Effects of combining robot-assisted therapy with neuromuscular electrical stimulation on motor impairment, motor and daily function, and quality of life in patients with chronic stroke: a double-blinded randomized controlled trial.
ABSTRACT: Robot-assisted therapy (RT) is a widely used intervention approach to enhance motor recovery in patients after stroke, but its effects on functional improvement remained uncertain. Neuromuscular electrical stimulation (NMES) is one potential adjuvant intervention approach to RT that could directly activate the stimulated muscles and improve functional use of the paretic hand.This was a randomized, double-blind, sham-controlled study. Thirty-nine individuals with chronic stroke were randomly assigned to the RT combined with NMES (RT?+?ES) or to RT with sham stimulation (RT?+?Sham) groups. The participants completed the intervention 90 to 100 minutes/day, 5 days/week for 4 weeks. The outcome measures included the upper extremity Fugl-Meyer Assessment (UE-FMA), modified Ashworth scale (MAS), Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and Stroke Impact Scale 3.0 (SIS). All outcome measures were assessed before and after intervention, and the UE-FMA, MAL, and SIS were reassessed at 3 months of follow-up.Compared with the RT?+?Sham group, the RT?+?ES group demonstrated greater improvements in wrist flexor MAS score, WMFT quality of movement, and the hand function domain of the SIS. For other outcome measures, both groups improved significantly after the interventions, but no group differences were found.RT?+?ES induced significant benefits in reducing wrist flexor spasticity and in hand movement quality in patients with chronic stroke.ClinicalTrials.gov. NCT01655446.
Project description:BACKGROUND:Different mechanical supporting strategies to the joints in the upper extremity (UE) may lead to varied rehabilitative effects after stroke. This study compared the rehabilitation effectiveness achieved by electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-robotic systems when supporting to the distal fingers and to the proximal (wrist-elbow) joints. METHODS:Thirty subjects with chronic stroke were randomly assigned to receive motor trainings with NMES-robotic support to the finger joints (hand group, n = 15) and with support to the wrist-elbow joints (sleeve group, n = 15). The training effects were evaluated by the clinical scores of Fugl-Meyer Assessment (FMA), Action Research Arm Test (ARAT), and Modified Ashworth Scale (MAS) before and after the trainings, as well as 3 months later. The cross-session EMG monitoring of EMG activation level and co-contraction index (CI) were also applied to investigate the recovery progress of muscle activations and muscle coordination patterns through the training sessions. RESULTS:Significant improvements (P < 0.05) in FMA full score, FMA shoulder/elbow (FMA-SE) and ARAT scores were found in both groups, whereas significant improvements (P < 0.05) in FMA wrist/hand (FMA-WH) and MAS scores were only observed in the hand group. Significant decrease of EMG activation levels (P < 0.05) of UE flexors was observed in both groups. Significant decrease in CI values (P < 0.05) was observed in both groups in the muscle pairs of biceps brachii and triceps brachii (BIC&TRI) and the wrist-finger flexors (flexor carpi radialis-flexor digitorum) and TRI (FCR-FD&TRI). The EMG activation levels and CIs of the hand group exhibited faster reductions across the training sessions than the sleeve group (P < 0.05). CONCLUSIONS:Robotic supports to either the distal fingers or the proximal elbow-wrist could achieve motor improvements in UE. The robotic support directly to the distal fingers was more effective than to the proximal parts in improving finger motor functions and in releasing muscle spasticity in the whole UE. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov , identifier NCT02117089; date of registration: April 10, 2014. https://clinicaltrials.gov/ct2/show/NCT02117089.
