The Italian version of the Erasmus MC modifications to the Nottingham Sensory Assessment for patients following acquired brain injury: Translation and reliability study.

OBJECTIVE: To develop the Italian version of the Erasmus MC modifications to the Nottingham Sensory Assessment and to investigate its internal consistency, intra- and inter-rater reliability. DESIGN: Prospective cohort study. SETTING: Rehabilitation department. SUBJECTS: A total of 34 patients with acquired brain injury. MAIN MEASURE: The translation and cultural adaptation process was completed, and the testing procedures of the Italian version of the Erasmus MC modifications to the Nottingham Sensory Assessment were standardized. Internal consistency was evaluated using Cronbach's alpha index; assessment of intra- and inter-rater reliability was carried out using weighted kappa coefficient. RESULTS: The internal consistency of the tactile sensations and the proprioception items of the Italian version of the Erasmus MC modifications to the Nottingham Sensory Assessment were generally acceptable to excellent with a range of Cronbach's alpha between 0.73 and 0.97. The intra-rater reliability of the tactile sensations and the proprioception items of the Italian version of the Erasmus MC modifications to the Nottingham Sensory Assessment were generally good to excellent with a range of weighted kappa coefficients between 0.47 and 1.00. Likewise, the inter-rater reliabilities of these items were predominantly good to excellent with a range of weighted kappa coefficients between 0.42 and 0.92. CONCLUSION: The Italian version of the Erasmus MC modifications to the Nottingham Sensory Assessment is a reliable screening tool to evaluate primary somatosensory impairments in patients with acquired brain injury. Further research is necessary to consolidate these results and establish the validity and responsiveness of the Italian version of the Erasmus MC modifications to the Nottingham Sensory Assessment.

Beneficial Effects of Robot-Assisted Gait Training on Functional Recovery in Women after Stroke: A Cohort Study.

Background and Objectives: Robot-assisted gait training (RAGT) could be a rehabilitation option for patients after experiencing a stroke. This study aims to determine the sex-related response to robot-assisted gait training in a cohort of subacute stroke patients considering mixed results previously reported. Materials and Methods: In this study, 236 participants (145 males, 91 females) were admitted to a rehabilitation facility after experiencing a stroke and performed RAGT within a multidisciplinary rehabilitation program. Functional Independence Measure (FIM) and Functional Ambulatory Category (FAC) were assessed at admission and discharge to determine sex-related outcomes. Results: At the baseline, no significant difference among sexes was observed. At the end of rehabilitation, both males and females exhibited significant improvements in FIM (71% of males and 80% of females reaching the MCID cut-off value) and FAC (∆score: men 1.9 ± 1.0; women 2.1 ± 1.1). A more remarkable improvement was observed in women of the whole population during the study, but statistical significance was not reached. When analysing the FAC variations with respect to the total number of RAGT sessions, a more significant improvement was observed in women than men (p = 0.025). Conclusion: In conclusion, among subacute stroke patients, benefits were observed following RAGT during a multidisciplinary rehabilitation program in both sexes. A greater significant recovery for women with an ischemic stroke or concerning the number of sessions attended was also highlighted. The use of gait robotics for female patients may favour a selective functional recovery after stroke.

Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): A randomized controlled trial.

BACKGROUND: Rehabilitation may attenuate the impact on mobility of patients with progressive multiple sclerosis (MS) and severe gait disabilities. OBJECTIVE: In this randomized controlled trial, we compared robot-assisted gait training (RAGT) with conventional therapy (CT) in terms of gait speed, mobility, balance, fatigue and quality of life (QoL). METHODS: Seventy-two patients with MS (expanded disability status scale score 6.0-7.0) were randomized to receive 12 training sessions over a 4-week period of RAGT (n = 36) or overground walking therapy (n = 36). The primary outcome was gait speed, assessed by the timed 25-foot walk test. Secondary outcome measures were walking endurance, balance, depression, fatigue and QoL. Tests were performed at baseline, intermediate, at the end of treatment and at a 3-month follow-up. RESULTS: Sixty-six patients completed the treatments. At the end of treatment with respect to baseline, both groups significantly improved gait speed (p < 0.001) and most secondary outcomes without between-group differences. Outcome values returned to baseline at follow-up. CONCLUSIONS: RAGT was not superior to CT in improving gait speed in patients with progressive MS and severe gait disabilities where a positive, even transitory, effect of rehabilitation was observed.

