[Abstract] Investigating music-based cognitive rehabilitation for individuals with moderate to severe chronic acquired brain injury: A feasibility experiment
BACKGROUND:Acquired brain injuries often cause cognitive impairment, significantly impacting participation in rehabilitation and activities of daily living. Music can influence brain function, and thus may serve as a uniquely powerful cognitive rehabilitation intervention.
OBJECTIVE:This feasibility study investigated the potential effectiveness of music-based cognitive rehabilitation for adults with chronic acquired brain injury.
METHODS:The control group participated in three Attention Process Training (APT) sessions, while the experimental group participated in three Music Attention Control Training (MACT) sessions. Pre-and post- testing used the Trail Making A & B, Digit Symbol, and Brown-Peterson Task as neuropsychological tests. RESULTS:ANOVA analyses showed no significant difference between groups for Trail A Test, Digit Symbol, and Brown-Peterson Task. Trail B showed significant differences at post-test favouring MACT over APT. The mean difference time between pre-and post-tests for the Trail B Test was also significantly different between APT and MACT in favour of MACT using a two-sample t-test as well as a follow-up nonparametric Mann Whitney U-test.
CONCLUSIONS:The group differences found in the Trail B tests provided preliminary evidence for the efficacy of MACT to arouse and engage attention in adults with acquired brain injury.
- Post-stroke spasticity can make it difficult to stretch, move, and accomplish everyday tasks.
- Modifying your home, working with an occupational therapist, practicing daily exercises, and using mobility aids can help you manage spasticity.
- Treatments, such as injections and medications, can help reduce long-term damage from spasticity.
Strokes occur when blood flow to the arteries in the brain become blocked, or (in more serious cases) leak or burst. This causes trauma to the brain and spinal cord, which can lead to other symptoms.
Between 25 percent and 43 percent of people will experience a condition called spasticity in the first year after a stroke, according to the American Stroke Association.
Spasticity causes muscles to become stiff and tight, making it difficult to stretch, move, and take care of everyday tasks.
Fortunately, treatments and lifestyle adjustments can help reduce the severity of the condition and its impact on your life.
Read on to learn more about spasticity and ways to manage it.
A stroke can damage the part of the brain that controls the signals to the muscles. If that happens, you may experience spasticity, or an abnormal increase in muscle tone.
It can cause your muscles to get stiff, tight, and painful, causing you to be unable to move fluidly.
That, in turn, can affect the way you speak, move, and walk. Your muscles may remain contracted in certain positions, like a bent wrist, clenched fist, or tucking your thumb into your palm, according to the American Association of Neurological Surgeons.
Other ways spasticity can affect the body after a stroke include:
- tight knees
- tension in the fingers
- bending your foot at an angle
- weakness in a foot, causing it to drag when walking
- bending your arm and holding it tight against the chest
- curling in the toes
Spasticity tends to be more common in younger people who have a stroke, according to the American Stroke Association. Strokes that are caused by a bleed can also increase the risk of spasticity.
Treatment options for spasticity after a stroke depend on the severity of your symptoms. Your doctor may also suggest trying a variety of treatments and management strategies at the same time.
Here are some common treatment options, according to the American Stroke Association:
- exercise and stretching
- muscle braces
- injections of certain medications, such botulinum toxin (Botox)
- oral medications, such as baclofen, diazepam, tizanidine, and dantrolene sodium
- intrathecal baclofen therapy (ITB)
There are also lifestyle changes people can make to reduce the symptoms of spasticity after a stroke.
While spasticity can be painful, there are ways to reduce symptoms of the condition and improve your quality of life.
Here are seven tips for living with spasticity:
1. Exercise or stretch the affected limbs
One of the best things you can do for spasticity after a stroke is to keep the affected limbs moving.
Regularly exercising these areas can help ease tightness, prevent muscles from shortening, and maintain your full range of motion.
A physical therapist or occupational therapist can show you exercises that may help your post-stroke spasticity.
