Community-based adaptive physical activity program for chronic stroke: feasibility, safety, and efficacy of the Empoli model.

OBJECTIVE: To determine whether Adaptive Physical Activity (APA-stroke), a community-based exercise program for participants with hemiparetic stroke, improves function in the community. METHODS: Nonrandomized controlled study in Tuscany, Italy, of participants with mild to moderate hemiparesis at least 9 months after stroke. Forty-nine participants in a geographic health authority (Empoli) were offered APA-stroke (40 completed the study). Forty-four control participants in neighboring health authorities (Florence and Pisa) received usual care (38 completed the study). The APA intervention was a community-based progressive group exercise regimen that included walking, strength, and balance training for 1 hour, thrice a week, in local gyms, supervised by gym instructors. No serious adverse clinical events occurred during the exercise intervention. Outcome measures included the following: 6-month change in gait velocity (6-Minute Timed Walk), Short Physical Performance Battery (SPPB), Berg Balance Scale, Stroke Impact Scale (SIS), Barthel Index, Hamilton Rating Scale for Depression, and Index of Caregivers Strain. RESULTS: After 6 months, the intervention group improved whereas controls declined in gait velocity, balance, SPPB, and SIS social participation domains. These between-group comparisons were statistically significant at P<.00015. Individuals with depressive symptoms at baseline improved whereas controls were unchanged (P<.003). Oral glucose tolerance tests were performed on a subset of participants in the intervention group. For these individuals, insulin secretion declined 29% after 6 months (P=.01). CONCLUSION: APA-stroke appears to be safe, feasible, and efficacious in a community setting.

Muscle performance and ankle joint mobility in long-term patients with diabetes.

BACKGROUND: Long-term patients with diabetes and peripheral neuropathy show altered foot biomechanics and abnormal foot loading. This study aimed at assessing muscle performance and ankle mobility in such patients under controlled conditions. METHODS: Forty six long-term diabetes patients with (DN) and without (D) peripheral neuropathy, and 21 controls (C) were examined. Lower leg muscle performance and ankle mobility were assessed by means of a dedicated equipment, with the patient seated and the examined limb unloaded. 3D active ranges of motion and moments of force were recorded, the latter during maximal isometric contractions, with the foot blocked in different positions. RESULTS: All patients showed reduced ankle mobility. In the sagittal and transversal planes reduction vs C was 11% and 20% for D, 20% and 21% for DN, respectively.Dorsal-flexing moments were significantly reduced in all patients and foot positions, the highest reduction being 28% for D and 37% for DN. Reductions of plantar-flexing moments were in the range 12-15% for D (only with the foot blocked in neutral and in dorsal-flexed position), and in the range 10-24% for DN. In all patients, reductions in the frontal and transversal planes ranged 14-41%. CONCLUSION: The investigation revealed ankle functional impairments in patients with diabetes, with or without neuropathy, thus suggesting that other mechanisms besides neuropathy might contribute to alter foot-ankle biomechanics. Such impairments may then play a role in the development of abnormal gait and in the onset of plantar ulcers.

New neural network classifier of fall-risk based on the Mahalanobis distance and kinematic parameters assessed by a wearable device.

Fall prevention lacks easy, quantitative and wearable methods for the classification of fall-risk (FR). Efforts must be thus devoted to the choice of an ad hoc classifier both to reduce the size of the sample used to train the classifier and to improve performances. A new methodology that uses a neural network (NN) and a wearable device are hereby proposed for this purpose. The NN uses kinematic parameters assessed by a wearable device with accelerometers and rate gyroscopes during a posturography protocol. The training of the NN was based on the Mahalanobis distance and was carried out on two groups of 30 elderly subjects with varying fall-risk Tinetti scores. The validation was done on two groups of 100 subjects with different fall-risk Tinetti scores and showed that, both in terms of specificity and sensitivity, the NN performed better than other classifiers (naive Bayes, Bayes net, multilayer perceptron, support vector machines, statistical classifiers). In particular, (i) the proposed NN methodology improved the specificity and sensitivity by a mean of 3% when compared to the statistical classifier based on the Mahalanobis distance (SCMD) described in Giansanti (2006 Physiol. Meas. 27 1081-90); (ii) the assessed specificity was 97%, the assessed sensitivity was 98% and the area under receiver operator characteristics was 0.965.

