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Open skin lesions at the right thigh (site if the body weight support belt) of a 5-year old girl wearing diapers during the therapy trial.
Source publication
The aim of the present study was to report on adverse events encountered with robotic-assisted treadmill therapy in children and adolescents with gait disorders.
Eighty-nine patients who underwent a trial of robotic assisted treadmill therapy in the two participating centres were analysed. Demographic data and safety data of the patients were analy...
Contexts in source publication
Context 1
... five patients, the adverse events were mild-to-moderate and interfered with further therapy continuation within a period of 4 weeks (Table II). These adverse events consisted of joint pain (n ¼ 2), open skin lesions (n ¼ 2, Figure 2) and tendinopathy (n ¼ 1). Severe side-effects were encountered in none of the patients. ...
Context 2
... is recom- mended that RATT should only be performed by a core physiotherapy team which uses the Lokomat on a frequent basis. In two cases the open skin lesions occurred adjacent to the area where diapers were worn (Figure 2). Thus, the authors state that special awareness is mandatory in patients wearing diapers when they show signs of mechanical skin erythema. ...
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... No safety issues have been reported following transcutaneous tibial nerve stimulation or following transcutaneous spinal cord (or transspinal) stimulation. In 38 out of 89 persons with SCI who received locomotor training with the Lokomat, adverse events included mild skin erythema at the sites of the cuffs, and muscle pain while open skin lesions (n = 2), joint pain (n = 2), or tendinopathy (n = 1) were also reported [96]. The events are predictable and are indicated as potential risks in the Informed Consent Form. ...
Background
The seemingly simple tasks of standing and walking require continuous integration of complex spinal reflex circuits between descending motor commands and ascending sensory inputs. Spinal cord injury greatly impairs standing and walking ability, but both improve with locomotor training. However, even after multiple locomotor training sessions, abnormal muscle activity and coordination persist. Thus, locomotor training alone cannot fully optimize the neuronal plasticity required to strengthen the synapses connecting the brain, spinal cord, and local circuits and potentiate neuronal activity based on need. Transcutaneous spinal cord (transspinal) stimulation alters motoneuron excitability over multiple segments by bringing motoneurons closer to threshold, a prerequisite for effectively promoting spinal locomotor network neuromodulation and strengthening neural connectivity of the injured human spinal cord. Importantly, whether concurrent treatment with transspinal stimulation and locomotor training maximizes motor recovery after spinal cord injury is unknown.
Methods
Forty-five individuals with chronic spinal cord injury are receiving 40 sessions of robotic gait training primed with 30 Hz transspinal stimulation at the Thoracic 10 vertebral level. Participants are randomized to receive 30 min of active or sham transspinal stimulation during standing or active transspinal stimulation while supine followed by 30 min of robotic gait training. Over the course of locomotor training, the body weight support, treadmill speed, and leg guidance force are adjusted as needed for each participant based on absence of knee buckling during the stance phase and toe dragging during the swing phase. At baseline and after completion of all therapeutic sessions, neurophysiological recordings registering corticospinal and spinal neural excitability changes along with clinical assessment measures of standing and walking, and autonomic function via questionnaires regarding bowel, bladder, and sexual function are taken.
Discussion
The results of this mechanistic randomized clinical trial will demonstrate that tonic transspinal stimulation strengthens corticomotoneuronal connectivity and dynamic neuromodulation through posture-dependent corticospinal and spinal neuroplasticity. We anticipate that this mechanistic clinical trial will greatly impact clinical practice because, in real-world clinical settings, noninvasive transspinal stimulation can be more easily and widely implemented than invasive epidural stimulation. Additionally, by applying multiple interventions to accelerate motor recovery, we are employing a treatment regimen that reflects a true clinical approach.
Trial registration
ClinicalTrials.gov NCT04807764 . Registered on March 19, 2021.
... Prior to and post-surgery, clinical assessments for our clinical care setting include 3D gait analysis, GMFM-66, GOAL questionnaire, and the Goal Attainment Scale. Intensive, task-specific rehabilitation blocks including robotic-enhanced therapies [41][42][43] or serious gaming technologies using inpatient, outpatient and/or home-based protocols should be based on the capacity of the family. The interventions should be accompanied by the above-mentioned assessments at 6 and 24 months after surgery and from there on as necessary. ...
... After title and abstract reading, 35 articles met the requirements to proceed to the full-text reading stage. In this stage, four further articles were excluded due to the absence of a rehabilitation treatment [22][23][24][25]. This process led to 31 selected papers being included in the review ( Table 2). ...
