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.

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.

Feasibility of a wearable soft-robotic glove to support impaired hand function in stroke patients.

OBJECTIVE: To investigate the feasibility of a wear-able, soft-robotic glove system developed to combine assistive support in daily life with performing therapeutic exercises on a computer at home (the HandinMind system). DESIGN: Feasibility study. PATIENTS: Five chronic stroke patients with limitations in activities of daily living due to impaired hand function. METHODS: Participants performed a usability test and several functional tasks with the HandinMind system across 2 sessions. Feasibility was measured using the System Usability Scale (SUS), Intrinsic Motivation Inventory (IMI) and performance times of the functional tasks. RESULTS: User acceptance measured by the SUS and IMI was scored high. The median SUS scores of sessions 1 and 2 were 80.0 (interquartile range (IQR) 70.0-88.8) and 77.5 (IQR 75.0-87.5), respectively, and the median IMI score was 6.3 points out of 7 points (IQR 6.2-6.3). Functional task performance was initially slower with the HandinMind glove compared with performance without the glove, but improved up to the level of performance without the glove across no more than 3 repetitions. CONCLUSION: Chronic stroke patients with impaired hand function were positive about the feasibility of the first prototype of the HandinMind system. How-ever, performance and ease of use of the system should be improved further in future development phases.

Influence of functional electrical stimulation of the hamstrings on knee kinematics in stroke survivors walking with stiff knee gait.

OBJECTIVE: To explore whether functional electrical stimulation of the hamstrings results in improved knee kinematics in chronic stroke survivors walking with a stiff knee gait. DESIGN: Quasi-experimental. SUBJECTS: Sixteen adult chronic stroke survivors. METHODS: Survivors received functional electrical stimulation of the hamstrings, 3 times a week for 1 h during a period of 5 weeks. 3D kinematics was calculated before the training period and after 5 weeks of training. Knee kinematics of walking without stimulation before the training period was compared with walking with stimulation after 5 weeks of training. (intervention effect). In addition, knee kinematics of walking without stimulation before the training period was compared with walking without stimulation after the training period (therapeutic effect). RESULTS: The intervention effect showed a significant increase, of mean 8.7° (standard deviation (SD) 8.3, p = 0.001), in peak knee flexion. The therapeutic effect showed a significant increase in peak knee flexion, of mean 3.1° (SD 4.7, p = 0.021) Conclusion: The results of this exploratory study suggest an increase in knee kinematics in swing after functional electrical stimulation of the hamstrings in stroke survivors walking with a stiff knee gait. The largest improvement in peak knee flexion in swing was seen when participants walked with hamstring stimulation. Participants with low neurological impairment responded better to hamstring stimulation, and there are indications that the effect of hamstring stimulation can be predicted during a single session. The effect of functional electrical stimulation is comparable to that of more invasive treatment options, such as botulinum toxin or soft-tissue surgery. This makes functional electrical stimulation a feasible treatment option for daily clinical practice.

Applying a soft-robotic glove as assistive device and training tool with games to support hand function after stroke: Preliminary results on feasibility and potential clinical impact.

Recent technological developments regarding wearable soft-robotic devices extend beyond the current application of rehabilitation robotics and enable unobtrusive support of the arms and hands during daily activities. In this light, the HandinMind (HiM) system was developed, comprising a soft-robotic, grip supporting glove with an added computer gaming environment. The present study aims to gain first insight into the feasibility of clinical application of the HiM system and its potential impact. In order to do so, both the direct influence of the HiM system on hand function as assistive device and its therapeutic potential, of either assistive or therapeutic use, were explored. A pilot randomized clinical trial was combined with a cross-sectional measurement (comparing performance with and without glove) at baseline in 5 chronic stroke patients, to investigate both the direct assistive and potential therapeutic effects of the HiM system. Extended use of the soft-robotic glove as assistive device at home or with dedicated gaming exercises in a clinical setting was applicable and feasible. A positive assistive effect of the soft-robotic glove was proposed for pinch strength and functional task performance 'lifting full cans' in most of the five participants. A potential therapeutic impact was suggested with predominantly improved hand strength in both participants with assistive use, and faster functional task performance in both participants with therapeutic application.

The effect of arm support combined with rehabilitation games on upper-extremity function in subacute stroke: a randomized controlled trial.

