Combining robotics and functional electrical stimulation for assist-as-needed support of leg movements in stroke patients: A feasibility study.

PURPOSE: Rehabilitation technology can be used to provide intensive training in the early phases after stroke. The current study aims to assess the feasibility of combining robotics and functional electrical stimulation (FES), with an assist-as-needed approach to support actively-initiated leg movements in (sub-)acute stroke patients. METHOD: Nine subacute stroke patients performed repetitions of ankle dorsiflexion and/or knee extension movements, with and without assistance. The assist-as-needed algorithm determined the amount and type of support needed per repetition. The number of repetitions and range of motion with and without assistance were compared with descriptive statistics. Fatigue scores were obtained using the visual analogue scale (score 0-10). RESULTS: Support was required in 44 % of the repetitions for ankle dorsiflexion and in 5 % of the repetitions of knee extension, The median fatigue score was 2.0 (IQR: 0.2) and 4.0 (IQR: 1.5) for knee and ankle, respectively, indicating mild to moderate perceived fatigue. CONCLUSION: This study demonstrated the feasibility of assist-as-needed assistance through combined robotic and FES support of leg movements in stroke patients. It proved particularly useful for ankle dorsiflexion. Future research should focus on implementing this approach in a clinical setting, to assess clinical applicability and potential effects on leg function.

Therapy effect on hand function after home use of a wearable assistive soft-robotic glove supporting grip strength.

BACKGROUND: Soft-robotic gloves with an assist-as-needed control have the ability to assist daily activities where needed, while stimulating active and highly functional movements within the user's possibilities. Employment of hand activities with glove support might act as training for unsupported hand function. OBJECTIVE: To evaluate the therapeutic effect of a grip-supporting soft-robotic glove as an assistive device at home during daily activities. METHODS: This multicentre intervention trial consisted of 3 pre-assessments (averaged if steady state = PRE), one post-assessment (POST), and one follow-up assessment (FU). Participants with chronic hand function limitations were included. Participants used the Carbonhand glove during six weeks in their home environment on their most affected hand. They were free to choose which activities to use the glove with and for how long. The primary outcome measure was grip strength, secondary outcome measures were pinch strength, hand function and glove use time. RESULTS: 63 patients with limitations in hand function resulting from various disorders were included. Significant improvements (difference PRE-POST) were found for grip strength (+1.9 kg, CI 0.8 to 3.1; p = 0.002) and hand function, as measured by Jebson-Taylor Hand Function Test (-7.7 s, CI -13.4 to -1.9; p = 0.002) and Action Research Arm Test (+1.0 point, IQR 2.0; p≤0.001). Improvements persisted at FU. Pinch strength improved slightly in all fingers over six-week glove use, however these differences didn't achieve significance. Participants used the soft-robotic glove for a total average of 33.0 hours (SD 35.3), equivalent to 330 min/week (SD 354) or 47 min/day (SD 51). No serious adverse events occurred. CONCLUSION: The present findings showed that six weeks use of a grip-supporting soft-robotic glove as an assistive device at home resulted in a therapeutic effect on unsupported grip strength and hand function. The glove use time also showed that this wearable, lightweight glove was able to assist participants with the performance of daily tasks for prolonged periods.

A robot-based hybrid lower limb system for Assist-As-Needed rehabilitation of stroke patients: Technical evaluation and clinical feasibility.

BACKGROUND: Although early rehabilitation is important following a stroke, severely affected patients have limited options for intensive rehabilitation as they are often bedridden. To create a system for early rehabilitation of lower extremities in these patients, we combined the robotic manipulator ROBERT® with electromyography (EMG)-triggered functional electrical stimulation (FES) and developed a novel user-driven Assist-As-Needed (AAN) control. The method is based on a state machine able to detect user movement capability, assessed by the presence of an EMG-trigger and the movement velocity, and provide different levels of assistance as required by the patient (no support, FES only, and simultaneous FES and mechanical assistance). METHODS: To technically validate the system, we tested 10 able-bodied participants who were instructed to perform specific behaviors to test the system states while conducting knee extension and ankle dorsal flexion exercises. The system was also tested on two stroke patients to establish its clinical feasibility. RESULTS: The technical validation showed that the state machine correctly detected the participants' behavior and activated the target AAN state in more than 96% of the exercise repetitions. The clinical feasibility test showed that the system successfully recognized the patients' movement capacity and activated assistive states according to their needs providing the minimal level of support required to exercise successfully. CONCLUSIONS: The system was technically validated and preliminarily proved clinically feasible. The present study shows that the novel system can be used to deliver exercises with a high number of repetitions while engaging the participants' residual capabilities through the AAN strategy.

