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"Paresis"
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Effect of a four-week virtual reality-based training versus conventional therapy on upper limb motor function after stroke: A multicenter parallel group randomized trial
by
Schuster-Amft, Corina
,
Kiper, Daniel
,
Lehmann, Isabelle
in
Activities of daily living
,
Adult
,
Aged
2018
Virtual reality-based training has found increasing use in neurorehabilitation to improve upper limb training and facilitate motor recovery.
The aim of this study was to directly compare virtual reality-based training with conventional therapy.
In a multi-center, parallel-group randomized controlled trial, patients at least 6 months after stroke onset were allocated either to an experimental group (virtual reality-based training) or a control group receiving conventional therapy (16x45 minutes within 4 weeks). The virtual reality-based training system replicated patients´ upper limb movements in real-time to manipulate virtual objects. Blinded assessors tested patients twice before, once during, and twice after the intervention up to 2-month follow-up for dexterity (primary outcome: Box and Block Test), bimanual upper limb function (Chedoke-McMaster Arm and Hand Activity Inventory), and subjective perceived changes (Stroke Impact Scale).
54 eligible patients (70 screened) participated (15 females, mean age 61.3 years, range 20-81 years, time since stroke 3.0±SD 3 years). 22 patients were allocated to the experimental group and 32 to the control group (3 drop-outs). Patients in the experimental and control group improved: Box and Block Test mean 21.5±SD 16 baseline to mean 24.1±SD 17 follow-up; Chedoke-McMaster Arm and Hand Activity Inventory mean 66.0±SD 21 baseline to mean 70.2±SD 19 follow-up. An intention-to-treat analysis found no between-group differences.
Patients in the experimental and control group showed similar effects, with most improvements occurring in the first two weeks and persisting until the end of the two-month follow-up period. The study population had moderate to severely impaired motor function at entry (Box and Block Test mean 21.5±SD 16). Patients, who were less impaired (Box and Block Test range 18 to 72) showed higher improvements in favor of the experimental group. This result could suggest that virtual reality-based training might be more applicable for such patients than for more severely impaired patients.
ClinicalTrials.gov NCT01774669.
Journal Article
Three-dimensional, task-specific robot therapy of the arm after stroke: a multicentre, parallel-group randomised trial
2014
Arm hemiparesis secondary to stroke is common and disabling. We aimed to assess whether robotic training of an affected arm with ARMin—an exoskeleton robot that allows task-specific training in three dimensions—reduces motor impairment more effectively than does conventional therapy.
In a prospective, multicentre, parallel-group randomised trial, we enrolled patients who had had motor impairment for more than 6 months and moderate-to-severe arm paresis after a cerebrovascular accident who met our eligibility criteria from four centres in Switzerland. Eligible patients were randomly assigned (1:1) to receive robotic or conventional therapy using a centre-stratified randomisation procedure. For both groups, therapy was given for at least 45 min three times a week for 8 weeks (total 24 sessions). The primary outcome was change in score on the arm (upper extremity) section of the Fugl-Meyer assessment (FMA-UE). Assessors tested patients immediately before therapy, after 4 weeks of therapy, at the end of therapy, and 16 weeks and 34 weeks after start of therapy. Assessors were masked to treatment allocation, but patients, therapists, and data analysts were unmasked. Analyses were by modified intention to treat. This study is registered with ClinicalTrials.gov, number NCT00719433.
Between May 4, 2009, and Sept 3, 2012, 143 individuals were tested for eligibility, of whom 77 were eligible and agreed to participate. 38 patients assigned to robotic therapy and 35 assigned to conventional therapy were included in analyses. Patients assigned to robotic therapy had significantly greater improvements in motor function in the affected arm over the course of the study as measured by FMA-UE than did those assigned to conventional therapy (F=4·1, p=0·041; mean difference in score 0·78 points, 95% CI 0·03–1·53). No serious adverse events related to the study occurred.