Assessment of fall-risk by means of a neural network based on parameters assessed by a wearable device during posturography.

We have investigated the use of an Artificial Neural Network (ANN) for the assessment of fall-risk (FR) in patients with different neural pathologies. The assessment integrates a clinical tool based on a wearable device (WD) with accelerometers (ACCs) and rate gyroscopes (GYROs) properly suited to identify trunk kinematic parameters that can be measured during a posturography test with different constraints. Our ANN--a Multi Layer Perceptron Neural Network with four layers and 272 neurones--shows to be able to classify patients in three well-known fall-risk levels. The training of the neural network was carried on three groups of 30 subjects with different Fall-Risk Tinetti scores. The validation of our neural network was carried out on three groups of 100 subjects with different Fall-Risk Tinetti scores and this validation demonstrated that the neural network had high specificity (> or =0.88); sensitivity (> or =0.87); area under Receiver-Operator Characteristic Curves (>0.854).

Tele-rehabilitation: present and future.

SUMMARY: During the last decade we assisted to relevant progress in rehabilitation studies and in technological development. From the combination of these issues rises the tele-rehabilitation--a subfield of telemedicine consisting of a system to control rehabilitation "at distance"--as an actual possibility of application and a promising development in the future. The present paper offers a short review of the state of the art in the field of tele-rehabilitation, with a special focus on upper limb tele-rehabilitation. The experience is also briefly reported of the preliminary application of the H-CAD (home care activity desk) system and the HELLODOC (Healthcare service linking tele-rehabilitation to disabled people and clinicians) tele-rehabilitation service, conducted by the authors within two European projects in the period 2003-2005 and 2005-2007 respectively.

Technical assessment of the HELLODOC service.

SUMMARY: A technical assessment activity has been conducted by Istituto Superiore di Sanità (ISS) in the European project HELLODOC (Healthcare service linking tele-rehabilitation to disabled people and clinicians) for evaluating the tele-rehabilitation service. The activity was mainly focussed on architectural aspects and a step by step monitoring of the service. It was mainly related to the following aspects: service implementation, service performances, service integration and fault management. The technical assessment analysis demonstrated that the service worked in a quite satisfactory way, also considering the pioneering aspect of the project; the set of malfunctioning occurred, which had a low impact on the service continuity, are typical of a post-debug phase.

Tele-rehabilitation and e-learning: the HELLODOC educational experience.

SUMMARY: A web-based learning activity in the field of tele-rehabilitation was conducted by Istituto Superiore di Sanità (ISS), the Italian National Institute of Health, within the EU project HELLODOC. The activity aimed at training professionals to effectively manage the tele-rehabilitation service. ISS adapted the Moodle e-learning platform and implemented the problem-based learning (PBL) methodology. One clinical and one technical module were prepared by using traditional learning sources as well as interactive tools. Each module included 4 units; each unit was based on a 5-days cycle. The courses remained open from January to October 2006. Fifty percent of the registered students attended the courses. Traditional and interactive learning resources were equally used. Overall feedback was positive, unless for the amount of time requested for the study and the lack of an official certificate of attendance. Both modules are now in the process of being revised, improved and generalised, in order to be integrated into the ISS Rehabilitation website.

Clinical assessment of the HELLODOC tele-rehabilitation service.

SUMMARY: Within the EU project HELLODOC, the clinical effectiveness was investigated of the home care activity desk (H-CAD). Eighty-one patients with chronic stroke, traumatic brain injury (TBI) and multiple sclerosis (MS) were recruited; 50 out of 81 received 1 month of H-CAD intervention, with one training session a day lasting 30 minutes for 5 days a week. The overall satisfaction of both patients and therapists was high. The Action Research Arm (ARA) and the Nine Hole Peg Test (NHPT) were used as main outcome measures. They proved the H-CAD system to be at least as effective as usual care. Maybe due to limited length and intensity of treatment, during the training month subjects improved on the individual H-CAD exercises but, as in the usual care group, the arm/hand function remained at the same level.

Inertial measurement units furnish accurate trunk trajectory reconstruction of the sit-to-stand manoeuvre in healthy subjects.