The Effect of Botulinum Toxin Type A Injection in the Rectus Femoris in Stroke Patients Walking With a Stiff Knee Gait: A Randomized Controlled Trial.

BACKGROUND: Over activity of the rectus femoris is often cited as a main cause for stiff knee gait (SKG). Botulinum toxin (BoNT) can be used to reduce this over activity. Inconsistent results for the effect of BoNT injections were found in literature which can possibly be explained by the study design as these were uncontrolled or non-randomized studies. OBJECTIVE: To conduct a randomized controlled trial (RCT) to investigate the effect of botulinum toxin type A (BoNT-A) injections in the rectus femoris on gait kinematics and functional outcome in adult stroke patients. METHODS: Twenty-six participants were included in this triple-blind cross-over RCT. The intervention consisted of an injection with BoNT-A. Placebo is an injection with saline. Besides knee and hip kinematics, functional outcomes were measured. RESULTS: Comparison of the effect of BoNT-A injection to placebo injection showed a significant increase in peak knee flexion and knee range of motion of 6.7° and 4.8° respectively. There was no difference in hip kinematics. In functional outcomes, only the 6 Minute Walking Test showed a significant increase of 18.3 m. CONCLUSIONS: BoNT-A injections in the rectus femoris is a valuable treatment option for stroke patients walking with a SKG to improve knee kinematics. To study the effect on functional outcome more research is necessary with different functional outcome measures that can capture the effect in kinematics. It is important to use kinematic measurements to demonstrate effects in quality of movement that are not captured by commonly used functional outcome measurements post stroke.Clinical Trial Registration: https://trialsearch.who.int/Trial2.aspx?TrialID=NTR2169.

Evaluating the clinical effects of a dynamic shoulder orthosis.

BACKGROUND: Shoulder orthoses reduce the gravitational pull on the shoulder by providing an upward force to the arm, which can decrease shoulder pain caused by stress on the glenohumeral structures. OBJECTIVE: In this interventional study, the clinical effects of a recently developed dynamic shoulder orthosis were assessed in 10 patients with chronic shoulder pain. The shoulder orthosis provides an upward force to the arm with 2 elastic bands. These bands are arranged to statically balance the arm, such that the supportive force is always directed toward the glenohumeral joint and shoulder movements are not impeded. STUDY DESIGN: Clinical effect study. METHODS: The study population was provided with a dynamic shoulder orthosis for 2 weeks. In the week before the orthosis fitting, the participants had no intervention. The primary outcome measures were the mean shoulder pain scores before and during the intervention, and the distance between the humeral head and the acromion without and with orthosis. RESULTS: Ultrasound evaluation showed that the shoulder orthosis resulted in a reduction of the distance between the acromion and humeral head at different levels of arm support. In addition, it was demonstrated that the mean shoulder pain scores (range 0-10) decreased from 3.6 to 3 (in rest) and from 5.3 to 4.2 (during activities) after 2 weeks of orthosis use. In general, patients were satisfied with the weight, safety, ease in adjusting, and effectiveness of the orthosis. CONCLUSIONS: The results of this study show that the orthosis has the potential to reduce shoulder complaints in patients with chronic shoulder pain.

Mechanical design and feasibility of a finger exoskeleton to support finger extension of severely affected stroke patients.

