Reaching exercise for chronic paretic upper extremity after stroke using a novel rehabilitation robot with arm-weight support and concomitant electrical stimulation and vibration: before-and-after feasibility trial.

BACKGROUND: Our group developed a rehabilitation robot to assist with repetitive, active reaching movement of a paretic upper extremity. The robot is equipped with a servo motor-controlled arm-weight support and works in conjunction with neuromuscular electrical stimulation and vibratory stimulation to facilitate agonist-muscle contraction. In this before-and-after pilot study, we assessed the feasibility of applying the robot to improve motor control and function of the hemiparetic upper extremity in patients who suffered chronic stroke. METHODS: We enrolled 6 patients with chronic stroke and hemiparesis who, while sitting and without assistance, could reach 10 cm both sagitally and vertically (from a starting position located 10 cm forward from the patient's navel level) with the affected upper extremity. The patients were assigned to receive reaching exercise intervention with the robot (Yaskawa Electric Co., Ltd. Fukuoka, Japan) for 2 weeks at 15 min/day in addition to regular occupational therapy for 40 min/day. Outcomes assessed before and after 2 weeks of intervention included the upper extremity component of the Fugl-Meyer Assessment (UE-FMA), the Action Research Arm Test (ARAT), and, during reaching movement, kinematic analysis. RESULTS: None of the patients experienced adverse events. The mean score of UE-FMA increased from 44.8 [SD 14.4] to 48.0 [SD 14.4] (p = 0.026, r = 0.91), and both the shoulder-elbow and wrist-hand scores increased after 2-week intervention. An increase was also observed in ARAT score, from mean 29.8 [SD 16.3] to 36.2 [SD 18.1] (p = 0.042, r = 0.83). Kinematic analysis during the reaching movement revealed a significant increase in active range of motion (AROM) at the elbow, and movement time tended to decrease. Furthermore, trajectory length for the wrist ("hand path") and the acromion ("trunk compensatory movement") showed a decreasing trend. CONCLUSIONS: This robot-assisted modality is feasible and our preliminary findings suggest it improved motor control and motor function of the hemiparetic upper extremity in patients with chronic stroke. Training with this robot might induce greater AROM for the elbow and decrease compensatory trunk movement, thus contributing to movement efficacy and efficiency. Trial registration UMIN Clinical Trial Registry, as UMIN000018132, on June 30, 2015. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000020398.

Effects of concomitant neuromuscular electrical stimulation during repetitive transcranial magnetic stimulation before repetitive facilitation exercise on the hemiparetic hand.

BACKGROUND: Repetitive transcranial magnetic stimulation (rTMS) and Repetitive facilitative exercise (RFE) improves motor impairment after stroke. OBJECTIVE: To investigate whether neuromuscular electrical stimulation (NMES) can facilitate the effects of rTMS and RFE on the function of the hemiparetic hand in stroke patients. METHODS: This randomized double-blinded crossover study divided 20 patients with hemiparesis into two groups and provided treatment for 4 weeks at 5 days/week. NMES-before-sham group and NMES-following-sham group performed NMES sessions and sham NMES sessions for each 2 weeks. Patients received NMES or sham NMES for the affected extensor muscle concurrently with 1 Hz rTMS for the unaffected motor cortex for 10 min and performed RFE for 60 min. The Fugl-Meyer Assessment (FMA), Action Research Arm Test (ARAT), Box and Block Test (BBT) and Modified Ashworth Scale (MAS) were used for evaluation. RESULTS: FMA and ARAT improved significantly during both sessions. The gains in the BBT during an NMES session were significantly greater than those during a sham NMES session. MAS for the wrist and finger significantly decreased only during an NMES session. CONCLUSIONS: NMES combined with rTMS might facilitate, at least in part, the beneficial effects of RFE on motor function and spasticity of the affected upper limb.

Rationale and design of the theRapeutic effects of peroneal nerve functionAl electrical stimuLation for Lower extremitY in patients with convalescent poststroke hemiplegia (RALLY) study: study protocol for a randomised controlled study.

