A Sensor-Based Upper Limb Treatment in Hemiplegic Patients: Results from a Randomized Pilot Study.

In post-stroke patients, the disabling motor deficit mainly affects the upper limb. The focus of rehabilitation is improving upper limb function and reducing long-term disability. This study aims to evaluate the feasibility of using the Gloreha Aria (R-Lead), a sensor-based upper limb in-hospital rehabilitation, compared with conventional physiotherapist-led training in subacute hemiplegic patients. Twenty-one patients were recruited and randomised 1:1 to a sensor-based group (treatment group TG) or a conventional group (control group, CG). All patients performed 30 sessions of 30 min each of dedicated upper limb rehabilitation. The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) was the primary evaluation., both as a motor score and as individual items. Secondary evaluations were Functional Independence Measure; global disability assessed with the Modified Barthel Index; Motor Evaluation Scale for UE in stroke; power grip; and arm, shoulder, and hand disability. All the enrolled patients, 10 in the TG and 11 in the CG, completed all hand rehabilitation sessions during their hospital stay without experiencing any adverse events. FMA-UE scores in upper limb motor function improved in both groups [delta change CG (11.8 ± 9.2) vs. TG (12.7 ± 8.6)]. The score at T1 for FMA joint pain (21.8 vs. 24 best score) suggests the use of the Gloreha Aria (R-Lead) as feasible in improving arm function abilities in post-stroke patients.

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.

Feasibility and cost-effectiveness of a multidisciplinary home-telehealth intervention programme to reduce falls among elderly discharged from hospital: study protocol for a randomized controlled trial.

BACKGROUND: Fall incidents are the third cause of chronic disablement in elderly according to the World Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk assessment and management programmes are effective in all older population studied. However, the application of these programmes may not be the same in all National health care setting and, consequently, needs to be evaluated by cost-effectiveness studies before to plan this intervention in regular care. In Italy structured collaboration between hospital staff and primary care is generally lacking and the role of Information and Communication Technologies (ICT) in a fall prevention programme at home has never been explored. METHODS AND DESIGN: This will be a two-group randomised controlled trial aiming to evaluate the effects of a home-based intervention programme delivered by a multidisciplinary health team. The home tele-management programme, previously adopted in our Institute for chronic patients, will be proposed to elderly people affected by chronic diseases at high risk of falling at hospital discharge. The programme will involve the hospital staff and will be managed thanks to the collaboration between hospital and primary care setting. Patients will be followed for 6 months after hospital discharge. A nurse-tutor telephone support and tele-exercise will characterize the intervention programme. People in the control group will receive usual care. The main outcome measure of the study will be the percentage of patients sustaining a fall during the 6-months follow-up period. An economic evaluation will be performed from a societal perspective and will involve calculating cost-effectiveness and cost utility ratios. DISCUSSION: To date, no adequately powered studies have investigated the effect of the Information and Communication Technologies (ICT) in a home fall prevention program. We aim the program will be feasible in terms of intensity and characteristics, but particularly in terms of patient and provider compliance. The results of the economic evaluation could provide information about the cost-effectiveness of the intervention and the effects on quality of life. In case of shown effectiveness and cost effectiveness, the program could be implemented into health services settings. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02487589 ).

Home-based telesurveillance and rehabilitation after stroke: a real-life study.