2. Adjust your posture
Try to avoid staying in one position too long if you’re coping with spasticity after a stroke. That can cause muscles and joints to get stiff and sore.
Caregivers should aim to help people with spasticity switch positions every 1–2 hours to help keep the body limber.
3. Support affected limbs
Providing extra support for affected limbs can also keep you more comfortable and reduce the effects of spasticity. For example, try not to let your arm or leg fall off the side of the bed or wheelchair.
Be especially mindful when lying down. Placing your affected arm or leg under your body when resting can worsen spasticity.
Lying on your back can help keep your limbs in a more comfortable position. If you prefer to lie on your side, avoid putting the weight on the side that the stroke affected.
Special braces can help support limbs and prevent spasticity from getting worse.
4. Adapt your home
Making adjustments around the home can make it easier for people with spasticity to move around and accomplish tasks.
Here are some ways you can adapt your home, according to the American Stroke Association:
- install ramps to doorways
- add grab bars to the bathroom
- install raised toilet seats
- place a bench in your tub or shower
- use plastic adhesive strips on the bottom of your tub
5. Ask for support
People with spasticity, along with their caregivers, can find it helpful to seek support from family, friends, and other loved ones. They can encourage active movement and help with tasks around the home.
It can also be a great way to bond and enjoy time together. If your loved one is stretching, for instance, try stretching with them for encouragement.
6. Work with an occupational therapist
Occupational therapists help people with disabilities and health conditions learn new ways of performing everyday tasks more easily.
This may mean learning to get dressed with the opposite hand, or modifying eating habits. While learning something new is always a journey, staying positive can help make the process easier.
7. Use mobility aids
If spasticity has made it difficult to get around after a stroke, using mobility aids can help you move more easily. Common mobility aids include:
Talk with an occupational therapist to see if a mobility aid can be helpful for you.
Spasticity often occurs between 3 and 6 weeks after a stroke, according to research from 2018. The muscular symptoms of spasticity have been shown to continue increasing at 6 months after a stroke.
If left untreated, spasticity can cause permanent shrinking and contracting of the muscles, along with joints locked into single positions.
While there’s no cure for post-stroke spasticity, treatments and lifestyle changes can help reduce symptoms and maintain your range of motion.
At least a quarter of people will develop spasticity after a stroke. The condition can cause tight, stiff muscles and reduce your mobility.
You can manage symptoms and improve your quality of life with spasticity by modifying your home, practicing daily exercises, working with an occupational therapist, and using mobility aids.
Treatments can also help prevent long-term damage from spasticity. Talk with a doctor to see if medication or injections are right for you.
[ARTICLE] Validity, reliability, and sensitivity to motor impairment severity of a multi-touch app designed to assess hand mobility, coordination, and function after stroke – Full Text
The assessment of upper-limb motor impairments after stroke is usually performed using clinical scales and tests, which may lack accuracy and specificity and be biased. Although some instruments exist that are capable of evaluating hand functions and grasping during functional tasks, hand mobility and dexterity are generally either not specifically considered during clinical assessments or these examinations lack accuracy. This study aimed to determine the convergent validity, reliability, and sensitivity to impairment severity after a stroke of a dedicated, multi-touch app, named the Hand Assessment Test.
The hand mobility, coordination, and function of 88 individuals with stroke were assessed using the app, and their upper-limb functions were assessed using the Fugl-Meyer Assessment for Upper Extremity, the Jebsen-Taylor Hand Function Test, the Box and Block Test, and the Nine Hole Peg Test. Twenty-three participants were further considered to investigate inter- and intra-rater reliability, standard error of measurement, and the minimal detectable change threshold of the app. Finally, participants were categorized according to motor impairment severity and the sensitivity of the app relative to these classifications was investigated.
Significant correlations, of variable strengths, were found between the measurements performed by the app and the clinical scales and tests. Variable reliability, ranging from moderate to excellent, was found for all app measurements. Exercises that involved tapping and maximum finger-pincer grasp were sensitive to motor impairment severity.