In this paper we presented the mechanical design and evaluation of a low-profile and lightweight exoskeleton that supports the finger extension of stroke patients during daily activities without applying axial forces to the finger. The exoskeleton consists of a flexible structure that is secured to the index finger of the user while the thumb is fixed in an opposed position. Pulling on a cable will extend the flexed index finger joint such that objects can be grasped. The device can achieve a grasp size of at least 7 cm. Technical tests confirmed that the exoskeleton was able to counteract the passive flexion moments corresponding to the index finger of a severely affected stroke patient (with an MCP joint stiffness of k = 0.63Nm/rad), requiring a maximum cable activation force of 58.8N. A feasibility study with stroke patients (n=4) revealed that the body-powered operation of the exoskeleton with the contralateral hand caused a mean increase of 46° in the range of motion of the index finger MCP joint. The patients (n=2) who performed the Box & Block Test were able to grasp and transfer maximally 6 blocks in 60 sec. with exoskeleton, compared to 0 blocks without exoskeleton. Our results showed that the developed exoskeleton has the potential to partially restore hand function of stroke patients with impaired finger extension capabilities. An actuation strategy that does not involve the contralateral hand should be implemented during further development to make the exoskeleton suitable for bimanual daily activities.

Head support in wheelchairs (scoping review): state-of-the-art and beyond.

BACKGROUND: Many wheelchair users experience disabilities in stabilising and positioning of the head. For these users, adequate head support is required. Although several types of head supports are available, further development of these systems is needed to improve functionality and quality of life, especially for the group of severely challenged users. For this group, user needs have not been clearly established. In this article, we provide an overview of the state-of-the-art in wheelchair mounted head supports and associated scientific evidence in order to identify requirements for the next generation of head support systems. MATERIALS AND METHODS: A scoping review was performed including scientific literature (PubMed/Scopus), patents (Espacenet/Google Scholar) and commercial information. Types of head support and important system characteristics for future head support systems were proposed from consultations with wheelchair users (n = 3), occupational therapists (n = 3) and an expert panel. RESULTS: Forty scientific papers, 90 patents and 80 descriptions of commercial devices were included in the scoping review. The identified head support systems were categorised per head support type. Only limited scientific clinical evidence with respect to the effectiveness of existing head support systems was found. From the user and expert consultations, a need was identified for personalised head support systems that intuitively combine changes in sitting and head position with continuous optimal support of the head to accommodate severely challenged users. CONCLUSIONS: This study presents the state-of-the-art in head support systems. Additionally, several important system characteristics are introduced that provide guidance for the development and improvement of head supports.Implications for rehabilitationEspecially for the group of severely challenged wheelchair users, current head support systems require further development to improve their users' quality of life.The desired system characteristics which are discussed in this review are an important step in the definition of requirements for the next generation of head supports.

Feasibility of reconstructing the glenohumeral center of rotation with a single camera setup.

BACKGROUND: An accurate estimation of the glenohumeral joint center of rotation (CoR) is important during alignment of braces and exoskeletons, as a misalignment will introduce undesired forces on the human body. The aim of this research was to develop a new method to estimate the glenohumeral CoR and register the location to the body using a single camera and two printed markers. METHODS: During shoulder anteflexion, the arm roughly describes an arc in the sagittal plane, with the glenohumeral joint in the center. Two binary square-fiducial ArUco markers were secured to the upper arm and the scapula, their position and orientation were obtained, and a sphere was fitted to the coordinates of the arm marker. The sphere center position was then registered on the skin. The accuracy was assessed with a test bench with a known rotational center. The repeatability was assessed in vivo with five healthy participants. RESULTS: The mean absolute offset between the true CoR of the test bench and the fitted sphere centers across multiple trials was 2.7 mm at a velocity of 30 degrees/s, and 2.5 mm at 60 degrees/s. The root mean squared distance from the estimated sphere centers after each trial to the mean sphere center across all trials per participant was 5.1 mm on average for the novice examiner and 5.2 mm for the expert examiner. CONCLUSIONS: The proposed method is able to accurately and precisely estimate the glenohumeral CoR.

Amputation and prosthetics of the lower extremity: The 2020 Dutch evidence-based multidisciplinary guideline.