INTRODUCTION: Increasing evidence supports the utilisation of functional electrical stimulation (FES) to improve gait following stroke; however, few studies have focused exclusively on its use in the convalescent phase. In addition, its efficacy in patients with a non-Western life style has not been evaluated. METHODS AND ANALYSIS: This is a randomised, controlled, open-label multicentre study, comparing rehabilitation with and without FES. The purpose of our study is to test the hypothesis that the FES system improves walking ability in Japanese patients with hemiplegia during the convalescent phase. Two hundred patients aged 20-85 years who had an initial stroke ≤6 months prior to the enrolment, are in a convalescent phase (after the end of acute phase treatment, within 6 months after the onset of stroke) with functional ambulation classification 3 or 4 and have a hemiplegic gait disorder (drop foot) due to stroke have been recruited from 21 institutions in Japan. The patients are randomised in 1:1 fashion to usual gait rehabilitation or rehabilitation using FES (Walkaide). The trial duration is 8 weeks, and the primary outcome measured will be the change in maximum distance from baseline to the end of the trial, as measured with the 6 min walk test (6-MWT). The 6-MWT is performed barefoot, and the two treatment groups are compared using the analysis of covariance. ETHICS AND DISSEMINATION: This study is conducted in accordance with the principles of the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects and is approved by the ethics committee of all participating institutions. The published results will be disseminated to all the participants by the study physicians. TRIAL REGISTRATION NUMBER: The University Hospital Medical Information Network-Clinical Studies Registry (UMIN000020604).

Development of Quality Indicators of Stroke Centers and Feasibility of Their Measurement Using a Nationwide Insurance Claims Database in Japan　­ J-ASPECT Study ­

BACKGROUND: We aimed to develop quality indicators (QIs) related to primary and comprehensive stroke care and examine the feasibility of their measurement using the existing Diagnosis Procedure Combination (DPC) database. METHODS AND RESULTS: We conducted a systematic review of domestic and international studies using the modified Delphi method. Feasibility of measuring the QI adherence rates was examined using a DPC-based nationwide stroke database (396,350 patients admitted during 2013-2015 to 558 hospitals participating in the J-ASPECT study). Associations between adherence rates of these QIs and hospital characteristics were analyzed using hierarchical logistic regression analysis. We developed 17 and 12 measures as QIs for primary and comprehensive stroke care, respectively. We found that measurement of the adherence rates of the developed QIs using the existing DPC database was feasible for the 6 QIs (primary stroke care: early and discharge antithrombotic drugs, mean 54.6% and 58.7%; discharge anticoagulation for atrial fibrillation, 64.4%; discharge antihypertensive agents, 51.7%; comprehensive stroke care: fasudil hydrochloride or ozagrel sodium for vasospasm prevention, 86.9%; death complications of diagnostic neuroangiography, 0.4%). We found wide inter-hospital variation in QI adherence rates based on hospital characteristics. CONCLUSIONS: We developed QIs for primary and comprehensive stroke care. The DPC database may allow efficient data collection at low cost and decreased burden to evaluate the developed QIs.

Effect of Underwater Exercise on Lower-Extremity Function and Quality of Life in Post-Stroke Patients: A Pilot Controlled Clinical Trial.

OBJECTIVES: To date, controlled clinical trials evaluating the efficacy of underwater exercise in improving the lower-extremity function and quality of life (QOL) in post-stroke patients have yet to be conducted. The purpose of the present study was to determine whether repeated underwater exercise enhances the therapeutic effect of conventional therapy for post-stroke patients. DESIGN: This was a pilot controlled clinical trial. SETTING: The study took place in a research facility attached to a rehabilitation hospital. PATIENTS: This prospective trial included 120 consecutive post-stroke inpatients with hemiplegic lower limbs (Brunnstrom stage 3-6). Patients were assigned to either an experimental or a control group. Patients in the experimental group received both repeated underwater exercise and conventional rehabilitation therapy. INTERVENTIONS: The underwater exercise consisted of 30-min training sessions in a pool with a water temperature of 30-31°C in which patients followed the directions and movements of trained staff. Training sessions were conducted once a day on 2 days of the week for a total of 24 times. Patients in the control group received only the conventional therapy. OUTCOME MEASURES: The 10-Minute Walk Test (10MWT), the Modified Ashworth Scale, and the 36-Item Short Form Health Survey were the outcome measures used. Lower-extremity function and QOL were assessed before and upon completion of the 12-week program. RESULTS: Improvements in 10MWT results and spasticity parameters were greater in the experimental group than they were in the control group (p < 0.01). Significant differences between the groups were observed in magnitudes of changes of all QOL parameters (p < 0.01). CONCLUSIONS: Combining conventional therapy with repeated underwater exercise may improve both lower-extremity function and QOL in post-stroke patients.

Effects of repetitive facilitative exercise with neuromuscular electrical stimulation, vibratory stimulation and repetitive transcranial magnetic stimulation of the hemiplegic hand in chronic stroke patients.