BACKGROUND: After discharge from in-hospital rehabilitation, post-stroke patients should have the opportunity to continue the rehabilitation through structured programs to maintain the benefits acquired during intensive rehabilitation treatment. OBJECTIVE: The primary objective was to evaluate the feasibility of implementing an home-based telesurveillance and rehabilitation (HBTR) program to optimize the patient's recovery by reducing dependency degree. METHOD: Post-stroke patients were consecutively screened. Data were expressed as mean ± standard deviation (SD). 26 patients enrolled: 15 were sub-acute (time since stroke: 112 ± 39 days) and 11 were chronic (time since stroke: 470 ± 145 days). For 3 months patients were followed at home by a nurse-tutor, who provided structured phone support and vital signs telemonitoring, and by a physiotherapist (PT) who monitored rehabilitation sessions by videoconferencing. RESULTS: 23 patients completed the program; 16.7 ± 5.2 phone contacts/patient were initiated by the nurse and 0.9 ± 1.8 by the patients. Eight episodes of atrial fibrillation that required a change in therapy were recorded in two patients. Physiotherapists performed 1.2 ± 0.4 home visits, 1.6 ± 0.9 phone calls and 4.5 ± 2.8 videoconference-sessions per patient. At least three sessions/week of home exercises were performed by 31% of patients, two sessions by 54%. At the end of the program, global functional capacity improved significantly (P < 0.001), in particular, static (P < 0.001) and dynamic (P = 0.0004) postural balance, upper limb dexterity of the paretic side (P = 0.01), and physical performance (P = 0.002). Symptoms of depression and caregiver strain also improved. CONCLUSION: The home-based program was feasible and effective in both sub-acute and chronic post-stroke patients, improving their recovery, and maintaining the benefits reached during inpatient rehabilitation.

Effects of Motor Rehabilitation on Balance and Functional Activities in Elderly Patients with Peripheral Neuropathy and Recurrent Falls.

To date, little is known about the effects of motor rehabilitation in peripheral neuropathy (PN) patients with a history of recurrent falls (RFH). This study aimed to assess balance and the activities of daily living (ADLs) in elderly lower limb PN patients with and without RFH and to verify the effects of motor rehabilitation on balance and ADLs in these patients. We collected data from 64 lower limb PN patients, who underwent a conventional motor rehabilitation program: 35 patients had a history of recurrent falls, and 29 did not. The Berg Balance Scale (BBS) and motor FIM, before and after rehabilitation, were the outcome measures. After rehabilitation, lower limb PN patients with RFH had significantly higher scores in BBS and motor FIM (p < 0.001, for both) than at entry. The final BBS score and effectiveness in the BBS score of lower limb PN patients with RFH were lower than those of patients without RFH (p < 0.05 and p = 0.009, respectively). The study shows that conventional motor rehabilitation improves both balance and ADLs in patients, but balance improvement is lower in those with RFH. Thus, motor rehabilitation can be a therapeutic option for the management of these patients.

Walking function determinants in parkinson patients undergoing rehabilitation.

BACKGROUND: To date little is known about factors affecting walking rehabilitation in Parkinson's disease (PD) patients. OBJECTIVE: This prospective observational cohort study evaluated the walking distance covered in 6 minutes (6 MWD) before and after conventional rehabilitation and verified which among PD motor disorders was the most important determinant of walking distance in PD patients undergoing rehabilitation. METHODS: Data were collected from 55 PD patients, performing a conventional outpatient motor rehabilitation program. The 6MWD at the end of rehabilitation and gain in 6MWD were the outcome measures. The Unified Parkinson's Disease Rating Scale, Hoehn and Yahr scale, Nine Hole Peg Test, Grip and Pinch test, ROM wrist motility, and Berg Balance Scale (BBS) were used to assess PD patients at admission and were considered as dependent variables. Backward multiple regression analyses identified the determinants of 6MWD outcomes. RESULTS: The 6MWD was 246.58±115 meters at admission and 286.90±116 at the end of rehabilitation. At end of rehabilitation, the 6MWD was 42.32±47 meters greater than admission (p < 0.001), corresponding to an increase of +17.16%. At the end of rehabilitation, the 6MWD was significantly longer in PD patients with stages 1-3 of the Hoehn and Yahr scale. Berg Balance Scale (ß= 0.47, p < 0.001) and right Grip and Pinch at admission (ß= 0.36, p = 0.001) were the only determinants of final 6MWD. The R2 value of the model was 0.47 (R2 adjusted 0.45). No variable was a determinant of gain in 6MWD. CONCLUSIONS: The study indicates that balance and generalized muscle strength are important determinants of walking rehabilitation in PD patients, in whom it is essential to maintain high levels of balance and muscle strength for a time as long as possible. These findings suggest planning more intensive rehabilitation treatments in PD patients with low levels of balance and muscle strength.

