Rationale for prescription, and effectiveness of, upper limb orthotic intervention for children with cerebral palsy: a systematic review.

PURPOSE: To explore (i) reasons for upper limb orthosis prescription for children with cerebral palsy (CP), (ii) the link between reason and effect according to intended outcome and outcome measure utilized and (iii) to classify the prescribed orthoses using standard terminology. METHOD: A prospectively registered (center for reviews and dissemination: 42015022067) systematic review searched for experimental and observational studies investigating rigid/thermoplastic upper limb orthotic intervention for children aged 0-18 with CP. The Cochrane central register, MEDLINE, CINAHL, Embase, SCOPUS and Web of Science databases were searched. Included studies were assessed for risk of bias. RESULTS: Sixteen studies met selection criteria. Two studies described a specific reason for orthosis prescription, six prescribed orthoses to manage a clinical symptom and eight did not describe a reason. Eight studies were analyzed for effect according to intended outcome with no clear connection found between reasons for prescription, outcome measures utilized and effect reported. INTERPRETATION: The lack of evidence for upper limb orthotic intervention for children with CP leads to uncertainty when considering this treatment modality. Future research is needed to evaluate the effect of orthosis wear in relation to intended outcome utilizing robust methods and valid and reliable outcome measures. Implications for rehabilitation: Insufficient evidence exists about the reason for prescription of upper limb orthoses. The connection between reason for orthosis prescription, intended outcome, outcome measure utilized and observed effect is unclear. Recommend orthosis prescription to be accompanied by clear documentation of the aim of the orthosis and description using orthosis classification system terminology. Outcome measures consistent with the reason for orthosis prescription and intended outcome of the intervention are essential to measure effectiveness of the intervention.

The influence of a powered knee-ankle-foot orthosis on walking in poliomyelitis subjects: A pilot study.

BACKGROUND: Traditionally, the anatomical knee joint is locked in extension when walking with a conventional knee-ankle-foot orthosis. A powered knee-ankle-foot orthosis was developed to provide restriction of knee flexion during stance phase and active flexion and extension of the knee during swing phase of gait. OBJECTIVE: The purpose of this study was to determine differences of the powered knee-ankle-foot orthosis compared to a locked knee-ankle-foot orthosis in kinematic data and temporospatial parameters during ambulation. STUDY DESIGN: Quasi-experimental design. METHODS: Subjects with poliomyelitis (n = 7) volunteered for this study and undertook gait analysis with both the powered and the conventional knee-ankle-foot orthoses. Three trials per orthosis were collected while each subject walked along a 6-m walkway using a calibrated six-camera three-dimensional video-based motion analysis system. RESULTS: Walking with the powered knee-ankle-foot orthosis resulted in a significant reduction in both walking speed and step length (both 18%), but a significant increase in stance phase percentage compared to walking with the conventional knee-ankle-foot orthosis. Cadence was not significantly different between the two test conditions (p = 0.751). There was significantly higher knee flexion during swing phase and increased hip hiking when using the powered orthosis. CONCLUSION: The new powered orthosis permitted improved knee joint kinematic for knee-ankle-foot orthosis users while providing knee support in stance and active knee motion in swing in the gait cycle. Therefore, the new powered orthosis provided more natural knee flexion during swing for orthosis users compared to the locked knee-ankle-foot orthosis. CLINICAL RELEVANCE: This orthosis has the potential to improve knee joint kinematics and gait pattern in poliomyelitis subjects during walking activities.

Medical devices; physical medicine devices; classification of the powered lower extremity exoskeleton; republication. Final order; republication.

The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled ``Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton'' that published in the Federal Register on February 24, 2015. FDA is republishing to correct an inadvertent omission of information. FDA is classifying the powered lower extremity exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered lower extremity exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Effects and effectiveness of dynamic arm supports: a technical review.