Neurorehabilitation therapy including task-oriented training with an exoskeleton robot can enhance improvement of motor function in a chronically impaired paretic arm after stroke more effectively than conventional therapy. However, the absolute difference between effects of robotic and conventional therapy in our study was small and of weak significance, which leaves the clinical relevance in question.
Swiss National Science Foundation and Bangerter-Rhyner Stiftung.
Journal Article
Bilateral effect of acupuncture on cerebrum and cerebellum in ischaemic stroke patients with hemiparesis: a randomised clinical and neuroimaging trial
2024
BackgroundAcupuncture involving the limb region may be effective for stroke rehabilitation clinically, but the visualised and explanatory evidence is limited. Our objectives were to assess the specific effects of acupuncture for ischaemic stroke (IS) patients with hemiparesis and investigate its therapy-driven modification in functional connectivity.MethodsIS patients were randomly assigned (2:1) to receive 10 sessions of hand-foot 12 needles acupuncture (HA, n=30) or non-acupoint (NA) acupuncture (n=16), enrolling gender-matched and age-matched healthy controls (HCs, n=34). The clinical outcomes were the improved Fugl-Meyer Assessment scores including upper and lower extremity (ΔFM, ΔFM-UE, ΔFM-LE). The neuroimaging outcome was voxel-mirrored homotopic connectivity (VMHC). Static and dynamic functional connectivity (sFC, DFC) analyses were used to study the neuroplasticity reorganisation.Results46 ISs (mean(SD) age, 59.37 (11.36) years) and 34 HCs (mean(SD) age, 52.88 (9.69) years) were included in the per-protocol analysis of clinical and neuroimaging. In clinical, ΔFM scores were 5.00 in HA group and 2.50 in NA group, with a dual correlation between ΔFM and ΔVMHC (angular: r=0.696, p=0.000; cerebellum: r=−0.716, p=0.000) fitting the linear regression model (R2=0.828). In neuroimaging, ISs demonstrated decreased VMHC in bilateral postcentral gyrus and cerebellum (Gaussian random field, GRF corrected, voxel p<0.001, cluster p<0.05), which fitted the logistic regression model (AUC=0.8413, accuracy=0.7500). Following acupuncture, VMHC in bilateral superior frontal gyrus orbital part was increased with cerebro-cerebellar changes, involving higher sFC between ipsilesional superior frontal gyrus orbital part and the contralesional orbitofrontal cortex as well as cerebellum (GRF corrected, voxel p<0.001, cluster p<0.05). The coefficient of variation of VMHC was decreased in bilateral posterior cingulate gyrus (PPC) locally (GRF corrected, voxel p<0.001, cluster p<0.05), with integration states transforming into segregation states overall (p<0.05). There was no acupuncture-related adverse event.ConclusionsThe randomised clinical and neuroimaging trial demonstrated acupuncture could promote the motor recovery and modified cerebro-cerebellar VMHC via bilateral static and dynamic reorganisations for IS patients with hemiparesis.
Journal Article
Measurement properties of movement smoothness metrics for upper limb reaching movements in people with moderate to severe subacute stroke
by
Cornec, Gwenaël
,
Medee, Beatrice
,
Remy-Neris, Olivier
in
Adult
,
Aged
,
Biomechanical Phenomena
2024
Background
Movement smoothness is a potential kinematic biomarker of upper extremity (UE) movement quality and recovery after stroke; however, the measurement properties of available smoothness metrics have been poorly assessed in this group. We aimed to measure the reliability, responsiveness and construct validity of several smoothness metrics.
Methods
This ancillary study of the REM-AVC trial included 31 participants with hemiparesis in the subacute phase of stroke (median time since stroke: 38 days). Assessments performed at inclusion (Day 0, D0) and at the end of a rehabilitation program (Day 30, D30) included the UE Fugl Meyer Assessment (UE-FMA), the Action Research Arm Test (ARAT), and 3D motion analysis of the UE during three reach-to-point movements at a self-selected speed to a target located in front at shoulder height and at 90% of arm length. Four smoothness metrics were computed: a frequency domain smoothness metric, spectral arc length metric (SPARC); and three temporal domain smoothness metrics (TDSM): log dimensionless jerk (LDLJ); number of submovements (nSUB); and normalized average rectified jerk (NARJ).
