Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study.

OBJECTIVE: The purpose of the study was to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation in improving arm function abilities in sub-acute hemiplegic patients. DESIGN: Randomized controlled pilot study. SETTING: Inpatient rehabilitation centers. PARTICIPANTS: Thirty hemiplegic stroke patients (Ashworth spasticity index <3) were recruited and randomly divided into a Treatment group (TG) and Control group (CG). INTERVENTIONS: Patients in the TG received intensive hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the CG received the same amount of time in terms of conventional hand rehabilitation. MAIN OUTCOME MEASURES: Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences, (Δ) mean(standard deviation), compared between groups. Results Twenty-seven patients concluded the program: 14 in the TG and 13 in the CG. None of the patients refused the device and only one adverse event of rheumatoid arthritis reactivation was reported. Baseline data did not differ significantly between the two groups. In TG, ΔMI 23(16.4), ΔNHPT 0.16(0.16), ΔGRIP 0.27(0.23) and ΔPINCH 0.07(0.07) were significantly greater than in CG, ΔMI 5.2(9.2), ΔNHPT 0.02(0.07), ΔGRIP 0.03(0.06) and ΔPINCH 0.02(0.03)] ( p=0.002, p=0.009, p=0.003 and p=0.038, respectively). CONCLUSIONS: Gloreha Professional is feasible and effective in recovering fine manual dexterity and strength and reducing arm disability in sub-acute hemiplegic patients.

Robot-Assisted Rehabilitation of Hand Paralysis After Stroke Reduces Wrist Edema and Pain: A Prospective Clinical Trial.

OBJECTIVE: The purpose of this study was to determine whether passive robotic-assisted hand motion, in addition to standard rehabilitation, would reduce hand pain, edema, or spasticity in all patients following acute stroke, in patients with and without hand paralysis. METHODS: Thirty-five participants, aged 45 to 80 years, with functional impairments of their upper extremities after a stroke were recruited for the study from September 2013 to October 2013. One group consisted of 16 patients (mean age ± SD, 68 ± 9 years) with full paralysis and the other groups included 14 patients (mean age ± SD, 67 ± 8 years) with partial paralysis. Patients in the both groups used the Gloreha device for passive mobilization of the hand twice a day for 2 consecutive weeks. The primary outcome measure was hand edema. Secondary outcome measures included pain intensity and spasticity. All outcome measures were collected at baseline and immediately after the intervention (2 weeks). RESULTS: Analysis of variance revealed that the partial paralysis group experienced a significantly greater reduction of edema at the wrist (P = .005) and pain (P = .04) when compared with the full paralysis group. Other outcomes were similar for the groups. CONCLUSION: The results of the current study suggest that the partial paralysis group experienced a significantly greater reduction of edema at the wrist and pain when compared with the full paralysis group. The reduction in pain did not meet the threshold of a minimal clinically important difference.

[Epidemiology of amputations: from medical causes to traumatic ones and at work]. / Epidemiologia delle amputazioni: dalle cause mediche a quelle traumatiche e sul lavoro.

The aim of our work is to describe the epidemiology of amputees. Through the causes, the treatment procedures and finally the social and economic impact that these complex patients determine in the health system. Although the epidemiological picture may be affected by some investigation limits, which mainly depend on the indicators used and on the scientific knowledge of the observation time, it remains an useful tool of knowledge both for clinicians and experts in health planning.

[Pre-prosthetics: role of the physiotherapist in the treatment of the residual limb and prosthetic preparation of the person]. / Fase pre protesica: ruolo del fisioterapista nel trattamento del moncone e preparazione della persona alla protesizzazione.

The rehabilitation of amputees requires a multi-discipline approach. Within the work of the team, physiotherapy plays a central role both in terms of the technical skills made available to the patient, as well as in terms of the psychological-motivational support offered to the amputee during treatment. The pre-prosthetic phase of rehabilitation is the beginning of a complex rehabilitative process during which starts with an assessment of the general clinical condition of the patient and their residual capacities, so as to develop personalised rehabilitative strategies based upon the needs of the amputee. This whole process aims to get the amputee standing with a prosthetic as quickly as possible, thus allowing the social reintegration of the amputee.

[The path to customized prosthesis: role of the occupational therapist in the recovery of autonomy]. / Il percorso protesico personalizzato: ruolo del T.O. nel recupero dell'autonomia.