BACKGROUND: Lower-limb amputations are rare but debilitating events in the lives of affected persons. Treatment of persons with amputation inherently involves many different health care professions at different stages leading to and after an amputation. There are prevailing clinical questions within the work field related to different facets of care including peri/postoperative aspects, prosthetic components, rehabilitation treatment, and health care processes. OBJECTIVES: To provide an up-to-date multidisciplinary evidence-based guideline for health care professionals involved in the treatment of persons with lower-limb amputation in the Netherlands. METHODS: Identification of key questions in a focus group, systematic review of the evidence (up to March 2019, using Embase and MEDLINE databases), and weighing considerations, culminating in clinical recommendations. RESULTS: Twelve key questions were formulated. Recommendations of two key questions were upheld in line with the previous 2012 guideline. Ten systematic literature searches were performed, leading to the inclusion of 59 studies. CONCLUSION: A summary of evidence-based conclusions, considerations, and recommendations of the 2020 guideline is presented.

Detection thresholds for electrostimulation combined with robotic leg support in sub-acute stroke patients.

Stroke is one of the leading causes of disability in adults in the European Union. It often leads to motor impairments, such as a hemiparetic lower extremity. Research indicates that early task-specific and intensive training promotes neuroplasticity and leads to recovery and/or compensation. One way to provide intensive training early after a stroke is via robot-supported training. A rehabilitation robot was designed by Life Science Robotics (Aalborg, Denmark) that can provide continuous repetitive movements of the hip, knee, and/or ankle in e.g., a lying position. In order to emphasize active contribution by the patient, actively triggered electrical stimulation (via muscle activation) can be combined with robotic assistance. The current study aims to compare different threshold estimation methods for detection of movement intention from muscle activity for actively triggered electrical stimulation during robot-supported leg movement in stroke patients. Three sub-acute stroke patients were included for a single measurement session. They performed knee extension and/or ankle dorsal flexion with four different threshold estimation methods to assess the intention detection threshold to initiate electrostimulation. The thresholds were based on the resting level of muscle activity (of m. rectus femoris or m. tibialis anterior) plus two or three times the standard deviation of the average resting value, or the resting level plus 5% or 10% of the peak muscle activity during a maximal voluntary contraction. The results showed that the method based on the resting muscle activity plus two times the standard deviation was the most stable across the three included stroke patients. This method had a detection success rate of 86.7% and was experienced as moderately comfortable. In conclusion, performing knee extension and/or ankle dorsal flexion with electromyography triggered electrostimulation is feasible in sub-acute stroke patients. Muscle activity-triggered electrostimulation combined with robotic support based on a threshold of resting levels plus two times the standard deviation seems to detect movement initiation most consistently in this small sample of sub-acute stroke patients.

Effect on Hand Function After Six-week Use of a Wearable Soft-Robotic Glove Assisting ADL: Interim Results of an Ongoing Clinical Study.

In an ongoing study, an assistive wearable soft-robotic glove is tested at home for 6 weeks by subjects with decreased handgrip strength, due to different hand injuries or diseases, to assess whether use of this assistive grip-supporting glove will result in improved hand strength/ function. An interim analysis of the available dataset of 46 participants showed that (unsupported) grip strength and hand function improved after using the soft-robotic glove as assistive aid during activities of daily living (ADLs) during 6 weeks at home. After glove use is ended, this is maintained for at least 4 weeks. Considering that in the current situation the analysis is underpowered, these interim results are promising for finding a clinical (therapeutic) effect of using a soft-robotic glove as assistance during ADLs. If this is the case, this might open up entirely new opportunities for extending rehabilitation into people's homes, while also providing them with assistance to directly support performance of daily activities. Such a combination is becoming available with the development of mature and user-friendly wearable soft-robotic devices. This would enable very high doses of training throughout the day, in the most functional, task-specific way possible, and possibly prevention of learned non-use.

Design and feasibility of the T-GRIP thumb exoskeleton to support the lateral pinch grasp of spinal cord injury patients.