Effect of Rehabilitation Treatments on Disability in Persons With Disorders of Consciousness: A Propensity Score Study.

OBJECTIVE: To evaluate the effects of rehabilitation (physical and cognitive) treatments on the diagnosis severity and Disability Rating Scale (DRS) scores, adjusted for a number of potential confounders measured at baseline, in a large cohort of patients with disorders of consciousness across time. DESIGN AND SETTING: An observational, longitudinal (2 evaluations), multicenter project was made in 90 Italian centers. PARTICIPANTS: Patients (N=364) with a diagnosis of disorders of consciousness. MAIN OUTCOME MEASURES: Primary outcome was the severity of diagnosis, expressed on an ordinal scale (Other

Effects of a Robot-Assisted Arm Training Plus Hand Functional Electrical Stimulation on Recovery After Stroke: A Randomized Clinical Trial.

OBJECTIVE: To compare the effects of unilateral, proximal arm robot-assisted therapy combined with hand functional electrical stimulation with intensive conventional therapy for restoring arm function in survivors of subacute stroke. DESIGN: This was a single-blinded, randomized controlled trial. SETTING: Inpatient rehabilitation university hospital. PARTICIPANTS: Patients (N=40) diagnosed as having ischemic stroke (time since stroke <8wk) and upper limb impairment were enrolled. INTERVENTIONS: Participants randomized to the experimental group received 30 sessions (5 sessions/wk) of robot-assisted arm therapy and hand functional electrical stimulation (RAT+FES). Participants randomized to the control group received a time-matched intensive conventional therapy. MAIN OUTCOME MEASURES: The primary outcome was arm motor recovery measured with the Fugl-Meyer Motor Assessment. Secondary outcomes included motor function, arm spasticity, and activities of daily living. Measurements were performed at baseline, after 3 weeks, at the end of treatment, and at 6-month follow-up. Presence of motor evoked potentials (MEPs) was also measured at baseline. RESULTS: Both groups significantly improved all outcome measures except for spasticity without differences between groups. Patients with moderate impairment and presence of MEPs who underwent early rehabilitation (<30d post stroke) demonstrated the greatest clinical improvements. CONCLUSIONS: RAT+FES was no more effective than intensive conventional arm training. However, at the same level of arm impairment and corticospinal tract integrity, it induced a higher level of arm recovery.

Effectiveness of blood flow-restricted slow walking on mobility in severe multiple sclerosis: A pilot randomized trial.

OBJECTIVE: We tested the safety, feasibility, and effectiveness of blood flow restriction-empowered low-intensity interval walking exercise (BFR-W) compared with conventional intensive overground walking (CON-W) at improving gait speed and functional capacity in patients with multiple sclerosis (MS) and severe gait disabilities. METHODS: 24 patients (58 ± 5 years; 7 males) with progressive MS (Expanded Disability Status Scale 5.5 - 6.5) were randomized to receive 12 rehabilitation sessions over 6 weeks. The BFR-W group (n = 12) performed interval walking (speed paced by a metronome that increased weekly) with BFR bands at the thighs. The CON-W group (n = 12) received physiotherapist-assisted overground walking therapy. The primary outcome was gait speed, measured by the timed 25-foot walk test. Secondary outcomes included walking endurance, balance, strength, fatigue, and quality of life. The measurements were collected at baseline, at the end of training, and a 6-week follow-up. RESULTS: The two groups did not present any baseline difference. BFR-W group safely walked without limitations due to sleeve compression, with lower increase in perceived exertion (RPE) (P < .001) and heart rate (P = .031) compared with the CON-W. Gait speed improved significantly in both groups (BFR-W + 13%; CON-W + 5%) with greater increases in the BFR-W group at end of the training (P = .001) and at the follow-up (P = .041). Most of the secondary outcomes significantly improved in the two groups, without between-group differences. CONCLUSIONS: Slow interval walking with moderate BFR to the lower limbs was superior to overground walking in improving gait speed in patients with MS with a lower training load and a more durable clinical benefit.

Bilateral M1 anodal transcranial direct current stimulation in post traumatic chronic minimally conscious state: a pilot EEG-tDCS study.

