To investigate the effects of unilateral hybrid therapy (UHT) and bilateral hybrid therapy (BHT) compared with robot-assisted therapy (RT) alone in patients with chronic stroke.
Results from a clinical trial testing the MyoRegulator device for the non-invasive treatment of spasticity, published recently in Bioelectronic Medicine, suggest evidence for using MyoRegulator to treat upper extremity spasticity in subjects with chronic stroke, PathMaker Neurosystems Inc announces.
PathMaker Neurosystems Inc is a clinical-stage bioelectronic medicine company that develops non-invasive systems for the treatment of patients with spasticity and paralysis. The MyoRegulator is an investigational medical device and is limited by US Federal law to investigational use only.
The device is based on PathMaker’s proprietary DoubleStim technology (combining anodal trans-spinal direct current stimulation (tsDCS) and peripheral nerve direct current stimulation (pDCS)), which provides simultaneous non-invasive stimulation intended to suppress hyperexcitable spinal neurons involved with spasticity, the company explains in a media release.
“Current pharmacological approaches to managing spasticity have, at best, short-term efficacy, are confounded by adverse effects, and are often unpleasant for the patient,” said co-author Zaghloul Ahmed, PhD, professor and chairman, Department of Physical Therapy and Professor, Center for Developmental Neuroscience, CUNY and Scientific Founder of PathMaker Neurosystems.
“The initial study results demonstrate the potential of a novel, non-invasive treatment to reduce spasticity and improve functional recovery in patients with upper motor neuron syndrome after stroke.”
The single-blind, sham-controlled, crossover design study, authored by researchers at Feinstein Institute for Medical Research at Northwell Health (and led by Bruce Volpe, MD, included patients with upper limb hemiparesis and wrist spasticity at least 6 months after their initial stroke to test whether MyoRegulator treatment reduces chronic upper-extremity spasticity.
Twenty subjects received five consecutive 20-minute daily treatments with sham stimulation followed by a 1-week washout period, then five consecutive 20-minute daily treatments with active stimulation. Subjects were told that the order of active or sham stimulation would be randomized.
Clinical and objective measures of spasticity and motor function were collected before the first session of each condition (baseline), immediately following the last session of each condition, and weekly for 5 weeks after the completion of active treatments.
The results demonstrated significant group mean reductions from baseline in both Modified Tardieu Scale scores (summed across the upper limb, P<0.05), and in objectively measured muscle resistance at the wrist flexor (P<0.05) following active treatment as compared to following sham treatment.
Motor function also improved significantly (measured by the Fugl-Meyer and Wolf Motor Function Test; P<0.05 for both tests) after active treatment, even without additional prescribed activity or training. The effect of the active MyoRegulator treatment was durable for the 5-week follow-up period, the release continues.
“We are highly encouraged by these clinical results which demonstrate the potential of MyoRegulator to improve outcomes for patients suffering from spasticity, without the need for surgery or drugs,” says Nader Yaghoubi, MD, PhD, president and chief executive officer of PathMaker.
“Building on these results and our ongoing clinical trial in Europe, we expect to initiate a US multi-center, pivotal, double-blind clinical trial supported by the National Institute of Neurological Disorders and Stroke (NINDS) in early 2020.”
[Source: PathMaker Neurosystems Inc]
Objective: To compare the effects of transcranial direct current stimulation (TDCS) with traditional Chinese acupuncture on upper-extremity (UE) function among patients with stroke.
Materials and Methods: Participants with subacute to chronic stroke who had moderate to severe UE functional impairment were randomly allocated to the TDCS or electro-acupuncture group, then underwent three weeks of physical therapy and occupational therapy, with 20 minutes of a-TDCS (2 mA) or electro-acupuncture applied during training once weekly. Primary outcome was determined using the Fugl-Meyer Assessment of motor recovery at 1-month follow-up.
Results: The 18 participants were allocated into two groups. Fugl-Meyer Assessment increased in both the TDCS and electroacupuncture groups (5.00±3.08, p=0.001 and 7.4±4.9, p=0.002, respectively). However, no difference was found between groups, and no significant difference was observed in grip strength and task specific performance in both groups.
