINICS, V67, P151, DOI 10.6061/clinics/2012(02)10
- Randelli P, 2008, ARTHROSCOPY, V24, P834, DOI 10.1016/j.arthro.2008.01.011
- Rodriguez DD, 2013, DIABETES-METAB RES, V29, P139, DOI 10.1002/dmrr.2366
- Sacco ICN, 2015, DIABETES TECHNOL THE, V17, P405, DOI 10.1089/dia.2014.0284
- Sartor CD, 2018, BRAZ J PHYS THER, V22, P222, DOI 10.1016/j.bjpt.2017.10.004
- Sartor CD, 2014, BMC MUSCULOSKEL DIS, V15, DOI 10.1186/1471-2474-15-137
- Sartor CD, 2012, BMC MUSCULOSKEL DIS, V13, DOI 10.1186/1471-2474-13-36
- Sawacha Zimi, 2010, J Diabetes Sci Technol, V4, P1127
- Shaffer S, 2005, J GERIATR PHYS THER, V28, P112, DOI 10.1519/00139143-200512000-00019
- Shun CT, 2004, BRAIN, V127, P1593, DOI 10.1093/brain/awh180
- Stebbins J, 2006, GAIT POSTURE, V23, P401, DOI 10.1016/j.gaitpost.2005.03.002
- Watari R, 2014, J NEUROENG REHABIL, V11, DOI 10.1186/1743-0003-11-11
- Williams DSB, 2007, J APPL BIOMECH, V23, P251, DOI 10.1123/jab.23.4.251
- York RM, 2009, PM&R, V1, P434, DOI 10.1016/j.pmrj.2009.03.001
- Zhang XG, 2014, ARCH PHYS MED REHAB, V95, P832, DOI 10.1016/j.apmr.2014.01.003