[WEB] Enspire announces publication of trial evaluating DBS plus rehab for stroke patients

Enspire DBS Therapy has announced the publication of the results of the EDEN trial—an early feasibility study led by Cleveland Clinic (Cleveland, USA) researchers assessing electrical stimulation of the dentate nucleus for upper-extremity hemiparesis due to ischaemic stroke—in Nature Medicine.

The EDEN study was designed to evaluate whether deep brain stimulation (DBS) plus rehabilitation therapy (DBS plus rehab) would improve motor function in post-ischaemic stroke patients more effectively than rehab alone.

The study demonstrated that the majority of participants (9/12) showed the most significant improvements in both motor impairment and function during the combination therapy, DBS plus rehab. Importantly, an Enspire press release notes, participants with at least minimal preservation of distal motor function at enrolment showed clinically significant gains. The safety profile of this therapy is similar to other approved DBS therapies, the release adds.

These findings build on more than a decade of preclinical work led by principal investigators Andre Machado and Kenneth Baker (both Cleveland Clinic, Cleveland, USA). Machado patented the DBS method in stroke recovery to which Enspire has an exclusive license. He also holds stock options and equity ownership rights with Enspire, and serves as the company’s chief scientific officer.

“We saw patients in the study regain levels of function and independence they did not have before enrolling in the research,” Machado said. “We look forward to expanding as we have begun the next phase of clinical investigation.”

Enspire has also launched RESTORE, a pivotal study continuing to investigate the safety and effectiveness of DBS plus rehab in patients with chronic upper-extremity impairment due to stroke. The study has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) and is actively recruiting patients.

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[Abstract + References] Repetitive peripheral magnetic stimulation combined with transcranial magnetic stimulation in rehabilitation of upper extremity hemiparesis following stroke: a pilot study

ABSTRACT

Objective: To investigate the effect of combined repetitive peripheral magnetic stimulation and transcranial magnetic stimulation on upper extremity function in subacute stroke patients.

Design: Pilot study.

Subjects: Subacute stroke patients.

Methods: Included patients were randomized into 3 groups: a central-associated peripheral stimulation (CPS) group, a central-stimulation-only (CS) group, and a control (C) group. The CPS group underwent a new paired associative stimulation (combined repetitive peripheral magnetic stimulation and transcranial magnetic stimulation), the CS group underwent repetitive transcranial magnetic stimulation, and the C group underwent sham stimulation. All 3 groups received physiotherapy after the stimulation or sham stimulation. The treatment comprised 20 once-daily sessions. Primary outcome was the Fugl-Meyer Assessment Upper Extremity (FMA-UE) score, and secondary outcomes were the Barthel Index and Comprehensive Functional Assessment scores, and neurophysiological assessments were mainly short-interval intracortical inhibition. A 3-group (CPS, CS, C) × 2-time (before, after intervention) repeated measures analysis of variance was conducted to determine whether changes in scores were significantly different between the 3 groups.

Results: A total of 45 patients were included in the analysis. Between-group comparisons on the FMA-UE demonstrated a significant improvement (group × time interaction, F_2,42 = 4.86; p = 0.013; C vs CS, p = 0.020; C vs CPS, p = 0.016; CS vs CPS, p = 0.955). Correlation analysis did not find any substantial positive correlation between changes in FMA-UE and short-interval intracortical inhibition variables (C, r = –0.196, p = 0.483; CS, r = –0.169, p = 0.546; CPS, r = –0.424, p = 0.115).

Conclusion: This study suggests that the real-stimulus (CS and CPS) groups had better outcomes than the control (C) group. In addition, the CPS group showed a better trend in clinical and neurophysiological assessments compared with the CS group.