Conclusion: The application of TDCS might provide benefits in recovering hand motor function among patients with subacute to chronic stroke but does not go beyond those of electro-acupuncture.
via Comparison between Transcranial Direct Current Stimulation and Acupuncture on Upper Extremity Rehabilitation in Stroke: A Single-Blind Randomized Controlled Trial | Hathaiareerug | JOURNAL OF THE MEDICAL ASSOCIATION OF THAILAND
An investigational, non-invasive medical device shows promise as a possible treatment for spasticity in patients who have experienced a stroke, Feinstein Institutes for Medical Research scientists report.
Their study, published in Springer Nature’s Bioelectronic Medicine, suggests that trans-spinal direct current stimulation and peripheral nerve direct current stimulation significantly reduced upper limb spasticity in participants who experienced a stroke.
Spasticity is a residual inability of the brain to control muscle tone. It increases muscle stiffness, which inhibits movement of the hands, arms, and legs; can affect the face and throat; and sometimes causes pain.
Efforts to treat upper limb spasticity have focused on intensive, repetitive, activity-dependent learning; however, it is common to experience residual spasticity despite aggressive therapy. When spasticity continues to worsen and causes pain, the standard-of-care is botox (botulinum toxin) injection, according to a media release from Feinstein Institutes for Medical Research.
“Spasticity is a persistent and common inhibitor of movement in patients with chronic stroke, and it has been a great hurdle as we continue to use intensive training to assist motor recovery,” says Bruce T. Volpe, MD, professor at the Feinstein Institutes and lead author of the paper, in the release.
“The surprise in these clinical results were the improved motor functions that apparently occurred with the focused treatment only of spasticity. We are eager to start a trial that couples motor training and anti-spasticity treatment.”
The treatment involves passing a direct electrical current across the spinal cord with a skin surface electrode, known as trans-spinal direct current stimulation (tsDCS), and adding a peripheral direct current stimulation (pDCS) in the paralyzed upper limb. There are additional benefits to patients when tsDCS is combined with pDCS.
Volpe, along with a team that includes Johanna Chang, MS, Alexandra Paget-Blanc, BS, and Maira Saul, MD, employed this device in patients with chronic stroke and hemiparesis to test whether treatment would decrease upper limb spasticity. The trial was a single-blind cross-over design study.
Twenty six participants were treated with five consecutive days of 20 minutes of active, paired tsDCS+pDCS. The participants received both active and sham stimulation conditions, but were not told the order of stimulation.
The device used in the trial was PathMaker Neurosystems Inc’s MyoRegulator, a non-invasive device designed to provide simultaneous, non-invasive stimulation intended to suppress hyperexcitable spinal neurons involved with spasticity.
The results demonstrated that the active treatment condition significantly reduced upper limb spasticity for up to five weeks and these patient responders saw significant improvements in motor function, the release explains.
[Source(s): Feinstein Institutes for Medical Research, PR Newswire]
To investigate the effects of unilateral hybrid therapy (UHT) and bilateral hybrid therapy (BHT) compared with robot-assisted therapy (RT) alone in patients with chronic stroke.
A single-blind, randomized controlled trial
Forty-four outpatients with chronic stroke and mild to moderate motor impairment.
UHT combined unilateral RT (URT) and modified constraint-induced therapy. BHT combined bilateral RT (BRT) and bilateral arm training. The RT group received URT and the BRT. The intervention frequency for the 3 groups was 90 min/day, 3 days/week, for 6 weeks.
Fugl-Meyer Assessment (FMA, divided into the proximal and distal subscale) and Stroke Impact Scale (SIS) version 3.0 scores before, immediately after, and 3 months after treatment, and Wolf Motor Function Test (WMFT) and Nottingham Extended Activities of Daily Living (NEADL) scale scores before and immediately after treatment.