BACKGROUND: Use of rehabilitation technology, such as (electro)mechanical devices or robotics, could partly relieve the increasing strain on stroke rehabilitation caused by an increasing prevalence of stroke. Arm support (AS) training showed improvement of unsupported arm function in chronic stroke. OBJECTIVE: To examine the effect of weight-supported arm training combined with computerized exercises on arm function and capacity, compared with dose-matched conventional reach training in subacute stroke patients. METHODS: In a single-blind, multicenter, randomized controlled trial, 70 subacute stroke patients received 6 weeks of training with either an AS device combined with computerized exercises or dose-matched conventional training (CON). Arm function was evaluated pretraining and posttraining by Fugl-Meyer assessment (FM), maximal reach distance, Stroke Upper Limb Capacity Scale (SULCS), and arm pain via Visual Analogue Scale, in addition to perceived motivation by Intrinsic Motivation Inventory posttraining. RESULTS: FM and SULCS scores and reach distance improved significantly within both groups. These improvements and experienced pain did not differ between groups. The AS group reported higher interest/enjoyment during training than the CON group. CONCLUSIONS: AS training with computerized exercises is as effective as conventional therapy dedicated to the arm to improve arm function and activity in subacute stroke rehabilitation, when applied at the same dose.

Gaming and Conventional Exercises for Improvement of Arm Function After Stroke: A Randomized Controlled Pilot Study.

OBJECTIVE: The use of new technologies in rehabilitation, such as virtual reality and/or computerized gaming exercises, may be useful to enable patients to practice intensively in a motivating way. The objective of the present randomized controlled pilot study was to compare the effect of reach training using a target group specific-designed rehabilitation game to time-matched standardized conventional reach training on arm function after stroke. MATERIALS AND METHODS: Twenty chronic stroke patients were randomized to either the rehabilitation game group or the conventional training group. Both groups received three arm training sessions of 30 minutes each week, during a period of 6 weeks. Arm (the upper extremity part of Fugl-Meyer [FM] assessment) and hand (the Action Research Arm [ARA] test) functions were tested 1 week before (T0) and 1 week after (T1) training. A follow-up measurement was performed at 1 month after T1 (T2). RESULTS: ARA and FM scores improved significantly within both groups. Post hoc comparisons revealed significant increases in test scores between T0 and T1 and between T0 and T2 for both ARA and FM, but not for changes from T1 to T2. There were no significant differences between both groups for either clinical test. CONCLUSIONS: The present randomized controlled pilot study showed that both arm and hand function improved as much after training with a rehabilitation game as after time-matched conventional training.

Wii™-habilitation of upper extremity function in children with cerebral palsy. An explorative study.

OBJECTIVE: Commercially available virtual reality systems can possibly support rehabilitation objectives in training upper arm function in children with Cerebral Palsy (CP). The present study explored the effect of the Nintendo Wii™ training on upper extremity function in children with CP. METHODS: During six weeks, all children received twice a week training with the Wii™, with their most affected arm. The Melbourne Assessment of Upper Limb Function and ABILHAND-Kids were assessed pre- and post- training. In addition, user satisfaction of both children and health professionals was assessed after training. Enjoyment in gaming was scored on a visual analogue scale scale after each session by the children. RESULTS: Fifteen children with CP participated in the study. The quality of upper extremity movements did not change (-2.1, p > 0.05), while a significant increase of convenience in using hands/arms during performance of daily activities was found (0.6, p < 0.05). CONCLUSION: Daily activities seem to be easier performed after Wii™ training for most of the included children with CP.

Effects of an implantable two-channel peroneal nerve stimulator versus conventional walking device on spatiotemporal parameters and kinematics of hemiparetic gait.

OBJECTIVE: The aims of this study were: (i) to compare the neuro-prosthetic effect of implantable peroneal nerve stimulation to the orthotic effect of a standard of care intervention (no device, shoe or ankle foot orthosis) on walking, as assessed by spatiotemporal parameters; and (ii) to examine whether there is evidence of an enhanced lower-limb flexion reflex with peroneal nerve stimulation and compare the kinematic effect of an implantable peroneal nerve stimulation device vs standard of care intervention on initial loading response of the paretic limb, as assessed by hip, knee and ankle kinematics. DESIGN: Randomized controlled trial. SUBJECTS: A total of 23 chronic stroke survivors with drop foot. METHODS: The intervention group received an implantable 2-channel peroneal nerve stimulator for correction of drop foot. The control group continued using a conventional walking device. Spatiotemporal parameters and hip, knee and ankle kinematics were measured while subjects walked with the device on using a 3-dimensional video camera system during baseline and after a follow-up period of 26 weeks. RESULTS: Peroneal nerve stimulation normalized stance and double support of the paretic limb and single support of the non-paretic limb, in comparison with using a conventional walking device. In addition, peroneal nerve stimulation is more effective to provide ankle dorsiflexion during swing and resulted in a normalized initial loading response. CONCLUSION: Although peroneal nerve stimulation and ankle foot orthosis are both prescribed to correct a drop foot in the same patient population, spatiotemporal parameters, dorsiflexion during swing and loading response are influenced in a functionally different way.