The aim of the rehabilitative treatment of the amputee is to facilitate the reintegration of the patient into daily life: within social, family, and working contexts. Occupational therapy relates to 'doing', to everyday life. These are the activities carried out by individuals during daily life: catching the bus, driving a car, cooking a meal, playing cards or changing a light bulb. During the process of rehabilitation of the amputee the occupational therapist must evaluate the residual capacities of the patient, discover their needs and requirements so as to develop suitable rehabilitative strategiesfor retraining motor-skills, acceptance of the new living conditions, and social reintegration.

[Bioelectric prostheses: review of classifications and control strategies]. / Bioelectric prostheses: review of classifications and control strategies.

Bioelectric prosthesis are those mechatronical devices able to substitute the total or partial loss of a limb or a system, and controlled by the patient thanks to wilful bioelectric signals, such as muscular contractions (electromyographic signals, EMG) or activation of specific encephalic areas (which can be revealed by encephalogram, EEG). At the end of an analysis of the devices currently in literature and on the market, the present paper collects and synthesize the possible classification strategies of these prosthetic devices, paying particular attention also to the classification obtained by possible control strategies of the prosthesis. This summary aims to support and sustain physicians and patients along the identification of the most appropriate prosthesis, for the specific subject, the choice of the "optimal" device, must consider also patient needs and expectations, possible pathological constraints and technological complexity of the system. This paper presents, after a brief theoretical introduction about the background, a short description of materials and methods implemented in order to identify classification typologies; the main results, collected in 2 tables, will be then described, and commented highlighting advantages and limbs of the proposed classifications.

Multimodal treatment of distal sensorimotor polyneuropathy in diabetic patients: a randomized clinical trial.

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of the application of analyzing treadmill, muscle strengthening, and balance training compared with a standard care intervention in patients with diabetic neuropathy. METHODS: Twenty-seven patients, 63% female (mean ± standard deviations age, 72 ±9 years), with diabetic neuropathy randomly assigned to receive a multimodal manual treatment approach including analyzing treadmill with feedback focused, isokinetic dynamometric muscle strengthening, and balance retraining on dynamic balance platform or a standard care intervention for activities targeted to improve endurance, manual exercises of muscle strengthening, stretching exercises, gait, and balance exercises (5 weekly over 4 weeks). This study was designed as a double-blind, randomized clinical trial. Measures were assessed at pretreatment, 4 weeks posttreatment, and 2-month follow-up. RESULTS: No important baseline differences were observed between groups. At the end of the treatment period, the experimental group showed a significant increase in gait endurance in a 6-minute walk test, 65.6 m (F[2.0] = 9.636; P = .001). In addition, the 6-minute walk test increased after the intervention, and an even greater difference was found at follow-up (P = .005) for the standard care group. The Functional Independence Measure in both groups increased (P < .01) and continued until the follow-up in the standard care group (P = .003). CONCLUSIONS: The results suggest that the experimental rehabilitation program showed positive effects on the gait endurance after 4 weeks of treatment, whereas it did not produce significant improvements of the gait speed. Both the treatments produced significant improvement of functionalities of the patient.

Robot-Assisted Training for Upper Limb in Stroke (ROBOTAS): An Observational, Multicenter Study to Identify Determinants of Efficacy.

BACKGROUND: The loss of arm function is a common and disabling outcome after stroke. Robot-assisted upper limb (UL) training may improve outcomes. The aim of this study was to explore the effect of robot-assisted training using end-effector and exoskeleton robots on UL function following a stroke in real-life clinical practice. METHODS: A total of 105 patients affected by a first-ever supratentorial stroke were enrolled in 18 neurorehabilitation centers and treated with electromechanically assisted arm training as an add-on to conventional therapy. Both interventions provided either an exoskeleton or an end-effector device (as per clinical practice) and consisted of 20 sessions (3/5 times per week; 6-8 weeks). Patients were assessed by validated UL scales at baseline (T0), post-treatment (T1), and at three-month follow-up (T2). The primary outcome was the Fugl-Meyer Assessment for the upper extremity (FMA-UE). RESULTS: FMA-UE improved at T1 by 6 points on average in the end-effector group and 11 points on average in the exoskeleton group (p < 0.0001). Exoskeletons were more effective in the subacute phase, whereas the end-effectors were more effective in the chronic phase (p < 0.0001). CONCLUSIONS: robot-assisted training might help improve UL function in stroke patients as an add-on treatment in both subacute and chronic stages. Pragmatic and highmethodological studies are needed to confirm the showed effectiveness of the exoskeleton and end-effector devices.

