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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.

ABSTRACT: Polyneuropathy is a complication of diabetes mellitus that has been very challenging for clinicians. It results in high public health costs and has a huge impact on patients' quality of life. Preventive interventions are still the most important approach to avoid plantar ulceration and amputation, which is the most devastating endpoint of the disease. Some therapeutic interventions improve gait quality, confidence, and quality of life; however, there is no evidence yet of an effective physical therapy treatment for recovering musculoskeletal function and foot rollover during gait that could potentially redistribute plantar pressure and reduce the risk of ulcer formation.A randomised, controlled trial, with 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 the 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 min each session. The follow-up period is 24 weeks from the baseline condition.Herein, we present a more comprehensive and specific physiotherapy approach for foot and ankle function, by choosing simple tasks, focusing on recovering range of motion, strength, and functionality of the joints most impaired by diabetic polyneuropathy. In addition, this intervention aims to transfer these peripheral gains to the functional and more complex task of foot rollover during gait, in order to reduce risk of ulceration. If it shows any benefit, this protocol can be used in clinical practice and can be indicated as complementary treatment for this disease.ClinicalTrials.gov Identifier: NCT01207284.

SUBMITTER: Sartor CD

PROVIDER: S-EPMC3395854 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature

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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.

Sartor Cristina Dallemole CD Watari Ricky R Pássaro Anice Campos AC Picon Andreja Paley AP Hasue Renata Haydée RH Sacco Isabel C N IC

BMC musculoskeletal disorders 20120319

<h4>Background</h4>Polyneuropathy is a complication of diabetes mellitus that has been very challenging for clinicians. It results in high public health costs and has a huge impact on patients' quality of life. Preventive interventions are still the most important approach to avoid plantar ulceration and amputation, which is the most devastating endpoint of the disease. Some therapeutic interventions improve gait quality, confidence, and quality of life; however, there is no evidence yet of an e ...[more]

PMID: 22429765

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Project description:BackgroundFoot musculoskeletal deficits are seldom addressed by preventive medicine despite their high prevalence in patients with diabetic polyneuropathy.AimTo investigate the effects of strengthening, stretching, and functional training on foot rollover process during gait.MethodsA two-arm parallel-group randomized controlled trial with a blinded assessor was designed. Fifty-five patients diagnosed with diabetic polyneuropathy, 45 to 65 years-old were recruited. Exercises for foot-ankle and gait training were administered twice a week, for 12 weeks, to 26 patients assigned to the intervention group, while 29 patients assigned to control group received recommended standard medical care: pharmacological treatment for diabetes and foot care instructions. Both groups were assessed after 12 weeks, and the intervention group at follow-up (24 weeks). Primary outcomes involved foot rollover changes during gait, including peak pressure (PP). Secondary outcomes involved time-to-peak pressure (TPP) and pressure-time integral (PTI) in six foot-areas, mean center of pressure (COP) velocity, ankle kinematics and kinetics in the sagittal plane, intrinsic and extrinsic muscle function, and functional tests of foot and ankle.ResultsEven though the intervention group primary outcome (PP) showed a not statistically significant change under the six foot areas, intention-to-treat comparisons yielded softening of heel strike (delayed heel TPP, p=.03), better eccentric control of forefoot contact (decrease in ankle extensor moment, p<.01; increase in function of ankle dorsiflexion, p<.05), earlier lateral forefoot contact with respect to medial forefoot (TPP anticipation, p<.01), and increased participation of hallux (increased PP and PTI, p=.03) and toes (increase in PTI, medium effect size). A slower COP mean velocity (p=.05), and an increase in overall foot and ankle function (p<.05) were also observed. In most cases, the values returned to baseline after the follow-up (p<.05).ConclusionsIntervention discreetly changed foot rollover towards a more physiological process, supported by improved plantar pressure distribution and better functional condition of the foot ankle complex. Continuous monitoring of the foot status and patient education are necessary, and can contribute to preserving the integrity of foot muscles and joints impaired by polyneuropathy.Trial registrationClinicalTrials.gov Identifier: NCT01207284, registered in 20th September 2010.