Improving the impaired hand function of spinal cord injury patients with a robotic exoskeleton can highly impact their self-management, and ultimately their quality of life. In this paper the design and evaluation of a new, lightweight (50 gram) robotic thumb exoskeleton, called TGRIP, was presented that supports the lateral pinch grasp. The mechanism consists of a linear actuator that was mounted to the dorsal side of the hand, and a force transmission mechanism that flexes the thumb towards the side of the index finger. The thumb movement was controlled through contralateral wrist rotation. Experimental results from an evaluation with three spinal cord injury patients showed that the achieved grip force (~ 7N) was higher and the overall performance during the Grasp and Release Test was better with the T-GRIP than without device. The device shows great potential for improving the hand function of patients with cervical spinal cord injury by actuating only a single degree of freedom.

Accurate Estimation of Upper Limb Orthosis Wear Time Using Miniature Temperature Loggers.

OBJECTIVE: To propose and validate a new method for estimating upper limb orthosis wear time using miniature temperature loggers attached to locations on the upper body. DESIGN: Observational study. SUBJECTS: Fifteen healthy participants. METHODS: Four temperature loggers were attached to the arm and chest with straps. Participants were asked to remove and re-attach the straps at specified time-points. The labelled temperature data obtained were used to train a decision tree classification algorithm to estimate wear time. The final performance (mean error and 95% confidence interval) of the trained classifier and the wear time estimation were assessed with a hold-out data-set. RESULTS: The trained algorithm can correctly classify unseen temperature data with a mean classification error between 1.1% and 3.1% for the arm, and between 1.8% and 4.0% for the chest, depending on the sampling time of the temperature logger. This resulted in mean wear time errors between 0.5% and 8.3% for the arm, and 0.13% and 13.0% for the chest. CONCLUSION: The proposed method based on a classifier can accurately estimate upper limb orthosis wear time. This method could enable healthcare professionals to gain insight into the wear time of any upper limb orthosis.

Does the Duncan-Ely test predict abnormal activity of the rectus femoris in stroke survivors with a stiff knee gait?

OBJECTIVE: To determine the diagnostic value of the Duncan-Ely test in predicting abnormal rectus femoris activity during gait in stroke survivors walking with a stiff knee gait. DESIGN: Cross-sectional diagnostic study. SUBJECTS: A total of 95 patients with chronic stroke. METHODS: During physical examination, the Duncan-Ely test was performed and scored. Surface electromyography of the rectus femoris was then recorded during dynamic gait. To determine the diagnostic value, the results of the Duncan-Ely test and surface electromyography recordings (gold standard) were compared. RESULTS: The Duncan-Ely test had a sensitivity of 73%, a specificity of 29%, a positive predictive value of 60%, and a negative predictive value of 42%. The area under the curve was 0.488 ([AQ1] CI 0.355-0.621, p = 0.862), showing that the Duncan-Ely test is not better than random guessing. CONCLUSION: The Duncan-Ely test has no predictive value for determining abnormal activity of the rectus femoris during gait. Using this test can lead to incorrect identification of abnormal rectus femoris activity, which might hamper the selection of optimal treatment options. We recommend stopping use of the Duncan-Ely test to predict rectus femoris overactivity during swing, and instead use surface electromyography.

A newly designed shoulder orthosis for patients with glenohumeral subluxation: a clinical evaluation study.

BACKGROUND: Shoulder complaints from glenohumeral subluxation are a common problem and limit patients during daily activities. OBJECTIVE: To assess the clinical pros and cons and usability of a newly developed shoulder orthosis (Roessingh Omo Support [ROS]) in patients with chronic shoulder complaints. STUDY DESIGN: Retrospective cross-sectional study. METHODS: All patients older than 18 years who received the ROS were invited. Medical information was collected from medical records. Two questionnaires were sent to the patient: The "Shoulder Rating Questionnaire" (SRQ, max 100 points) for evaluation before and during use and a custom orthosis usability questionnaire. RESULTS: In total, 28 patients (34 orthoses) participated in the study. Neuralgic amyotrophy was the most common diagnosis (64.3%). The SRQ showed a significant positive change of 8.9 points (from 35.0 [SD 12.6] to 43.9 [SD 14.3]). The most described goal was pain reduction (76.5%). 47.1% of the patients achieved their goal(s), and 71.4% were still using the orthosis. The mean satisfaction rate was 7.1 (SD 1.4). CONCLUSION: The use of the ROS shows a significant functional improvement (SRQ), a decrease of pain, and a high degree of satisfaction, although the individual experiences of the patients are highly variable. Some modifications to the design to improve comfort may be needed.