... Only four devices were provided with the CE mark and, hence, are commercially available. Except for the Lokomat (Hocoma AG, Volketswil, Switzerland), which has been widely investigated in children with neurological disabilities [25,[27][28][29][32][33][34]37,41,49,50], each of the other devices were investigated in few studies. ...
... Along with its effectiveness, the safety and acceptability by patients and therapists represent other relevant aspects in robot-assisted rehabilitation. Borggraefe et al. [25] have investigated the safety and feasibility of robot-assisted treadmill training in 83 children and adolescents, and no severe side effects were found. In most patients, the adverse events were clinically insignificant and did not prevent children from undergoing the treatment. ...
In the last two decades, a growing interest has been focused on gait and balance robot-assisted rehabilitation in children with neurological disabilities. Robotic devices allow the implementation of intensive, task-specific training fostering functional recovery and neuroplasticity phenomena. However, limited attention has been paid to the protocols used in this research framework. This systematic review aims to provide an overview of the existing literature on robotic systems for the rehabilitation of gait and balance in children with neurological disabilities and their rehabilitation applications. The literature search was carried out independently and synchronously by three authors on the following databases: MEDLINE, Cochrane Library, PeDro, Institute of Electrical and Electronics Engineers, ScienceDirect, and Google Scholar. The data collected included three subsections referring to clinical, technical, and regulatory aspects. Thirty-one articles out of 81 found on the primary literature search were included in the systematic review. Most studies involved children with cerebral palsy. Only one-third of the studies were randomized controlled trials. Overall, 17 devices (nine end-effector systems and eight exoskeletons) were investigated, among which only 4 (24%) were bore the CE mark. Studies differ on rehabilitation protocols duration, intensity, and outcome measures. Future research should improve both rehabilitation protocols’ and devices’ descriptions.
... They only look at system level behavior (not individual sensor functionality) and are closely related to the concept of safety skills. The protocols are testing procedures for safety validation and not to be confused with protocols used to evaluate safety during robot use, e.g., by monitoring adverse events in clinical trials (Nef et al., 2007;Borggraefe et al., 2010;Rodgers et al., 2019). While addressing comfort and safety during use of rehabilitation robots is important (Bessler et al., 2020), we are aiming to develop procedures for validating mechanical safety in the development phase, usually without a human in the loop. ...
The assessment of rehabilitation robot safety is a vital aspect of the development process,
which is often experienced as difficult. There are gaps in best practices and knowledge to
ensure safe usage of rehabilitation robots. Currently, safety is commonly assessed by
monitoring adverse events occurrence. The aim of this article is to explore how safety of
rehabilitation robots can be assessed early in the development phase, before they are used
with patients. We are suggesting a uniform approach for safety validation of robots closely
interacting with humans, based on safety skills and validation protocols. Safety skills are an
abstract representation of the ability of a robot to reduce a specific risk or deal with a
specific hazard. They can be implemented in various ways, depending on the application
requirements, which enables the use of a single safety skill across a wide range of
applications and domains. Safety validation protocols have been developed that
correspond to these skills and consider domain-specific conditions. This gives robot
users and developers concise testing procedures to prove the mechanical safety of their
robotic system, even when the applications are in domains with a lack of standards and
best practices such as the healthcare domain. Based on knowledge about adverse events
occurring in rehabilitation robot use, we identified multi-directional excessive forces on the
soft tissue level and musculoskeletal level as most relevant hazards for rehabilitation robots
and related them to four safety skills, providing a concrete starting point for safety
assessment of rehabilitation robots. We further identified a number of gaps which
need to be addressed in the future to pave the way for more comprehensive
guidelines for rehabilitation robot safety assessments. Predominantly, besides new
developments of safety by design features, there is a strong need for reliable
measurement methods as well as acceptable limit values for human-robot interaction
forces both on skin and joint level.