OBJECTIVE: We tested the preliminary effects of bilateral anodal transcranial direct current stimulation (tDCS) in patients with disorders of consciousness. DESIGN: Open label pilot study. SUBJECTS: Ten chronic (greater than 12 months) patients in a minimally conscious state (MCS) following severe traumatic brain injury. METHODS: The patients received 10 sessions of bilateral M1 anodal tDCS. Behavioural changes were assessed with the Coma Recovery Scale-Revised (CRS-R) before stimulation (T-1, T0), after five sessions (T1), at the end of the stimulation (T2), after two weeks (T3) and after three months (T4). Moreover, an EEG assessment was conducted. RESULTS: Eight out of 10 patients showed new clinical signs of consciousness; specifically, a 2-point CRS-R improvement was detected in the last follow-up (p = 0.004). EEG upper α bandwidth was greater in the parietal site at T1 (p < 0.034). In addition, we found a significant correlation between behavioral and EEG indices at T1 (r =  0.89; p =  0.001). CONCLUSION: This preliminary study presents several limitations (small sample size and no control group). However, it provides important initial data that can be used to design randomized clinical trials testing this novel approach in MCS and to further explore EEG as a neural marker for the effects of tDCS.

A near-infrared spectroscopy-assisted test discriminates patients with peripheral arterial disease and venous insufficiency with changes of foot oxygenation following light elastic compression therapy.

Background: Elastic compression therapy (CT) in patients with peripheral artery disease (PAD) and chronic venous insufficiency (CVI) may compromise arterial perfusion. We evaluated the feasibility of a toe-flexion test, which quantifies dynamic foot perfusion by near-infrared spectroscopy (NIRS), for the assessment of hemodynamic sustainability of CT in PAD patients with CVI. Patients and methods: In this prospective observational study, PAD patients aged 50-85 with combined CVI at CEAP stages II-IV were studied. The ankle-brachial index (ABI) was measured, and foot perfusion was determined after 10 consecutive toe-flexion movements with NIRS sensors placed on the dorsum of each foot. Knee-high open-toe compression stockings were applied, and the degree of compression was measured. Toflex-area was determined by calculating the area under the curve of the oxygenated hemoglobin track recorded by NIRS. A toflex-area reduction > 20 % following CT was arbitrarily defined to identify limbs of patients with improved foot perfusion. These subjects received CT to be worn and a diary to report adherence and symptoms. Results: Forty-seven PAD patients (74 ± 9 years; ABI 0.67 ± 0.24) with CVI were enrolled. For all legs, superimposable toflex-areas were observed for the first two attempts (ICC 0.92). Following application of CT (17 ± 2 mmHg), the toflex-area improved (from -162 ± 110 a.u. to -112 ± 104 a.u.; p < .001). Sixty-two limbs (n = 32 patients) exhibited improved foot perfusion after CT, with a mean variation of 80 ± 47 a.u., while 32 limbs (n = 23 patients) showed stable or worsened values. In a regression model, favorable variations in toflex-area after CT were linked to a worse baseline toflex-area (R2 = 0.18; p < 0.001; rpartial = -0.42) while the percentage improvement directly correlated with CEAP class (p = 0.033). Conclusions: The NIRS-assisted test, which is feasible in a laboratory context, objectively discriminates the hemodynamic tolerability of the treatment and identifies subjects with combined PAD and CVI with improved perfusion after CT, in spite of the presence of PAD.

Changes in expression profiles of internal jugular vein wall and plasma protein levels in multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is an inflammatory, demyelinating and degenerative disorder of the central nervous system (CNS). Several observations support interactions between vascular and neurodegenerative mechanisms in multiple sclerosis (MS). To investigate the contribution of the extracranial venous compartment, we analysed expression profiles of internal jugular vein (IJV), which drains blood from CNS, and related plasma protein levels. METHODS: We studied a group of MS patients (n = 19), screened by echo-color Doppler and magnetic resonance venography, who underwent surgical reconstruction of IJV for chronic cerebrospinal venous insufficiency (CCSVI). Microarray-based transcriptome analysis was conducted on specimens of IJV wall from MS patients and from subjects undergoing carotid endarterectomy, as controls. Protein levels were determined by multiplex assay in: i) jugular and peripheral plasma from 17 MS/CCSVI patients; ii) peripheral plasma from 60 progressive MS patients, after repeated sampling and iii) healthy individuals. RESULTS: Of the differentially expressed genes (≥ 2 fold-change, multiple testing correction, P < 0.05), the immune-related CD86 (8.5 fold-change, P = 0.002) emerged among the up regulated genes (N = 409). Several genes encoding HOX transcription factors and histones potentially regulated by blood flow, were overexpressed. Smooth muscle contraction and cell adhesion processes emerged among down regulated genes (N = 515), including the neuronal cell adhesion L1CAM as top scorer (5 fold-change, P = 5 × 10- 4). Repeated measurements in jugular/peripheral plasma and overtime in peripheral plasma showed conserved individual plasma patterns for immune-inflammatory (CCL13, CCL18) and adhesion (NCAM1, VAP1, SELL) proteins, despite significant variations overtime (SELL P < 0.0001). Both age and MS disease phenotypes were determinants of VAP1 plasma levels. Data supported cerebral related-mechanisms regulating ANGPT1 levels, which were remarkably lower in jugular plasma and correlated in repeated assays but not between jugular/peripheral compartments. CONCLUSIONS: This study provides for the first time expression patterns of the IJV wall, suggesting signatures of altered vascular mRNA profiles in MS disease also independently from CCSVI. The combined transcriptome-protein analysis provides intriguing links between IJV wall transcript alteration and plasma protein expression, thus highlighting proteins of interest for MS pathophysiology.

