Daniele Munari

Improved gait after repetitive locomotor training in children with cerebral palsy.

Objective:The aim of this study was to evaluate the effectiveness of repetitive locomotor training with an electromechanical gait trainer in children with cerebral palsy. Design:In this randomized controlled trial, 18 ambulatory children with diplegic or tetraplegic cerebral palsy were randomly assigned to an experimental group or a control group. The experimental group received 30 mins of repetitive locomotor training with an applied technology (Gait Trainer GT I) plus 10 mins of passive joint mobilization and stretching exercises. The control group received 40 mins of conventional physiotherapy. Each subject underwent a total of 10 treatment sessions over a 2-wk period. Performance on the 10-m walk test, 6-min walk test, WeeFIM scale, and gait analysis was evaluated by a blinded rater before and after treatment and at 1-mo follow-up. Results:The experimental group showed significant posttreatment improvement on the 10-m walk test, 6-min walk test, hip kinematics, gait speed, and step length, all of which were maintained at the 1-mo follow-up assessment. No significant changes in performance parameters were observed in the control group. Conclusions:Repetitive locomotor training with an electromechanical gait trainer may improve gait velocity, endurance, spatiotemporal, and kinematic gait parameters in patients with cerebral palsy.

Combined transcranial direct current stimulation and robot-assisted gait training in patients with chronic stroke: a preliminary comparison

Objective: To evaluate whether robot-assisted gait training combined with transcranial direct current stimulation is more effective than robot-assisted gait training alone or conventional walking rehabilitation for improving walking ability in stroke patients. Design: Pilot randomized clinical trial. Setting: Rehabilitation unit of a university hospital. Subjects: Thirty patients with chronic stroke. Interventions: All patients received ten 50-minute treatment sessions, five days a week, for two consecutive weeks. Group 1 (n = 10) underwent a robot-assisted gait training combined with transcranial direct current stimulation; group 2 (n = 10) underwent a robot-assisted gait training combined with sham transcranial direct current stimulation; group 3 (n = 10) performed overground walking exercises. Main measures: Patients were evaluated before, immediately after and two weeks post treatment. Primary outcomes: six-minute walking test, 10-m walking test. Results: No differences were found between groups 1 and 2 for all primary outcome measures at the after treatment and follow-up evaluations. A statistically significant improvement was found after treatment in performance on the six-minute walking test and the 10-m walking test in favour of group 1 (six-minute walking test: 205.20 ± 61.16 m; 10-m walking test: 16.20 ± 7.65 s) and group 2 (six-minute walking test: 182.5 ± 69.30 m; 10-m walking test: 17.71 ± 8.20 s) compared with group 3 (six-minute walking test: 116.30 ± 75.40 m; 10-m walking test: 26.30 ± 14.10 s). All improvements were maintained at the follow-up evaluation. Conclusions: In the present pilot study transcranial direct current stimulation had no additional effect on robot-assisted gait training in patients with chronic stroke. Larger studies are required to confirm these preliminary findings.

Systematic review of outcome measures of walking training using electromechanical and robotic devices in patients with stroke

OBJECTIVE The aim of this systematic review was to identify appropriate selection criteria of clinical scales for future trials, starting from those most commonly reported in the literature, according to their psychometric properties and International Classification of Functioning, Disability and Health (ICF) domains. DATA SOURCES A computerized literature research of articles was conducted in MEDLINE, EMBASE, CINALH, PubMed, PsychINFO and Scopus databases. STUDY SELECTION Clinical trials evaluating the effects of electromechanical and robot-assisted gait training trials in stroke survivors. DATA EXTRACTION Fifteen independent authors performed an extensive literature review. DATA SYNTHESIS A total of 45 scales was identified from 27 studies involving 966 subjects. The most commonly used outcome measures were: Functional Ambulation Category (18 studies), 10-Meter Walking Test (13 studies), Motricity Index (12 studies), 6-Minute Walking Test (11 studies), Rivermead Mobility Index (8 studies) and Berg Balance Scale (8 studies). According to the ICF domains 1 outcome measure was categorized into Body Function and Structure, 5 into Activity and none into Participation. CONCLUSION The most commonly used scales evaluated the basic components of walking. Future studies should also include instrumental evaluation. Criteria for scale selection should be based on the ICF framework, psychometric properties and patient characteristics.

Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial

Background: Extensive research on both healthy subjects and patients with central nervous damage has elucidated a crucial role of postural adjustment reactions and central sensory integration processes in generating and “shaping” locomotor function, respectively. Whether robotic-assisted gait devices might improve these functions in Multiple sclerosis (MS) patients is not fully investigated in literature. Purpose: The aim of this study was to compare the effectiveness of end-effector robot-assisted gait training (RAGT) and sensory integration balance training (SIBT) in improving walking and balance performance in patients with MS. Methods: Twenty-two patients with MS (EDSS: 1.5–6.5) were randomly assigned to two groups. The RAGT group (n = 12) underwent end-effector system training. The SIBT group (n = 10) underwent specific balance exercises. Each patient received twelve 50-min treatment sessions (2 days/week). A blinded rater evaluated patients before and after treatment as well as 1 month post treatment. Primary outcomes were walking speed and Berg Balance Scale. Secondary outcomes were the Activities-specific Balance Confidence Scale, Sensory Organization Balance Test, Stabilometric Assessment, Fatigue Severity Scale, cadence, step length, single and double support time, Multiple Sclerosis Quality of Life-54. Results: Between groups comparisons showed no significant differences on primary and secondary outcome measures over time. Within group comparisons showed significant improvements in both groups on the Berg Balance Scale (P = 0.001). Changes approaching significance were found on gait speed (P = 0.07) only in the RAGT group. Significant changes in balance task-related domains during standing and walking conditions were found in the SIBT group. Conclusion: Balance disorders in patients with MS may be ameliorated by RAGT and by SIBT.

Sensory integration balance training in patients with multiple sclerosis: A randomized, controlled trial

Background: Impaired sensory integration contributes to balance disorders in patients with multiple sclerosis (MS). Objective: The objective of this paper is to compare the effects of sensory integration balance training against conventional rehabilitation on balance disorders, the level of balance confidence perceived, quality of life, fatigue, frequency of falls, and sensory integration processing on a large sample of patients with MS. Methods: This single-blind, randomized, controlled trial involved 80 outpatients with MS (EDSS: 1.5–6.0) and subjective symptoms of balance disorders. The experimental group (n = 39) received specific training to improve central integration of afferent sensory inputs; the control group (n = 41) received conventional rehabilitation (15 treatment sessions of 50 minutes each). Before, after treatment, and at one month post-treatment, patients were evaluated by a blinded rater using the Berg Balance Scale (BBS), Activities-specific Balance Confidence Scale (ABC), Multiple Sclerosis Quality of Life-54, Fatigue Severity Scale (FSS), number of falls and the Sensory Organization Balance Test (SOT). Results: The experimental training program produced greater improvements than the control group training on the BBS (p < 0.001), the FSS (p < 0.002), number of falls (p = 0.002) and SOT (p < 0.05). Conclusions: Specific training to improve central integration of afferent sensory inputs may ameliorate balance disorders in patients with MS. Clinical Trial Registration (NCT01040117).

Immediate versus delayed electrical stimulation boosts botulinum toxin effect: A pilot study.

We carried out a pilot study aimed atcomparing the efficacy of a single ES session of the injectedmuscles immediately after BTX-A administration versusrepeated ES sessions beginning the day after inoculation.Patients were recruited in the Neurorehabilitation Unit ofthe University Hospital of Verona, Italy. Inclusion criteriawere first unilateral stroke, between 6 and 18 months afterstroke, flexed elbow with spasticity of biceps brachii (BB)graded at least 2 (range, 0–5) on the Modified AshworthScale (MAS), and last BTX-A injection or any rehabilitativetreatment at least 6 months prior to recruitment. Exclusioncriteria were fixed contractures or bony deformities of theaffected arm, previous treatment of arm spasticity with neu-rolytic or surgical procedures, and other neurological or or-thopedic conditions involving the affected arm. Concentricneedle electromyography was used to rule out patients withactive denervation. Patients gave their consent for participa-tion in the study, which was approved by the local EthicsCommittee.BTX-A (Botox; Allergan, Irvine, CA) 100 IU diluted with2 mL of saline 0.9% was injected into the BB and the ab-ductor digiti minimi (ADM) muscles of the affected arm.ADM was chosen because it offers a simple neurophysiologi-cal marker of neuromuscular blockade and would havecaused a very small disadvantage in the case of completeblockade. The BTX-A dose was 80 U for the BB and 15 Ufor the ADM in each patient. After injection, patients wererandomized into 2 groups. All patients received ES of theinjected muscles (rectangular current pulses, 4 Hz, 0.2 ms,intensity adjusted to elicit visible muscle contraction). GroupA received ES of the injected muscles for 60 minutes imme-diately after BTX-A administration. Group B received ES for30 minutes a day for 3 consecutive days, beginning the dayafter injection. None of the patients underwent any othertreatment for spasticity during the study period.All patients were evaluated immediately before (T0) and 4weeks after (T1) BTX-A injection by the same examiner,who was blinded to the ES procedure they had received.Outcome measures were BB spasticity measured with theMAS and ADM compound muscle action potential (CMAP)amplitude. A decreased CMAP amplitude is considered avalid neurophysiologic quantification of toxin-induced neu-romuscular blockade.