... We identified 1,081 unique records through database searching and one addition through reference searching (Figure 1). Of those, 139 records remained after title and abstract screening, of which 50 met the inclusion criteria and were analyzed (Husemann et al., 2007;Mayr et al., 2007;Freivogel et al., 2008Freivogel et al., , 2009Lo and Triche, 2008;Ng et al., 2008;Hesse and Werner, 2009;Borggraefe et al., 2010;Chin et al., 2010;Lo et al., 2010;Geroin et al., 2011;Morone et al., 2011;Turiel et al., 2011;Benito-Penalva et al., 2012;Carda et al., 2012;Gizzi et al., 2012;Picelli et al., 2012Picelli et al., , 2015Vaney et al., 2012;Geigle et al., 2013;Kelley et al., 2013a,b;Aach et al., 2014;Labruyère and van Hedel, 2014;Nilsson et al., 2014;Stoller et al., 2014Stoller et al., , 2015Asbeck et al., 2015;Filippo et al., 2015;Ochi et al., 2015;Schoenrath et al., 2015a,b;Sczesny-Kaiser et al., 2015, 2017Wu et al., 2015;Chua et al., 2016;Forrester et al., 2016;Ikumi et al., 2016;Kumru et al., 2016a,b;Aurich-Schuler et al., 2017;Bae et al., 2017;Chisholm et al., 2017;Esquenazi et al., 2017;Grasmücke et al., 2017;Jansen et al., 2017Jansen et al., , 2018Kim et al., 2019;Straudi et al., 2019;Tanaka et al., 2019). We identified some studies with overlap in patients (Kelley et al., 2013a,b;Aach et al., 2014;Stoller et al., 2014Stoller et al., , 2015Sczesny-Kaiser et al., 2015;Jansen et al., 2017Jansen et al., , 2018 and excluded double reports in the analysis of subject numbers and AE numbers. ...
... The included studies described RAGT in 985 subjects of which 14 were healthy individuals, 341 SCI patients, 326 stroke patients, 42 traumatic brain injury patients, 67 cerebral palsy patients, 74 Parkinson's disease patients, 76 multiple sclerosis patients, 15 cardiac patients, and 30 patients with other diagnoses. Two of the included studies focused on children and adolescents (Borggraefe et al., 2010;Aurich-Schuler et al., 2017). The identified studies reported on gait training in 10 different devices: Lokomat (489 subjects in 27 studies), Gait Trainer GT (301 subjects in 8 studies; 244 subjects trained in GT II, 24 in GT I, and for 33 subjects the model was not specified), HAL (108 subjects in 9 studies), MorningWalk (25 subjects in 1 study), LokoHelp (22 subjects in 2 studies), Anklebot (14 subjects in 1 study), Gait-Assistance Robot GAR (13 subjects in 1 study), G-EO (7 subjects in 1 study), a soft exosuit (5 subjects in 1 study), and PH-EXOS (1 subject in 1 study). ...
... The AE descriptions from the 18 studies that did report AEs are collected in Table 3. The most frequently reported AEs were changes to the skin or soft tissue (more than 47 occurrences in 40 subjects) including skin reddening, skin lesions, skin abrasions, a blood blister, chafing, skin irritation due to electromyography (EMG) electrodes, and bruises (Husemann et al., 2007;Borggraefe et al., 2010;Vaney et al., 2012;Kelley et al., 2013a,b;Nilsson et al., 2014;Stoller et al., 2014;Esquenazi et al., 2017;Jansen et al., 2018). The most severe AE reported was one bone fracture in the context of Lokomat training (Filippo et al., 2015). ...
Robot-assisted gait training (RAGT) devices are used in rehabilitation to improve patients' walking function. While there are some reports on the adverse events (AEs) and associated risks in overground exoskeletons, the risks of stationary gait trainers cannot be accurately assessed. We therefore aimed to collect information on AEs occurring during the use of stationary gait robots and identify associated risks, as well as gaps and needs, for safe use of these devices. We searched both bibliographic and full-text literature databases for peer-reviewed articles describing the outcomes of stationary RAGT and specifically mentioning AEs. We then compiled information on the occurrence and types of AEs and on the quality of AE reporting. Based on this, we analyzed the risks of RAGT in stationary gait robots. We included 50 studies involving 985 subjects and found reports of AEs in 18 of those studies. Many of the AE reports were incomplete or did not include sufficient detail on different aspects, such as severity or patient characteristics, which hinders the precise counts of AE-related information. Over 169 device-related AEs experienced by between 79 and 124 patients were reported. Soft tissue-related AEs occurred most frequently and were mostly reported in end-effector-type devices. Musculoskeletal AEs had the second highest prevalence and occurred mainly in exoskeleton-type devices. We further identified physiological AEs including blood pressure changes that occurred in both exoskeleton-type and end-effector-type devices. Training in stationary gait robots can cause injuries or discomfort to the skin, underlying tissue, and musculoskeletal system, as well as unwanted blood pressure changes. The underlying risks for the most prevalent injury types include excessive pressure and shear at the interface between robot and human (cuffs/harness), as well as increased moments and forces applied to the musculoskeletal system likely caused by misalignments (between joint axes of robot and human). There is a need for more structured and complete recording and dissemination of AEs related to robotic gait training to increase knowledge on risks. With this information, appropriate mitigation strategies can and should be developed and implemented in RAGT devices to increase their safety.