A decision making algorithm for rehabilitation after stroke: A guide to choose an appropriate and safe treadmill training.

BACKGROUND: Walking independently after a stroke can be difficult or impossible, and walking reeducation is vital. But the approach used is often arbitrary, relying on the devices available and subjective evaluations by the doctor/physiotherapist. Objective decision making tools could be useful. OBJECTIVES: To develop a decision making algorithm able to select for post-stroke patients, based on their motor skills, an appropriate mode of treadmill training (TT), including type of physiotherapist support/supervision required and safety conditions necessary. METHODS: We retrospectively analyzed data from 97 post-stroke inpatients admitted to a NeuroRehabilitation unit. Patients attended TT with body weight support (BWSTT group) or without support (FreeTT group), depending on clinical judgment. Patients' sociodemographic and clinical characteristics, including the Cumulative Illness Rating Scale (CIRS) plus measures of walking ability (Functional Ambulation Classification [FAC], total Functional Independence Measure [FIM] and Tinetti Performance-Oriented Mobility Assessment [Tinetti]) and fall risk profile (Morse and Stratify) were retrieved from institutional database. RESULTS: No significant differences emerged between the two groups regarding sociodemographic and clinical characteristics. Regarding walking ability, FAC, total FIM and its Motor component and the Tinetti scale differed significantly between groups (for all, p < 0.001). FAC and Tinetti scores were used to elaborate a decision making algorithm classifying patients into 4 risk/safety (RS) classes. As expected, a strong association (Pearson chi-squared, p < 0.0001) was found between RS classes and the initial BWSTT/FreeTT classification. CONCLUSION: This decision making algorithm provides an objective tool to direct post-stroke patients, on admission to the rehabilitation facility, to the most appropriate form of TT.

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.

Aphasia and activities of daily living in stroke patients.

BACKGROUND: Few studies have investigated the relationships between aphasia and activities of daily living (ADLs) in stroke patients. AIM: This study was aimed firstly to determine which task within the ADLs has poorer functional recovery in stroke patients with aphasia after rehabilitation, second to identify which specific task is related to aphasia. DESIGN: This is a prospective and observational study. SETTING: Inpatients of our Rehabilitation Unit. POPULATION: The study was carried out in 219 patients with primary diagnosis of stroke with (104) and without aphasia (115). METHODS: All patients underwent usual rehabilitation. Aachen Aphasia Test and Functional Independence Measure scale were used to assess severity of aphasia and ADLs, respectively. Gain in ADLs was the main outcome measure. RESULTS: At the end of rehabilitation patients with aphasia had lower gain in bathing, dressing upper body, dressing lower body, toileting, stair climbing, and higher gain in social interaction, problem solving, and memory with respect to patients without aphasia. However, when data were adjusted for side of hemiplegia, Fugl-Meyer score and trunk control test, patients with aphasia showed lower gain in dressing upper body (P=0.027), dressing lower body (P=0.009), lower toileting (P=0.027), and higher gain in social interaction (P<0.001). In the multivariate regression analysis, aphasia was an important determinant of gain in bathing (ß=0.26), dressing upper body (ß=0.24), dressing lower body (ß=0.22), lower toileting (ß=0.22), and social interaction (ß=-0.29). CONCLUSIONS: The current study points out that, after usual rehabilitation, the patients with aphasia show a poor gain in personal care activities and higher gain in social interaction. CLINICAL REHABILITATION IMPACT: Knowledge of these findings: 1) can guide the rehabilitation team in selecting specific and appropriate therapies aimed to give patient with aphasia the highest possible functional independence in ADLs; 2) is useful to family members and social rehabilitation services for domiciliary management of patients with aphasia.