A New Shoulder Orthosis to Dynamically Support Glenohumeral Subluxation.

OBJECTIVE: In this paper we presented a novel shoulder subluxation support that aims to reduce the stress on the passive structures around the shoulder of patients with glenohumeral subluxation and glenohumeral-related shoulder pain. The device applies a force to the upper arm without impeding the functional range of motion of the arm. Our design contains a mechanism that statically balances the arm with two elastic bands. METHODS: A technical evaluation study was conducted to assess the performance of the orthosis. Additionally, two patients evaluated the orthosis. RESULTS: The results of the technical validation confirm the working of the balancing mechanism. The pilot study demonstrated that the shoulder support increased the feeling of stability of the shoulder joint and, to a lesser extent, decreased shoulder pain. Furthermore, both patients reported that the orthosis did not impede their range of motion. CONCLUSION: In this research we developed a shoulder orthosis based on two statically balanced springs that support the shoulder of patients with glenohumeral subluxation that have residual shoulder muscle force. Compared to existing shoulder supports, our design does not impede the range of motion of the arm, and continues to provide a stabilizing force to the shoulder, even if the arm is moved away from the neutral position. Tests with two participants showed promising results. SIGNIFICANCE: The device presented in this work could have a significant impact on the shoulder function which may improve rehabilitation outcome and improve the quality of life of patients suffering from glenohumeral subluxation and shoulder pain.

The effect of a wearable soft-robotic glove on motor function and functional performance of older adults.

Reduced grip strength, resulting in difficulties in performing daily activities, is a common problem in the population of older adults. Newly developed soft-robotic devices have the potential to support older adults with reduced grip in daily activities. The objective of this study was to evaluate the direct, assistive effect of grip support from the wearable, soft-robotic ironHand glove.In total, 65 older adults with self-reported decline of hand function resulting from various disorders participated in this cross-sectional study. They performed various hand function tests with and without the glove during a single session. At the end, usability was scored.Participants were able to produce more pinch strength with the glove compared to without glove (p ≤ 0.001) and usability was rated very positively. However, this was not reflected in improved functional performance with the glove, as measured with timed tasks (p < 0.001). Furthermore, no correlation was found between baseline handgrip strength and changes in performance (between without and with glove) of all assessments (ρ ≤ 0.137, p ≥ 0.288).Further design adaptations are desired and more research is needed to investigate if performance with the glove can improve, when taking quality of task performance into account, or when applying a longer acquaintance period with the glove.

Home rehabilitation supported by a wearable soft-robotic device for improving hand function in older adults: A pilot randomized controlled trial.

BACKGROUND: New developments, based on the concept of wearable soft-robotic devices, make it possible to support impaired hand function during the performance of daily activities and intensive task-specific training. The wearable soft-robotic ironHand glove is such a system that supports grip strength during the performance of daily activities and hand training exercises at home. DESIGN: This pilot randomized controlled clinical study explored the effect of prolonged use of the assistive ironHand glove during daily activities at home, in comparison to its use as a trainings tool at home, on functional performance of the hand. METHODS: In total, 91 older adults with self-perceived decline of hand function participated in this study. They were randomly assigned to a 4-weeks intervention of either assistive or therapeutic ironHand use, or control group (received no additional exercise or treatment). All participants performed a maximal pinch grip test, Box and Blocks test (BBT), Jebsen-Taylor Hand Function Test (JTHFT) at baseline and after 4-weeks of intervention. Only participants of the assistive and therapeutic group completed the System Usability Scale (SUS) after the intervention period. RESULTS: Participants of the assistive and therapeutic group reported high scores on the SUS (mean = 73, SEM = 2). The therapeutic group showed improvements in unsupported handgrip strength (mean Δ = 3) and pinch strength (mean Δ = 0.5) after 4 weeks of ironHand use (p≤0.039). Scores on the BBT and JTHFT improved not only after 4 weeks of ironHand use (assistive and therapeutic), but also in the control group. Only handgrip strength improved more in the therapeutic group compared to the assistive and control group. No significant correlations were found between changes in performance and assistive or therapeutic ironHand use (p≥0.062). CONCLUSION: This study showed that support of the wearable soft-robotic ironHand system either as assistive device or as training tool may be a promising way to counter functional hand function decline associated with ageing.