A simple inertial measurement unit (IMU) incorporating rate gyroscopes and accelerometers has been tested to investigate the trunk kinematics during the sit-to-stand. It was affixed at trunk L5 level and used for sit-to-stand position and orientation reconstruction. The method was validated with standard optoelectronic equipment and results were also compared to the ones obtained by means of a Fast Video Camera. Comparative results showed for the IMU better performance than the system based on the Fast Video Camera. During the rising the mean pitch error was always lower than 5.2 x 10(-1) degrees and the mean Euclidean error lower than 5.9 x 10(-3) m in the sagittal plane.

Gait analysis with an integrated system for functional assessment of talocalcaneal coalition.

There is little knowledge of the functional performance of patients with talocalcaneal coalition because of the marginal quantitative information accessible using current motion-analysis and plantar pressure-measurement techniques. A novel system was developed for comprehensively measuring foot-floor interaction during the stance phase of gait that integrates instrumentation for simultaneously measuring bony segment position, ground reaction force, and plantar pressure with synchronization of spatial and temporal variables. An advanced anatomically based analysis of foot joint rotations was also applied. Tracking of numerous anatomical landmarks allowed accurate selection of three footprint subareas and reliable estimation of relevant local forces and moments. Eight patients (11 feet) with talocalcaneal coalition were analyzed. Major impairment of the rearfoot was found in nonsurgical patients, with an everted attitude, limited plantarflexion, and overloading in all three components of ground reaction force. Surgical patients showed more normal loading patterns in each footprint subarea. This measuring system allowed for accurate inspection of the effects of surgical treatment in the entire foot and at several footprint subareas. Surgical treatment of talocalcaneal coalition seems to be effective in restoring more physiologic subtalar and forefoot motion and loading patterns.

The development and test of a device for the reconstruction of 3-D position and orientation by means of a kinematic sensor assembly with rate gyroscopes and accelerometers.

In this paper, we propose a device for the Position and Orientation (P&O) reconstruction of human segmental locomotion tasks. It is based on three mono-axial accelerometers and three angular velocity sensors, geometrically arranged to form two orthogonal terns. The device was bench tested using step-by-step motor-based equipment. The characteristics of the six channels under bench test conditions were: crosstalk absent, non linearity < +/- 0.1% fs, hysteresis < 0.1% fs, accuracy 0.3% fs, overall resolution better than 0.04 deg/s, 2 x g x 10(-4). The device was validated with the stereophotogrammetric body motion analyzer during the execution of three different locomotion tasks: stand-to-sit, sit-to-stand, gait-initiation. Results obtained comparing the trajectories of the two methods showed that the errors were lower than 3 x 10(-2) m and 2 deg during a 4s of acquisition and lower than 6 x 10(-3) m and 0.2 deg during the effective duration of a locomotory task; showing that the wearable device hereby presented permits the 3-D reconstruction of the movement of the body segment to which it is affixed for time-limited clinical applications.

Audio-biofeedback for balance improvement: an accelerometry-based system.

This paper introduces a prototype audio-biofeedback system for balance improvement through the sonification using trunk kinematic information. In tests of this system, normal healthy subjects performed several trials in which they stood quietly in three sensory conditions while wearing an accelerometric sensory unit and headphones. The audio-biofeedback system converted in real-time the two-dimensional horizontal trunk accelerations into a stereo sound by modulating its frequency, level, and left/right balance. Preliminary results showed that subjects improved balance using this audio-biofeedback system and that this improvement was greater the more that balance was challenged by absent or unreliable sensory cues. In addition, high correlations were found between the center of pressure displacement and trunk acceleration, suggesting accelerometers may be useful for quantifying standing balance.

Walking strategy in diabetic patients with peripheral neuropathy.