Telemedical home-monitoring of diabetic foot disease using photographic foot imaging--a feasibility study.

We assessed the feasibility of using a photographic foot imaging device (PFID) as a tele-monitoring tool in the home environment of patients with diabetes who were at high risk of ulceration. Images of the plantar foot were taken three times a week over a period of four months in the home of 22 high-risk patients. The images were remotely assessed by a diabetic foot specialist. At the end of the study, 12% of images were missing, mainly due to modem or server failures (66%), or non-adherence (11%). All three referrals for diagnosed ulcers and 31 of 32 referrals for abundant callus resulted in treatment. Health-related quality of life (EQ-5D visual analogue scale), increased from 7.5 at baseline to 7.9 at end of follow-up, but not significantly. Mean scores on a visual analogue scale for different usability domains (independence, ease of use, technical aspects and value) ranged from seven to nine. The study demonstrates the feasibility of using the PFID for the early diagnosis of foot disease, which may prevent complications in high-risk patients with diabetes.

Quantifying loss of independent joint control in acute stroke with a robotic evaluation of reaching workspace.

Early recovery after stroke is significant for slow emergence of volitional movement. Initial movements are constrained by stereotypical co-activation of muscle groups such as shoulder abductors and distal limb flexors resulting in the loss of independent joint control. The objective of this study was to utilize new quantitative methods to evaluate the emergence and progression of the loss of independent joint control in the acute phase of recovery from stroke. Fifteen participants have been followed a maximum range of 2 to 32 weeks post-stroke. Participants underwent weekly and monthly robotic evaluations of horizontal plane reaching workspace as a function of abduction loading (0%-200% of limb weight). The magnitude of loss of independent joint control, indicated by the rate of work area reduction as a function of abduction loading, was evident even as early as 2 weeks post-stroke. Group analysis indicated that individuals with mild stroke show immediate presence of the impairment with an exponential rate of recovery over time while individuals with severe stroke show persistent impairment. Early detection and quantification of reaching impairments, such as the loss of independent joint control, will allow clinicians to more efficiently identify patients who would benefit from impairment-based targeted interventions. For example, patients with severe loss of independent joint control will likely benefit from early administration of an intervention attempting to reduce abnormal shoulder abductor/distal limb flexor co-activations during reaching. The field of rehabilitation robotics has demonstrated such interventions to be promising in the chronic severe stroke population.

Measuring quality of life in stroke subjects receiving an implanted neural prosthesis for drop foot.

The aim was to determine if the treatment of a drop foot by means of an implantable two-channel peroneal nerve stimulator improves health-related quality of life (HRQoL). All subjects were measured at baseline and after a follow-up period of 12 and 26 weeks. Twenty-nine stroke survivors with chronic hemiplegia with drop foot who fulfilled the predefined inclusion and exclusion criteria were included in the present randomized controlled trial. The intervention group received an implantable two-channel peroneal nerve stimulator for correction of their drop foot. The control group continued using their conventional walking device, consisting of an ankle-foot orthosis, orthopedic shoes, or no device. HRQoL was assessed in two different ways: (i) by taking descriptive measures, that is, the Short Form-36 (SF-36; generic measure) and the Disability Impact Profile (DIP; specific measure); and (ii) by obtaining preference-based utilities both measured with the time trade-off (direct way) and by calculating them from the EuroQol (EQ-5D) and SF-36. A significant positive effect of the implantable device was found on the physical functioning domain, the general health domain, and the physical component summary score of the SF-36. For the DIP, a significant improvement was found on the domains mobility, self-care, and psychological status in the intervention group. Regarding the preference-based utility measures, a significant effect was found for the utility index calculated from the EQ-5D. The implantable two-channel peroneal nerve stimulator seems to be efficient to improve HRQoL, mainly the domains related to physical functioning. A relation was present between the utility indexes calculated from the EQ-5D and SF-36.

Therapeutic effect of an implantable peroneal nerve stimulator in subjects with chronic stroke and footdrop: a randomized controlled trial.