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[REVIEW] Repetitive Transcranial Magnetic Stimulation and Rehabilitation Therapy for Upper Limb Hemiparesis in Stroke Patients: A Narrative Review – Full Text PDF

Abstract and Figures

Recent technological advances in non-invasive brain stimulation (NIBS) have led to the development of therapies for post-stroke upper extremity paralysis. Repetitive transcranial magnetic stimulation (rTMS), a NIBS technique, controls regional activity by non-invasively stimulating selected areas of the cerebral cortex. The therapeutic principle by which rTMS is thought to work is the correction of interhemispheric inhibition imbalances. The guidelines for rTMS for post-stroke upper limb paralysis have graded it as a highly effective treatment, and, based on functional brain imaging and neurophysiological testing, it has been shown to result in progress toward normalization. Our research group has published many reports showing improvement in upper limb function after administration of the NovEl Intervention Using Repetitive TMS and intensive one-to-one therapy (NEURO), demonstrating its safety and efficacy. Based on the findings to date, rTMS should be considered as a treatment strategy based on a functional assessment of the severity of upper extremity paralysis (Fugl-Meyer Assessment), and NEURO should be combined with pharmacotherapy, botulinum treatment, and extracorporeal shockwave therapy to maximize therapeutic effects. In the future, it will be important to establish tailormade treatments in which stimulation frequency and sites are adjusted according to the pathological conditions of interhemispheric imbalance, as revealed by functional brain imaging.

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[BLOG POST] Hemiplegia vs. Hemiparesis

Do you ever get mixed up trying to distinguish hemiplegia from hemiparesis? With all of the confusing stroke terminology out there, it’s hard to tell the difference.

Hemiplegia and hemiparesis may seem very similar because hemiplegia and hemiparesis have the same underlying symptoms. However, these terms have slightly different meanings.

In this article, we’ll break down the difference between hemiplegia and hemiparesis, describe how to manage hemiplegic or hemiparetic arm weakness, and review the long-term outcomes of each condition.

Hemiplegia and Hemiparesis

• Definitions
• Causes
• Symptoms
• Management
• Prognosis
• Conclusion

Definitions of Hemiplegia and Hemiparesis

How can one tell the differences between hemiparesis and hemiplegia? Both conditions may be accompanied by symptoms including loss of movement, loss of sensation, abnormal muscle tone (hyper or hypotonicity), and loss of postural control. One-sided weakness from hemiparesis or hemiplegia may span from the head (including facial muscles), through the trunk and the arm, and down to the legs. These can conditions even cause weakness on muscles inside of the body!

Ultimately, there is a distinction between the two terms:

Hemiparesis
Hemiparesis indicates a mild to moderate degree of muscular weakness on one side of the body.

Hemiplegia
Hemiplegia indicates a severe or complete loss of movement function on one side of the body.

Although these terms are similar and often used synonymously, hemiparesis relates to a milder form of one-sided weakness than hemiplegia. Hopefully that begins to clear things up!

Causes

Hemiplegia and hemiparesis often have the same causes; however, use of one term or the other depends on the severity of muscle weakness and dysfunction resulting from central nervous system (brain or spinal cord) injury.

Brain damage can disrupt many functions, including movement control, sensation, coordination, and thinking skills. Damage may alter or destroy the brain’s underlying neural pathways, the structures responsible for sending messages related to controlling the rest of the body. Abnormalities in brain areas responsible for controlling movement and muscle tone are primarily responsible for causing hemiparesis or hemiplegia.

Hemiparesis or hemiplegia may occur as a result of the following diagnoses:

• Stroke: Stroke is one of the most common causes of one-sided bodily weakness. The severity of muscle weakness that you experience can depend on the size and location damage within the brain
• Traumatic brain injury (TBI): A TBI can cause permanent brain damage. If the trauma only affects one side of the brain, hemiplegia can result on the opposite side of the body. Common causes of trauma include car accidents, falls, or blows to the head.
• Spinal cord injury (SCI): SCI has many presentations. Depending on where the spinal cord was damaged, resultant weakness may affect only one side of the body.
• Brain Tumors: Brain tumors can lead to a variety of physical problems including hemiplegia. Symptoms of hemiplegia may get worse as the tumor grows and invades brain areas that control movement.
• Additional Causes: Multiple sclerosis, muscular dystrophy, cerebral palsy, amyotrophic lateral sclerosis (ALS)

Symptoms

Hemiplegia or hemiparesis may present differently from person to person. Common symptoms of these conditions include:

• Muscle weakness wasting, or atrophy
• Loss of coordination lack of gross or fine motor skills resulting in difficulties sitting, standing, walking, or reaching
• Loss of normal muscle tone resulting in stiffness, spasticity, flaccidity
• Loss of sensation difficulty detecting texture, temperature, touch, or pain

Management

There are many ways to manage symptoms of one-sided weakness from hemiplegia or hemiparesis. Common treatment approaches include remediating physical function by strengthening muscles and restoring lost skills or compensating for independent function using supportive devices.