OBJECTIVE: Diabetic neuropathic patients show a peculiar loading pattern of the foot, which led us to hypothesize that a substantial modification exists in their deambulatory strategy. The aim of the present study was to support this hypothesis by quantifying the changes of the loading patterns and by monitoring the excursion of center of pressure (COP) during gait. RESEARCH DESIGN AND METHODS: -A total of 21 healthy volunteers (C) and 61 diabetic patients were evaluated: 27 diabetic subjects without neuropathy (D), 19 with neuropathy (DN), and 15 with previous neuropathic ulcer (DPU). A piezo-dynamometric platform was used to record the foot-to-floor interaction by measuring loading time and the instantaneous COP position during the stance phase of gait. RESULTS: Loading time was significantly longer in neuropathic patients than in control subjects (DPU: 816.8 +/- 150 ms; DN: 828.6 +/- 152 ms; D: 766.5 +/- 89.9 ms; C: 723.7 +/- 65.7 ms; P < 0.05). COP excursion along the medio-lateral axis of the foot clearly decreased from C to DPU groups (C: 6.41 +/- 0.1 cm; D: 4.88 +/- 0.2 cm; DN: 4.57 +/- 0.1 cm; DPU: 3.36 +/- 0.1 cm; P < 0.05) as well as COP excursion along the longitudinal axis for the DPU group only (C: 26.6 +/- 1 cm; D: 26.9 +/- 1 cm; DN: 27.2 +/- 1 cm; DPU: 24.2 +/- 1 cm; P < 0.05). COP integrals were significantly reduced for all pathological classes (DPU: 14.2 +/- 8 cm(2); DN: 25.8 +/- 6 cm(2); D: 27.7 +/- 3 cm(2); C: 38.6 +/- 6 cm(2); P < 0.05). CONCLUSIONS: The accurate quantification of loading patterns and of COP excursions and integrals highlights changes of foot-to-floor interaction in diabetic neuropathic patients. The decreased medio-lateral and longitudinal COP excursions and corresponding changes of loading times and patterns support our hypothesis that a change in the walking strategy of diabetic patients with peripheral neuropathy does occur.

Contribution of plantar fascia to the increased forefoot pressures in diabetic patients.

OBJECTIVES: Secondary to peripheral neuropathy, plantar hyperpressure is a proven risk factor for foot ulceration. But limited joint mobility (LJM) and soft tissue abnormalities may also contribute. The aim of this study was to evaluate the relationships among thickness of plantar fascia, mobility of the metatarso-phalangeal joint, and forces expressed under the metatarsal heads. RESEARCH DESIGN AND METHODS: We evaluated 61 diabetic patients: 27 without neuropathy (D group), 19 with neuropathy (DN group), and 15 with previous neuropathic foot ulceration (DNPU group). We also examined 21 control subjects (C). Ultrasound evaluation was performed with a high resolution 8- to 10-MHz linear array (Toshiba Tosbee SSA 240). The foot loading pattern was evaluated with a piezo-dynamometric platform. First metatarso-phalangeal joint mobility was assessed with a mechanic goniometer. RESULTS: Diabetic patients presented increased thickness of plantar fascia (D 2.9 +/- 1.2 mm, DN 3.0 +/- 0.8 mm, DNPU 3.1 +/- 1.0 mm, and C 2.0 +/- 0.5.mm; P < 0.05), and significantly reduced motion range at the metatarso-phalangeal joint (D 54.0 +/- 29.4 degrees, DN 54.9 +/- 17.2 degrees, DNPU 46.8 +/- 20.7 degrees, and C 100.0 +/- 10.0 degrees; P < 0.05). The evaluation of foot-floor interaction under the metatarsal heads showed increased vertical forces in DN and DNPU and increased medio-lateral forces in DNPU. An inverse correlation was found between the thickness of plantar fascia and metatarso-phalangeal joint mobility (r = -0.53). The thickness of plantar fascia was directly correlated with vertical forces under the metatarsal heads (r = 0.52). CONCLUSIONS: In diabetic patients, soft tissue involvement may contribute to the increase of vertical forces under the metatarsal heads. Changes in the structure of plantar fascia may also influence the mobility of the first metatarso-phalangeal joint.

Two-thirds power law in human locomotion: role of ground contact forces.

Are there general rules for the generation of curvilinear motion of the end-effector? Form and kinematics of the arm trajectory are typically inter-related. A relationship between velocity and curvature of the endpoint path has been previously described and quantified as the two-thirds power law. Here we show that the two-thirds power law holds also for the foot trajectory (during the swing phase) in human locomotion for a wide range of walking speeds and gravitational loads, but air-stepping. In air-stepping, it was violated systematically. The results suggest that the power law represents a general constrain of biological motion, may be attributed to both mechanical and neural factors and can depend on natural interactions with external environment.