Results
At D30, large clinical and kinematic improvements were observed. Only SPARC and LDLJ had an excellent reliability (intra-class correlation > 0.9) and a low measurement error (coefficient of variation < 10%). SPARC was responsive to changes in movement straightness (r
Spearman
=0.64) and to a lesser extent to changes in movement duration (r
Spearman
=0.51) while TDSM were very responsive to changes in movement duration (r
Spearman
>0.8) and not to changes in movement straightness (non-significant correlations). Most construct validity hypotheses tested were verified except for TDSM with low correlations with clinical metrics at D0 (r
Spearman
<0.5), ensuing low predictive validity with clinical metrics at D30 (non-significant correlations).
Conclusions
Responsiveness and construct validity of TDSM were hindered by movement duration and/or noise-sensitivity. Based on the present results and concordant literature, we recommend using SPARC rather than TDSM in reaching movements of uncontrolled duration in individuals with spastic paresis after stroke.
Trial Registration
NCT01383512,
https://clinicaltrials.gov/
, June 27, 2011.
Highlights
Reliability, responsiveness and construct validity of SPARC were satisfactory.
Responsiveness and construct validity of LDLJ, NARJ and nSUB were highly related to movement duration.
LDLJ had an excellent reliability and a low measurement error, but not NARJ and nSUB.
Journal Article
Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial
by
Gul, Fatma
,
Skoromets, Alexander
,
Vilain, Claire
in
Acetylcholine Release Inhibitors - administration & dosage
,
Acetylcholine Release Inhibitors - adverse effects
,
Acetylcholine Release Inhibitors - pharmacology
2015
Resistance from antagonistic muscle groups might be a crucial factor reducing function in chronic hemiparesis. The resistance due to spastic co-contraction might be reduced by botulinum toxin injections. We assessed the effects of abobotulinumtoxinA injection in the upper limb muscles on muscle tone, spasticity, active movement, and function.
In this randomised, placebo-controlled, double-blind study, we enrolled adults (aged 18–80 years) at least 6 months after stroke or brain trauma from 34 neurology or rehabilitation clinics in Europe and the USA. Eligible participants were randomly allocated in a 1:1:1 ratio with a computer-generated list to receive a single injection session of abobotulinumtoxinA 500 U or 1000 U or placebo into the most hypertonic muscle group among the elbow, wrist, or finger flexors (primary target muscle group [PTMG]), and into at least two additional muscle groups from the elbow, wrist, or finger flexors or shoulder extensors. Patients and investigators were masked to treatment allocation. The primary endpoint was the change in muscle tone (Modified Ashworth Scale [MAS]) in the PTMG from baseline to 4 weeks. Secondary endpoints were Physician Global Assessment (PGA) at week 4 and change from baseline to 4 weeks in the perceived function (Disability Assessment Scale [DAS]) in the principal target of treatment, selected by the patient together with physician from four functional domains (dressing, hygiene, limb position, and pain). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01313299.