Project description:BACKGROUND:Robotic rehabilitation of stroke survivors with upper extremity dysfunction may yield different outcomes depending on the robot type. Considering that excessive dependence on assistive force by robotic actuators may interfere with the patient's active learning and participation, we hypothesised that the use of an active-assistive robot with robotic actuators does not lead to a more meaningful difference with respect to upper extremity rehabilitation than the use of a passive robot without robotic actuators. Accordingly, we aimed to evaluate the differences in the clinical and kinematic outcomes between active-assistive and passive robotic rehabilitation among stroke survivors. METHODS:In this single-blinded randomised controlled pilot trial, we assigned 20 stroke survivors with upper extremity dysfunction (Medical Research Council scale score, 3 or 4) to the active-assistive robotic intervention (ACT) and passive robotic intervention (PSV) groups in a 1:1 ratio and administered 20 sessions of 30-min robotic intervention (5 days/week, 4 weeks). The primary (Wolf Motor Function Test [WMFT]-score and -time: measures activity), and secondary (Fugl-Meyer Assessment [FMA] and Stroke Impact Scale [SIS] scores: measure impairment and participation, respectively; kinematic outcomes) outcome measures were determined at baseline, after 2 and 4 weeks of the intervention, and 4 weeks after the end of the intervention. Furthermore, we evaluated the usability of the robots through interviews with patients, therapists, and physiatrists. RESULTS:In both the groups, the WMFT-score and -time improved over the course of the intervention. Time had a significant effect on the WMFT-score and -time, FMA-UE, FMA-prox, and SIS-strength; group?×?time interaction had a significant effect on SIS-function and SIS-social participation (all, p?<?0.05). The PSV group showed better improvement in participation and smoothness than the ACT group. In contrast, the ACT group exhibited better improvement in mean speed. CONCLUSIONS:There were no differences between the two groups regarding the impairment and activity domains. However, the PSV robots were more beneficial than ACT robots regarding participation and smoothness. Considering the high cost and complexity of ACT robots, PSV robots might be more suitable for rehabilitation in stroke survivors capable of voluntary movement. Trial registration The trial was registered retrospectively on 14 March 2018 at ClinicalTrials.gov (NCT03465267).
Project description:BACKGROUND AND OBJECTIVES:Bilateral upper limb training (BULT) and unilateral upper limb training (UULT) are two effective strategies for the recovery of upper limb motor function after stroke. This meta-analysis aimed to compare the improvements in motor impairment and functional performances of people with stroke after BULT and UULT. RESEARCH DESIGN AND METHODS:This systematic review and meta-analysis identified 21 randomized controlled trials (RCTs) met the eligibility criteria from CINAHL, Medline, Embase, Cochrane Library and PubMed. The outcome measures were the Fugl-Meyer Assessment of Upper Extremity (FMA-UE), Wolf Motor Function Test (WMFT), Action Research Arm Test (ARAT) and Box and Block Test (BBT), which are validated measures of upper limb function. RESULTS:Twenty-one studies involving 842 subjects with stroke were included. Compared with UULT, BULT yielded a significantly greater mean difference (MD) in the FMA-UE (MD = 2.21, 95% Confidence Interval (CI), 0.12 to 4.30, p = 0.04; I2 = 86%, p<0.001). However, a comparison of BULT and UULT yielded insignificant mean difference (MD) in terms of the time required to complete the WMFT (MD = 0.44; 95%CI, -2.22 to 3.10, p = 0.75; I2 = 55%, p = 0.06) and standard mean difference (SMD) in terms of the functional ability scores on the WMFT, ARAT and BBT (SMD = 0.25; 95%CI, -0.02 to 0.52, p = 0.07; I2 = 54%, p = 0.02). DISCUSSION AND IMPLICATIONS:Compared to UULT, BULT yielded superior improvements in the improving motor impairment of people with stroke, as measured by the FMA-UE. However, these strategies did not yield significant differences in terms of the functional performance of people with stroke, as measured by the WMFT, ARAT and BBT. More comparative studies of the effects of BULT and UULT are needed to increase the reliability of these conclusions.
Project description:End-effector (EE) and exoskeleton (Exo) robots have not been directly compared previously. The present study aimed to directly compare EE and Exo robots in chronic stroke patients with moderate-to-severe upper limb impairment. This single-blinded, randomised controlled trial included 38 patients with stroke who were admitted to the rehabilitation hospital. The patients were equally divided into EE and Exo groups. Baseline characteristics, including sex, age, stroke type, brain lesion side (left/right), stroke duration, Fugl-Meyer Assessment (FMA)-Upper Extremity score, and Wolf Motor Function Test (WMFT) score, were assessed. Additionally, impairment level (FMA, motor status score), activity (WMFT), and participation (stroke impact scale [SIS]) were evaluated. There were no significant differences in baseline characteristics between the groups. After the intervention, improvements were significantly better in the EE group with regard to activity and participation (WMFT-Functional ability rating scale, WMFT-Time, and SIS-Participation). There was no intervention-related adverse event. The EE robot intervention is better than the Exo robot intervention with regard to activity and participation among chronic stroke patients with moderate-to-severe upper limb impairment. Further research is needed to confirm this novel finding.