Rehabilitation Treatment
The concept of neuroplasticity, which states that the body can adapt to the environment and change even after the brain is damaged, suggests that it is possible to improve hemiplegic symptoms through rehabilitation. High-frequency and high repetition strengthening exercise and functional task training may help reduce weakness.

Equipment/devices
Assistive devices are used to enable independent functioning by supplementing skills that the user cannot perform independently.

Common assistive devices used to make up for one-sided weakness include:

• Mobility aids: wheelchair, walker, cane
• Meal aids: universal cuff, built-up utensils, suction cup plates, high wall plates, no-slip mats
• Dressing aids: reacher, sock aid, elastic shoelaces, long shoehorn
• Bath accessories: shower chair, tub bench, raised toilet seat, grab bars, long-handled sponge
• Bowel and bladder aids: catheter equipment, bowel program equipment
• Splints and braces for the arm or leg

Mental health management
A significant medical condition associated with reduced physical functioning, daily routine changes, or increased dependency on others can contribute to feelings of hopelesness or depression. It is recommended that survivors partake in psychological counseling to provide support, promote appropriate adjustment to disability, and instill coping mechanisms and hope. Always ask your primary doctor about mental health resources or a referral to a counselor in the event that you are struggling.

Prognosis

What is the prognosis for hemiparesis or hemiplegia?

The prognoses of hemiplegia and hemiparesis are difficult to predict because symptoms may change over time. Each person is different in how they recover from brain, spinal cord, or nerve damage due to variables like age, current health, and other underlying factors. Some will recover quickly with no treatment while others will only see minor improvements even with extensive therapy.

However, even after damage, nerve cells in the brain and spinal cord show capability to rewire and adapt to regain lost functions. It is possible for older nerve pathways to heal and resume their original function or for different, undamaged areas to perform the functions of the damaged area instead.

In order to promote neuroplastic changes for improved physical functioning, health management, rehabilitation, and therapeutic activities and exercise are vital. It helps to have a supportive medical team to guide you throughout the process.

WRITTEN BY

• Ashley Gatewood, OTR/LAshley is an occupational therapist and health writer based out of Richmond, VA. Ashley has seven years of experience across multiple practice settings and is currently working in adult home health.
• June LeeClinical Manager / Physical Therapist

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[ARTICLE] Effectiveness and Success Factors of Bilateral Arm Training After Stroke: A Systematic Review and Meta-Analysis – Full Text

Abstract

Bilateral arm training (BAT) presents as a promising approach in upper extremity (UE) rehabilitation after a stroke as it may facilitate neuroplasticity. However, the effectiveness of BAT is inconclusive, and no systematic reviews and meta-analyses have investigated the impact of different factors on the outcomes of BAT. This systematic review and meta-analysis aimed to (1) compare the effects of bilateral arm training (BAT) with unilateral arm training (UAT) and conventional therapy (CT) on the upper limb (UL) motor impairments and functional performance post-stroke, and (2) investigate the different contributing factors that may influence the success of BAT. A comprehensive literature search was performed in five databases. Randomized control trials (RCTs) that met inclusion criteria were selected and assessed for methodological qualities. Data relating to outcome measures, characteristics of participants (stroke chronicity and severity), and features of intervention (type of BAT and dose) were extracted for meta-analysis. With 25 RCTs meeting the inclusion criteria, BAT demonstrated significantly greater improvements in motor impairments as measured by Fugl-Meyer Assessment of Upper Extremity (FMA-UE) than CT (MD = 3.94, p = < 0.001), but not in functional performance as measured by the pooled outcomes of Action Research Arm Test (ARAT), Box and Block Test (BBT), and the time component of Motor Function Test (WMFT-time) (SMD = 0.28, p = 0.313). The superior motor impairment effects of BAT were associated with recruiting mildly impaired individuals in the chronic phase of stroke (MD = 6.71, p < 0.001), and applying a higher dose of intervention (MD = 6.52, p < 0.001). Subgroup analysis showed that bilateral functional task training (BFTT) improves both motor impairments (MD = 7.84, p < 0.001) and functional performance (SMD = 1.02, p = 0.049). No significant differences were detected between BAT and UAT for motor impairment (MD = −0.90, p = 0.681) or functional performance (SMD = −0.09, p = 0.457). Thus, our meta-analysis indicates that BAT may be more beneficial than CT in addressing post-stroke UL motor impairment, particularly in the chronic phase with mild UL paresis. The success of BAT may be dose-dependent, and higher doses of intervention may be required. BFTT appears to be a valuable form of BAT that could be integrated into stroke rehabilitation programs. BAT and UAT are generally equivalent in improving UL motor impairments and functional performance.

