JANE SUELEN SILVA PIRES FERREIRA
Projetos de Pesquisa
Unidades Organizacionais
LIM/54 - Laboratório de Bacteriologia, Hospital das Clínicas, Faculdade de Medicina
10 resultados
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- Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I(2020) FERREIRA, J. S. S. P.; CRUVINEL JUNIOR, R. H.; SILVA, E. Q.; VERISSIMO, J. L.; MONTEIRO, R. L.; PEREIRA, D. S.; SUDA, E. Y.; SARTOR, C. D.; SACCO, I. C. N.Background This study is part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for self-care to avoid more serious dysfunctions and complications, a self-manageable exercise protocol that focuses on strengthening the foot muscles is presented as a potentially effective preventive method for foot and gait complications. The aim of this trial is to investigate the effect of a customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD), on DPN status, functional outcomes and gait biomechanics in people with DPN. Methods/design Footcare (FOCA) trial I is a randomized, controlled and parallel two-arm trial with blind assessment. A total of 62 patients with DPN will be allocated into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD at home three times a week for 12 weeks). The exercise program will be customized throughout its course by a perceived effort scale reported by the participant after completion of each exercise. The participants will be assessed at three different times (baseline, completion at 12 weeks, and follow-up at 24 weeks) for all outcomes. The primary outcomes will be DPN symptoms and severity classification. The secondary outcomes will be foot-ankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance. Discussion As there is no evidence about the efficacy of rehabilitation technology in reducing DPN symptoms and severity or improving biomechanical, clinical, and functional outcomes for people with DPN, this research can contribute substantially to clarifying the therapeutic merits of software interventions. We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN. This rehabilitation technology is freely available, and we intend to introduce it into the public health system in Brazil after demonstrating its effectiveness.
- Foot function and strength of patients with diabetes grouped by ulcer risk classification (IWGDF)(2019) FERREIRA, Jane S. S. P.; PANIGHEL, Joao P.; SILVA, Erica Q.; MONTEIRO, Renan L.; CRUVINEL JUNIOR, Ronaldo H.; SACCO, Isabel C. N.Background: The stratification system from the International Working Group on the Diabetic Foot (IWGDF) was used to classify the participants as to the ulcer risk. However, it is not yet known what the classification groups' individual deficits are regarding sensitivity, function, and musculoskeletal properties and mechanics. This makes it difficult to design proper ulcer prevention strategies for patients. Thus, this study aimed to investigate the foot function, foot strength and health of people with diabetes mellitus (DM)-with or without DPN-while considering the different ulcer risk classifications determined by the IWGDF. Methods: The subject pool comprised 72 people with DM, with and without DPN. The patients were divided into three groups: Group 0 (G0), which comprised diabetic patients without DPN; Group 1 (G1), which comprised patients with DPN; and Group 2 (G2), which comprised patients with DPN who had foot deformities. The health and foot function of the subjects' feet were assessed using a foot health status questionnaire (FHSQ-BR) that investigated four domains: foot pain, foot function, footwear, and general foot health. The patients' foot strength was evaluated using the maximum force under each subject's hallux and toes on a pressure platform (emed q-100, Novel, Munich, Germany). Results: Moderate differences were found between G0 and G1 and G2 for the foot pain, foot function, general foot health, and footwear. There was also a small but significant difference between G0 and G2 in regards to hallux strength. Conclusion: Foot health, foot function and strength levels of people with DM and DPN classified by the ulcer risk are different and this must be taken into account when evaluating and developing treatment strategies for these patients.