Does 6-Month Home Caregiver-Supervised Physiotherapy Improve Post-Critical Care Outcomes?: A Randomized Controlled Trial.

OBJECTIVE: This study aims to determine whether a 6-month home physiotherapy program can improve outcomes in critical care survivors. DESIGN: Forty-eight consecutive patients were randomized. The treatment group underwent 2 sessions/day of breathing retraining and bronchial hygiene, physical activity (mobilization, sit-to-stand gait, limb strengthening), and exercise re-conditioning whereas controls underwent standard care. Maximum inspiratory/expiratory pressures (MIP/MEP), forced volumes, blood gases, dyspnea, respiratory rate, disability, peripheral force measurements, perceived health status (Euroquol-5D), patient adherence/satisfaction, safety, and costs were assessed. RESULTS: Outcomes of treatment versus controls: MIP 14 ± 17 vs. -0.2 ± 14 cm H2O, MEP 27 ± 27 vs. 6 ± 21 cm H2O both P < 0.03; in addition, quality of life (Euroquol-5D) (P = 0.04), FEV1 (P = 0.03), dyspnea (P = 0.002), and respiratory rate (P = 0.009) were significantly improved for treated cardiorespiratory patients only. Eighty-three percent of the treated patients were decannulated versus 14% of controls (P = 0.01). Compliance was high (74 ± 25%) and there were no side effects. The majority (87.4%) expressed satisfaction with the program. Treatment cost was 459&OV0556;/patient/month. CONCLUSIONS: Carrying over regular bronchial hygiene techniques, physical activity, and exercise into the home after long critical care stays is safe and has a beneficial effect on respiratory muscles, decannulation, pulmonary function, and quality of life.

Effects of a multidisciplinary care program on disability, autonomy, and nursing needs in subjects recovering from acute respiratory failure in a chronic ventilator facility.

BACKGROUND: The aim of this study was to analyze the effects of a multidisciplinary program carried out in a chronic ventilator facility on disability, autonomy, and nursing needs of patients after a prolonged ICU stay. Secondary outcome measures were survival, weaning rate, chronic ventilator facility stay, and discharge destination. METHODS: Multidisciplinary assessment, clinical stabilization, weaning attempts, and a new Disabled Patients Autonomy Planning tool to assess daily care needs were investigated in 240 subjects in a chronic ventilator facility (52 subjects after cardiovascular surgery, 60 subjects with acute respiratory failure, 71 subjects with COPD, and 57 subjects with neurological disease). RESULTS: At admission, nursing needs, disability, and autonomy differed according to diagnosis (P < .001); weaned subjects had greater nursing needs (P < .001) and disability (P = .0014) than unweaned subjects. During the stay, 13.8% of the subjects died irrespective of diagnosis (P = .12); 47% (P < .001) were weaned with significant differences (P <.007) by diagnosis. In the 207 surviving subjects, nursing needs increased as disability increased (r = 0.59, P < .001) and autonomy decreased (r = -0.66, P < .001); disability and autonomy were inter-related (r = 0.61, P < .001). Oxygen saturation, hypercapnia, dyspnea, disability, autonomy, and nursing needs significantly improved (all, P < .001). Fifty-nine percent of the subjects were discharged home. Subjects discharged to nursing homes presented mainly neurological diseases, being more disabled and less autonomous, with higher nursing needs (all, P < .04). Mechanical ventilation use and tracheostomy increased the probability of being discharged to a nursing home (odds ratio [OR] of 1.84, P = .04; OR 2.47, P = .003, respectively). Mortality was higher in subjects who were ventilated (OR 8.44, P < .001), male (OR 2.64, P = .01), elderly (P < .001), or malnourished (P = .01) and in subjects with low autonomy (P < .001), greater nursing needs (P = .002), and more severe disabilities (P = .04). CONCLUSIONS: A specialized tailored multidisciplinary program in subjects after an ICU stay contributed to recovery from disability, autonomy, and fewer nursing needs irrespective of diagnosis. Subjects discharged to a nursing home were the most severely disabled.