Numerous dynamic arm supports have been developed in recent decades to increase independence in the performance of activities of daily living. Much effort and money have been spent on their development and prescription, yet insight into their effects and effectiveness is lacking. This article is a systematic review of evaluations of dynamic arm supports. The 8 technical evaluations, 12 usability evaluations, and 27 outcome studies together make 47 evaluations. Technical evaluations were often used as input for new developments and directed at balancing quality, forces and torques, and range of motion of prototypes. Usability studies were mostly single-measure designs that had varying results as to whether devices were usable for potential users. An increased ability to perform activities of daily living and user satisfaction were reported in outcome studies. However, the use of dynamic arm supports in the home situation was reported to be low. Gaining insight into why devices are not used when their developers believe them to be effective seems crucial for every new dynamic arm support developed. The methodological quality of the outcome studies was often low, so it is important that this is improved in the future.

Rigid versus semi-rigid orthotic use following TMC arthroplasty: a randomized controlled trial.

INTRODUCTION: The trapeziometacarpal (TMC) joint of the human thumb is the second most common joint in the hand affected by osteoarthritis. TMC arthroplasty is a common procedure used to alleviate symptoms. No randomized controlled trials have been published on the efficacy of different post-operative orthotic regimes. METHOD: Fifty six participants who underwent TMC arthroplasty were allocated to either rigid orthotic or semi-rigid orthotic groups. Both groups started an identical exercise program at two weeks following surgery. Outcome measures were assessed by an assessor blinded to group allocation. The primary outcome was the Patient Rated Wrist and Hand Evaluation (PRWHE) and secondary outcomes included the Michigan Hand Questionnaire (MHQ), thumb palmar abduction, first metacarpophalangeal extension and three point pinch grip. Measures were taken pre-operatively, at six weeks, three months and one year post-operatively. Between-group differences were analyzed with linear regression. RESULTS: Both groups performed equally well. There was no significant between-group difference for PRWHE scores (0.47, CI -11.5 to 12.4), including subscales for pain and function, or for any of the secondary outcomes at one year follow-up. CONCLUSION: We found no difference in outcomes between using a rigid or semi-rigid orthosis after TMC arthroplasty. Patient comfort, cost and availability may determine choice between orthoses in clinical practice. LEVEL OF EVIDENCE: 1b RCT.

The Araz medial linkage orthosis: a new orthosis for walking in patients with spinal cord injury: a single patient study.

BACKGROUND: This article describes the development and evaluation of a new medial linkage orthosis to potentially assist paraplegic patients to ambulate. CASE DESCRIPTION AND METHODS: The orthosis was initially designed using the solid works program and was subsequently evaluated when used by a spinal cord injury subject to test the structure during standing and walking. Gait analysis was used to compare the medial linkage orthosis to a standard hip-knee-ankle-foot orthosis. FINDINGS AND OUTCOMES: The results demonstrated improvements in gait velocity, step length, and decreased compensatory motions in the new orthosis compared to the hip-knee-ankle-foot orthosis. CONCLUSIONS: The results propose that this new Araz medial linkage orthosis could be used to assist paraplegic subjects who have adequate ranges of motion and also with weakness or reduced tone to stand and walk. Clinical relevance The Araz medial linkage orthosis can potentially provide standing and walking assistance for spinal cord injury patients.

Medical devices; physical medicine devices; classification of the powered exoskeleton. Final order.

: The Food and Drug Administration (FDA) is classifying the powered exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Effect of 2 different thoracolumbar orthoses on the stability of the spine during various body movements.