Cranial nerves impairment in post-acute oropharyngeal dysphagia after COVID-19.

BACKGROUND: According to literature, after COVID-19, patients may require rehabilitation care because of different degrees of physical impairments. Neurologic disorders are often described but no specific data about postacute cranial nerves involvement and possible correlation with dysphagia development are yet available. CASE REPORT: The patient is a 69-year-old man who presented acquired weakness and dysphagia with clinical cranial nerves impairment of lingual, IX, X and XII after SARS-CoV-2 infection, without electrophysiological alterations. He underwent rehabilitation program for two months, with slow recovery. However, at discharge residual hypoglossal nerve deficit sign was present. CLINICAL REHABILITATION IMPACT: This single case expands knowledge about clinical picture after SARS-CoV-2 disease. Is important to notice that cranial, particularly bulbar nerves could be involved as late complications. Thus, we discuss about risk factors, the nature of the damage and the impact in dysphagia pathophysiology and recovery. If supported by further studies, this case may help to understand dysphagia features in these patients.

Self-selected speed gait training in Parkinson's disease: robot-assisted gait training with virtual reality versus gait training on the ground.

BACKGROUND: Parkinson's disease (PD) is a neurodegenerative disorder causing progressive gait disability. Although robot-assisted gait training (RAGT) using the Lokomat device has been demonstrated to improve gait in PD, it is not clear what the best training settings are, in particular if a self-selected treadmill speed can give better results. AIM: The aims of this study were: 1) to evaluate if self-selected speed training using Lokomat plus virtual reality (VR) can give better results compared to self-selected speed overground training; 2) to assess the possible influence of VR on patients' gait speed in the Lokomat group. DESIGN: Retrospective analysis. POPULATION: Patients with idiopathic PD (N.=20), aged 18-90 years, Hoehn & Yahr 2-3, Mini Mental State Examination (MMSE) ≥24, unchanged therapy, and without freezing episodes, dyskinesia, and neurological, orthopedic, cardiac, respiratory or severe visual impairments, who underwent four weeks of gait training (five 30-minute sessions/week): ten with Lokomat (Group 1) and ten without (Group 2). SETTING: Rehabilitation hospital; inpatients. METHODS: Group 1: Lokomat parameters: body weight support fixed at 30%, guidance force set at 80% bilaterally. Treadmill speed was self-selected by each patient, and subsequently modified on patient request. VR scenery was applied. Group 2: self-selected speed gait training on the ground. Both groups were assessed pre- and post-training with the Unified Parkinson's Disease Rating Scale (UPDRS), Functional Independence Measure (FIM) scale, and the 10-metre walking test (10-MWT). For group 1, a VR score was evaluated. RESULTS: All patients showed significant post-training improvement in UPDRS and FIM scores, with a significantly better improvement in Group 1 for total UPDRS (P=0.037). Velocity at 10-MWT significantly improved after rehabilitation in Group 2 (P=0.002). Lokomat treadmill speed and VR score both improved significantly after rehabilitation, but without any association (P=0.48), while a significant inverse relationship (P=0.014) was observed between the changes in 10-MWT and in treadmill speed. CONCLUSIONS: Self-selected speed Lokomat training in PD patients can provide clinical enhancements but is not superior to self-selected speed overground gait training; the influence of VR on motor performance seems to be related to non-motor aspects. CLINICAL REHABILITATION IMPACT: Regarding self-selected speed gait training, there seems to be no difference between RAGT and conventional overground gait training. Other parameter settings for RAGT need to be carefully investigated for a tailored use of RAGT in PD.

Lower Tinetti scores can support an early diagnosis of spatial neglect in post-stroke patients.

BACKGROUND: Neglect represents a severe complication of stroke, which impairs patients' daily activities. An early diagnosis of neglect is fundamental for management decisions. AIM: The aim of this study is to evaluate the usefulness of the Tinetti Test as an outcome of spatial neglect in post-stroke patients. DESIGN: Observational retrospective data analysis. SETTING: Rehabilitation Hospital. POPULATION: Cohort of post-stroke adults admitted in our Rehabilitation Unit. METHODS: One hundred and sixty stroke patients were evaluated between the 1st of January 2015 and the 31st of December 2016 at our Department. Eighty-nine inpatients matched the inclusion criteria. Their scores of the Tinetti Test for balance condition and gait function were compared with Bells Test and line bisection task for spatial neglect. Global independence activity was also assessed using Barthel Index and global cognitive functioning by means of the Mini-Mental State Examination. RESULTS: Twenty-two patients between the 89 patients included in this study were affected by spatial neglect at admission. A high statistical significant correlation was observed between lower Tinetti scores and neglect presence (mean Tinetti Score: 2.36 neglect; 7.82 non-neglect; P<0.001). CONCLUSIONS: The Tinetti Test is a well-established assessment scale to measure balance ability and gait function in post-stroke patients. Results from this study suggest that Tinetti Test may be considered as an early ecological screening tool for the diagnosis of neglect in post-stroke patients. CLINICAL REHABILITATION IMPACT: The alternative use of the Tinetti Test for the diagnosis of spatial neglect.