... 20%. The robot-assisted gait training has been considered to be a safe therapeutic option in the paediatric neurorehabilitation (Meyer -Heim, 2007;Borggraefe, 2010b;Aurich-Schuler, 2015). ...
Background:
Robot-assisted gait training (RAGT) allows an intensive gait training in patients with cerebral palsy (CP). There are few evidences on the effectiveness of RAGT in adults with CP.
Objective:
To assess the effect of RAGT on gross motor function in adolescent and adult patients with bilateral spastic CP and to compare the effect of RAGT with conventional kinesiotherapy.
Methods:
Forty-seven patients (mean age 21.2±5.33 years) with bilateral spastic CP were divided into two groups. Twenty-one patients underwent 20 therapeutic units of RAGT and 26 patients underwent 20 therapeutic units of conventional therapy/training (CON). The following parameters were evaluated before (V1) and after the therapy (V2): dimension A (lying and rolling), B (sitting), C (crawling and kneeling), D (standing), E (walking, running and jumping) of the Gross Motor Function Measure (GMFM-88). In patients in the experimental RAGT group, these parameters were also evaluated 3-4 months later (V3).
Results:
Comparing the mean improvements in endpoints in both groups (RAGT vs. CON) after 20 TUs, we observed the statistically significant difference (p < 0.001) and large effect size in all GMFM dimensions and total GMFM improvement in favour of the RAGT group. In RAGT patients, the improvement persisted even 3-4 months after RAGT (p < 0.001).
Conclusion:
We demonstrated that the intensive RAGT regimen is more effective than conventional therapy in terms of improvements in gross motor functions in adolescent and adult patients with bilateral spastic CP.
... Pain: Patients must be able to signal pain and discomfort reliably. During RAGT, pain as an adverse effect can occur (e.g., muscle pain, joint pain, skin redness and abrasions, tendon irritation, and pain caused by pressure of the cuffs and of the belt system) (Borggraefe et al. 2010b). Therefore, the patient needs to be monitored continuously during therapy and a ramp-up period for training duration is recommended. ...
... First studies using the pediatric Lokomat ® confirmed its feasibility and acceptability to patients, parents, and therapists in a rehabilitation setting (Meyer-Heim et al. 2007), as well as safety (Borggraefe et al. 2010b). Measures like the Gross Motor Function Measure (GMFM) and gait speed improved during an inpatient multidisciplinary therapy program including Lokomat ® training or also in patients who received out-patient services and participated in solely Lokomat ® training (Borggraefe et al. 2010c;Meyer-Heim et al. 2009) and some changes were maintained 6 months later (Borggraefe et al. 2010a). ...
In the last decade, robot-assisted gait training (RAGT) has become an increasingly used therapy option for children with cerebral palsy (CP). Training a physiological gait pattern with a high number of repetitions reflects recent approaches in neurorehabilitation, in which dose-dependency, task-specificity, and high patient engagement are the crucial factors for better gait outcomes. Different approaches of RAGT offer an attractive therapy option to achieve functional mobility, as it can (and should) be combined with patient rewarding strategies like exergames. RAGT, however, needs not only expensive devices but also a well-trained therapy team and careful patient selection. The clinical implementation of RAGT requires a high level of multidisciplinary organization in rehabilitation institutions. As for any other therapy, RAGT has indications and contraindications. Research is growing; however, findings from research on RAGT have not provided conclusive proof that this is an effective therapy option. Besides needed larger sample sizes and the methodological problems associated with RAGT studies, another major challenge for research is to keep up with the fast developing technology in the field of rehabilitation robotics.
... However, it is often a challenge for the therapy team to meet these expectations appropriately, as scientific evidence in this area shows large deficits. Although studies have provided evidence on the Lokomat's feasibility and safety in pediatric populations [8,11], information on the optimal frequency and duration of such interventions as well as the intensity and dosage of the training parameters is sparse. A recent systematic review concluded that no specific delivery modes for RAGT in children exist and that evidence of its effectiveness is still weak and inconsistent [12]. ...
Purpose:
To investigate the effectiveness of outpatient robot-assisted gait training (RAGT) in ambulatory children with spastic cerebral palsy.
Methods:
Children were randomized to two different intervention sequences within a pragmatic crossover design. They performed five weeks of RAGT (3 sessions per week) and five weeks of usual care (UC). Dimension E of the Gross Motor Function Measure - 88 (GMFM E) was the primary outcome as well as Dimension D (GMFM D), and timed walking tests were assessed before and after each treatment sequence and after a 5 - week follow - up.