The effect of ankle-foot orthoses on fall/near fall incidence in patients with (sub-)acute stroke: A randomized controlled trial.

Falls are commonly reported post-stroke. Ankle-foot orthoses (AFOs) are often provided to improve safety and walking, but the effect of their use in the reduction of falls after stroke is unknown. A randomized controlled trial (RCT) on the effects of AFO-provision after stroke was performed. Effects on clinical scales, 3D-gait kinematics and muscle-activity were previously reported. This paper aims to study the effects of AFO-provision on occurrence and circumstances of falls/near falls. The RCT included unilateral hemiparetic stroke patients. AFOs were provided either early (study week 1) or delayed (study week 9). Both groups were compared in the first eight weeks of the study and diaries were used to register falls/near falls and their circumstances. Follow-up measurements were performed in week 9-52, in which both groups were provided with AFOs. Functional Ambulation Categories and Berg Balance Scale were assessed to determine walking independence and balance, respectively. Last known scores were noted in case of an incident. Thirty-three subjects were included (16 early, 17 delayed). In week 1-8, the early group, who were provided with AFOs, fell significantly more frequently compared with the delayed group, 11 versus 4 times, respectively (Incidence Rate Ratio = 2.9, p = 0.039). Out of the falls recorded in the early group, 63.6% occurred without wearing AFOs. Most of these falls occurred during transfers (36.4%) and standing (27.3%), and notably it were the subjects who did not have independent walking ability. No differences were found for near falls in week 1-8, or for falls/near falls in week 9-52. Six severe consequences (including fractures) were reported from a fall. To conclude, the subjects provided with AFOs early after stroke reported a higher number of falls, compared to the subjects that had not yet been provided with AFOs. However, in the subjects provided with AFOs, 63.6% of the falls occurred whilst without wearing the AFO. Furthermore, the majority of these incidents took place whilst subjects had no independent walking ability. This raises an interesting question of the importance of careful instructions to patients and their relatives, and the influence of potential cognitive impairments on the ability of the subjects to take on these instructions.

Assistive Technology for the Upper Extremities After Stroke: Systematic Review of Users' Needs.

BACKGROUND: Technical innovations have the potential to compensate for loss of upper-limb motor functions after stroke. However, majority of the designs do not completely meet the needs and preferences of the end users. User-centered design methods have shown that the attention to user perspectives during development of assistive technology leads to devices that better suit the needs of the users. OBJECTIVE: To get more insight into the factors that can bring the design of assistive technology to higher levels of satisfaction and acceptance, studies about user perspectives on assistive technology for the upper limb after stroke are systematically reviewed. METHODS: A database search was conducted in PubMed, EMBASE, CINAHL, PsycINFO, and Scopus from inception to August 2017, supplemented with a search of reference lists. Methodological quality of the included studies was appraised. User perspectives of stroke survivors, carers, and health care professionals were extracted. A total of 35 descriptive themes were identified, from which 5 overarching themes were derived. RESULTS: In total, 9 studies with information gathered from focus groups, questionnaires, and interviews were included. Barriers and enablers influencing the adoption of assistive technology for the upper limb after stroke emerged within 5 overarching but highly interdependent themes: (1) promoting hand and arm performance; (2) attitude toward technology; (3) decision process; (4) usability; and (5) practical applicability. CONCLUSIONS: Expected use of an assistive technology is facilitated when it has a clear therapeutic base (expected benefit in enhancing function), its users (patients and health care professionals) have a positive attitude toward technology, sufficient information about the assistive technology is available, and usability and practical applicability have been addressed successfully in its design. The interdependency of the identified themes implies that all aspects influencing user perspectives of assistive technology need to be considered when developing assistive technology to enhance its chance of acceptance. The importance of each factor may vary depending on personal factors and the use context, either at home as an assistive aid or for rehabilitation at a clinic.