Effectiveness and safety of cervical catheter tip placement in intrathecal baclofen treatment of spasticity: A systematic review.

OBJECTIVE: To evaluate the effectiveness and safety of intrathecal baclofen treatment of spasticity, administered via a cervical catheter tip. DESIGN: A review of PubMed and the Cochrane Library up to September 2020. No restriction in study design. Two reviewers independently evaluated eligibility, extracted data and evaluated risk of bias. Studies were included in which patients were treated with intrathecal baclofen for spasticity, with the catheter tip at or above the first thoracic level, independent of diagnosis and age. RESULTS: Thirteen studies were eligible, with a moderate to critical risk of bias. Improvement in spasticity was seen only in the upper extremity in 6% of subjects, only in the lower extremity in 2%, in both upper and lower extremities in 50% and without specification of location in 41%. Upper extremity function improved in 88% of cases. Neither drug-related (1%) nor technical (21%) complications occurred more often than in lower placement of the tip. Effects on respiratory function and sleep apnoea were not investigated. CONCLUSION: Cervically administered intrathecal baclofen seems to improve upper extremity spasticity and function, without causing more complications than thoracolumbar intrathecal baclofen. However, the mainly drug-related complications have not been thoroughly investigated and the available literature is of poor methodological quality. Further research is needed to confirm the efficacy and safety of this procedure.

LOPES II--Design and Evaluation of an Admittance Controlled Gait Training Robot With Shadow-Leg Approach.

Robotic gait training is gaining ground in rehabilitation. Room for improvement lies in reducing donning and doffing time, making training more task specific and facilitating active balance control, and by allowing movement in more degrees of freedom. Our goal was to design and evaluate a robot that incorporates these improvements. LOPES II uses an end-effector approach with parallel actuation and a minimum amount of clamps. LOPES II has eight powered degrees of freedom (hip flexion/extension, hip abduction/adduction, knee flexion/extension, pelvis forward/aft and pelvis mediolateral). All other degrees of freedom can be left free and pelvis frontal- and transversal rotation can be constrained. Furthermore arm swing is unhindered. The end-effector approach eliminates the need for exact alignment, which results in a donning time of 10-14 min for first-time training and 5-8 min for recurring training. LOPES II is admittance controlled, which allows for the control over the complete spectrum from low to high impedance. When the powered degrees of freedom are set to minimal impedance, walking in the device resembles free walking, which is an important requisite to allow task-specific training. We demonstrated that LOPES II can provide sufficient support to let severely affected patients walk and that we can provide selective support to impaired aspects of gait of mildly affected patients.

Dutch evidence-based guidelines for amputation and prosthetics of the lower extremity: Amputation surgery and postoperative management. Part 1.

BACKGROUND: Surgeons still use a range of criteria to determine whether amputation is indicated. In addition, there is considerable debate regarding immediate postoperative management, especially concerning the use of 'immediate/delayed fitting' versus conservative elastic bandaging. OBJECTIVES: To produce an evidence-based guideline for the amputation and prosthetics of the lower extremities. This guideline provides recommendations in support of daily practice and is based on the results of scientific research and further discussions focussed on establishing good medical practice. Part 1 focuses on amputation surgery and postoperative management. STUDY DESIGN: Systematic literature design. METHODS: Literature search in five databases. Quality assessment on the basis of evidence-based guideline development. RESULTS: An evidence-based multidisciplinary guideline on amputation and prosthetics of the lower extremity. CONCLUSION: The best care (in general) for patients undergoing amputation of a lower extremity is presented and discussed. This part of the guideline provides recommendations for diagnosis, referral, assessment, and undergoing amputation of a lower extremity and can be used to provide patient information. CLINICAL RELEVANCE: This guideline provides recommendations in support of daily practice and is based on the results of scientific research and further discussions focussed on establishing good medical practice.

Dutch evidence-based guidelines for amputation and prosthetics of the lower extremity: Rehabilitation process and prosthetics. Part 2.

