RESUMEN
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-to-face, longer-term, and more intensive interventions may be needed to positively influence foot-ankle biomechanics and pressure parameters in other plantar areas.
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Diabetes Mellitus , Neuropatías Diabéticas , Humanos , Fenómenos Biomecánicos , Tobillo , Cinética , Terapia por Ejercicio , MarchaRESUMEN
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.Trial registration ClinicalTrials.gov NCT02790931 (06/06/2016).
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Diabetes Mellitus , Neuropatías Diabéticas , Humanos , Tobillo , Neuropatías Diabéticas/terapia , Terapia por Ejercicio , Marcha , Calidad de Vida , Método Simple Ciego , Velocidad al CaminarRESUMEN
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.
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Tobillo , Neuropatías Diabéticas , Terapia por Ejercicio , Pie , Anciano , Fenómenos Biomecánicos , Neuropatías Diabéticas/terapia , Estudios de Factibilidad , Femenino , Marcha , Humanos , Masculino , Persona de Mediana Edad , Calidad de VidaRESUMEN
BACKGROUND: The control of foot trajectory during swing phase is important to achieve safe clearance with the ground. Complexity of a physiological control system arises from the interaction of structural units and regulatory feedback loops that operate to enable the organism to adapt to a non-static environment. Diabetic polyneuropathy (DPN) impairs peripheral feedback inputs and alters ankle control during gait, which might affect toe clearance (ToC) parameters and its complexity, predisposing DPN-subjects to tripping and falling. RESEARCH QUESTION: How do different DPN-severity degrees change ToC trajectory and minimum ToC, and its complexity during gait of diabetic subjects? METHODS: 15 healthy controls and 69 diabetic subjects were assessed and classified into DPN-severity degrees by an expert fuzzy model: absent (nâ¯=â¯26), mild (nâ¯=â¯21) and severe (nâ¯=â¯22). Three-dimensional kinematics was measured during comfortable walking. ToC was the minimum vertical distance between the marker placed at the first metatarsal head and the ground during swing. Mean ToC, ToC standard deviation (SD) between trials, and sample entropy (SaEn) and standard deviation (SD) of ToC trajectory were calculated from the ToC temporal series. ANOVA and ANCOVA (with the walking speed as the covariate) and Bonferroni pairwise post-hoc tests (Pâ¯<â¯0.05) were used to compare groups. RESULTS: Mean ToC and ToC SD did not show differences between groups (ANCOVA Fâ¯=â¯0.436; dfâ¯=â¯3; Pâ¯=â¯0.705; F=1.719; df=3; P=0.170, respectively). ToC trajectory SD also did not show differences between groups (ANCOVA Fâ¯=â¯3.98; dfâ¯=â¯3; Pâ¯=â¯0.755). Severe-DPN subjects showed higher ToC_Traj_SaEn than controls (ANCOVA F=2.60; df=3; Pâ¯=â¯0.05). SIGNIFICANCE: Severe-DPN subjects showed a more complex pattern of overall foot-ankle trajectory in swing phase in comparison to controls, although did not present lower minimum ToC values. The higher complexity of ToC might lead to an increase in the motor system output (more strategies, increase in variability), resulting in a more unstable system and selected motor strategies.
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Diabetes Mellitus/fisiopatología , Neuropatías Diabéticas/fisiopatología , Pie/fisiología , Marcha/fisiología , Caminata/fisiología , Adulto , Anciano , Análisis de Varianza , Fenómenos Biomecánicos , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
BACKGROUND: Diabetic polyneuropathy (DPN) negatively affects foot and ankle function (strength and flexibility), which itself affects the daily physical activity and quality of life of patients. A physical therapy protocol aiming to strengthen the intrinsic and extrinsic foot muscles and increase flexibility may be a promising approach to improve lower-extremity function, prevent further complications, and improve autonomy for daily living activities in these patients. Thus, the inclusion of a specific foot-related exercises focused on the main musculoskeletal impairments may have additional effects to the conventional interventions in the diabetic foot. METHODS/DESIGN: A prospective, parallel-group, outcome-assessor blinded, randomized controlled trial (RCT) will be conducted in 77 patients with DPN who will be randomly allocated to usual care (control arm) or usual care with supervised foot-ankle exercises aiming to increase strengh and flexibility twice a week for 12 weeks and remotely supervised foot-ankle exercises for a year through a web software. Patients will be evaluated 5 times in a 1 year period regarding daily physical activity level, self-selected and fast gait speeds (primary outcomes), foot ulcer incidence, ulcer risk classification, neuropathy testing, passive ankle range of motion, quality of life, foot health and functionality, foot muscle strength, plantar pressure, and foot-ankle kinematics and kinetics during gait. DISCUSSION: This study aims to assess the effect of a foot-ankle strength and flexibility program on a wide range of musculoskeletal, activity-related, biomechanical, and clinical outcomes in DPN patients. We intend to demonstrate evidence that the year-long training program is effective in increasing gait speed and daily physical activity level and in improving quality of life; foot strength, functionality, and mobility; and biomechanics while walking. The results will be published as soon as they are available. TRIAL REGISTRATION: This study has been registered at ClinicalTrials.gov as NCT02790931 (June 6, 2016) under the name "Effects of foot muscle strengthening in daily activity in diabetic neuropathic patients".