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.

Therapeutic Effect of a Soft Robotic Glove for Activities of Daily Living In People With Impaired Hand Strength: Protocol for a Multicenter Clinical Trial (iHand).

BACKGROUND: Decline of hand function, especially reduced hand strength, is a common problem that can be caused by many disorders and results in difficulties performing activities of daily living. A wearable soft robotic glove may be a solution, enabling use of the affected arm and hand repeatedly during functional daily activities and providing intensive and task-specific training simultaneously with assistance of hand function. OBJECTIVE: We aim to investigate the therapeutic effect of an assistive soft robotic glove (Carbonhand). METHODS: This multicenter uncontrolled intervention study consists of 3 preassessments (T0, T1, and T2), a postassessment (T3), and a follow-up assessment (T4). Participants are patients who experience hand function limitations. For the intervention, participants will use the glove during activities of daily living at home for 6 weeks, with a recommended use of at least 180 minutes per week. The primary outcome measure is handgrip strength, and secondary outcome measures are related to functional arm and hand abilities, amount of glove use, and quality of life. RESULTS: The first participant was included on June 25, 2019. Currently, the study has been extended due to the COVID-19 pandemic; data collection and analysis are expected to be completed in 2022. CONCLUSIONS: The Carbonhand system is a wearable assistive device, allowing performance of functional activities to be enhanced directly during functional daily activities. At the same time, active movement of the user is encouraged as much as possible, which has potential to provide highly intensive and task-specific training. As such, it is one of the first assistive devices to incorporate assist-as-needed principles. This is the first powered clinical trial that investigates the unique application of an assistive grip-supporting soft robotic glove outside of clinical settings with the aim to have a therapeutic effect. TRIAL REGISTRATION: Netherlands Trial Register NTR NL7561; https://www.trialregister.nl/trial/7561. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34200.

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.

Quantifying upper extremity performance with and without assistance of a soft-robotic glove in elderly patients: A kinematic analysis.

OBJECTIVE: To explore the direct influence of a soft-robotic glove on movement duration and movement execution in elderly people with decreased hand function during a reach-and-grasp task. DESIGN: Cross-sectional study. PATIENTS: Eight subjects, aged 55+ years, with decreased hand function. METHODS: The direct effect of the glove was explored using kinematic analysis during a reach-and-grasp task with a light (100 g) and heavy (1,000/2,500 g) cylindrical object, performed with and without the soft-robotic glove. RESULTS: There was no difference in total movement time between performance with and without the glove. With the glove, the relative time needed to transport the heavy object was shorter, while the relative time needed to grasp the heavy object was longer. In addition, transporting light objects involved a lower peak velocity and larger elbow extension, and grasping the object involved a larger hand opening compared with without glove. CONCLUSION: As expected, no positive influence of the soft-robotic glove was found on total movement duration in elderly subjects. The influence of the glove on movement execution varied with movement phase. The positive and negative effects found may be due to a perceived confidence while carrying heavy objects with the glove, or compensation for loss of sensation, respectively. This information can be used to improve the glove design.

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.

The efficacy of removable devices to offload and heal neuropathic plantar forefoot ulcers in people with diabetes: a single-blinded multicentre randomised controlled trial.

Non-removable offloading is the 'gold standard' treatment for neuropathic diabetic plantar forefoot ulcers. However, removable offloading is the common 'standard of care'. We compared three removable offloading devices for ulcer healing efficacy. In this multicentre, randomised controlled trial, 60 persons with neuropathic diabetic plantar forefoot ulcers were randomly assigned to wear a custom-made knee-high cast [BTCC (bivalved TCC)], custom-made ankle-high cast shoe or a prefabricated ankle-high forefoot-offloading shoe (FOS). Primary outcome was healing at 12 weeks. Dynamic plantar pressures, daily stride count and treatment adherence were assessed on a randomly selected subset (n = 35). According to intention-to-treat analysis, 58% of patients healed with BTCC [OR 0·77 (95% CI 0·41-1·45) versus FOS], 60% with cast shoe [OR 0·81 (95% CI 0·44-1·49) versus FOS] and 70% with FOS (P = 0·70). Mean ± SD peak pressure in kPa at the ulcer site was 81 ± 55 for BTCC, 176 ± 80 for cast shoe and 107 ± 52 for FOS (P = 0·005); stride count was 4150 ± 1626, 3514 ± 1380 and 4447 ± 3190, respectively (P = 0·71); percentage of 2-week intervals that patients wore the device <50% of time was 17·3%, 5·2% and 4·9%, respectively. Non-significant differences in healing efficacy between the three devices suggest that, when non-removable offloading is contraindicated or not available, each can be used for plantar forefoot ulcer offloading. Efficacy is lower than previously found for non-removable offloading maybe because suboptimal adherence and high stride count expose the patient to high repetitive stresses. These factors should be carefully considered in decision making regarding ulcer treatment.