The results favored BHT over UHT on the FMA total score and distal score at the posttest (p = .03 and .04) and follow-up (p = .01 and .047) assessment, and BHT over RT on the follow-up FMA distal scores (p = .03). At the posttest assessment, the WMFT and SIS scores of the 3 groups improved significantly without between-group differences, and the RT group showed significantly greater improvement in the mobility domain of NEADL, as compared to the BHT group (p<.01).
BHT was more effective for improving upper extremity motor function, particularly distal motor function at follow-up, and individuals in the RT group demonstrated improved functional ambulation post intervention.
Background. Upper-limb chronic stroke hemiplegia was once thought to persist because of disproportionate amounts of inhibition imposed from the contralesional on the ipsilesional hemisphere. Thus, one rehabilitation strategy involves discouraging engagement of the contralesional hemisphere by only engaging the impaired upper limb with intensive unilateral activities. However, this premise has recently been debated and has been shown to be task specific and/or apply only to a subset of the stroke population. Bilateral rehabilitation, conversely, engages both hemispheres and has been shown to benefit motor recovery. To determine what neurophysiological strategies bilateral therapies may engage, we compared the effects of a bilateral and unilateral based therapy using transcranial magnetic stimulation.
Methods. We adopted a peripheral electrical stimulation paradigm where participants received 1 session of bilateral contralaterally controlled functional electrical stimulation (CCFES) and 1 session of unilateral cyclic neuromuscular electrical stimulation (cNMES) in a repeated-measures design. In all, 15 chronic stroke participants with a wide range of motor impairments (upper extremity Fugl-Meyer score: 15 [severe] to 63 [mild]) underwent single 1-hour sessions of CCFES and cNMES. We measured whether CCFES and cNMES produced different effects on interhemispheric inhibition (IHI) to the ipsilesional hemisphere, ipsilesional corticospinal output, and ipsilateral corticospinal output originating from the contralesional hemisphere.
Results. CCFES reduced IHI and maintained ipsilesional output when compared with cNMES. We found no effect on ipsilateral output for either condition. Finally, the less-impaired participants demonstrated a greater increase in ipsilesional output following CCFES.
Conclusions. Our results suggest that bilateral therapies are capable of alleviating inhibition on the ipsilesional hemisphere and enhancing output to the paretic limb.
via Bilateral Contralaterally Controlled Functional Electrical Stimulation Reveals New Insights Into the Interhemispheric Competition Model in Chronic Stroke – David A. Cunningham, Jayme S. Knutson, Vishwanath Sankarasubramanian, Kelsey A. Potter-Baker, Andre G. Machado, Ela B. Plow, 2019
Background. The recovery of motor function following stroke is largely dependent on motor learning–related neuroplasticity. It has been hypothesized that intensive aerobic exercise (AE) training as an antecedent to motor task practice may prime the central nervous system to optimize motor recovery poststroke.
Objective. The objective of this study was to determine the differential effects of forced or voluntary AE combined with upper-extremity repetitive task practice (RTP) on the recovery of motor function in adults with stroke.
Methods. A combined analysis of 2 preliminary randomized clinical trials was conducted in which participants (n = 40) were randomized into 1 of 3 groups: (1) forced exercise and RTP (FE+RTP), (2) voluntary exercise and RTP (VE+RTP), or (3) time-matched stroke-related education and RTP (Edu+RTP). Participants completed 24 training sessions over 8 weeks.
Results. A significant interaction effect was found indicating that improvements in the Fugl-Meyer Assessment (FMA) were greatest for the FE+RTP group (P = .001). All 3 groups improved significantly on the FMA by a mean of 11, 6, and 9 points for the FE+RTP, VE+RTP, and Edu+RTP groups, respectively. No evidence of a treatment-by-time interaction was observed for Wolf Motor Function Test outcomes; however, those in the FE+RTP group did exhibit significant improvement on the total, gross motor, and fine-motor performance times (P ≤ .01 for all observations).