AIM: Repetitive facilitative exercise (RFE) is a developed approach to the rehabilitation of hemiplegia. RFE can be integrated with neuromuscular electrical stimulation (NMES), direct application of vibratory stimulation (DAVS) and repetitive transcranial magnetic stimulation (rTMS). The aims of the present study were to retrospectively compare the effects of RFE and NMES, DAVS with those of RFE and rTMS, and to determine the maximal effect of the combination of RFE with NMES, DAVS, rTMS and pharmacological treatments in stroke patients. SUBJECTS AND METHODS: Thirty-three stroke patients were enrolled and divided into three groups: 15 who received RFE with rTMS (4 min) (TMS4 alone), 9 who received RFE with NMES, DAVS (NMES, DAVS alone) and 9 who received RFE with NMES, DAVS and rTMS (10 min) (rTMS10 + NMES, DAVS). The subjects performed the Fugl-Meyer Assessment (FMA) and Action Research Arm Test (ARAT) before and after the 2-week session. The 18 patients in the NMES, DAVS alone and rTMS10 + NMES, DAVS group underwent the intervention for 4 weeks. RESULT: There were no significant differences in the increases in the FMA, ARAT scores in the three groups. The FMA or ARAT scores in the NMES, DAVS alone and the rTMS10 + NMES, DAVS group were increased significantly. The FMA and ARAT scores were significantly improved after 4 weeks in the NMES, DAVS alone group. DISCUSSION: RFE with NMES, DAVS may be more effective than RFE with rTMS for the recovery of upper-limb function. Patients who received RFE with NMES, DAVS and pharmacological treatments showed significant functional recovery.

Anti-spastic effects of footbaths in post-stroke patients: a proof-of-principle study.

OBJECTIVES: To investigate whether a footbath inhibits spasticity in the hemiplegic lower limbs of post-stroke patients. DESIGN: Randomized, controlled study. SETTING: Rehabilitation education and research hospital. INTERVENTIONS: Twenty-two post-stroke patients were randomly allocated to control or experimental groups. After relaxing in a supine posture for 30min, the experimental group subject's legs were immersed in 41°C water below the knee joint for 15min, while the control group remained in a resting posture. MAIN OUTCOME MEASURES: Modified Ashworth Scale (MAS) scores of the affected triceps surae muscle and F-wave parameters (i.e., F-wave amplitude, F/M ratio, and F-wave persistence) were recorded before, immediately after, and 30min after each intervention. Physiological parameters were simultaneously monitored to determine the thermo-therapeutic mechanisms and side effects of footbath usage. RESULTS: At the time immediately after the intervention, F-wave amplitudes decreased significantly in the experimental group, compared to the control group (p<0.01, difference: -106.8; 95% CI; -181.58 to -32.09). F-wave amplitudes decreased significantly after 30-min intervention in the experimental group, with a total reduction of 161.2µV being recorded compared to 8.8µV increase in the control group (p<0.01, difference: -170.0; 95% CI; -252.73 to -87.33). There were also significant differences between the experimental and control group for both F/M ratio and F-wave persistence, immediately after and 30min after the intervention. Further, there were significant differences between the experimental and control group for the MAS scores immediately after the intervention (p<0.05, difference: -0.72; 95% CI; -1.262 to -0.193), and 30min after the intervention (p<0.05, difference: -0.73; 95% CI; -1.162 to -0.293). CONCLUSION: These findings demonstrate that the use of footbaths is an effective non-pharmacological anti-spastic treatment for use in stroke rehabilitation.

Novel neuromuscular electrical stimulation system for treatment of dysphagia after brain injury.

The purpose of this study was to compare the effects of a novel neuromuscular electrical stimulation (NMES) to the effects of conventional treatment in patients with dysphagia after brain injury. In total, 26 patients were non-randomly divided into an experimental group (n = 12) and a control group (n = 14). The experimental group received NMES intervention followed by conventional treatment, including thermaltactile stimulation with intensive repetition of a dry-swallow task. The control group received conventional treatment without NMES. NMES at a fixed pulse duration of 50 µs and a frequency of 50 Hz was delivered over the skin areas above the motor point of the target muscles, i.e., the bilateral geniohyoid, mylohyoid/anterior belly of the digastric, and thyrohyoid muscles, using a high-voltage pulsed-current device. The two groups received 40-min treatments once a day, 5 days per week, for 8 weeks. Outcome, assessed before and 8 weeks after treatment, was evaluated with regard to the videofluoroscopic dysphagia scale (VDS), the anterior and superior displacement of the hyoid bone and larynx, and the functional oral intake scale. Both groups exhibited improvement, but the experimental group exhibited more significant improvement in the displacement of the hyoid bone and larynx, VDS-total score, and VDS-pharyngeal score than the control group did. The results suggest that NMES combined with conventional treatment is superior to conventional treatment alone in patients with dysphagia following treatment for brain injury. Further investigations are necessary to examine the effects of NMES in patients with more varied types of diseases.