- Effects of a Home-Based Foot-Ankle Exercise Program with Educational Booklet for Foot Dysfunctions in People with Diabetic Neuropathy: Results of the FOCA-II Randomized Controlled Clinical Trial(2023) SILVA, erica Q.; VERISSIMO, Jady L.; FERREIRA, Jane S. S. P.; CRUVINEL-JUNIOR, Ronaldo H.; MONTEIRO, Renan L.; SUDA, Eneida Y.; SACCO, Isabel C. N.Exercise rehabilitation and education are important strategies for preventing the progression of diabetic neuropathy-related musculoskeletal deficits. The purpose of this randomized controlled trial was to investigate the effect of an 8-week home-based foot-ankle exercise program using an educational booklet on clinical outcomes (foot muscle strength and functionality; functional balance; diabetic neuropathy symptoms and severity; tactile and vibratory sensitivities; plantar pressure distribution; and foot-ankle, knee, and hip biomechanics during gait). Fifty participants with neuropathy were randomly allocated into an intervention group (59.1 +/- 6.4 years, 23.5 +/- 4.8 kg/m(2), males = 6, females = 19) that performed the exercises for 8 weeks and a control group (56.5 +/- 9.4 years, 22.9 +/- 3.6 kg/m(2), males = 5, females = 20) that received usual care recommendations. Generalized estimating equation method and intention-to-treat approaches were adopted. No significant differences were found for any clinical outcome after 8 weeks. Heel contact area increased in the intervention group compared to controls (p = 0.043, mean difference = 2.7 cm) and heel peak pressure was increased in controls compared to intervention (group effect p = 0.020, mean difference = -64.16 kPa) at 8 weeks. Controls showed increased joint moments for the hip at heel strike (p = 0.007) and for the knee and hip at push off over 8 and 16 weeks (p < 0.001 and p = 0.009, respectively). Although the intervention is easy to perform and showed a good adherence (72%), home-based foot-ankle exercise programs are unlikely to sufficiently modify the main risk factors related to foot ulcers and to change foot-ankle kinematics and kinetics.
- Effects of foot-ankle exercises on foot-ankle kinematics, plantar pressure, and gait kinetics in people with diabetic neuropathy: Secondary outcomes from a randomized controlled trial(2023) MONTEIRO, Renan L.; FERREIRA, Jane S. S. P.; SILVA, Erica Q.; CRUVINEL, Ronaldo H.; VERISSIMO, Jady L.; BUS, Sicco A.; SACCO, Isabel C. N.Background: Follow-up report of secondary outcomes of a randomized, single-blinded, parallel controlled trial that investigated the benefits of a foot-ankle therapeutic exercise program on foot-ankle kinematics, plantar pressure, and lower limb kinetics during gait in individuals with diabetic neuropathy (DPN).Methods: Sixty-six participants with DPN were randomly allocated into a control group (CG; n = 31), which received usual care, and an intervention group (IG; n = 35), which received usual care plus a 12-week group-based foot-ankle exercise program. Outcomes were assessed at baseline and 12 weeks by an assessor blinded to group allocation.Results: The generalized linear mixed model and intention-to-treat analysis revealed a greater hip extensor moment at push-off and greater hallux contact area in the IG than CG after 12 weeks. A within-group analysis revealed a larger arch height during stance and higher peak pressure and pressure-time integral at the central forefoot region in the IG after 12 weeks compared to baseline. There were no other significant group difference or changes over time in foot-ankle kinematics or in any other joint moment related to overall lower limb biomechanics.Conclusion: The increases in hip moment at push-off and hallux surface contact area suggest an improvement in the propulsion phase with greater participation of the toes in foot rollover after 12 weeks of a group-based foot-ankle exercises program for people with DPN. Individual face-toface, longer-term, and more intensive interventions may be needed to positively influence foot ankle biomechanics and pressure parameters in other plantar areas.& COPY; 2023 Associacao Brasileira de Pesquisa e Pos-Graduacao em Fisioterapia.