Introduction

Contralateral hemiparesis is one of the most common deficits following a stroke (Cramer et al., 1997; Van Der Lee et al., 2001). It is estimated that 48–77% of stroke patients encounter contralateral hemiparesis acutely (Lawrence et al., 2001; Held et al., 2019; Simpson et al., 2021), and 40–50% of patients will continue to have it chronically (Jørgensen et al., 1995; Cramer et al., 1997; Broeks et al., 1999). Although the most significant amount of recovery is suggested to happen in the first three months post-stroke (Wade et al., 1983; Kwakkel et al., 2003; Kwakkel and Kollen, 2013), research has supported that upper extremity (UE) recovery can still occur years after (Carey et al., 1993).

Due to the prevalence of UE impairments post-stroke and the importance of recovery for optimal function and performance of activities of daily living (ADLs), different rehabilitation strategies have been identified and studied. It is not surprising that most of the well-studied UE rehabilitation strategies to date are primarily focused on the unilateral arm since hemiparesis is more evident on one side of the body following a stroke (Beer et al., 2000; Wagner et al., 2006; Sathian et al., 2011; Kantak et al., 2017). However, there is evidence that stroke patients have reduced bilateral arm coordination and functional performance in most ADLs compared to the neurologically intact population (Kantak et al., 2017). In fact, most manual tasks in our daily life require the usage of both UEs and interlimb coordination. A relatively recent upper extremity (UE) rehabilitation strategy targeting interlimb coordination post-stroke is bilateral arm training (BAT). It involves incorporating both upper limbs to perform motor tasks simultaneously or sequentially to improve the movement of the affected limb (Mudie and Matyas, 2000; Waller et al., 2008). Several types of BAT have been identified, including bilateral functional task training (BFTT), bilateral arm training with rhythmic auditory cueing (BATRAC), bilateral robot-assisted training (BRAT), bilateral priming, and mirror therapy (Stoykov and Corcos, 2009; Wolf et al., 2014). Several hypotheses have been proposed regarding the positive effects of BAT on motor function. First, BAT may promote positive neural interactions between sensorimotor-related areas in the ipsilesional and contralesional hemispheres to enhance coupling effects post-stroke (Fan et al., 2015, 2016). Second, increased activity in the sensorimotor-related areas following BAT may contribute to functional reorganization and neuroplasticity (Whitall et al., 2011; Waller et al., 2014). Third, BAT may allow restoration of normalized interhemispheric transcallosal inhibition (IHI) and reduce short-interval intracortical inhibition (SICI) in the ipsilesional hemisphere, both of which are associated with recovery of motor function after stroke (Cicinelli et al., 2003; Stinear et al., 2008; Swayne et al., 2008).