243 patients were randomly allocated to placebo (n=81), abobotulinumtoxinA 500 U (n=81), or abobotulinumtoxinA 1000 U (n=81). Mean change in MAS score from baseline at week 4 in the PTMG was −0·3 (SD 0·6) in the placebo group (n=79), −1·2 (1·0) in the abobotulinumtoxinA 500 U group (n=80; difference −0·9, 95% CI −1·2 to −0·6; p<0·0001 vs placebo), and −1·4 (1·1) in the abobotulinumtoxinA 1000 U group (n=79; −1·1, −1·4 to −0·8; p<0·0001 vs placebo). Mean PGA score at week 4 was 0·6 (SD 1·0) in the placebo group (n=78), 1·4 (1·1) in the abobotulinumtoxinA 500 U group (n=80; p=0·0003 vs placebo), and 1·8 (1·1) in the abobotulinumtoxinA 1000 U group (n=78; p<0·0001 vs placebo). Mean change from baseline at week 4 in DAS score for the principal target of treatment was −0·5 (0·7) in the placebo group (n=79), −0·7 (0·8) in the abobotulinumtoxinA 500 U group (n=80; p=0·2560 vs placebo), and −0·7 (0·7) in the abobotulinumtoxinA 1000 U group (n=78; p=0·0772 vs placebo). Three serious adverse events occurred in each group and none were treatment related; two resulted in death (from pulmonary oedema in the placebo group and a pre-existing unspecified cardiovascular disorder in the abobotulinumtoxinA 500 U group). Adverse events that were thought to be treatment related occurred in two (2%), six (7%), and seven (9%) patients in the placebo, abobotulinumtoxinA 500 U, and abobotulinumtoxinA 1000 U groups, respectively. The most common treatment-related adverse event was mild muscle weakness. All adverse events were mild or moderate.
AbobotulinumtoxinA at doses of 500 U or 1000 U injected into upper limb muscles provided tone reduction and clinical benefit in hemiparesis. Future research into the treatment of spastic paresis with botulinum toxin should use active movement and function as primary outcome measures.
Ipsen.
Journal Article
The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study
by
Bortole, Magdo
,
Contreras-Vidal, Jose L
,
Moreno, Juan C
in
Activities of daily living
,
Adult
,
Algorithms
2015
Background
Stroke significantly affects thousands of individuals annually, leading to considerable physical impairment and functional disability. Gait is one of the most important activities of daily living affected in stroke survivors. Recent technological developments in powered robotics exoskeletons can create powerful adjunctive tools for rehabilitation and potentially accelerate functional recovery. Here, we present the development and evaluation of a novel lower limb robotic exoskeleton, namely H2 (Technaid S.L., Spain), for gait rehabilitation in stroke survivors.
Methods
H2 has six actuated joints and is designed to allow intensive overground gait training. An assistive gait control algorithm was developed to create a force field along a desired trajectory, only applying torque when patients deviate from the prescribed movement pattern. The device was evaluated in 3 hemiparetic stroke patients across 4 weeks of training per individual (approximately 12 sessions). The study was approved by the Institutional Review Board at the University of Houston. The main objective of this initial pre-clinical study was to evaluate the safety and usability of the exoskeleton. A Likert scale was used to measure patient’s perception about the easy of use of the device.
Results
Three stroke patients completed the study. The training was well tolerated and no adverse events occurred. Early findings demonstrate that H2 appears to be safe and easy to use in the participants of this study. The overground training environment employed as a means to enhance active patient engagement proved to be challenging and exciting for patients. These results are promising and encourage future rehabilitation training with a larger cohort of patients.
Conclusions
The developed exoskeleton enables longitudinal overground training of walking in hemiparetic patients after stroke. The system is robust and safe when applied to assist a stroke patient performing an overground walking task. Such device opens the opportunity to study means to optimize a rehabilitation treatment that can be customized for individuals.
Trial registration:
This study was registered at ClinicalTrials.gov (
https://clinicaltrials.gov/show/NCT02114450
).
Journal Article
Effects of device-assisted practice of activities of daily living in a close-to-normal pattern on upper extremity motor recovery in individuals with moderate to severe stroke: study protocol of a randomized control trial
by
Carmona, Carolina
,
Yao, Jun
,
Drogos, Justin M.
in
Activities of Daily Living
,
Arm hand
,
Biomedicine
2025
Background
The majority of individuals with chronic stroke have residual upper extremity (UE) disability which they cite as their greatest barrier to recovery. Using orthoses, robotic devices, and functional electrical stimulation (FES) represent rehabilitation techniques that have demonstrated the ability to improve arm and hand function in the chronic stroke population, but individuals with more severe impairments are typically not eligible for these studies. The very few studies incorporating these techniques with the severely impaired population do not utilize volitional FES control or modulated loading, which has been shown to promote greater motor recovery and functional improvement. An UE intervention utilizing an advanced orthosis incorporating volitionally controlled FES and robotically modulated shoulder abduction (SABD) loading may provide a pathway to improved coordinated use of the arm and hand for the more severely impaired chronic stroke population.