The effects of transcranial direct current stimulation (tDCS) combined with group exercise treatment in subjects with chronic low back pain: a pilot randomized control trial.

OBJECTIVE: To test the efficacy of transcranial direct current stimulation (tDCS) in addition to group exercise on non-specific chronic low back pain. DESIGN: Double-blinded randomized control trial. SUBJECTS: Patients with non-specific chronic low back pain. METHODS: A total of 35 subjects were recruited and allocated to real- or sham-tDCS followed by a group exercise protocol. Each patient underwent five sessions of brain stimulation followed by 10 sessions of group exercise. Subjects were evaluated before and after tDCS, after group exercise and one month after the combined treatment. Outcome measures were Visual Analog Scale for pain intensity, Roland Morris Disability Questionnaire, EuroQuol-5 Dimension and Patient Health Questionnaire-9. RESULTS: Significant between-group difference in pain intensity (-27.7 ± 30.4 mm in real-tDCS group compared to -2.2 ± 30.1 mm in sham-tDCS group) and Patient Health Questionnaire-9 (-4.9 ± 4.2 in real-tDCS group compared to -1.1 ± 2.7 in sham-tDCS group) was found one month after the combined treatment ( P < 0.05). CONCLUSION: Our results showed that real-tDCS can induce significant larger effects on pain and psychological well-being, compared to sham-tDCS, when it is associated with a group exercise program. The effects were observed mostly in the follow-up.

Home-based exercise for elderly patients with intermittent claudication limited by osteoarticular disorders - feasibility and effectiveness of a low-intensity programme.

BACKGROUND: Peripheral arterial disease (PAD) is a common cardiovascular pathology affecting mobility in elderly. Osteoarticular diseases (ODs), responsible for functional limitations and confounding leg symptoms, may interfere with exercise therapy. This study evaluates the feasibility and effectiveness of a structured home-based exercise programme on rehabilitative outcomes in a cohort of elderly PAD patients with and without coexisting ODs. PATIENTS AND METHODS: Patients were enrolled from 2002 to 2016 in an exercise programme prescribed and controlled at the hospital and based on two daily 10-minute home walking sessions below the self-selected speed. The presence and localization of ODs at baseline were derived from consultation of medical documents. The ankle-brachial index and functional outcomes, defined as speed at the onset of claudication and attainable maximal speed by an incremental treadmill test, were assessed at baseline and discharge. Feasibility was determined according to dropout rate, number of visits, duration of the programme, and adherence. RESULTS: A total of 1,251 PAD patients were enrolled (931 men; 71 ± 9 years; 0.63 ± 0.19 ankle-brachial index). Eight hundred sixty-four patients were free of ODs (ODfreePAD, 69 %), whereas 387 were affected by ODs (ODPAD, 31 %), predominantly located in the spine (72 %). In the logistic regression models, the presence of ODs was associated with female sex, overweight, sedentary and/or driving professions. At discharge, ODPAD and ODfreePAD did not differ in dropout rates (12 % each), programme duration (378 ± 241 vs. 390 ± 260 days), number of visits (7 ± 3 each), and adherence (80 % each). Similar improvements for ODPAD and ODfreePAD were observed for the ankle-brachial index (0.06 ± 0.12 each), the speed at onset of claudication (0.7 ± 0.7 vs. 0.7 ± 0.8 kmh-1; p = 0.70), and maximal speed (0.4 ± 0.6 vs. 0.4 ± 0.6 kmh-1; p = 0.77). CONCLUSIONS: Equally satisfactory rehabilitative outcomes were observed in elderly patients with claudication limited by ODs who completed a well-tolerated, low-impact structured exercise programme.