Despite the potential for the usage of BAT in the post-stroke population, the effectiveness of BAT is inconsistent across the studies. According to the Guidelines for Adult Stroke Rehabilitation and Recovery for Healthcare Professionals, bilateral training paradigms fall into Class-IIb in which benefits outweigh the risks, but usefulness/efficacy is less well-established, and additional research is needed (Winstein et al., 2016). The level of evidence is graded as “A” with multiple populations evaluated and data derived from multiple RCTs and meta-analyses. A recent meta-analysis (Chen et al., 2019) compared the effect of BAT with unilateral arm training (UAT) in the post-stroke population based upon the World Health Organization (WHO) International Classification of Functioning, Disability and Health (ICF) framework (World Health Organization, 2001). The results revealed that BAT yielded greater improvements in UE motor impairments but not functional performance. Similar findings have also been reported in other systematic reviews (Stewart et al., 2006; Cauraugh et al., 2010; Latimer et al., 2010; Wolf et al., 2014). However, the results should be cautiously interpreted since these reviews included non-RCTs, and some of the included studies did not comprise a comparison group, rendering it difficult to draw robust conclusions. In contrast, other reviews identified contradictory findings, claiming that BAT was similar or inferior to conventional therapy (CT) or UAT (Coupar et al., 2010; Van Delden et al., 2012; Lee et al., 2017b; Richardson et al., 2021). A recently published systematic review highlighted that UAT and BAT improved paretic UE function equivocally in adults with chronic stroke. Van Delden et al. (2012) also reported similar findings based on the categorization of the ICF framework. However, the small number of studies included in these two reviews may limit their generalizability.

Few studies to date have systematically investigated the factors influencing the success of BAT. Van Delden et al. (2012) pointed out that intervention success may depend on the severity of hemiparesis and time of intervention post-stroke. Additionally, (modified) constraint-induced movement therapy [(m)CIMT] has been reported to be more effective than BAT in one systematic review (Lee et al., 2017b). However, considering that (m)CIMT usually involves patients who are mildly impaired or in a later stage of stroke, it is reasonable to assume that the characteristics of participants are important factors when selecting an optimal intervention. Furthermore, different features of treatment within BAT, such as type and dosage of BAT intervention, may also affect the outcomes (Cooke et al., 2010; Pollock et al., 2014; Wolf et al., 2014). Cauraugh et al. (2010) found that BATRAC and coupled BAT with active stimulation are most effective, whereas Wolf et al. (2014) reported no differences between BFTT, BATRAC, and BRAT. Although the effect of dose of a post-stroke UE treatment has been studied (Kwakkel et al., 1997; Van Peppen et al., 2004; Cooke et al., 2010), no meta-analyses have yet reported the impact of dose on the outcomes of BAT. Therefore, a meta-analysis including high-quality RCTs is urgently needed to systematically investigate the factors influencing the effect of BAT.

Therefore, the purposes of the current systematic review and meta-analysis were twofold: Firstly, to compare the effects of BAT with other interventions in post-stroke UE rehabilitation on motor impairments and functional performance which are two domains of the WHO ICF framework, and secondly, to investigate different determinant factors and their contributions in optimizing comprehensive post-stroke interventions.[…]

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[Abstract] Constraint-induced movement therapy for lower extremity use in activities of daily living in people with chronic hemiparesis – multiple case study

Abstract

Lower extremity constraint-induced movement therapy (LE-CIMT) is an intensive intervention protocol recently reported to improve lower extremity use in individuals with chronic hemiparesis. To test if the LE-CIMT that uses essential CIMT components, including the transfer package and intensive task-oriented training, is a feasible and potentially effective intervention to improve the lower extremity real-world use and functional ability in a group of individuals with chronic hemiparesis. A quasi-experimental pre- and post-test design study with 12 individuals with chronic stroke and impaired ambulation skills engaged in a 10-weekday LE-CIMT. Intervention feasibility was assessed, examining the training adherence, acceptability, and safety. The lower extremity motor activity log (LE-MAL), lower extremity motor function test (LE-MFT), timed up and go (TUG) and spatiotemporal gait parameters were used as clinical outcomes. Clinical data were collected at baseline, 3-day post-CIMT protocol and 30-day follow-up assessment. At baseline, LE-MAL and LE-MFT outcomes were tested over 2-week apart to ensure a stable measurement and determine the smallest real difference (SRD) in the study sample. The LE-CIMT showed excellent adherence, acceptability and safety. Ten out of 12 participants showed improvements over SRD in LE-MAL composite score (1.2 point) and eight participants in LE-MFT adjusted scores (0.8 point) in post-CIMT and 30-day follow-ups. LE-CIMT is a feasible intervention that has the potential to promote improvements in real-world use and functional ability of the paretic lower extremity in individuals with chronic stroke.