The convergent validity, reliability, and sensitivity to motor impairment severity of the app, especially of those exercises that involved tapping and the maximum extension of the fingers, together with the widespread availability of the app, could support the use of this and similar apps to complement conventional clinical assessments of hand function after stroke.
Approximately 80% of stroke survivors suffer from motor dysfunctions that affect one or both upper limbs, with particular impacts on hand coordination and dexterity [1, 2]. Hand and upper-limb impairments are among the major causes of functional limitations in individuals with post-stroke hemiparesis [2, 3]. These limitations can reduce autonomy and, therefore, have consequences for the performance of daily living activities and decrease quality of life .
An adequate assessment of all motor impairments is necessary for establishing a realistic prognosis, planning customized rehabilitation interventions, and evaluating the effectiveness of those interventions. The assessment of upper-limb motor function is especially challenging because of the multidimensional nature of coordinated movements, requiring the use of multiple subsystems: eye-hand coordination, intra-limb coordination (including inter- and intra-muscle coordination), and inter-limb coordination [1, 4, 5]. In the clinical setting, assessments of motor conditions are usually performed using ‘standardized’ clinical scales and tests . Most clinical scales evaluate the active range of upper-limb movements , gross [8, 9] or fine arm motor function [8, 10], and the performance of daily functional activities [11,12,13,14], with some scales aiming to assess hand motor function and grasping during functional tasks [8, 15, 16]. Although these tools are usually easy to administer and are not time-consuming, instruments that are based on subjective ratings of the performance on different tasks may lack accuracy and be biased. In addition, instruments that are rated according to the performance on a task (such as the number of elements that can be grasped, moved, or placed or the time to complete those actions) may lack specificity, and not provide separate information of the different motor components that contribute to the performance. In addition, conventional instruments do not commonly consider hand mobility and dexterity during clinical assessments, and when they are considered, the examinations often lack specificity. Importantly, these skills are necessary to perform fast selective wrist and finger movements (wrist-finger speed) and to manipulate small objects (finger dexterity) or larger objects (manual dexterity) efficiently , and require precise thumb and finger movements, which can be severely reduced after stroke . Finally, the ability to keep the arm steady (steadiness), to move it quickly and precisely to an intended target (aiming), or to move it under constant visual control along a line (tracking) are equally relevant to arm motor function  and difficult to quantify.
Different technological solutions have been suggested to register the complex anatomy and mechanics of the hand , mostly using robotic devices [20,21,22,23], gloves [24,25,26], and camera-based solutions [27, 28]. Although these devices have primarily been used for rehabilitation, they also have the potential to overcome the limitations associated with conventional clinical tools, by providing objective and accurate measurements and performing separate analyses of specific finger movements . Unfortunately, many of these systems are either expensive and require dedicated space in the clinic or are not widely available, which limits their clinical use. Multi-touch technology, such as that included in many current smartphones and tablets, allows for the very precise detection of finger touches and hand gestures on a capacitive screen . This feature, together with the portability and low-cost features, could enable the successful assessment of hand mobility and dexterity with tablet devices and facilitate their use not only in the clinical setting but also at home. Previous research examining the use of tablet apps by persons with stroke has shown that interactions with these tools are feasible and acceptable , with most individuals being able to perform basic gestures on a tablet with at least one hand [2, 31], whereas the level of participation is dependent on the motor impairment severity . However, only two studies have investigated till date the feasibility of tablet-based assessments of the upper limb motor function after stroke. These preliminary studies showed excellent discriminative validity of different exercises, which included tapping [2, 32], and drawing and coordination exercises . These later exercises also showed poor to good reliability . Although these studies showed the potential of tablet apps to assess motor impairments after stroke, they include scarce exercises, ranging from one to three, and enrol a limited number of stroke survivors or mixed neurological conditions.