BACKGROUND: A structured, multidisciplinary approach in the rehabilitation process after amputation is needed that includes a greater focus on the involvement of both (para)medics and prosthetists. There is considerable variation in prosthetic prescription concerning the moment of initial prosthesis fitting and the use of replacement parts. OBJECTIVES: To produce an evidence-based guideline for the amputation and prosthetics of the lower extremities. This guideline provides recommendations in support of daily practice and is based on the results of scientific research and further discussions focussed on establishing good medical practice. Part 2 focuses on rehabilitation process and prosthetics. STUDY DESIGN: Systematic literature design. METHODS: Literature search in five databases and quality assessment on the basis of evidence-based guideline development. RESULTS: An evidence-based multidisciplinary guideline on amputation and prosthetics of the lower extremity. CONCLUSION: The best care (in general) for patients undergoing amputation of a lower extremity is presented and discussed. This part of the guideline provides recommendations for treatment and reintegration of patients undergoing amputation of a lower extremity and can be used to provide patient information. CLINICAL RELEVANCE: This guideline provides recommendations in support of daily practice and is based on the results of scientific research and further discussions focussed on establishing good medical practice.

Vibrotactile grasping force and hand aperture feedback for myoelectric forearm prosthesis users.

BACKGROUND: User feedback about grasping force and hand aperture is very important in object handling with myoelectric forearm prostheses but is lacking in current prostheses. Vibrotactile feedback increases the performance of healthy subjects in virtual grasping tasks, but no extensive validation on potential users has been performed. OBJECTIVES: Investigate the performance of upper-limb loss subjects in grasping tasks with vibrotactile stimulation, providing hand aperture, and grasping force feedback. STUDY DESIGN: Cross-over trial. METHODS: A total of 10 subjects with upper-limb loss performed virtual grasping tasks while perceiving vibrotactile feedback. Hand aperture feedback was provided through an array of coin motors and grasping force feedback through a single miniature stimulator or an array of coin motors. Objects with varying sizes and weights had to be grasped by a virtual hand. RESULTS: Percentages correctly applied hand apertures and correct grasping force levels were all higher for the vibrotactile feedback condition compared to the no-feedback condition. With visual feedback, the results were always better compared to the vibrotactile feedback condition. Task durations were comparable for all feedback conditions. CONCLUSION: Vibrotactile grasping force and hand aperture feedback improves grasping performance of subjects with upper-limb loss. However, it should be investigated whether this is of additional value in daily-life tasks. CLINICAL RELEVANCE: This study is a first step toward the implementation of sensory vibrotactile feedback for users of myoelectric forearm prostheses. Grasping force feedback is crucial for optimal object handling, and hand aperture feedback is essential for reduction of required visual attention. Grasping performance with feedback is evaluated for the potential users.

Feasibility of error-based electrotactile and auditive feedback in prosthetic walking.

BACKGROUND AND AIM: Several studies have shown that feedback in upper-leg prostheses is possible, but slow or difficult to interpret. In this study, electrotactile and auditive error-based feedback, only giving feedback when an undesired event occurs, were tested for its use in upper-leg prosthesis when provided during a perturbation. TECHNIQUE: A total of nine healthy subjects walked on a prosthetic simulator which was disturbed at the end of the swing phase. They received either no feedback, electrotactile feedback, or auditive feedback at the time of the perturbation. DISCUSSION: The reaction time of the subjects only improved by 40 ms when using auditory feedback, compared to the no-feedback condition. No changes in reaction time were found in the electrotactile feedback condition. Considering perturbation detection was not taken into account in this study, this improvement is not enough for practical applications in upper-leg prosthesis. CLINICAL RELEVANCE: Many transfemoral amputees are insecure about their prosthesis, are afraid of falling, or actually fall. Providing feedback specifically during a perturbation may prevent them from falling, or at least give them a chance to react.

Physical activity of children with a mitochondrial disease compared to children who are healthy.

PURPOSE: To compare the physical activity of a group of children with mitochondrial myopathy (MM) with children who are healthy and to evaluate the suitability of different measurement tools. METHODS: The physical activity of 6 children with MM and 10 children who are healthy was measured using accelerometry, heart rate monitoring, video observation, rating of their fatigue, and 2 questionnaires about their physical activity and quality of life. RESULTS: The children with MM spent less time in moderate to vigorous activity, and their activity level measured with the accelerometer was lower than the children who are healthy. Also, the children with MM indicated a higher level of fatigue and a lower quality of life. CONCLUSIONS: Children with MM are on average less physically active, report a higher level of fatigue, and a lower quality of life than children who are healthy.