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[Abstract] The Effect of Music-Based Rhythmic Auditory Stimulation on Balance and Functional Outcomes after Stroke

Abstract

Purpose: the purpose of this paper was to evaluate the effects of music-based rhythmic auditory stimulation on balance and motor function after stroke and whether there are differences depending on the affected hemisphere, lesion site and age.

Materials and methods: This study was an observational and longitudinal study. Adult stroke survivors (n = 28), starting no later than 3 weeks after a stroke, conducted 90 min sessions of music-based rhythmic auditory stimulation 3 days a week, in addition to 60 min a day of conventional physiotherapy. Balance ability was evaluated using the Mini Best Test and the Tinetti Test; motor function was evaluated using the Motor Assessment Scale.

Results: All of the participants significantly improved their balance ability and motor function variables upon comparing scores at discharge and admission. Intragroup differences were observed upon comparing subgroups of patients by lesion site and by the degree of motor impairment. Age, stroke type and affected hemisphere seemed not to be directly related to the amount of improvement.

Conclusions: This study suggests that the effects of music-based rhythmic auditory stimulation (RAS) on balance ability and motor function varies depending on the scale or test used for evaluation and on the variables that the tests measure. Patients with hemiparesis seemed to improve more than those with hemiplegia.

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[ARTICLE] Effects of ankle-foot orthoses on the stability of post-stroke hemiparetic gait – Full Text

ABSTRACT

BACKGROUND: Ankle-foot orthoses are used to improve gait stability in patients with post-stroke gait; however, there is not enough evidence to support their beneficial impact on gait stability.

AIM: To investigate the effects of ankle-foot orthoses on post-stroke gait stability.

DESIGN: An experimental study with repeated measurements of gait parameters with and without orthosis.

SETTING: Inpatients and outpatients in the Fujita Health University Hospital, Toyoake, Japan.

POPULATION: Thirty-two patients (22 males; mean age 48.3±20.0 years) with post-stroke hemiparesis participated in the study.

METHODS: Three-dimensional treadmill gait analysis was performed with and without ankle-foot orthosis for each participant. Spatiotemporal parameters, their coefficient of variation, and margin of stability were evaluated. Toe clearance, another major target of orthosis, was also examined. The effect of orthosis in the patients with severe (not able to move within the full range of motion, defying gravity) and mild ankle impairment (able to move within the full range but have problem with speed and/or smoothness of the ankle movement) was compared.

RESULTS: In the total group comparison, the decrease in the coefficient of variation of step width (P=0.012), and margin of stability on the paretic side (P=0.023) were observed. In the severe ankle impairment groups, the decreased in the coefficient of variation of the non-paretic step length (P=0.007), stride length (P=0.037), and step width (P=0.033) and margin of stability on the paretic side (P=0.006) were observed. No significant effects were observed in the mild ankle impairment group; rather, the coefficient of variation of non-paretic step length increased with the use of orthosis in this group (P=0.043); however, toe clearance increased with the use of ankle-foot orthosis (P=0.041).

CONCLUSIONS: Ankle-foot orthoses improved gait stability indices; however, the effect was either not significant or showed possible worsening in the patients with mild ankle impairment, while the effect on toe clearance was significant. These results suggest that the effects of using orthoses in patients with mild impairment should be carefully evaluated.

CLINICAL REHABILITATION IMPACT: Understanding the effects of ankle-foot orthoses on the stability of post-stroke gait and their relationship with ankle impairment severity may support clinical decision-making while prescribing orthosis for post-stroke hemiparesis.