We have designed a free, dedicated app to examine hand mobility, coordination, and function, by measuring performance on a series of exercises that attempt to represent the hand movements associated with daily basic activities [33, 34], including tapping, the analytic extension of the fingers, pincer grips with different fingers, hand opening and closing, and visuomotor coordination during drawing and target reachingFootnote1 . We hypothesized that the proposed exercises had convergent validity with clinical instruments, and were reliable and sensitive to impairment severity. If these hypotheses were corroborated, the multi-touch exercises could complement clinical assessment of the arm and hand function with more objective and accurate measures of specific finger and hand movements.
Consequently, the objectives of this study were three-fold. First, to determine the convergent validity of the app compared with standardized clinical tests performed in a representative sample of individuals with stroke. Second, to quantify the reliability of the app, as defined by inter- and intra-rater reliability, standard error of measurement, and minimal detectable change. Finally, to investigate the sensitivity of the app for the differentiation of post-stroke motor impairment severity.[…]
[Abstract] The effects of unilateral step training and conventional treadmill training on gait asymmetry in patients with chronic stroke
• Step-length asymmetry is common after stroke.
• Effects of unilateral step training and conventional treadmill training were tested.
• Training effectiveness was related to the direction of step-length asymmetry.
• Benefits were only observed in patients who took a shorter step with the paretic leg.
• Training to improve gait asymmetry is not a “one-size-fits-all” approach.
Step length asymmetry is common after stroke. Unilateral step training (UST) can improve step length asymmetry for patients who take a longer step with their paretic leg (P-long). UST has not been tested with patients who take a shorter step with their paretic leg (P-short).
Does training patients according to the direction of their asymmetry improve step length asymmetry?
Adults 18 years and older with asymmetrical gait at least 6 months post-stroke completed three 20 min treadmill training sessions at least 48 h apart: Conventional treadmill; UST with the non-paretic leg stationary on the side of the treadmill and the paretic leg stepping on the moving treadmill belt (P-stepping); and UST with the paretic leg stationary on the side of the treadmill and the non-paretic leg stepping on the moving belt (NP-stepping). Spatiotemporal gait parameters before, immediately, 10 min and 30 min after training were recorded at self-selected and fastest walking pace. Asymmetry values for each parameter were calculated. RmANOVAs were used to investigate the effects of training type on spatiotemporal parameters and paired-samples t-tests used to investigate potential contributors to training effects on asymmetry.
Twenty participants (16 male, median age 65 (43–80) years; 11 P-long, 9 P-short) were included. Improvements in step length asymmetry were observed immediately after both Conventional (9.1 %; 95 % CI 2.7–15.4%) and P-stepping (11.6 %; 95 % CI 5.3–17.8 %) treadmill training in participants who take a shorter step with their paretic leg, however effects were only sustained after Conventional training. Step length asymmetry did not improve for P-long participants with any training type.
The effectiveness of unilateral step training may be related to the direction of step length asymmetry. Further investigation is required before considering using unilateral step training as a rehabilitation tool for gait asymmetry after stroke.
Posted by Debbie Overman
The U.S. Food and Drug Administration has authorized the marketing of the IpsiHand, a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion.
The IpsiHand Upper Extremity Rehabilitation System (IpsiHand System), from Neurolutions Inc, is a Brain-Computer-Interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity—or hand, wrist and arm—disability.
“Thousands of stroke survivors require rehabilitation each year. Today’s authorization offers certain chronic stroke patients undergoing stroke rehabilitation an additional treatment option to help them move their hands and arms again and fills an unmet need for patients who may not have access to home-based stroke rehabilitation technologies.”
— Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health
Designed for Post-Stroke Rehab
Although stroke is a brain disease, it can affect the entire body and sometimes causes long-term disability such as complete paralysis of one side of the body (hemiplegia) or one-sided weakness (hemiparesis) of the body. Stroke survivors may have problems with the simplest of daily activities, including speaking, walking, dressing, eating and using the bathroom.
Post-stroke rehabilitation helps individuals overcome disabilities that result from stroke damage. The IpsiHand System uses non-invasive electroencephalography (EEG) electrodes instead of an implanted electrode or other invasive feature to record brain activity. The EEG data is then wirelessly conveyed to a tablet for analysis of the intended muscle movement (intended motor function) and a signal is sent to a wireless electronic hand brace, which in turn moves the patient’s hand. The device aims to help stroke patients improve grasping. The device is prescription-only and may be used as part of rehabilitation therapy.