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.

A wearable soft-robotic glove enables hand support in ADL and rehabilitation: A feasibility study on the assistive functionality.

BACKGROUND: Elderly people frequently experience a decline in hand function, due to ageing or diseases. This leads to decreased independence in activities of daily living (ADL). Assistive technology may enhance independence. OBJECTIVES: The objective of this paper was to explore user acceptance of an affordable wearable soft-robotic glove (ironHand (iH) system), that supports grip and hand opening in ADL. In addition, functional performance with the iH system was explored. METHODS: For this study 28 elderly people used the iH system across two sessions. During these sessions, participants performed six functional tasks with and without the iH system. Outcome measures were System Usability Scale (SUS), Intrinsic Motivation Inventory (IMI) and performance time of the functional tasks. RESULTS: User acceptance scored highly, with a mean SUS score of at least 63.4 (SD = 19.0) and a mean IMI score of 5.1 points (SD = 0.97 points). Functional task performance improved across repetitions both with and without the glove (p ≤ 0.017), but all functional tasks were performed faster without the glove (p ≤ 0.032). CONCLUSION: Participants perceived the iH system as useful, pleasant and meaningful. The learning curve in functional performance time (improvements across repetitions) is promising, since it suggests there is room for improved performance when a longer acquaintance period is applied.

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.

Relationship between participation in leisure time physical activities and aerobic fitness in children with DCD.

PURPOSE: (1) To explore participation in leisure time physical activities (LTPAs) in children with developmental coordination disorder (DCD) compared with children developing typically. (2) To examine the association between participation in LTPA and aerobic fitness. METHODS: Thirty-eight children with DCD (aged 7-12 years) were age and gender matched with 38 children developing typically. Participation in LTPA was self-administered by using an activity questionnaire, and aerobic fitness was estimated using a Shuttle Run Test. RESULTS: Children with DCD spent significantly less time in overall, nonorganized, and vigorous LTPA compared with children developing typically. Aerobic fitness was significantly lower for children with DCD. The best model, including age, group, and overall LTPA, explained 46.2% of the variance in aerobic fitness. CONCLUSIONS: Suitable physical activities should be fostered in children with DCD, who have a low participation rate and aerobic fitness level.

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.

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.

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.

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.

Women's experiences of wearing therapeutic footwear in three European countries.

BACKGROUND: Therapeutic footwear is recommended for those people with severe foot problems associated with rheumatoid arthritis (RA). However, it is known that many do not wear them. Although previous European studies have recommended service and footwear design improvements, it is not known if services have improved or if this footwear meets the personal needs of people with RA. As an earlier study found that this footwear has more impact on women than males, this study explores women's experiences of the process of being provided with it and wearing it. No previous work has compared women's experiences of this footwear in different countries, therefore this study aimed to explore the potential differences between the UK, the Netherlands and Spain. METHOD: Women with RA and experience of wearing therapeutic footwear were purposively recruited. Ten women with RA were interviewed in each of the three countries. An interpretive phenomenological approach (IPA) was adopted during data collection and analysis. Conversational style interviews were used to collect the data. RESULTS: Six themes were identified: feet being visibly different because of RA; the referring practitioners' approach to the patient; the dispensing practitioners' approach to the patient; the footwear being visible as different to others; footwear influencing social participation; and the women's wishes for improved footwear services. Despite their nationality, these women revealed that therapeutic footwear invokes emotions of sadness, shame and anger and that it is often the final and symbolic marker of the effects of RA on self perception and their changed lives. This results in severe restriction of important activities, particularly those involving social participation. However, where a patient focussed approach was used, particularly by the practitioners in Spain and the Netherlands, the acceptance of this footwear was much more evident and there was less wastage as a result of the footwear being prescribed and then not worn. In the UK, the women were more likely to passively accept the footwear with the only choice being to reject it once it had been provided. All the women were vocal about what would improve their experiences and this centred on the consultation with both the referring practitioner and the practitioner that provides the footwear. CONCLUSION: This unique study, carried out in three countries has revealed emotive and personal accounts of what it is like to have an item of clothing replaced with an 'intervention'. The participant's experience of their consultations with practitioners has revealed the tension between the practitioners' requirements and the women's 'social' needs. Practitioners need greater understanding of the social and emotional consequences of using therapeutic footwear as an intervention.

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.