Conclusions. Results indicate that FE administered prior to RTP enhanced motor skill acquisition greater than VE or stroke-related education. AE, FE in particular, should be considered as an effective antecedent to enhance motor recovery poststroke.
via Forced, Not Voluntary, Aerobic Exercise Enhances Motor Recovery in Persons With Chronic Stroke – Susan M. Linder, Anson B. Rosenfeldt, Sara Davidson, Nicole Zimmerman, Amanda Penko, John Lee, Cynthia Clark, Jay L. Alberts, 2019
Telerehabilitation was not inferior to in-clinic rehabilitation therapy in helping to improve arm function after stroke but could substantially increase access to therapy for those who are unable to access a rehabilitation clinic, researchers opine.
“Few patients fully recover from arm weakness after a stroke. The remainder demonstrate persistent arm impairments that are directly linked to activity limitations, participation restrictions, reduced quality of life, and decreased well-being,” Steven C. Cramer, MD, from the department of neurology at the University of California, Irvine, and colleagues write, in a study published in JAMA Neurology.
“Some rehabilitation therapies can improve these deficits, with higher doses associated with better outcomes. However, many patients do not receive high doses of rehabilitation therapy, for reasons that include cost, difficulty traveling to the location where therapy is provided, shortage of regional rehabilitation care, and poor adherence with assignments,” they continue, in a media release from Healio.
Cramer and colleagues conducted a randomized, assessor-blinded, noninferiority clinical trial to compare telerehabilitation and in-clinic rehabilitation therapy outcomes for patients who had a stroke that resulted in arm motor deficit.
Patients were enrolled in the study at 4 to 36 weeks after experiencing an ischemic stroke or intracerebral hemorrhage that resulted in arm weakness. After enrollment, participants were randomly assigned to receive intensive arm motor therapy in a rehabilitation clinic or in their home using telerehabilitation delivery services with a computer connected to the internet. Scores on the Fugl-Myer arm motor scale were measured at the baseline and after treatment to determine changes in arm motor function.
All patients received 36 treatment sessions (70 minutes) in a 6- to 8-week period, which included 18 supervised and 18 unsupervised sessions. The content of therapy was carefully matched, with each group using the same exercises and standard exercise equipment.
A total of 124 participants were included in the study. Participants had a mean age of 61 years, a mean baseline Fugl-Meyer score of 43 points and were enrolled for a mean 18.7 weeks following stroke, the release explains.
Patients in the in-clinic group were adherent to 33.6 of 36 therapy sessions (93.3%), and those who received telerehabilitation at home were adherent to 35.4 of 36 therapy sessions (98.3%).
Both groups experienced significant changes in Fugl-Meyer scores from the baseline period to 30 days after treatment, with a mean change of 8.36 points in patients who received in-clinic therapy and 7.86 points in those who received telerehabilitation therapy.
The noninferiority margin was 2.47 and fell outside the 95% confidence interval, suggesting that telerehabilitation was not inferior to in-clinic therapy.
“Our study found that a 6-week course of daily home-based [telerehabilitation] is safe, is rated favorably by patients, is associated with excellent treatment adherence, and produces substantial gains in arm function that were not inferior to dose-matched interventions delivered in the clinic,” Cramer and colleagues conclude, in the release.
[Source: Healio Primary Care]
The work reintegration following shoulder biomechanical overload illness is a multidimensional process, especially for those tasks requiring strength, movement control and arm dexterity. Currently different robotic devices used for upper limb rehabilitation are available on the market, but these devices are not based on activities focused on the work reintegration. Furthermore, the rehabilitation programmes aimed to the work reintegration are insufficiently focused on the recovery of the necessary skills for the re-employment.
In this study the details of the design of an innovative robotic platform integrated with wearable sensors and virtual reality scenarios for upper limbs motor rehabilitation and visuomotor coordination is presented. The design of control strategy will also be introduced. The robotic platform is based on a robotic arm characterized by seven degrees of freedom and by an adaptive control, wearable sensorized insoles, virtual reality (VR) scenarios and the Leap Motion device to track the hand gestures during the rehabilitation training. Future works will address the application of deep learning techniques for the analysis of the acquired big amount of data in order to automatically adapt both the difficulty level of the VR serious games and amount of motor assistance provided by the robot.