The effects of video game therapy on balance and attention in chronic ambulatory traumatic brain injury: an exploratory study.

BACKGROUND: Patients with traumatic brain injury often have balance and attentive disorders. Video game therapy (VGT) has been proposed as a new intervention to improve mobility and attention through a reward-learning approach. In this pilot randomized, controlled trial, we tested the effects of VGT, compared with a balance platform therapy (BPT), on balance, mobility and selective attention in chronic traumatic brain injury patients. METHODS: We enrolled chronic traumatic brain injury patients (n = 21) that randomly received VGT or BPT for 3 sessions per week for 6 weeks. The clinical outcome measures included: i) the Community Balance & Mobility Scale (CB&M); ii) the Unified Balance Scale (UBS); iii) the Timed Up and Go test (TUG); iv) static balance and v) selective visual attention evaluation (Go/Nogo task). RESULTS: Both groups improved in CB&M scores, but only the VGT group increased on the UBS and TUG with a between-group significance (p < 0.05). Selective attention improved significantly in the VGT group (p < 0.01). CONCLUSIONS: Video game therapy is an option for the management of chronic traumatic brain injury patients to ameliorate balance and attention deficits. TRIAL REGISTRATION: NCT01883830 , April 5 2013.

Neuroplasticity-Based Technologies and Interventions for Restoring Motor Functions in Multiple Sclerosis.

Motor impairments are very common in multiple sclerosis (MS), leading to a reduced Quality of Life and active participation. In the past decades, new insights into the functional reorganization processes that occur after a brain injury have been introduced. Specifically, the motor practice seems to be determinant to induce neuroplastic changes and motor recovery. More recently, these findings have been extended to multiple sclerosis, in particular, it has been hypothesized that disease progression, functional reorganization and disability are mutually related. For this reason, neuroplasticity-based technologies and interventions have been rapidly introduced in MS rehabilitation. Constraint-induced movement therapy (CIMT), robotics and virtual reality training are new rehabilitative interventions that deliver an intensive e task-specific practice, which are two critical factors associated with functional improvements and cortical reorganization. Another promising strategy for enhancing neuroplastic changes is non-invasive brain stimulation that can be used with a priming effect on motor training. The aims of this chapter are to review the evidence of neuroplastic changes in multiple sclerosis and to present technologies and interventions that have been tested in clinical trials.

Use of Nintendo Wii Balance Board for posturographic analysis of Multiple Sclerosis patients with minimal balance impairment.

BACKGROUND: The Wii Balance Board (WBB) has been proposed as an inexpensive alternative to laboratory-grade Force Plates (FP) for the instrumented assessment of balance. Previous studies have reported a good validity and reliability of the WBB for estimating the path length of the Center of Pressure. Here we extend this analysis to 18 balance related features extracted from healthy subjects (HS) and individuals affected by Multiple Sclerosis (MS) with minimal balance impairment. METHODS: Eighteen MS patients with minimal balance impairment (Berg Balance Scale 53.3 ± 3.1) and 18 age-matched HS were recruited in this study. All subjects underwent instrumented balance tests on the FP and WBB consisting of quiet standing with the eyes open and closed. Linear correlation analysis and Bland-Altman plots were used to assess relations between path lengths estimated using the WBB and the FP. 18 features were extracted from the instrumented balance tests. Statistical analysis was used to assess significant differences between the features estimated using the WBB and the FP and between HS and MS. The Spearman correlation coefficient was used to evaluate the validity and the Intraclass Correlation Coefficient was used to assess the reliability of WBB measures with respect to the FP. Classifiers based on Support Vector Machines trained on the FP and WBB features were used to assess the ability of both devices to discriminate between HS and MS. RESULTS: We found a significant linear relation between the path lengths calculated from the WBB and the FP indicating an overestimation of these parameters in the WBB. We observed significant differences in the path lengths between FP and WBB in most conditions. However, significant differences were not found for the majority of the other features. We observed the same significant differences between the HS and MS populations across the two measurement systems. Validity and reliability were moderate-to-high for all the analyzed features. Both the FP and WBB trained classifier showed similar classification performance (>80%) when discriminating between HS and MS. CONCLUSIONS: Our results support the observation that the WBB, although not suitable for obtaining absolute measures, could be successfully used in comparative analysis of different populations.