The FDA assessed the safety and effectiveness of the IpsiHand System device through clinical data submitted by the company, including an unblinded study of 40 patients over a 12-week trial. All participants demonstrated motor function improvement with the device over the trial. Adverse events reported included minor fatigue and discomfort and temporary skin redness.
The IpsiHand System device should not be used by patients with severe spasticity or rigid contractures in the wrist and/or fingers that would prevent the electronic hand brace from being properly fit or positioned for use or those with skull defects due to craniotomy or craniectomy.
The IpsiHand System device was granted Breakthrough Device designation, which is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The FDA reviewed the IpsiHand System device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.
This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
The FDA granted marketing authorization of the Neurolutions IpsiHand Upper Extremity Rehabilitation System to Neurolutions Inc.
[Source(s): US Food and Drug Administration, PR Newswire]
[Abstract] THE EFFECT OF EMG-DRIVEN ROBOTIC TREATMENT ON THE RECOVERY OF THE HAND NINE YEARS AFTER STROKE – Case report
• There is a need for new studies in stroke cases that are quite chronic.
• It may be beneficial to support subjective evaluations used in stroke rehabilitation with objective evaluations such as electrophysiological measurements.
• The robotic rehabilitation system has some advantages, such as providing high repetitive activities, compared to the traditional rehabilitation approaches.
• In stroke rehabilitation, it should be aimed to transfer the gains obtained after the treatment to daily life.
To investigate the effect of electromyography (EMG)-driven robotic therapy on the recovery of the hand in a stroke case lasting 9 years.
An 18-year-old patient with hemiparesis due to the ischemic lesion was admitted to our clinic with hand impairment. Fifteen sessions (5 weeks x 3 times) of robotic rehabilitation were applied with the Hand of Hope©. Average EMG (mV) of flexor digitorum superficialis (FDS) muscle, average force (N) and the rate of force development (RFD)(N/s) were also assessed before and after the treatment following the 5th and 10th sessions and at the end of treatment. Also Fugl-Meyer Assessment of Upper Extremity Scale (FMU-UE), Motor Activity Log (MAL), Canadian Occupational Performance Score (COPM) and Visual Analog Scale (VAS) were used for assessment before and after the treatment.
The average EMG measured from FDS increased from 0.093 to 0.133 mV. The average force and average RFD increased from 45.6 to 97.7 and from 135.6 to 172.6 respectively. While affected/ unaffected side force ratio increased dramatically from 54% to 82%, the FMA-UE score increased from 56 to 59. The MAL quality of use score increased from 3.93 to 4.13. Performance and satisfaction scores of COPM changed from 5.25 to 7.25 and 4.5 to 8.25 respectively. VAS score for fatigue changed from 6 to 4.
The improvement achieved 9 years later with 15 sessions of rehabilitation suggests that improvement may be possible for chronic stroke patients.
[ARTICLE] Task-specific training for improving propulsion symmetry and gait speed in people in the chronic phase after stroke: a proof-of-concept study – Full Text
After stroke, some individuals have latent, propulsive capacity of the paretic leg, that can be elicited during task-specific gait training. The aim of this proof-of-concept study was to investigate the effect of five-week robotic gait training for improving propulsion symmetry by increasing paretic propulsion in chronic stroke survivors.
Twenty-nine individuals with chronic stroke and impaired paretic propulsion (≥ 8% difference in paretic vs. non-paretic propulsive impulse) were enrolled. Participants received ten 60-min sessions of individual robotic gait training targeting paretic propulsion (five weeks, twice a week), complemented with home exercises (15 min/day) focusing on increasing strength and practicing learned strategies in daily life. Propulsion measures, gait kinematics and kinetics, self-selected gait speed, performance of functional gait tasks, and daily-life mobility and physical activity were assessed five weeks (T0) and one week (T1) before the start of intervention, and one week (T2) and five weeks (T3) after the intervention period.