Project description:We investigated the training effects of interlimb force coupling training on paretic upper extremity outcomes in patients with chronic stroke and analyzed the relationship between motor recovery of the paretic hand, arm and functional performances on paretic upper limb.A randomized controlled trial with outcome assessment at baseline and after 4 weeks of intervention.Taipei Veterans General Hospital, National Yang-Ming University.Thirty-three subjects with chronic stroke were recruited and randomly assigned to training (n = 16) and control groups (n = 17).The computer-aided interlimb force coupling training task with visual feedback included different grip force generation methods on both hands.The Barthel Index (BI), the upper extremity motor control Fugl-Meyer Assessment (FMA-UE), the Motor Assessment Score (MAS), and the Wolf Motor Function Test (WMFT). All assessments were executed by a blinded evaluator, and data management and statistical analysis were also conducted by a blinded researcher.The training group demonstrated greater improvement on the FMA-UE (p<.001), WMFT (p<.001), MAS (p = .004) and BI (p = .037) than the control group after 4 weeks of intervention. In addition, a moderate correlation was found between the improvement of scores for hand scales of the FMA and other portions of the FMA UE (r = .528, p = .018) or MAS (r = .596, p = .015) in the training group.Computer-aided interlimb force coupling training improves the motor recovery of a paretic hand, and facilitates motor control and enhances functional performance in the paretic upper extremity of people with chronic stroke.ClinicalTrials.gov NCT02247674.
Project description:The ArmAssist is a simple low-cost robotic system for upper limb motor training that combines known benefits of repetitive task-oriented training, greater intensity of practice, and less dependence on therapist assistance. The aim of this preliminary study was to compare the efficacy of ArmAssist (AA) robotic training against matched conventional arm training in subacute stroke subjects with moderate-to-severe upper limb impairment. Twenty-six subjects were enrolled within 3 months of stroke and randomly assigned to the AA group or Control group (n = 13 each). Both groups were trained 5 days per week for 3 weeks. The primary outcome measure was Fugl-Meyer Assessment-Upper Extremity (FMA-UE) motor score, and the secondary outcomes were Wolf Motor Function Test-Functional Ability Scale (WMFT-FAS) and Barthel index (BI). The AA group, in comparison to the Control group, showed significantly greater increases in FMA-UE score (18.0 ± 9.4 versus 7.5 ± 5.5, p = 0.002) and WMFT-FAS score (14.1 ± 7.9 versus 6.7 ± 7.8, p = 0.025) after 3 weeks of treatment, whereas the increase in BI was not significant (21.2 ± 24.8 versus 13.1 ± 10.7, p = 0.292). There were no adverse events. We conclude that arm training using the AA robotic device is safe and able to reduce motor deficits more effectively than matched conventional arm training in subacute phase of stroke. The study has been registered at the ClinicalTrials.gov, ID: NCT02729649.
Project description:Objective. The aim of this exploratory pilot study is to test the effects of bilateral tDCS combined with upper extremity robot-assisted therapy (RAT) on stroke survivors. Methods. We enrolled 23 subjects who were allocated to 2 groups: RAT + real tDCS and RAT + sham-tDCS. Each patient underwent 10 sessions (5 sessions/week) over two weeks. Outcome measures were collected before and after treatment: (i) Fugl-Meyer Assessment-Upper Extremity (FMA-UE), (ii) Box and Block Test (BBT), and (iii) Motor Activity Log (MAL). Results. Both groups reported a significant improvement in FMA-UE score after treatment (p < 0.01). No significant between-groups differences were found in motor function. However, when the analysis was adjusted for stroke type and duration, a significant interaction effect (p < 0.05) was detected, showing that stroke duration (acute versus chronic) and type (cortical versus subcortical) modify the effect of tDCS and robotics on motor function. Patients with chronic and subcortical stroke benefited more from the treatments than patients with acute and cortical stroke, who presented very small changes. Conclusion. The additional use of bilateral tDCS to RAT seems to have a significant beneficial effect depending on the duration and type of stroke. These results should be verified by additional confirmatory studies.
Project description:Although the effects of robot-assisted arm training after stroke are promising, the relative effects of unilateral (URT) vs. bilateral (BRT) robot-assisted arm training remain uncertain. This study compared the effects of URT vs. BRT on upper extremity (UE) control, trunk compensation, and function in patients with chronic stroke.This was a single-blinded, randomized controlled trial. The intervention was implemented at 4 hospitals. Fifty-three patients with stroke were randomly assigned to URT, BRT, or control treatment (CT). Each group received UE training for 90 to 105 min/day, 5 days/week, for 4 weeks. The kinematic variables for arm motor control and trunk compensation included normalized movement time, normalized movement units, and the arm-trunk contribution slope in unilateral and bilateral tasks. Motor function and daily function were measured by the Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and ABILHAND Questionnaire.The BRT and CT groups elicited significantly larger slope values (i.e., less trunk compensation) at the start of bilateral reaching than the URT group. URT led to significantly better effects on WMFT-Time than BRT. Differences in arm control kinematics and performance on the MAL and ABILHAND among the 3 groups were not significant.BRT and URT resulted in differential improvements in specific UE/trunk performance in patients with stroke. BRT elicited larger benefits than URT on reducing compensatory trunk movements at the beginning of reaching. In contrast, URT produced better improvements in UE temporal efficiency. These relative effects on movement kinematics, however, did not translate into differential benefits in daily functions.ClinicalTrials.gov: NCT00917605.