A longitudinal study of shoulder and arm morbidity in breast cancer survivors 7 years after sentinel lymph node biopsy or axillary lymph node dissection.

Knowledge about long-term consequences of breast cancer treatment on shoulder and arm function and volume in stages I-II breast cancer survivors is limited. The effects of shoulder-arm function shortly after surgery on long-term function are unknown. One hundred and ninety-four women were examined pre-surgery (T0) and 6 weeks after surgery (T1). Of those, 110 were re-examined 7 years later (T2). Thirty-four women underwent sentinel lymph node biopsy (SLNB) and 76 underwent axillary lymph node dissection (ALND). Differences between affected and unaffected side were calculated for four ranges of motion functions, three strength functions and arm volume. These were used to analyse time and group effects. Differences exceeding 20° in range of motion, 20 % in strength and 200 ml in arm volume were considered clinically relevant. Multivariate regression analyses examined the effect of shoulder-arm function at T1 on shoulder-arm function at T2. Additional predictor variables included were age, follow-up time, Body Mass Index, complications, chemotherapy, radiation, SLNB/ALND and type of breast surgery. At T2, range of motion (except external rotation), abduction strength and arm volume were impaired compared to T0. After ALND, women had significantly more forward flexion impairment, increased arm volume and clinically relevant impairments (70 %) than after SLNB (41 %). T1 external rotation, abduction-external rotation, grip strength and arm volume were the strongest predictors of these variables at T2. Age was the strongest predictor of the remaining four variables. ALND predicted arm volume only. Seven years after breast cancer surgery, two-fifth of the women after SLNB and seven out of ten women after ALND had impairments. Impairments were found in five of eight shoulder-arm functions. After SLNB, women have less forward flexion impairment and less arm volume increase than after ALND. Shoulder-arm function at 6 weeks after surgery and age are the strongest predictors of long-term shoulder-arm function.

Dynamic Balance Control (DBC) in lower leg amputee subjects; contribution of the regulatory activity of the prosthesis side.

BACKGROUND: Regaining effective postural control after lower limb amputation requires complex adaptation strategies in both the prosthesis side and the non-amputated side. The objective in this study is to determine the individual contribution of the ankle torques generated by both legs in balance control during dynamic conditions. METHODS: Subjects (6 transfemoral and 8 transtibial amputees) stood on a force platform mounted on a motion platform and were instructed to stand quietly. The experiment consisted of 1 static and 3 perturbation trials of 90 s duration each. The perturbation trials consisted of continuous randomized sinusoidal platform movements of different amplitude in the sagittal plane. Weight distribution during the static and dynamic perturbation trials was calculated by dividing the average vertical force below the prosthesis foot by the sum of forces below both feet. The Dynamic Balance Control represents the ratio between the stabilizing mechanism of the prosthetic leg and the stabilizing mechanism of the non-amputated leg. The stabilizing mechanism is calculated from the corrective ankle torque in response to sway. The relationship between the prosthetic ankle stiffness and the performance during the platform perturbations was calculated. FINDINGS: All patients showed a (non-significant) weight bearing asymmetry in favor of the non-amputated leg. The Dynamic Balance Control ratio showed that the contribution of both legs to balance control was even more asymmetrical. Moreover, the actual balance contribution of each leg was not tightly coupled to weight bearing in each leg, as was the case in healthy controls. There was a significant positive correlation between the prosthetic ankle stiffness and the Dynamic Balance Control. INTERPRETATION: The Dynamic Balance Control provides, in addition to weight distribution, information to what extent the stabilizing mechanism of the corrective ankle torque of both legs contributes to balance control. Knowledge of the stiffness properties may optimize the prescription process of prosthetic foot in lower leg amputee subjects in relation to standing stability.

Myoelectric forearm prostheses: state of the art from a user-centered perspective.

User acceptance of myoelectric forearm prostheses is currently low. Awkward control, lack of feedback, and difficult training are cited as primary reasons. Recently, researchers have focused on exploiting the new possibilities offered by advancements in prosthetic technology. Alternatively, researchers could focus on prosthesis acceptance by developing functional requirements based on activities users are likely to perform. In this article, we describe the process of determining such requirements and then the application of these requirements to evaluating the state of the art in myoelectric forearm prosthesis research. As part of a needs assessment, a workshop was organized involving clinicians (representing end users), academics, and engineers. The resulting needs included an increased number of functions, lower reaction and execution times, and intuitiveness of both control and feedback systems. Reviewing the state of the art of research in the main prosthetic subsystems (electromyographic [EMG] sensing, control, and feedback) showed that modern research prototypes only partly fulfill the requirements. We found that focus should be on validating EMG-sensing results with patients, improving simultaneous control of wrist movements and grasps, deriving optimal parameters for force and position feedback, and taking into account the psychophysical aspects of feedback, such as intensity perception and spatial acuity.