Novel neuromuscular electrical stimulation system for the upper limbs in chronic stroke patients: a feasibility study.

OBJECTIVE: The aim of this study was to assess the feasibility of applying a novel neuromuscular electrical stimulation system, targeting shoulder flexion, elbow extension, wrist extension, and individual finger extensions, to improve motor control and function of the hemiparetic upper limbs in chronic stroke patients. DESIGN: Fifteen participants with chronic (>1 yr after cerebrovascular accident) upper limb hemiparesis were enrolled. The subjects underwent upper limb training for 60 mins per day, 6 days per week, for 2 wks, using both a shoulder-and-elbow stimulation device and a wrist-and-finger stimulation device developed by the study investigators. Outcomes were assessed using the upper extremity component of the Fugl-Meyer assessment, the action research arm test, and the modified Ashworth scale before and after intervention. RESULTS: All patients completed the training successfully using the neuromuscular electrical stimulation system without any safety incidents or other complications reported. Nonparametric statistical analyses indicated significant improvements in the upper extremity component of the Fugl-Meyer assessment and action research arm test scores, both at P < 0.01. There were also significant reductions in modified Ashworth scale scores for the elbow and the wrist flexor, both at P < 0.01. CONCLUSIONS: The multimuscle stimulation approach and method presented in this study seem feasible, and the improvements of upper limb motor control and functional test in chronic stroke patients justify further controlled investigation.

Feasibility of using whole body vibration as a means for controlling spasticity in post-stroke patients: a pilot study.

To examine the feasibility of adapting whole body vibration (WBV) in the hemiplegic legs of post-stroke patients and to investigate the anti-spastic effects, and the improvement of motor function and walking ability. Twenty-five post-stroke patients with lower-limb spasticity were enrolled in the study. Each subject sat with hip joint angles to approximately 90° of flexion, and with knee joint angles to 0° of extension. WBV was applied at 30 Hz (4-8 mm amplitude) for 5 min on hamstrings, gastrocnemius and soleus muscles. The modified Ashworth scale was significantly decreased, active and passive range of motion (A-ROM, P-ROM) for ankle dorsiflexion and straight leg raising increased, and walking speed and cadence both improved during the 5-min intervention. Our proposed therapeutic approach could therefore be a novel neuro-rehabilitation strategy among patients with various severities.

Repetitive facilitative exercise under continuous electrical stimulation for severe arm impairment after sub-acute stroke: a randomized controlled pilot study.

OBJECTIVE: To investigate the effectiveness of repetitive facilitative exercise (RFE) under surface neuromuscular electrical stimulation (NMES) in patients with post-stroke hemiplegia. METHODS: This randomized, controlled, observer-blinded, pilot trial randomized 27 adults with severe arm impairment [Fugl-Meyer Arm scale (FMA) ≤ 20] due to stroke of 3-13 weeks duration into three groups and provided treatment on a 4-week, 40 minutes/day, 5 days/week schedule. The RFE-under-NMES group were given 100-150 repetitions of standardized movements of shoulder, elbow and wrist joints of their affected arm with concurrent low-amplitude NMES for each corresponding musculature. The RFE group was given the same exercise regimen but without NMES. The control group was treated with a conventional arm rehabilitation programme without NMES. FMA was assessed at baseline and 4 weeks. RESULTS: All 27 participants (nine in each group) completed the trial. At 4 weeks, the RFE-under-NMES group evidenced significantly greater improvement compared with the control group on the FMA (p = 0.003), but not with the RFE group (p = 0.092). The RFE group showed improvement compared with the control group, but it was not significant (p = 0.199). CONCLUSIONS: RFE under NMES is feasible in clinical settings and may be more effective than conventional rehabilitation in lessening arm impairment after sub-acute stroke.

Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients: a proof-of-principle study.

OBJECTIVE: To investigate whether the direct application of vibratory stimuli inhibits spasticity in the hemiplegic upper limbs of post-stroke patients. DESIGN: A randomized controlled study. SUBJECTS: Thirty-six post-stroke patients. METHODS: Patients were randomly allocated to the "Rest group", "Stretch group", or "Direct application of vibratory stimuli group". After relaxing in a supine posture for 30 min, subjects received the interventions for 5 min. The Modified Ashworth Scale scores and F-wave parameters were recorded before, immediately after and 30 min after each intervention. RESULTS: The Rest group showed no significant changes in F-wave parameters and Modified Ashworth Scale scores. The Stretch group showed a tendency to decrease in F-wave amplitude and F/M ratio immediately after the intervention, but not 30 min later. The Direct application of vibratory stimuli group showed significant improvements in F-wave parameters and Modified Ashworth Scale scores immediately after the intervention, which remained 30 minutes later. The changes in F-wave parameters and Modified Ashworth Scale scores observed in the Direct application of vibratory stimuli group significantly differed from those in the Rest group and the Stretch group. CONCLUSION: The direct application of vibratory stimuli has anti-spastic effects in the hemiplegic upper limbs of post-stroke patients.