The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial.

BACKGROUND: Gait and mobility impairments are common in progressive multiple sclerosis (MS), leading to reduced quality of life (QoL). OBJECTIVE: In this randomized controlled study, we tested the effects of robot-assisted gait training (RAGT) and compared it to conventional physiotherapy, measuring walking ability, depression, fatigue, and QoL in patients with progressive MS and severe gait disability. METHODS: Fifty-two participants (Expanded Disability Status Scale score 6-7) completed the study protocol. They received two sessions/week over 6 weeks of RAGT or conventional walking therapy. Outcome measures were Six-Minute Walk Test, Ten-Meter Walk Test, Timed Up and Go Test, Berg Balance Scale, Fatigue Severity Scale, Patient Health Questionnaire, and Short Form 36. They were performed pre-treatment, post-treatment, and at 3 months. RESULTS: Walking endurance (p < 0.01) and balance (p < 0.01) were improved among those in the RAGT group. Positive effects on depression in both treatment groups were highlighted. However, only among those in the RAGT group was perceived physical functioning QoL increased. No significant effects on fatigue were found. CONCLUSION: RAGT is a treatment option in progressive MS patients with severe gait impairments to induce short-lasting effects on mobility and QoL.

A task-oriented circuit training in multiple sclerosis: a feasibility study.

BACKGROUND: The aim of this study was to evaluate the safety, feasibility and preliminary effects of a high-intensity rehabilitative task-oriented circuit training (TOCT) in a sample of multiple sclerosis (MS) subjects on walking competency, mobility, fatigue and health-related quality of life (HRQoL). METHODS: 24 MS subjects (EDSS 4.89 ± 0.54, 17 female and 7 male, 52.58 ± 11.21 years, MS duration 15.21 ± 8.68 years) have been enrolled and randomly assigned to 2 treatment groups: (i) experimental group received 10 TOCT sessions over 2 weeks (2 hours/each session) followed by a 3 months home exercise program, whereas control group did not receive any specific rehabilitation intervention. A feasibility patient-reported questionnaire was administered after TOCT. Functional outcome measures were: walking endurance (Six Minute Walk Test), gait speed (10 Meter Walk Test), mobility (Timed Up and Go test) and balance (Dynamic Gait Index). Furthermore, self-reported questionnaire of motor fatigue (Fatigue Severity Scale), walking ability (Multiple Sclerosis Walking Scale - 12) and health-related quality of life (Multiple Sclerosis Impact Scale - 29) were included. Subjects' assessments were delivered at baseline (T0), after TOCT (T1) and 3 months of home-based exercise program (T2). RESULTS: After TOCT subjects reported a positive global rating on the received treatment. At 3 months, we found a 58.33% of adherence to the home-exercise program. After TOCT, walking ability and health-related quality of life were improved (p < 0.05) with minor retention after 3 months. The control group showed no significant changes in any variables. CONCLUSIONS: This two weeks high-intensity task-oriented circuit class training followed by a three months home-based exercise program seems feasible and safe in MS people with moderate mobility impairments; moreover it might improve walking abilities. TRIAL REGISTRATION: NCT01464749.

Acute oxygenation changes on ischemic foot of a novel intermittent pneumatic compression device and of an existing sequential device in severe peripheral arterial disease.