Project description:Effective poststroke motor rehabilitation depends on repeated limb practice with voluntary efforts. An electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-robot arm was designed for the multi-joint physical training on the elbow, the wrist, and the fingers.To investigate the training effects of the device-assisted approach on subacute stroke patients and to compare the effects with those achieved by the traditional physical treatments.This study was a pilot randomized controlled trial with a 3-month follow-up. Subacute stroke participants were randomly assigned into two groups, and then received 20-session upper limb training with the EMG-driven NMES-robotic arm (NMES-robot group, n = 14) or the time-matched traditional therapy (the control, n = 10). For the evaluation of the training effects, clinical assessments including Fugl-Meyer Assessment (FMA), Modified Ashworth Score (MAS), Action Research Arm Test (ARAT), and Function Independence Measurement (FIM) were conducted before, after the rehabilitation training, and 3 months later. Session-by-session EMG parameters in the NMES-robot group, including normalized co-contraction Indexes (CI) and EMG activation level of target muscles, were used to monitor the progress in muscular coordination patterns.Significant improvements were obtained in FMA (full score and shoulder/elbow), ARAT, and FIM [P < 0.001, effect sizes (EFs) > 0.279] for both groups. Significant improvement in FMA wrist/hand was only observed in the NMES-robot group (P < 0.001, EFs = 0.435) after the treatments. Significant reduction in MAS wrist was observed in the NMES-robot group after the training (P < 0.05, EFs = 0.145) and the effects were maintained for 3 months. MAS scores in the control group were elevated following training (P < 0.05, EFs > 0.24), and remained at an elevated level when assessed 3 months later. The EMG parameters indicated a release of muscle co-contraction in the muscle pairs of biceps brachii and flexor carpi radialis and biceps brachii and triceps brachii, as well as a reduction of muscle activation level in the wrist flexor in the NMES-robot group.The NMES-robot-assisted training was effective for early stroke upper limb rehabilitation and promoted independence in the daily living comparable to the traditional physical therapy. It could achieve higher motor outcomes at the distal joints and more effective release in muscle tones than the traditional therapy.ClinicalTrials.gov, identifier NCT02117089; date of registration: April 10, 2014.
Project description:<h4>Objective</h4>To determine if clinical evaluations of post-stroke arm function correspond to everyday motor performance indexed by arm accelerometers.<h4>Design</h4>Cross-sectional study analyzing baseline data from a larger trial (NCT02665052).<h4>Setting</h4>Outpatient research center.<h4>Participants</h4>Twenty community-dwelling adults with chronic arm motor deficits (stroke?6mo).<h4>Intervention</h4>72-hours of home wrist-worn accelerometry during normal routine.<h4>Main outcome measures</h4>Clinical evaluations included the Fugl-Meyer (FM), Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), and two self-assessments: the Motor Activity Log (MAL) and hand motor subscale of the Stroke Impact Scale (SIS). Accelerometer-derived variables included quantifications of movement intensity (magnitude) and duration of arm use.<h4>Results</h4>Participants had moderate arm impairment (FM 36.1 ± 9.4). The accelerometer-derived mean magnitude ratio correlated significantly with the FM (<i>?</i> = 0.60, p < 0.01), WMFT functional score (<i>?</i> = 0.59, p < 0.01), and ARAT (<i>?</i> = 0.50, p < 0.05). The hours of use ratio correlated with the MAL amount of use (<i>?</i> = 0.58, p < 0.01) and quality of movement (<i>?</i> = 0.61, p < 0.01). Total paretic hours did not correlate with the FM, WMFT or ARAT, and intensity variables did not correlate with the MAL or SIS.<h4>Conclusions</h4>Participants with higher baseline function had greater intensity of paretic arm movement at home; similarly, those who perceived they had less disability used their paretic arm more relative to their non-paretic arm. However, some participants with higher clinical scores did not exhibit greater arm use in everyday life, possibly due to neglect and learned non-use. Therefore, individualized home accelerometry profiles could provide valuable insight to better tailor post-stroke rehabilitation.