Between T0 and T1, no significant differences in outcomes were observed, except for a marginal increase in gait speed (+ 2.9%). Following the intervention, propulsion symmetry (+ 7.9%) and paretic propulsive impulse had significantly improved (+ 8.1%), whereas non-paretic propulsive impulse remained unchanged. Larger gains in propulsion symmetry were associated with more asymmetrical propulsion at T0. In addition, following the intervention significantly greater paretic trailing limb angles (+ 6.6%) and ankle plantarflexion moments (+ 7.1%) were observed. Furthermore, gait speed (+ 7.2%), 6-Minute Walk Test (+ 6.4%), Functional Gait Assessment (+ 6.5%), and daily-life walking intensity (+ 6.9%) had increased following the intervention. At five-week follow-up (T3), gains in all outcomes were retained, and gait speed had further increased (+ 3.6%).
The post-intervention gain in paretic propulsion did not only translate into improved propulsion symmetry and gait speed, but also pertained to performance of functional gait tasks and daily-life walking activity levels. These findings suggest that well-selected chronic stroke survivors may benefit from task-specific targeted training to utilize the residual propulsive capacity of the paretic leg. Future research is recommended to establish simple baseline measures for identification of individuals who may benefit from such training and confirm benefits of the used training concepts in a randomized controlled trial.
Trial registration: Registry number ClinicalTrials.gov (www.clinicaltrials.gov): NCT04650802, retrospectively registered 3 December 2020.
While the majority of stroke survivors regain independent walking , gait efficiency and speed are often persistently reduced compared to healthy adults . Post-stroke gait speed is associated with community ambulation, as a minimum speed of 0.4 m/s seems necessary for walking outside the home, and a speed faster than 0.8 m/s seems required for full community ambulation [3, 4]. In addition, impaired post-stroke gait speed is associated with reduced quality of life [5, 6]. Hence, a common goal for post-stroke rehabilitation interventions is to improve gait speed.
Gait speed is mainly generated by ankle push-off force during terminal stance, which helps propel the body forward. Gait propulsion is usually defined as the horizontal component of the ground reaction force during push-off. Propulsion is determined by the ankle plantarflexion moment , in combination with the angle of the trailing limb with the vertical during push-off [8,9,10]. Generally, larger trailing limb angles are associated with more anteriorly directed ground reaction forces , resulting in a larger contribution of the ankle plantarflexion moment to forward (instead of upward) acceleration of the body. After stroke, propulsion of the paretic leg is often lower than the values observed in healthy adults [12,13,14]. This is probably due to muscle weakness [9, 15, 16], loss of selective motor control , and/or balance uncertainty and reduced limb loading . Reductions in paretic compared to non-paretic propulsion result in propulsion asymmetry , which is associated with impaired walking capacity [19,20,21]. In addition, deficits in paretic propulsion are associated with reduced paretic knee flexion during swing [22, 23], which may affect walking efficiency [24, 25] and increase the risk of falling . In order to compensate for the lack of paretic propulsion, stroke survivors tend to rely more on the non-paretic leg’s propulsion generation [19, 27], as well as on paretic hip pull-off to progress the paretic leg during swing [14, 16]. These compensatory mechanism are, however, associated with reduced gait efficiency [25, 28]. Increasing the contribution of the paretic leg to propulsion is, therefore, a key target for restoring gait post stroke .
A recent review of studies evaluating propulsion and gait speed after single or multiple training sessions suggested that individuals in the chronic phase after stroke may not fully utilize their residual propulsive capacity, possibly due to ‘learned non-use’ of the paretic leg . It was suggested that targeted and challenging training focusing on stronger ankle plantarflexion and larger trailing limb angle may help people with stroke reactivate this latent propulsive capacity of the paretic leg, thus improving propulsion symmetry [21, 30, 31]. Yet, to date only few studies involved training programs primarily aimed at improving propulsion in individuals in the chronic phase after stroke [32,33,34,35,36,37], of which some evaluated the long-term training effects [32,33,34]. Overall, these studies yielded mixed results [32,33,34,35,36,37]. Their findings suggest that the latent propulsive capacity of the paretic leg can be elicited during task-specific training in individuals with chronic stroke, but it remains questionable if benefits are retained over time.