Methods
In a double-blinded, two-baseline, randomized control trial individuals with chronic moderate to severe stroke resulting in UE hemiparesis will participate in a task-based reaching-grasping-retrieving-releasing (GR3) intervention three times a week for 8 weeks. An anticipated 60 individuals will perform a repeated GR3 task with the ReIn-Hand device (ReIn-Hand), a customized forearm/hand orthosis integrating volitionally controlled FES, to assist with paretic hand-opening. Participants will be randomly assigned to a control group (ReIn-Hand only) or experimental group which will also receive modulated SABD loading via the PACT3D robot. Groups will be compared by (1) their change in function primarily measured by the Box and Blocks Test; (2) change in performance measured by kinematic analysis of reaching and hand-opening and (3) changes in neural motor recovery measured using electroencephalography (EEG) and magnetic resonance imaging (MRI).
Discussion
The present study will evaluate the effectiveness of a novel interventional device, with and without shoulder abduction assistance, as part of a task-specific training protocol with the moderate to severe chronic stroke population. The focus on the more impaired chronic stroke population provides the opportunity to improve the rehabilitation of this overlooked population. Functional and structural measures using advanced imaging techniques offer the possibility to further delineate recovery and compensation at the neuronal level.
Trial registration
ClinicalTrials.gov ID NCT04077073. Registration date: September 04, 2019.
Journal Article
Reinforced Feedback in Virtual Environment for Rehabilitation of Upper Extremity Dysfunction after Stroke : Preliminary Data from a Randomized Controlled Trial
2014
Objectives. To study whether the reinforced feedback in virtual environment (RFVE) is more effective than traditional rehabilitation (TR) for the treatment of upper limb motor function after stroke, regardless of stroke etiology (i.e., ischemic, hemorrhagic). Design. Randomized controlled trial. Participants. Forty-four patients affected by stroke. Intervention. The patients were randomized into two groups: RFVE (N=23) and TR (N=21), and stratified according to stroke etiology. The RFVE treatment consisted of multidirectional exercises providing augmented feedback provided by virtual reality, while in the TR treatment the same exercises were provided without augmented feedbacks. Outcome Measures. Fugl-Meyer upper extremity scale (F-M UE), Functional Independence Measure scale (FIM), and kinematics parameters (speed, time, and peak). Results. The F-M UE (P=0.030), FIM (P=0.021), time (P=0.008), and peak (P=0.018), were significantly higher in the RFVE group after treatment, but not speed (P=0.140). The patients affected by hemorrhagic stroke significantly improved FIM (P=0.031), time (P=0.011), and peak (P=0.020) after treatment, whereas the patients affected by ischemic stroke improved significantly only speed (P=0.005) when treated by RFVE. Conclusion. These results indicated that some poststroke patients may benefit from RFVE program for the recovery of upper limb motor function. This trial is registered with NCT01955291.
Journal Article
Effects and neural mechanisms of a brain–computer interface-controlled soft robotic glove on upper limb function in patients with subacute stroke: a randomized controlled fNIRS study
2025
Background and purpose
The brain-computer interface-based soft robotic glove (BCI-SRG) holds promise for upper limb rehabilitation in subacute stroke patients, yet its efficacy and neural mechanisms are unclear. This study aimed to investigate the therapeutic effects and neural mechanisms of BCI-SRGs by functional near-infrared spectroscopy (fNIRS).