Analysis of healthy sitting behavior: interface pressure distribution and subcutaneous tissue oxygenation.

Pressure ulcers are a large problem in individuals who use a wheelchair for their mobility and have limited trunk stability and motor function. Because no relation between interface pressure and pressure ulcer development has been established and no clinical threshold for pressure ulcer development can be given, looking at the sitting behavior of nondisabled individuals is important. Nondisabled individuals do not develop pressure ulcers because they continuously shift posture. We analyzed the sitting behavior of 25 nondisabled male subjects by using a combination of interface pressure measurement and subcutaneous tissue oxygenation measurement by means of the Oxygen to See. These subjects shifted posture on average 7.8 +/- 5.2 times an hour. These posture shifts were merely a combination of posture shifts in the frontal and sagittal plane. Subcutaneous oxygen saturation increased on average 2.2% with each posture adjustment, indicating a positive effect of posture shifts on tissue viability. The results of this study can be used as a reference for seating interventions aimed at preventing pressure ulcers. Changing the sitting load at least every 8 minutes is recommended for wheelchair users.

Quality of life after sentinel lymph node biopsy or axillary lymph node dissection in stage I/II breast cancer patients: a prospective longitudinal study.

BACKGROUND: Breast cancer patients' quality of life (QoL) after surgery has been reported to improve significantly over time. Little is known about QoL recovery after sentinel lymph node biopsy (SLNB) in comparison to axillary lymph node dissection (ALND). METHODS: 175 of 195 stage I/II breast cancer patients completed the EORTC QLQ-C30: one day before surgery (T0) and after 6 (T1), 26 (T2), 52 (T3) and 104 (T4) weeks. Of these, 54 patients underwent SLNB, 56 SLNB+ALND and 65 ALND. General linear models and paired T-tests between T0-T4 and T1-T4 were computed. Complications, radiotherapy and systemic therapy were added to the model. RESULTS: Significant time effects were found on physical, role and emotional functioning. Physical and role functioning decreased between T0 and T1. At T4, SLNB patients' functioning had increased to their T0 level; ALND (+/- SLNB) patients' functioning had increased, but had not improved to T0 level. Emotional functioning increased linearly between T0 and T4. At T4, emotional functioning was significantly higher in all groups as compared with T0. No significant group or interaction (time x group) effects were found. Complications and chemotherapy had a significant negative effect on role, emotional and cognitive functioning. Complications had a significant effect on social functioning also. Effect sizes varied between 0.00 and 0.06. CONCLUSION: Two years post surgery, breast cancer patients' QoL is comparable to that shortly before surgery. Women rated their emotional functioning as even better. SLNB is not associated with a better QoL than ALND. However, undergoing systemic therapy and/or experiencing complications affects QoL negatively.

Gait in children with cerebral palsy: observer reliability of Physician Rating Scale and Edinburgh Visual Gait Analysis Interval Testing scale.

The aim of this study was to test the inter- and intraobserver reliability of the Physician Rating Scale (PRS) and the Edinburgh Visual Gait Analysis Interval Testing (GAIT) scale for use in children with cerebral palsy (CP). Both assessment scales are quantitative observational scales, evaluating gait. The study involved 24 patients ages 3 to 10 years (mean age 6.7 years) with an abnormal gait caused by CP. They were all able to walk independently with or without walking aids. Of the children 15 had spastic diplegia and 9 had spastic hemiplegia. With a minimum time interval of 6 weeks, video recordings of the gait of these 24 patients were scored twice by three independent observers using the PRS and the GAIT scale. The study showed that both the GAIT scale and the PRS had excellent intraobserver reliability but poor interobserver reliability for children with CP. In the total scores of the GAIT scale and the PRS, the three observers showed systematic differences. Consequently, the authors recommend that longitudinal assessments of a patient should be done by one observer only.