BACKGROUND AND PURPOSE: Footdrop, characterized by a person's inability to raise the foot at the ankle, is a common problem in patients with stroke. A randomized controlled trial was performed to determine the therapeutic effect of using a new implantable, 2-channel peroneal nerve stimulator for 6 months versus an ankle-foot orthosis (AFO). SUBJECTS: Twenty-nine patients with chronic stroke and footdrop participated in the study. The mean time from stroke was 7.3 years (SD=7.3), and all subjects were community ambulators. METHODS: The study used a randomized controlled trial design. The functional electrical stimulation (FES) group received the implantable stimulation system for correction of their footdrop. The control group continued using their conventional walking device (ie, AFO, orthopedic shoes, or no walking device). All subjects were measured at baseline and at weeks 4, 8, 12, and 26 in the gait laboratory. The therapeutic effect of FES on the maximum value of the root mean square (RMSmax) of the tibialis anterior (TA) muscle with both flexed and extended knees and walking speed were selected as the primary outcome measures. The RMSmax of the peroneus longus (PL), gastrocnemius (GS), and soleus (SL) muscles with both flexed and extended knees and muscle activity of the TA muscle of the affected leg during the swing phase of gait were selected as secondary outcome measures. RESULTS: A significantly higher RMSmax of the TA muscle with extended knee was found after using FES. No change in walking speed was found when the stimulator was not switched on. A significantly increased RMSmax of the GS muscle with both flexed and extended knees was found after using FES. DISCUSSION AND CONCLUSION: Functionally, no therapeutic effect of implantable peroneal nerve stimulation was found. However, the significantly increased voluntary muscle output of the TA and GS muscles after the use of FES suggests that there was a certain extent of plasticity in the subjects in this study.

A randomized controlled trial of an implantable 2-channel peroneal nerve stimulator on walking speed and activity in poststroke hemiplegia.

OBJECTIVE: To determine the effect of a new implantable 2-channel peroneal nerve stimulator on walking speed and daily activities, in comparison with the usual treatment in chronic stroke survivors with a drop foot. DESIGN: Randomized controlled trial. SETTING: All subjects were measured 5 times in the gait laboratory. PARTICIPANTS: Twenty-nine stroke survivors with chronic hemiplegia with drop foot who fulfill the predefined inclusion and exclusion criteria were included in the study. INTERVENTION: The intervention group received an implantable 2-channel peroneal nerve stimulator for correction of their drop foot. The control group continued using their conventional walking device, consisting of an ankle-foot orthosis, orthopedic shoes, or no device. MAIN OUTCOME MEASURES: Walking speed, assessed both by a six-minute walk test (6MWT) and by using a 10-m walkway, was selected as primary outcome measure and activity monitoring data, consisting of percentage time spent on stepping, standing, and sitting/lying were selected as secondary outcome measure. RESULTS: Functional electric stimulation (FES) resulted in a 23% improvement of walking speed measured with the 6MWT, whereas the improvement in the control group was only 3% (P=.010). Comfortable walking speed measured on a 10-m walkway was also significantly improved in favor of FES (P=.038). The percentage time spent on stepping deteriorated with 3% in the intervention and 0.8% in control group, which was not statistically significant between both groups (P=.13). CONCLUSIONS: The present study shows a clinically relevant effect of the implantable 2-channel peroneal nerve stimulator on walking speed in the sample of stroke survivors included in our study.

The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review.

OBJECTIVE: Analysis of the available evidence on the improvement of walking in stroke patients with a dropped foot when using peroneus stimulation. METHODS: A systematic review was performed to identify trials that investigated the orthotic effect of functional electrical stimulation (FES) on walking in stroke patients with a dropped foot. Two independent raters scored the methodological quality of the included articles. Walking speed and physiological cost index (PCI) were selected as the primary outcome measures. Studies that measured walking speed were pooled and a pooled difference including confidence interval was calculated. RESULTS: Eight studies were included in the review, of which one was a randomized controlled trial. Methodological score ranged from 8 to 18 out of 19. Six studies measured walking speed. The pooled improvement in walking speed was 0.13 m/s (0.07-0.2) or 38% (22.18-53.8). CONCLUSIONS: The present review suggests a positive orthotic effect of functional electrical stimulation on walking speed.

The sensitivity and selectivity of an implantable two-channel peroneal nerve stimulator system for restoration of dropped foot.

The objective of this study was to evaluate the stimulation responses on each channel of an implantable two-channel stimulator that stimulates the peroneal nerve branches innervating the muscles for dorsiflexion and eversion movements. Currently five Dutch patients and five English patients have been implanted with this system. Isometric ankle torque measurements were carried out in the patient with the longest follow-up period (1 y). A force sensor measured the three components of moment generated at the ankle joint. Stimulation intensity can be adjusted with great accuracy. Dorsiflexion moments are almost entirely determined by the setting of channel 1. Eversion moments are determined mainly by channel 2 and to a lesser extent by channel 1. Both channels determined abduction/adduction moments. We conclude that stimulation responses in both dorsiflexion and eversion direction can be set individually and with great accuracy and are reproducible over a prolonged period.