Giovanni Taveggia

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.

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.

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.

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.

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.

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

Abstract 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.