The primary aim of this study was to investigate the effect of a five-week gait training for improving propulsion symmetry by increasing propulsion of the paretic leg in individuals in the chronic phase after stroke. The training was conducted in robotic gait trainer LOPES II . LOPES II training allowed participants to focus attention on their paretic leg, attributable to the provided balance support and guided weight shifts. Compensatory movements could be reduced through mechanical assistance of the lower limbs (by LOPES II) and by providing real-time feedback of the individual’s gait performance. Propulsion was challenged by increasing step length and velocity, or moving against robotic resistance. In addition to paretic leg propulsion, we also determined its constituent factors, namely the trailing limb angle and the ankle plantarflexion moment of the paretic leg. Our secondary aim was to determine whether the capacity of participants to increase their paretic propulsive impulse at baseline would be an indicator of the latent propulsive capacity of the paretic leg  and, thus, a relevant patient-related predictor of a positive training response. In addition, we assessed paretic knee flexion during swing (ICF-impairment level); self-selected gait speed and functional gait tasks (ICF-capacity level); and daily-life mobility impact and physical activity (ICF-performance level). We hypothesized that five weeks (ten sessions) of gait training in LOPES II would improve propulsion symmetry and, thereby, gait speed and execution of functional gait tasks. In addition, we expected that improved gait capacity might lead to a lower impact of stroke on daily-life mobility and a higher physical activity level.[…]
[Abstract] Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial
Long-term loss of arm function after ischaemic stroke is common and might be improved by vagus nerve stimulation paired with rehabilitation. We aimed to determine whether this strategy is a safe and effective treatment for improving arm function after stroke.
In this pivotal, randomised, triple-blind, sham-controlled trial, done in 19 stroke rehabilitation services in the UK and the USA, participants with moderate-to-severe arm weakness, at least 9 months after ischaemic stroke, were randomly assigned (1:1) to either rehabilitation paired with active vagus nerve stimulation (VNS group) or rehabilitation paired with sham stimulation (control group). Randomisation was done by ResearchPoint Global (Austin, TX, USA) using SAS PROC PLAN (SAS Institute Software, Cary, NC, USA), with stratification by region (USA vs UK), age (≤30 years vs >30 years), and baseline Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score (20–35 vs 36–50). Participants, outcomes assessors, and treating therapists were masked to group assignment. All participants were implanted with a vagus nerve stimulation device. The VNS group received 0·8 mA, 100 μs, 30 Hz stimulation pulses, lasting 0·5 s. The control group received 0 mA pulses. Participants received 6 weeks of in-clinic therapy (three times per week; total of 18 sessions) followed by a home exercise programme. The primary outcome was the change in impairment measured by the FMA-UE score on the first day after completion of in-clinic therapy. FMA-UE response rates were also assessed at 90 days after in-clinic therapy (secondary endpoint). All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT03131960.
Between Oct 2, 2017, and Sept 12, 2019, 108 participants were randomly assigned to treatment (53 to the VNS group and 55 to the control group). 106 completed the study (one patient for each group did not complete the study). On the first day after completion of in-clinic therapy, the mean FMA-UE score increased by 5·0 points (SD 4·4) in the VNS group and by 2·4 points (3·8) in the control group (between group difference 2·6, 95% CI 1·0–4·2, p=0·0014). 90 days after in-clinic therapy, a clinically meaningful response on the FMA-UE score was achieved in 23 (47%) of 53 patients in the VNS group versus 13 (24%) of 55 patients in the control group (between group difference 24%, 6–41; p=0·0098). There was one serious adverse event related to surgery (vocal cord paresis) in the control group.
Vagus nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after ischaemic stroke.