- Foot-ankle functional outcomes of using the Diabetic Foot Guidance System (SOPeD) for people with diabetic neuropathy: a feasibility study for the single-blind randomized controlled FOotCAre (FOCA) trial I(2021) CRUVINEL JUNIOR, Ronaldo H.; FERREIRA, Jane S. S. P.; I, Raquel Beteli; SILVA, Erica Q.; VERISSIMO, Jady L.; MONTEIRO, Renan L.; SUDA, Eneida Y.; SACCO, Isabel C. N.Background: Diabetic neuropathy dramatically affects musculoskeletal structure and function of the lower limbs by impairing their muscle strength and mobility. Specific muscle strengthening through physiotherapy strategies appears to be promising; however, adherence to physiotherapy treatment is low in people with chronic diseases. Thus, an internet-based foot-ankle exercise program was created as a potential telerehabilitation alternative for people with diabetes to improve their self-monitoring and self-care management. This study assessed the feasibility, safety, acceptability, and changes in foot health and neuropathy symptoms in people with diabetes after 12 weeks of the intervention program with the Sistema de Orientacao ao Pe diabetico - Diabetic Foot Guidance System (SOPeD). Methods: Fourteen individuals were recruited and randomized to either the usual care (control group) or usual care plus an internet-based foot-ankle exercise program through SOPeD (intervention group) three times per week for 12 weeks. For feasibility, we assessed contact and recruitment rates per week; program adherence, determined as completing over 70% of the 36 sessions; and participant satisfaction and safety assessed through a questionnaire and scored on a 5-point Likert scale. We assessed changes in neuropathy symptoms and foot health and functionality from baseline to 12 weeks estimating differences or median of differences and 95% confidence intervals in the intervention group. Results: In 24 weeks, of the 822 patients in the database, 192 were contacted, 65 were assessed for eligibility, and 20 were considered eligible. The recruitment rate was 0.83 participants per week. Fourteen out of the 20 eligible participants agreed to participate, resulting in recruitment success of 70%. Adherence to the program was 66.7%, and there was no dropout. Participants' median level of satisfaction was 5.0 (IQR: 4.5-5.0) and perceived safety was 5.0 (IQR: 5.0-5.0). Conclusion: The internet-based foot-ankle exercise program using SOPeD is feasible, satisfactory, and safe. Although this study had moderate adherence and a zero-dropout rate, recruitment needs to be improved in the larger trial.
- Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial(2020) MONTEIRO, Renan L.; FERREIRA, Jane S. S. P.; SILVA, Erica Q.; DONINI, Asha; CRUVINEL-JUNIOR, Ronaldo H.; VERISSIMO, Jady L.; BUS, Sicco A.; SACCO, Isabel C. N.Foot-ankle strengthening and mobility exercises are part of international guideline recommendations for people at risk of diabetic foot disease. We examined the feasibility and preliminary efficacy of a 12-week foot-ankle exercise program on clinical, functional and biomechanical outcomes in people with diabetic neuropathy (DPN). We randomly allocated 30 people with DPN to usual care (control) or usual care plus a supervised exercise program (intervention). For feasibility, we assessed recruitment rate and participant adherence and satisfaction. For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests (p< 0.05). In 52 weeks, we recruited 45 eligible participants (0.90/week). Program adherence was 80% and participants' satisfaction had a mean (SD) of 4.57 (0.70) out of 5. The intervention group significantly improved on toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures increased over time; controls showed significantly increased heel peak pressures and force. The exercise program was feasible, based on a moderate recruitment rate and an adherent and satisfied population, and the intervention showed several positive preliminary effects over time compared to usual care.
- Could an Internet-Based Foot-Ankle Therapeutic Exercise Program Modify Clinical Outcomes and Gait Biomechanics in People with Diabetic Neuropathy? A Clinical Proof-of-Concept Study(2022) CRUVINEL-JUNIOR, Ronaldo H. H.; FERREIRA, Jane S. S. P.; VERISSIMO, Jady L.; MONTEIRO, Renan L. L.; SUDA, Eneida Y. Y.; SILVA, Erica Q.; SACCO, Isabel C. N.Previous studies have shown the efficacy of foot-ankle exercises in people with diabetic peripheral neuropathy (DPN), but the quality of evidence is still low. This proof-of-concept study pursues preliminary evidence for potential clinical and gait biomechanical benefits from an internet-based foot-ankle therapeutic exercise program for people with DPN. We randomized 30 individuals with DPN (IWGDF risk category 1 or 2) into either the control group (CG) receiving the usual care or the intervention group (IG) receiving the usual care plus an internet-based foot-ankle exercise program, fully guided by the Sistema de Orientacao ao Pe Diabetico (SOPeD; translation: Diabetic Foot Guidance System) three times per week for 12 weeks. We assessed face-to-face clinical and biomechanical outcomes at baseline, 12 weeks, and 24 weeks (follow up). Participants had good adherence to the proposed intervention and it led to only mild adverse events. The IG showed improvements in the ankle and first metatarsophalangeal joint motion after 12 and 24 weeks, changed forefoot load absorption during foot rollover during gait after 24 weeks, reduced foot pain after 12 weeks, and improved foot function after 24 weeks. A 12-week internet-based foot-ankle exercise program using the SOPeD software (version 1.0) has the potential to reduce foot pain, improve foot function, and modify some important foot-ankle kinematic outcomes in people with DPN.
- Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II(2021) SILVA, Erica Q.; SANTOS, Danilo P.; BETELI, Raquel I.; MONTEIRO, Renan L.; FERREIRA, Jane S. S. P.; CRUVINEL-JUNIOR, Ronaldo H.; DONINI, Asha; VERISSIMO, Jady L.; SUDA, Eneida Y.; SACCO, Isabel C. N.This study sought to assess the feasibility of design, adherence, satisfaction, safety and changes in outcomes followed by a home-based foot-ankle exercise guided by a booklet in individuals with diabetic peripheral neuropathy (DPN). 20 participants were allocated usual care [control group (CG)] or usual care plus home-based foot-ankle exercises [intervention group (IG)] for 8 weeks. For feasibility, we assessed contact, preliminary screening and recruitment rates, adherence, and using a 5-point Likert scale to satisfaction and safety of the booklet. In the IG, we assessed preliminary changes in DPN symptoms, DPN severity (classified by a fuzzy model) and foot-ankle range of motion between baseline and Week 8. In the first 20 weeks, 1310 individuals were screened for eligibility by phone contact. Contact rate was 89% (contacted participants/20w), preliminary screening success 28% (participants underwent screening/20w), and recruitment rate 1.0 participants/week (eligible participants/20w). The recruitment rate was less than the ideal rate of 5 participants/week. The adherence to the exercises programme was 77%, and the dropout was 11% and 9% for the IG and CG, respectively. In the IG, participants' median level of satisfaction was 4 (IQR: 4-5) and perceived safety was 3 (IQR: 3-5). IG significantly decreased the DPN severity (p=0.020), increased hallux relative to forefoot (first metatarsal) range of motion (ROM) (p<0.001) and decreased maximum forefoot relative to hindfoot (midfoot motion) dorsiflexion during gait (p=0.029). The home-based programme was feasible, satisfactory, safe and showed preliminary positive changes in DPN severity and foot motion during gait.Trial Registration ClinicalTrials.gov, NCT04008745. Registered 02/07/2019. https://clinicaltrials.gov/ct2/show/NCT04008745.
- Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: a randomized controlled trial(2022) MONTEIRO, Renan L.; FERREIRA, Jane S. S. P.; SILVA, Erica Q.; CRUVINEL-JUNIOR, Ronaldo H.; VERISSIMO, Jady L.; BUS, Sicco A.; SACCO, Isabel C. N.This study sought to determine whether a foot-ankle therapeutic exercise program can improve daily physical activity (i.e. number of steps) and fast and self-selected gait speed in people with diabetic peripheral neuropathy (DPN). In this single-blind randomized controlled trial and intention-to-treat analysis, 78 volunteers with DPN were allocated into a control group, which received usual care, and an intervention group (IG), which received usual care plus a 12-week foot-ankle exercise program. The adherence at 12 weeks rate in the IG was 92.3% (36 participants) and the dropout was 5.1% in the control group (2 participants). The number of steps and self-selected gait speed did not change significantly in either group (p > 0.05), although a 1,365-step difference between groups were observed at 1-year followup. The 12-week foot-ankle therapeutic exercises improved significantly fast-gait speed (primary outcome) (p = 0.020), ankle range of motion (p = 0.048), and vibration perception (secondary outcomes) (p = 0.030), compared with usual-care at 12 weeks. At 24 weeks, the IG showed better quality of life than controls (p = 0.048). At 1-year, fast-gait speed and vibration perception remained higher in the IG versus controls. Overall, the program may be a complementary treatment strategy for improving musculoskeletal and functional deficits related to DPN.
- 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(2020) SILVA, E. Q.; SUDA, E. Y.; SANTOS, D. P.; VERISSIMO, J. L.; FERREIRA, J. S. S. P.; CRUVINEL JUNIOR, R. H.; MONTEIRO, R. L.; SARTOR, C. D.; SACCO, I. C. N.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.