Ankle-foot orthoses (AFOs) are widely used as clinical devices to support ankle function and improve gait ability in hemiparetic stroke patients. The benefits of AFOs on various parameters related to hemiparetic gait have been observed, such as gait velocity, gait symmetry, and walking efficiency,^1-3 which may be due to the improved ankle joint stability and subsequent increase in postural stability and toe clearance. Previous studies have reported an increase in toe clearance and reduction in compensatory movements using AFOs.^{4, 5} Regarding stability, several reports have evaluated the effect of AFOs on static balance improvement.^{6, 7} However, dynamic balance improvement during walking is not well-understood. A previous study supported the reduction in variability of spatiotemporal parameters,⁸ revealing an improvement in the stability of gait patterns with the use of AFO; however, there is a lack of more direct evidence on the effect of the dynamic balance control during gait. The AFO’s ability to improve the static balance may support the improvement in gait balance control; however, in healthy individuals, restricting ankle motion with AFO has reportedly had a negative influence on dynamic balance.⁹ It is also possible that AFO’s effects on stability vary depending on the kinematic function of the ankle joint.

In this study, we examined stability improvement with AFOs in stroke patients and whether the effect of AFOs differed with varying degrees of ankle joint motor impairment. To evaluate the stability of gait patterns, we assessed the coefficient of variation (CV) in spatiotemporal gait parameters in stroke patients with and without AFOs and the margin of stability (MoS), based on the relationship between the center of mass (COM) and the base of support, using three-dimensional gait analysis systems. Furthermore, the relationship between the gait parameters, including the stability and toe clearance indices, and the severity of ankle paralysis was also examined.

Materials and methods

Participants

The patients with post-stroke hemiparesis who underwent rehabilitation at the Fujita Health University Hospital were recruited, using the convenience sampling method. The measurements were performed between April 2009 and May 2020. Inclusion criteria were: 1) unilateral hemiparesis caused by cerebrovascular disease; 2) more than 60 days after onset; 3) continuous use of an AFO for walking for more than a week; and 4) ability to walk independently on a treadmill without orthoses, handrails, or assistive devices. Exclusion criteria were: 1) a history of previous neuromuscular diseases and/or orthopedic conditions that could interfere with the walking ability; and 2) impaired cognition and/or communication affecting the ability to follow instructions. Neurological motor impairments were evaluated using the stroke impairment assessment set.^{10, 11} Lower limb motor function was evaluated by the hip-flexion, knee-extension, and foot-tap tests included in the stroke impairment assessment set. For each test, motor function was rated from 0 (severely impaired) to 5 (normal). The scores in the foot-tap test were used to divide participants into two groups according to ankle motor function: the participants who scored ≥3 points, indicating that they could perform the full range of dorsiflex motion, were classified as having a mild ankle impairment, while the participants who scored ≤2 points, indicating insufficient dorsiflexion or severer impairment, were classified as having a severe ankle impairment.

The sample size was calculated using the G*power software (G*power; Aichach, Germany) version 3.1.9.2,^{12, 13} and it was based on the effect of AFO on limitation of ankle movement described in a previous study with a similar setting.⁵ The effect size was 0.71, and accordingly, the minimum sample size was calculated to be 14 (alpha 0.05, 1-beta 0.80). Consequently, we recruited more than 14 patients for the severe and mild ankle impairment groups. All participants were prescribed either a thermoplastic AFO (tAFO) or an adjustable posterior strut AFO (APS-AFO) (Figure 1). The APS-AFO is an orthosis with a posterior strut made by carbon, which is generally a stiffer ankle orthosis than tAFO.

Figure 1.—Adjustable posterior strut ankle-foot orthosis (APS-AFO).

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[Abstract] New treatments for induction of motor plasticity after stroke – Thesis