Exercise and movement in musculoskeletal pain: a double-edged problem.

PURPOSE OF REVIEW: Exercise and movement are increasingly used in pain management and in palliative care, outside the traditional context of physical medicine and rehabilitation. This critical review aims to provide specialists in pain and palliative medicine with recent insights into the use of exercise and movement in the approach to musculoskeletal disorders when pain and disability are the major complaints. RECENT FINDINGS: If there is a common sense linking pain and movement in both directions, that is pain influencing movement - as a withdrawal movement or a reduction of mobility as a defense reaction - or movement evoking pain, not so clear and recognized is the link between exercise and movement in controlling pain. SUMMARY: Conflicting results emerge between absolutely convincing basic science research confirming important effects induced by movement and exercise on pain and substantial poor low evidence level from clinical research as stated by almost all systematic reviews. The need of rigorous clinical trials is mandatory to ascertain a real clinical benefit for the use of movement and exercise for pain control.

Home-based hand rehabilitation with a robotic glove in hemiplegic patients after stroke: a pilot feasibility study.

OBJECTIVE: To evaluate the feasibility and safety of home rehabilitation of the hand using a robotic glove, and, in addition, its effectiveness, in hemiplegic patients after stroke. METHODS: In this non-randomized pilot study, 21 hemiplegic stroke patients (Ashworth spasticity index ≤ 3) were prescribed, after in-hospital rehabilitation, a 2-month home-program of intensive hand training using the Gloreha Lite glove that provides computer-controlled passive mobilization of the fingers. Feasibility was measured by: number of patients who completed the home-program, minutes of exercise and number of sessions/patient performed. Safety was assessed by: hand pain with a visual analog scale (VAS), Ashworth spasticity index for finger flexors, opponents of the thumb and wrist flexors, and hand edema (circumference of forearm, wrist and fingers), measured at start (T0) and end (T1) of rehabilitation. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip test) were also measured at T0 and T1. RESULTS: Patients performed, over a mean period 56 (49-63) days, a total of 1699 (1353-2045) min/patient of exercise with Gloreha Lite, 5.1 (4.3-5.8) days/week. Seventeen patients (81%) completed the full program. The mean VAS score of hand pain, Ashworth spasticity index and hand edema did not change significantly at T1 compared to T0. The MI, NHPT and Grip test improved significantly (p = 0.0020, 0.0156 and 0.0024, respectively) compared to baseline. CONCLUSION: Gloreha Lite is feasible and safe for use in home rehabilitation. The efficacy data show a therapeutic effect which need to be confirmed by a randomized controlled study.

Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: A Randomized Clinical Trial.

BACKGROUND: We evaluated the effectiveness of robot-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT) on stroke patients with hand paralysis. METHODS: A randomized controlled trial was conducted. Thirty-two patients, 34.4% female (mean ± SD age: 68.9 ± 11.6 years), with hand paralysis after stroke participated. The experimental group received 30 minutes of passive mobilization of the hand through the robotic device Gloreha (Brescia, Italy), and the control group received an additional 30 minutes of PT and OT for 3 consecutive weeks (3 d/wk) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale, Barthel Index (BI), Motricity Index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and the visual analog scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks). RESULTS: A significant effect of time interaction existed for NIHSS, BI, MI, and QuickDASH, after stroke immediately after the interventions (all, P < .001). The experimental group had a greater reduction in pain compared with the control group at the end of the intervention, a reduction of 11.3 mm compared with 3.7 mm, using the 100-mm VAS scale. CONCLUSIONS: In the treatment of pain and spasticity in hand paralysis after stroke, robot-assisted mobilization performed in conjunction with traditional PT and OT is as effective as traditional rehabilitation.

Conflicting results of robot-assisted versus usual gait training during postacute rehabilitation of stroke patients: a randomized clinical trial.