Results:
The trial was stopped early because of recruitment problems. We included 16 children with a mean age of 11.3 years (6.0-15.3 years). GMFM E median (IQR) change scores were - 0.7 (-2.8 to 3.5) after RAGT and 0 (-2.4 to 2.4) after UC. Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow - up, or carry - over effects observable.
Conclusions:
RAGT as a single intervention was not effective in improving walking abilities in the included children. It should be embedded in a holistic treatment approach, as it cannot cover all aspects relevant to gait. Furthermore, children's personalized rehabilitation goals should be carefully monitored with individualized measurement instruments.
... Another study reported on adverse events encountered during gait training of children and adolescents with the Lokomat ® (Hocoma AG, Volketswil, Switzerland), an exoskeleton device with a treadmill and a suspension system [14,15]. In 89 patients who underwent 12 therapy sessions for over a 3-week period, 16 (34.0%) ...
... had skin erythema, 4 (8.5%) had open skin lesions, and 1 (2.1%) had tendinopathy. Skin erythema at the cuffs and leg orthoses of the device and muscle and joint pains were generally mild, but in 5 (5.6%) patients, open skin lesions (n = 2), joint pain (n = 2), or tendinopathy (n = 1) led to discontinuation of the therapy [14]. In the present study, there were also 2 cases of skin erythema at the saddle site, but it was not very severe to interfere with the treatment. ...
... Muscle and joint pain as well as skin erythema were reported to be the most common adverse events in exoskeleton type robots, with joint pain affecting lower extremity, including the hip, knee, and ankles [14]. In the present study, the knee joint was the most common site of pain occurrence, and developed only in patients with spinal cord injuries and was the most common cause of discontinuity in these patients. ...
Unlabelled:
Robots are being used to assist the recovery of walking ability for patients with neurologic disorders. This study aimed to evaluate the feasibility and functional improvement of training with robot-assisted gait training (RAGT) using the Morning Walk®, an end-effector type robot using footplates and saddle seat support. A total of 189 individuals (65.1% men, 34.9% women; mean age, 53.2 years; age range: 5-87 years) with brain lesions, spinal cord injuries, Parkinson's disease, peripheral neuropathies, and pediatric patients were involved in this retrospectively registered clinical trial. Each participant performed 30 minutes of RAGT, five times a week, for a total of 24 sessions. Failure was defined as an inability to complete all 24 sessions, and the reasons for discontinuation were analyzed. Parameters of Medical Research Council scales and Functional Ambulation Categories were analyzed before and after RAGT training. Among the 189 patients, 22 (11.6%) failed to complete the RAGT. The reasons included decreased cooperation, musculoskeletal pain, saddle seat discomfort, excessive body-weight support, joint spasticity or restricted joint motion, urinary incontinence from an indwelling urinary catheter, and fatigue. Comparison between the pre- and post-training motor and ambulatory functions showed significant improvement. The result of the study indicates that the Morning Walk® is feasible and safe and useful for functional improvement in patients with various neurologic disorders.
Trial registration:
Clinical Research Information Service Identifier: KCT0003627.
... Some mild adverse events occurred, but all participants completed HAL-T. Borggraefe et al. [22] reported an adverse event rate of approximately 43% for children and adolescents with gait disorders who underwent Lokomat-assisted treadmill therapy. The most common events for their participants were mild skin erythema at the device's cuff sites and muscle pain. ...
To investigate whether Robot Suit HAL treatment (HAL-T) is safe and feasible for gait disorders in adolescents and adults with cerebral palsy (CP). We tested HAL-T in adolescents and adults with bilateral spastic CP (four men, four women; mean age: 18.2 years). Three participants were classified as level III under the Gross Motor Function Classification System (GMFCS), and five were classified as level IV. The participants underwent HAL-T twice per week for 4 weeks. The outcome measures, which were assessed before and after HAL-T, included comfortable gait speed (CGS), step length (SL), cadence, and GMFCS level. Adverse events were noted. All participants completed the HAL-T sessions despite some mild adverse events occurring. The mean increases in CGS, SL, and cadence were 0.19 ± 0.14 m/s (p = 0.006), 0.09 ± 0.08 m (p = 0.020), and 18.0 ± 15.9 steps/min (p = 0.015), respectively. HAL-T is safe and feasible for gait disorders in patients with CP. HAL-T can significantly improve CGS, SL, and cadence and may be effective for improving walking ability in adolescents and adults with CP.