Effects of thermal therapy combining sauna therapy and underwater exercise in patients with fibromyalgia.

Fibromyalgia syndrome (FMS) is a chronic disorder that is characterized by widespread pain with localized tenderness. We aimed to investigate whether thermal therapy combining sauna therapy and underwater exercise improved pain, symptoms, and quality of life (QOL) in FMS patients. Forty-four female FMS patients who fulfilled the American College of Rheumatology (ACR) criteria received 12-week thermal therapy program comprising sauna therapy once daily for 3 days/week and underwater exercise once daily for 2 days/week. Pain, symptoms, and QOL were assessed using a pain visual analog scale (VAS), a fibromyalgia impact questionnaire (FIQ), and a short form 36-item questionnaire (SF-36), respectively. All of the patients reported significant reductions in pain and symptoms of 31-77% after the 12-week thermal therapy program, which remained relatively stable (28-68%) during the 6-month follow-up period (that is, the thermal therapy program improved both the short-term and the long-term VAS and FIQ scores). Improvements were also observed in the SF-36 score. Thermal therapy combining sauna therapy and underwater exercise improved the QOL as well as the pain and symptoms of FMS patients.

Beneficial effects of footbaths in controlling spasticity after stroke.

Footbaths are considered to provide beneficial thermal therapy for post-stroke patients with spasticity, but their anti-spastic effects have not been investigated comprehensively. The present study aimed to evaluate alterations in motor-neuron excitability using F-wave parameters in post-stroke patients with spastic hemiplegia. Subjects' legs below the knee joint were immersed in water at 41 degrees C and F-wave recordings were made over the abductor hallucis muscle before, immediately after, and 30 min after thermal treatment. Antidromic stimulation was performed on the tibial nerve at the ankle. Measurements included F-wave amplitude, F-wave/M-response ratio, changes in modified Ashworth scale (MAS), body temperature and surface-skin temperature. The mean values of both F-wave parameters were higher on the affected side before footbath treatment. In post-stroke patients, the mean values of F-wave parameters were significantly reduced after footbath treatment (P < 0.01). The anti-spastic effects of footbath treatment were indicated by decreased F-wave parameters, in parallel with decreases in MAS. Body temperature was significantly increased both immediately after, and 30 min following footbath treatment in both groups, which appeared to play an important role in decreased spasticity. Surface-skin temperature increased immediately after footbath treatment in both groups and returned to baseline 30 min later. These findings demonstrate that the use of footbaths is an effective nonpharmacological anti-spastic treatment that might facilitate stroke rehabilitation.

New functional vibratory stimulation device for extremities in patients with stroke.

The utility of a new device that delivers functional vibratory stimulation to the extremities was studied in 13 patients with stroke. We hypothesized that vibratory stimulation of the hemiplegic lower limb would increase gait speed in these patients. The device consisted of one battery, two small vibrators and a connecting wire. The small vibrators were stabilized on the anterior tibial muscle and gluteus medius muscle by a bandage. An analysis of the effects of functional vibratory stimulation on hemiplegic lower limb on gait speed indicated that gait speed was greater during stimulation than without. These results suggest that the new device of functional vibratory stimulation is useful for treatment in patients with stroke.

Reduction of central poststroke pain with the selective serotonin reuptake inhibitor fluvoxamine.

To investigate the effect of the selective serotonin reuptake inhibitor (SSRI) fluvoxamine on central poststroke pain (CPSP), fluvoxamine (25 to 125 mg daily) was given to 31 patients. Although 3 patients dropped out within 1 week, 28 patients who received fluvoxamine for 2 to 4 weeks showed a significant reduction in the visual analog scale (VAS) for pain from 7.7 +/- 2.2 to 6.0 +/- 3.4 (p < .01). This improvement in VAS was significant in patients within less than 1 year after stroke, but not in those with a duration of more than 1 year. Zung's Self-rating Depression Scale (SDS) was also significantly improved after treatment, but there was no significant correlation between the changes in VAS and SDS. Although this is not a double-blind, placebo-controlled trial, these results suggest that fluvoxarnine is useful for the control of CPSP regardless of depression when used relatively early after stroke.