High-intensity treadmill training improves gait ability, VO2peak and cost of walking in stroke survivors: preliminary results of a pilot randomized controlled trial.

BACKGROUND Stroke is a major cause of death and long-term disability across the globe. Previous studies have demonstrated the trainability of stroke survivors and documented beneficial effects of aerobic exercises on cardiovascular fitness and gait ability. AIM The main aim of this study was to compare the effects of a high-intensity treadmill training (HITT) against low-intensity treadmill training (LITT) on gait ability, quality of life, cardiorespiratory fitness and cost of walking in chronic stroke subjects. DESIGN Randomized, controlled pilot study. SETTING Patients were recruited among Neurorehabilitation Unit outpatient. POPULATION The sample was composed of 16 subjects suffering from chronic stroke. METHODS Subjects were enrolled and randomly allocated either in the HITT (N.=8) or in the LITT (N.=8). Both groups performed 3-month training, 3 times per week. Subjects were evaluated before starting the training and after the end of the training by mean of clinical scales (Six-Minute Walk Test, Ten-Meter Walk Test, Health Survey Questionnaire SF-36, Stroke Impact Scale) and instrumental tests (gait analysis, VO2peak and walking energy cost). RESULTS Fifteen subjects completed the study and no dropouts were observed. One patient in the LITT refused to initiate the training. The HITT group produced greater improvements than LITT group on the Six-Minute Walk Test (HITT: 64.25 meters, LITT: 6 meters; p=0.005) and Ten-Meter Walk Test performances (HITT: -1.7 s, LITT: 0.6 s; P=0.007), stride length (HITT: 3.3 cm, LITT: 0.4 cm, P=0.003), step length non-paretic side (HITT: 0.5 cm, LITT: 2.4 cm, P=0.008), step length paretic side (HITT: 1.8 cm, LITT: 0.7 cm, P=0.004), cadence (HITT: 1.6 step/min, LITT: 0.6 step/min, P=0.021) and symmetry ratio (HITT: 0.04 cm, LITT: 0.01 cm, P=0.004), VO2peak (HITT: 4.6 mL/kg/min, LITT: 0.87 mL/kg/min; P=0.015) and walking energy cost at 100% of self-selected speed (HITT: -30.8 mL/kg∙km, LITT: -20 5 mL/kg∙km; P=0.021). Significant changes were found on Six-Minute Walk Test (P=0.012) and Ten-Meter Walk Test (P=0.042) performances, spatio-temporal gait parameters (stride length P=0.011, step length paretic side P=0.012, cadence P=0.037 and symmetry ratio P=0.012), VO2peak (P=0.025) and cost of walking at 100% of self-selected speed (P=0.018) in the HITT group. In the LITT no significant results were observed. CONCLUSIONS HITT could be considered a feasible training and led to improvement in gait ability and enhanced VO2peak and reduction in cost of walking compared to LITT. CLINICAL REHABILITATION IMPACT Chronic stroke survivors should be encouraged to engage regular aerobic treadmill training at medium/high intensity. HITT is safe and feasible and has positive effects on gait ability, cardiovascular fitness and cost of walking in subjects with stroke in chronic phase.

Exercise training on locomotion in patients with Alzheimer's disease. A feasibility Study

BACKGROUND Although current literature has shown that patients with Alzheimers disease (AD) have worse locomotion compared with healthy counterparts, no studies have focused on the efficacy of exercise training in improving gait abnormalities including biomechanics and metabolic aspects, in this population. OBJECTIVE To verify the effectiveness of exercise training (ET) on gait parameters (i.e., speed, step and stride length, single and double support, and energy cost of walking (Cw)) in patients with AD with respect to a standard cognitive treatment (CT). METHODS In this study, we included a small portion of data belonging to a larger study (ClinicalTrials.gov number, NCT03034746). Patients with AD (Mini-Mental State Examination 22±5) were included in the study. Gait parameters and Cw were assessed at baseline and after 6 months (72 treatment sessions) of treatment. ET included 90 min of aerobic and strength training. CT included 90 min of cognitive stimuli. RESULTS The 16 patients assigned to ET exhibited significant improvement of Cw (-0.9±0.1 J/kg·m-1), while differences in gait parameters were negligible. The effect on gait parameters were undetectable in the 18 patients assigned to CT (-0.2±0.5 J/kg·m-1). CONCLUSIONS Data from this study showed that ET program seems effective in improving Cw in patients with AD. Interestingly, the positive effect of ET on Cw was not coupled with ameliorations of patients gait parameters, suggesting that the gain of metabolic aspects of locomotion were the main factors responsible for this positive result.

The influence of cognitive factors on balance and gait

Gait and balance impairments are known to be omnipresent among the general elderly population, and especially among elderly people with neurological diseases (see Segev-Jacubovski et al. in Expert Rev Neurother 11:1057–1075, [1] for a review).