Robot gait training has the potential to increase the effectiveness of walking therapy. Clinical outcomes after robotic training are often not superior to conventional therapy. We evaluated the effectiveness of a robot training compared with a usual gait training physiotherapy during a standardized rehabilitation protocol in inpatient participants with poststroke hemiparesis. This was a randomized double-blind clinical trial in a postacute physical and rehabilitation medicine hospital. Twenty-eight patients, 39.3% women (72±6 years), with hemiparesis (<6 months after stroke) receiving a conventional treatment according to the Bobath approach were assigned randomly to an experimental or a control intervention of robot gait training to improve walking (five sessions a week for 5 weeks). Outcome measures included the 6-min walk test, the 10 m walk test, Functional Independence Measure, SF-36 physical functioning and the Tinetti scale. Outcomes were collected at baseline, immediately following the intervention period and 3 months following the end of the intervention. The experimental group showed a significant increase in functional independence and gait speed (10 m walk test) at the end of the treatment and follow-up, higher than the minimal detectable change. The control group showed a significant increase in the gait endurance (6-min walk test) at the follow-up, higher than the minimal detectable change. Both treatments were effective in the improvement of gait performances, although the statistical analysis of functional independence showed a significant improvement in the experimental group, indicating possible advantages during generic activities of daily living compared with overground treatment.

Efficacy of robot-assisted rehabilitation for the functional recovery of the upper limb in post-stroke patients: a randomized controlled study.

BACKGROUND: A prompt and effective physical and rehabilitation medicine approach is essential to obtain recovery of an impaired limb to prevent tendon shortening, spasticity and pain. Robot-assisted virtual reality intervention has been shown to be more effective than conventional interventions and achieved greater improvement in upper limb function. AIM: The aim of this study was to evaluate the effectiveness of robotic-assisted motion and activity in addition to PRM for the rehabilitation of the upper limb in post-stroke inpatients. DESIGN: Randomized controlled trial. SETTING: Departments of Physical and Rehabilitation Medicine from three different hospitals (Sarnico, Brescia; Bergamo; Milan). POPULATION: A total of 54 patients and enrolled 23 men and 31 women with post-stroke hemiparesis, aged 18 to 80 years old, enrolled from July 2014 to February 2015. METHODS: Of the 54 enrolled patients, 57% were female (mean age 71±12 years), and all had upper limb function deficit post-stroke. The experimental group received a passive mobilization of the upper limb through the robotic device ARMEO Spring and the control group received PRM for 6 consecutive weeks (5 days/week) in addition to traditional PRM. We assessed the impact on functional recovery (Functional Independence Measure [FIM] scale), strength (Motricity Index [MI]), spasticity (Modified Ashworth Scale [MAS]) and pain (Numeric Rating Pain Scale [NRPS]). All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). RESULTS: Both control and experimental groups evidenced an improvement of the outcomes after the treatment (MI, Ashworth and NRPS with P<0.05). The experimental group showed further improvements after the follow up (all outcomes with P<0.01). CONCLUSIONS: In the treatment of pain, disability and spasticity in upper limb after stroke, robot-assisted mobilization associated to PRM is as effective as traditional rehabilitation. CLINICAL REHABILITATION IMPACT: Robot-assisted treatment has an impact on upper limb motor function in stroke patients.

Robotic tilt table reduces the occurrence of orthostatic hypotension over time in vegetative states.

The aim of this study is to evaluate the effects of verticalization with or without combined movement of the lower limbs in patients in a vegetative state or a minimally conscious state. In particular, we aimed to study whether, in the group with combined movement, there was better tolerance to verticalization. This was a randomized trial conducted in a neurorehabilitation hospital. Twelve patients with vegetative state and minimally conscious state 3-18 months after acute acquired brain injuries were included. Patients were randomized into A and B treatment groups. Study group A underwent verticalization with a tilt table at 65° and movimentation of the lower limbs with a robotic system for 30 min three times a week for 24 sessions. Control group B underwent the same rehabilitation treatment, with a robotic verticalization system, but an inactive lower-limb movement system. Systolic and diastolic blood pressure and heart rate were determined. Robotic movement of the lower limbs can reduce the occurrence of orthostatic hypotension in hemodynamically unstable patients. Despite the small number of patients involved (only eight patients completed the trial), our results indicate that blood pressures and heart rate can be stabilized better (with) by treatment with passive leg movements in hemodynamically unstable patients.