Project description:BackgroundThe prevalence of diabetes mellitus has reached epidemic proportions, this condition may result in multiple and chronic invalidating long term complications. Among these, the diabetic foot, is determined by the simultaneous presence of both peripheral neuropathy and vasculopathy that alter the biomechanics of the foot with the formation of callosity and ulcerations. To diagnose and treat the diabetic foot is crucial to understand the foot complex kinematics. Most of gait analysis protocols represent the entire foot as a rigid body connected to the shank. Nevertheless the existing multisegment models cannot completely decipher the impairments associated with the diabetic foot.MethodsA four segment foot and ankle model for assessing the kinematics of the diabetic foot was developed. Ten normal subjects and 10 diabetics gait patterns were collected and major sources of variability were tested. Repeatability analysis was performed both on a normal and on a diabetic subject. Direct skin marker placement was chosen in correspondence of 13 anatomical landmarks and an optoelectronic system was used to collect the data.ResultsJoint rotation normative bands (mean plus/minus one standard deviation) were generated using the data of the control group. Three representative strides per subject were selected. The repeatability analysis on normal and pathological subjects results have been compared with literature and found comparable. Normal and pathological gait have been compared and showed major statistically significant differences in the forefoot and midfoot dorsi-plantarflexion.ConclusionEven though various biomechanical models have been developed so far to study the properties and behaviour of the foot, the present study focuses on developing a methodology for the functional assessment of the foot-ankle complex and for the definition of a functional model of the diabetic neuropathic foot. It is, of course, important to evaluate the major sources of variation (true variation in the subject's gait and artefacts from the measurement procedure). The repeatability of the protocol was therefore examined, and results showed the suitability of this method both on normal and pathological subjects. Comparison between normal and pathological kinematics analysis confirmed the validity of a similar approach in order to assess neuropathics biomechanics impairment.

Project description:IntroductionStudies have indicated that hip and knee muscle strengthening are effective in reducing pain, improving self-reported function and increasing lower limb strength, without, however, decreasing knee joint overload during gait in patients with knee osteoarthritis (KOA). Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain. The aim of this paper is to investigate whether an 8-week therapeutic foot-ankle exercise programme improves pain, functionality, foot strength, foot kinematics and knee joint overload during gait, and decreases medication intake in individuals with KOA.Methods and analysisThis two-arm, prospectively registered, randomised controlled trial with blinded assessors will involve 88 patients with medial tibiofemoral osteoarthritis. Subjects will be randomly allocated to a control group that will receive no specific foot intervention and will follow treatment recommended by the medical team; or an intervention group that will undergo an 8-week physiotherapist-supervised strengthening programme for extrinsic and intrinsic foot muscles, three times a week. The primary outcome will be the pain domain of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcomes include WOMAC stiffness and function domains, total WOMAC score, physical function, foot muscle isometric strength, foot kinematics and knee kinetics during gait, and medication intake. Data will be analysed on intention-to-treat principles and a per protocol basis.Ethics and disseminationInvestigators and sponsors will communicate trial results to participants and healthcare professionals through scientific databases and social media. In addition, findings will be reported in peer-review publications, and at national and international conference presentations. Ethics approval: Ethics Committee of the Universidade Federal de São Carlos, São Carlos, SP, Brazil (N° 3.488.466).Trial registration numberNCT04154059.

Project description:BackgroundDiabetic 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/designA 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.DiscussionThis 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 registrationThis 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".

Project description:Objective: Physical and cognitive impairments are common with aging and often coexist. Changes in the level of physical and mental activity are prognostic for adverse health events and falls. Dual-task (DT) training programs that can improve mobility and cognition simultaneously can bring significant improvements in rehabilitation. The objective of this mixed methods exploratory RCT was to provide evidence for the feasibility and therapeutic value of a novel game-assisted DT exercise program in older adults. Methods: Twenty-two community dwelling participants, between the ages of 70-85 were randomized to either dual-task treadmill walking (DT-TR) or dual-task recumbent bicycle (DT-RC). Both groups viewed a standard LED computer monitor and performed a range of cognitive game tasks while walking or cycling; made possible with the use of a "hands-free", miniature, inertial-based computer mouse. Participants performed their respective 1-h DT exercise program twice a week, for 12 weeks at a community fitness centre. Semi-structured interviews and qualitative analysis was conducted to evaluate the participant's experiences with the exercise program. Quantitative analysis included measures of standing balance, gait function (spatiotemporal gait variable), visuomotor and executive cognitive function, tested under single and DT walking conditions. Results: Compliance was 100% for all 22 participants. Four themes captured the range of participant's experiences and opinions: 1) reasons for participation, 2) difficulties with using the technologies, 3) engagement with the computer games, and 4) positive effects of the program. Both groups showed significant improvements in standing balance performance, visuomotor and visuospatial executive function. However, significant improvement in dual task gait function was observed only in the DT-TR group. Medium to large effect sizes were observed for most balance, spatiotemporal gait variables, and cognitive performance measure. Conclusion: With only minor difficulties with the technology being reported, the findings demonstrate feasible trial procedures and acceptable DT oriented training with a high compliance rate and positive outcomes. These findings support further research and development, and will direct the next phase of a full-scale RCT.

Dataset Information

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.

Publications

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.

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