Methods
Forty subacute stroke patients with left-sided hemiparesis were randomized into the BCI-SRG (n = 20) and soft robotic glove (SRG) (n = 20) groups. Both groups received 20 sessions of intervention over 4 weeks in addition to conventional rehabilitation. The BCI-SRG group was trained using a soft robotic glove controlled by a brain‒computer interface (BCI), whereas the SRG group used the same soft robotic glove without BCI control. The clinical outcomes included the Action Research Arm Test (ARAT), the Fugl-Meyer Assessment Upper Limb (FMA-UL), and Modified Barthel Index (MBI) scores. In addition, fNIRS was used to explore potential clinical brain mechanisms. All assessments were performed before treatment and after 4 weeks of treatment.
Results
A total of 39 participants completed the intervention and clinical assessments (BCI-SRG: n = 20; SRG: n = 19). Compared with the SRG group, the BCI-SRG group showed greater improvements in the ARAT (Z = − 2.139,
P
= 0.032) and FMA-UL (Z = − 2.588,
P
= 0.010), with no notable difference in the MBI (Z = − 1.843,
P
= 0.065). fNIRS data were available for 35 participants (BCI-SRG: n = 17; SRG: n = 18). Within-group comparisons revealed significant postintervention increases in cortical activation in the bilateral sensorimotor cortex (SMC) and medial prefrontal cortex (MPFC) in the BCI-SRG group, whereas no significant changes were observed in the SRG group. Between-group comparisons further revealed significantly greater changes in HbO concentrations in the BCI-SRG group than in the SRG group across the same cortical regions. Moreover, changes in prefrontal activation (post–pre) were positively correlated with improvements in ARAT scores, with significant correlations observed in the left dorsal lateral prefrontal cortex (LDLPFC) (Ch9, r = 0.592,
P
= 0.012; Ch25, r = 0.488,
P
= 0.047) and right dorsal lateral prefrontal cortex (RDLPFC) (Ch19, r = 0.671,
P
= 0.003).
Conclusions
BCI-SRG training significantly enhances upper limb function and facilitates bilateral motor and sensory cortical reorganization. PFC activation is correlated with functional improvements, suggesting a potential mechanism underlying the benefits of rehabilitation in stroke patients.
Trial registration
This trial was registered under the Chinese Clinical Trial Registry (ChiCTR2400082786) and was retrospectively registered on April 8, 2024.
Journal Article
Quality-of-Life Change Associated With Robotic-Assisted Therapy to Improve Hand Motor Function in Patients With Subacute Stroke: A Randomized Clinical Trial
by
Jay L. Alberts
,
Steven L. Wolf
,
Rebecca Zhang
in
Activities of Daily Living
,
Affect
,
Care and treatment
2010
At 6 months poststroke, most patients cannot incorporate their affected hand into daily activities, which in turn is likely to reduce their perceived quality of life.
This preliminary study explored change in patient-reported, health-related quality of life associated with robotic-assisted therapy combined with reduced therapist-supervised training.
A single-blind, multi-site, randomized clinical trial was conducted.
Seventeen individuals who were 3 to 9 months poststroke participated.
Sixty hours of therapist-supervised repetitive task practice (RTP) was compared with 30 hours of RTP combined with 30 hours of robotic-assisted therapy.
Participants completed the Stroke Impact Scale (SIS) at baseline, immediately postintervention, and 2 months postintervention. Change in SIS score domains was assessed in a mixed model analysis.
The combined therapy group had a greater increase in rating of mood from preintervention to postintervention, and the RTP-only group had a greater increase in rating of social participation from preintervention to follow-up. Both groups had statistically significant improvement in activities of daily living and instrumental activities of daily living scores from preintervention to postintervention. Both groups reported significant improvement in hand function postintervention and at follow-up, and the magnitude of these changes suggested clinical significance. The combined therapy group had significant improvements in stroke recovery rating postintervention and at follow-up, which appeared clinically significant; this also was true for stroke recovery rating from preintervention to follow-up in the RTP-only group. LIMITATIONS OUTCOMES: of 30 hours of RTP in the absence of robotic-assisted therapy remain unknown.
Robotic-assisted therapy may be an effective alternative or adjunct to the delivery of intensive task practice interventions to enhance hand function recovery in patients with stroke.
Journal Article