Abstract

Stroke is a major health issue. It is one of the main causes of acquired adult disability. A common deficit after stroke is the hemiparesis of the contralateral upper limb, with more than 80% of stroke inpatients experiencing this condition and in spite of intensive rehabilitation care, more than 40% of the patients still have this impairment chronically. The overall aim of this thesis is to understand how we reduce impairment in stroke patients with new treatment approaches. Previous studies have shown possible targets for new treatments. Patients with severe motor deficits show severe damage of the cortico-spinal tract (CST) and secondary degradation of white matter during the weeks after stroke. In these patients, inducing plasticity at the level of the CST or avoiding secondary degradation may enable the motor recovery processes, which are usually very limited or absent in these patients. Patients with mild or moderate motor deficits show high FC between the motor areas and the rest of the brain in the first weeks after stroke, which associates with better clinical recovery. In these patients, enhancing FC may improve the motor outcome above the proportional rule. In a first study, we recruited patients with mild and moderate motor deficits. We targeted the neural interactions of the perilesional cortical areas with the application of 4 different transcranial direct current stimulation (tDCS) montages: conventional anodal, high-definition (HD) anodal, bi-hemispheric, and SHAM. We aimed to find the optimal montage that would increase FC the most and lead to the best clinical outcome. After comparison, the HD tDCS montage had the most effect on motor outcome.The effect only appeared in the Action Research Arm Test and not in our primary outcome which was the Fugl-Meyer assessment of the upper extremity (FMA-UE). On a neurophysiological level, the MEP analyses pointed out a tendency of the HD montage to increase the MEP amplitudes and reduce the rest motor threshold in the contralesional hemisphere rather than having an effect in the ipsilesional hemisphere. The computation of FC confirmed previous findings where connectivity was an early marker of good motor recovery, while its late arrival was associated with worse recovery. In a second study, we recruited patients with severe motor deficits. Here, a closed-loop setup combining functional electrical stimulations (FES) contingent with a brain-computer interface (BCI) aimed to prevent the secondary degeneration of the CST integrity. The motor scores did not display significant differences between the BCI and a control group consisting of triggering the FES based on the contingency of patients undergoing the real BCI training. However, BCI-FES reduced spasticity of the patients as evaluated with the Ashworth score. On a group level, global FC between the primary motor cortex and the rest of the brain was significantly reduced after BCI-FES as compared to after SHAM treatment, and this reduction of global FC was correlated with greater FMA-UE improvement. Regarding CST integrity, the two groups evolved similarly. FA asymmetry showed that the CST of all patients did not deteriorate during the brief observation time window. No significant difference was observed in the MEPs of the ipsilesional or the contralesional side. In a third study, we explored the feasibility of developing a neurofeedback training targeting FC for clinical use. We aimed at finding an analysis pipeline that would allow to compute source FC of a region of interest based on a low-density EEG coverage and a template MRI. We compared 3 several algorithms that would allow an FC reconstruction from only 19 channels. We used numerical simulations of coherent sources as well as real datasets. Of these analyses, the use of beamformer inverse solution emerged as the best performing under the constraints imposed. We finally tested its performance in an independent dataset recorded from a low-density EEG using dry-gel electrodes. However, we could not reproduce the findings of the previous dataset. This may be due to the quality of the signal or to the design of the FC reconstruction, which was not yet efficient enough. In conclusion, this thesis allowed the observation of innovative treatments on the patients themselves in the first two projects, and as a proof-of-concept in the third project. Although promising, the three treatments still need more research to fine-tune their setup for more efficient interventions. Faced with motor deficits that are still too present, it is important to pursue research to perfect these interventions until the condition of the patients is improved. To that end, from our studies the next steps are to 1) go in the main phase to compare HD-tDCS against SHAM-tDCS, 2) add more BCI sessions to reach the usual amount of training, 3) perform complementary FC analyses to observe the neural interactions between motor areas, 4) implement a neurofeedback targeting FC with a high-density EEG using sponge electrodes.

Thesis (6.9 MB) – PDF file – Free access

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[Abstract] Assistive Robotics: Robotic Trajectory Planning for Upper Extremity Rehabilitation in Patients with Hemiparesis

Abstract

Rehabilitation of upper limb movements in patients with hemiparesis has been a longstanding struggle for physical therapy professionals. Tools such as robotically assisted therapies have shown great potential to assist in the rehabilitation process of patients. Regarding traditional rehabilitation interventions, robotic systems can provide more effective and intensive physical therapy as new interventions are now being used to assist in the rehabilitation of patients with certain movement restrictions especially after stroke. Currently, this research work aims to present a study on the trajectory planning of a robotic arm, which will be suggested to the patient in order to perform the movement for rehabilitation. Furthermore, it is intended that the trajectory can be generated in real time to better meet the patient’s movement requirements and restrictions. In view of the need for real-time trajectory generation, it is necessary that a simple model of the manipulator work area is used as a boundary and boundary condition for the task space. In parallel, there is the development of a prototype of the REHABOT robot, a mechanical project developed with components from the Cyton Gamma 1500 and Reachy robots.

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