Is it feasible to reconstruct body segment 3-D position and orientation using accelerometric data?

The analysis of the mechanics of the musculo-skeletal system during the execution of a motor task requires the determination of the instantaneous position and orientation of the body segments involved in relation to an inertial system of reference. By using adequately assembled uniaxial accelerometric sensors, an easy-to-manage measurement system can be obtained that estimates the three-dimensional position and orientation (P&O) of a body segment through an appropriate analytical model. However, the extent to which experimental errors, in particular accelerometers (ACs) assembly inaccuracies, affect such estimation has never been systematically investigated. This paper systematically analyzes the sensitivity of analytical models of body segment P&O reconstruction through a six-AC system and a nine-AC system to different sources of experimental error. We simulated and statistically assessed the performance of these models in the case of body segment motions typical of movements under muscular control. The results obtained indicated that the inaccuracy in the orientation of the individual AC's active axes and the offset error in the AC responses were the major sources of P&O estimation errors. In particular, no accurate estimation of position was possible with the analytical models analyzed. Under the motion conditions simulated in this study, no substantial advantages were found in using a nine-AC system rather than a six-AC system. Considering that the magnitudes of the simulated experimental errors were quite low (< or = 0.1 deg: AC's orientation; < or = 10(-4) m: uncertainty of the distance between two ACs; < or = 10(-2) ms(-2): random error; 0.5 x 10(-2) ms(-2): offset error), the results indicate that none of the two ACs systems analyzed is suitable for body segment P&O estimation in routine biomechanical applications.

Objective analysis of finger function.

Hand motor tasks, even those commonly required by daily life activities, entail complex muscle activation. This article describes a self-contained experimental set-up for the objective kinetic and kinematic analysis of each finger function under several working conditions. Special attention is given to grasping and pressing under isometric conditions. The analysis of the contribution of the thumb is particular to this system. This system has proved accurate, reliable, easy-to-use, and suitable for applications in research environments, and as a support to clinicians for diagnosis and during rehabilitation.

Gait transitions in simulated reduced gravity.

Gravity has a strong effect on gait and the speed of gait transitions. A gait has been defined as a pattern of locomotion that changes discontinuously at the transition to another gait. On Earth, during gradual speed changes, humans exhibit a sudden discontinuous switch from walking to running at a specific speed. To study the effects of altered gravity on both the stance and swing legs, we developed a novel unloading exoskeleton that allows a person to step in simulated reduced gravity by tilting the body relative to the vertical. Using different simulation techniques, we confirmed that at lower gravity levels the transition speed is slower (in accordance with the previously reported Froude number ∼0.5). Surprisingly, however, we found that at lower levels of simulated gravity the transition between walking and running was generally gradual, without any noticeable abrupt change in gait parameters. This was associated with a significant prolongation of the swing phase, whose duration became virtually equal to that of stance in the vicinity of the walk-run transition speed, and with a gradual shift from inverted-pendulum gait (walking) to bouncing gait (running).

Methodological issues in monitoring health services and outcomes for stroke survivors: a case study.

BACKGROUND: Obtaining comprehensive health outcomes and health services utilization data on stroke patients has been difficult. This research grew out of a memorandum of understanding between the NIH and the ISS (its Italian equivalent) to foster collaborative research on rehabilitation. OBJECTIVE: The purpose of this study was to pilot a methodology using administrative data to monitor and improve health outcomes for stroke survivors in Tuscany. METHODS: This study used qualitative and quantitative methods to study health resources available to and utilized by stroke survivors during the first 12 months post-stroke in two Italian health authorities (AUSL10 and 11). Mortality rates were used as an outcome measure. RESULTS: Number of inpatient days, number of prescriptions, and prescription costs were significantly higher for patients in AUSL 10 compared to AUSL 11. There was no significant difference between mortality rates. CONCLUSION: Using administrative data to monitor process and outcomes for chronic stroke has the potential to save money and improve outcomes. However, measures of functional impairment and more sensitive outcome measures than mortality are important. Additional recommendations for enhanced data collection and reporting are discussed.