BACKGROUND: Intermittent pneumatic compression (IPC) improves haemodynamics in peripheral arterial disease (PAD), but its effects on foot perfusion were scarcely studied. In severe PAD patients we measured the foot oxygenation changes evoked by a novel intermittent IPC device (GP), haemodynamics and compliance to the treatment. Reference values were obtained by a sequential foot-calf device (SFC). METHODS: Twenty ischemic limbs (Ankle-Brachial Index = 0.5 ± 0.2) of 12 PAD patients (7 male, age: 74.5 ± 10.8 y) with an interval of 48 ± 2 hours received a 35 minute treatment in supine position with two IPC devices: i) a Gradient Pump (GP), which slowly inflates a single thigh special sleeve and ii) an SFC (ArtAssist®, ACI Medical, San Marcos, CA, USA), which rapidly inflates two foot-calf sleeves. MAIN OUTCOME MEASURE: changes of oxygenated haemoglobin at foot (HbO2foot) by continuous near-infrared spectroscopy recording and quantified as area-under-curve (AUC) for periods of 5 minutes. Other measures: haemodynamics by echo-colour Doppler (time average velocity (TAV) and blood flow (BF) in the popliteal artery and in the femoral vein), patient compliance by a properly developed form. RESULTS: All patients completed the treatment with GP, 9 with SFC. HbO2foot during the working phase, considered as average value of the 5 minutes periods, increased with GP (AUC 458 ± 600 to 1216 ± 280) and decreased with SFC (AUC 231 ± 946 to -1088 ± 346), significantly for most periods (P < 0.05). The GP treatment was associated to significant haemodynamic changes from baseline to end of the treatment (TAV = 10.2 ± 3.3 to 13.5 ± 5.5 cm/sec, P = 0.004; BF = 452.0 ± 187.2 to 607.9 ± 237.8 ml/sec, P = 0.0001), not observed with SFC (TAV = 11.2 ± 3.4 to 11.8 ± 4.3 cm/sec; BF = 513.8 ± 203.7 to 505.9 ± 166.5 ml/min, P = n.s.). GP obtained a higher score of patient compliance (P < 0.0001). CONCLUSIONS: A novel IPC thigh device, unlike a traditional SFC device, increased foot oxygenation in severe PAD, together with favourable haemodynamic response and high compliance to the treatment under the present experimental conditions.

Muscle oxygen consumption by NIRS and mobility in multiple sclerosis patients.

BACKGROUND: The study of muscle metabolism by near-infrared spectroscopy (NIRS) has been poorly implemented in multiple sclerosis (MS). Aims of the study were to compare resting muscle oxygen consumption (rmVO2) at gastrocnemius in MS patients and in age-matched healthy controls (HC) measured using NIRS, and to evaluate its possible relationship with patients' mobility. METHODS: Twenty-eight consecutively enrolled MS patients (male, n = 16; age = 42.7 ± 14.0 y, Relapsing-Remitting, n = 19; Primary-Progressive, n = 9) and 22 HC (male, n = 13; age = 36.0 ± 8.2 y) were studied during rest applying the NIRS probes at gastrocnemius, producing a venous occlusion at the thigh using a cuff, and analyzing the slope of the total hemoglobin to calculate rmVO2. Mobility was assessed by a 6-Minute Walking Test and 6-Minute Walking Distance (6MWD) was recorded. RESULTS: rmVO2 was higher in MS compared to HC (0.059 ± 0.038 vs 0.039 ± 0.016 mlO2/min/100 g, P < 0.003), not different in clinical subtypes, not correlated to patients' characteristics (age, disease duration, Expanded Disability Status Scale, resting heart rate, skinfold thickness), and significantly higher in patients with lower walking ability (6MWD < 450 m, n = 12) compared to those at better performance (respectively, 0.072 ± 0.043 vs 0.049 ± 0.032 mlO2/min/100 g, P = 0.03). CONCLUSION: rmVO2 values, significantly higher in MS patients compared to HC, and in low versus high performing patients, might represent a marker of peripheral adaptations occurred to sustain mobility, as observed in other chronic diseases.

Variations in Health-Related Quality of Life After Stroke: Insights From a Clinical Trial on Arm Rehabilitation With a Long-Term Follow-Up.

Despite rehabilitation, stroke patients continue to have impaired function and reduced health-related quality of life (HRQoL) even in a chronic stage. However, no clear information is available on long-term variations in HRQoL. In this study, we aimed to report the short- and long-term changes in HRQoL in a subacute stroke sample that was enrolled in a clinical trial on arm rehabilitation. Thirty-nine stroke survivors (62% male, mean age 68 years) were assessed using the Stroke Impact Scale Version 2.0 (SIS 2.0) pre and post rehabilitation and at 6 months and 6 years follow-up. Long-term changes in physical function were explored through clinically meaningful changes in the Stroke Impact Scale-16 (SIS-16). After rehabilitation (P < .001), an overall improvement was found in all SIS domains except the memory and thinking, emotions, and communication domains. The baseline SIS-16 score (P < .001), the presence of a sensory deficit, and rehabilitation setting (P < .05) were factors related to the SIS-16 domain scores at the end of rehabilitation and at 6 months follow-up. Patients showed the most deterioration in the mobility (P < .001), strength (P < .003), and hand function (P < .05) domains 6 years after stroke. Stroke severity, male gender, and age ⩾65 years are related with a long-term HRQoL reduction after stroke.