STUDY DESIGN: Biomechanical volunteer study. OBJECTIVE: To quantify the stabilizing effect of 2 different semirigid thoracolumbar orthoses during various body movements. SUMMARY OF BACKGROUND DATA: Various spinal diseases need to be treated by immobilization. The literature shows, that the immobilizing effect of orthoses strongly depends on the orthosis design and on the loading direction. Few data are available for loading directions other than flexion and extension. METHODS: Ten young and healthy volunteers (22-44 yr, 5 male, 5 female) performed 4 different tasks: full active flexion/extension, lateral bending, and axial rotation as well as a full active everyday movement (flexion plus lateral bending plus axial rotation). These tasks were carried out without orthosis, with the DorsoFX (BORT GmbH, Weinstadt-Benzach, Germany) and with the SofTec Dorso orthosis (Bauerfeind AG, Zeulenroda-Triebes, Germany). The flexibility of the spine was measured using a 3-dimensional motion capturing system (Zebris Medical GmbH, Isny, Germany). Additionally, the pressure exerted by the orthoses on the subject's body surface was measured using a pressure sensor (Tekscan Inc., South Boston, MA). RESULTS: The range of motion significantly decreased in all loading planes by 42% to 69%. The movement with the largest decrease was axial rotation and the smallest decreases were observed in extension (DorsoFX), flexion and the everyday movement (SofTec Dorso), respectively. The differences between the 2 orthoses were small and not statistically significant. The pressure between orthosis and the body surface was similar for both orthoses but differed between the movements. CONCLUSION: Both orthoses had a similar stabilizing effect on the thoracolumbar spine. The stabilizing effect differed between the 4 movements, which indicates that all loading planes should be tested to understand the effect of an orthosis completely. Complete immobilization of the thoracolumbar spine was not possible with either of the 2 orthoses, but the stability increase was statistically significant. LEVEL OF EVIDENCE: N/A.

Orthotic variations in the management of infantile tibia vara and the results of treatment.

BACKGROUND: Infantile tibia vara is an acquired form of tibial deformity associated with tibial varus and internal torsion. Several methods have been described for orthotics treatment. The purpose of this study was to determine the effectiveness of orthotics treatment in infantile tibia vara. STUDY DESIGN: Controlled trial. OBJECTIVE: The aim of this study was to compare the effect of different types of orthoses and correction methods on decreasing the curve in children with severe genu varum. METHODS: Three different types of knee-ankle-foot orthoses were applied to 35 lower extremities of 22 pediatric participants who were 19-38 months of age. The same orthotic design principles were used to correct the femur, while different designs were applied to correct the tibia. The orthoses used on 20 participants were evaluated for differences among them and their effects on the treatment process. In addition, methods used in the treatment, problems encountered, production of different types of orthoses, convenience of application of the orthoses, and degree of patients satisfaction are discussed in this article. RESULTS: The mean duration of treatment of the participants until completion of treatment was 25.3 ± 9.7 weeks with a minimum of 9 weeks and a maximum of 41 weeks. No statistically significant correlation was found between the duration of orthotic use in patients with a successful outcome and percentile height and percentile weight. When the duration of treatment using the different types of orthoses was analyzed, significant differences were found between Type 1 and Type 2, and Type 1 and Type 3 orthoses (p < 0.05), while no difference was observed between Type 2 and Type 3 orthoses (p > 0.05). CONCLUSION: We found that bracing is an effective form of treatment for infantile tibia vara up to 38 months of age. We conclude that full-time use of knee-ankle-foot orthoses exerting corrective forces from five points along the full length of the limb was effective.

The effect of a knee ankle foot orthosis incorporating an active knee mechanism on gait of a person with poliomyelitis.

BACKGROUND: The aim of this case study was to identify the effect of a powered stance control knee ankle foot orthosis on the kinematics and temporospatial parameters of walking by a person with poliomyelitis when compared to a knee ankle foot orthosis. CASE DESCRIPTION AND METHODS: A knee ankle foot orthosis was initially manufactured by incorporating drop lock knee joints and custom molded ankle foot orthoses and fitted to a person with poliomyelitis. The orthosis was then adapted by adding electrically activated powered knee joints to provide knee extension torque during stance and also flexion torque in swing phase. Lower limb kinematic and kinetic data plus data for temporospatial parameters were acquired from three test walks using each orthosis. FINDINGS AND OUTCOMES: Walking speed, step length, and vertical and horizontal displacement of the pelvis decreased when walking with the powered stance control knee ankle foot orthosis compared to the knee ankle foot orthosis. When using the powered stance control knee ankle foot orthosis, the knee flexion achieved during swing and also the overall pattern of walking more closely matched that of normal human walking. The reduced walking speed may have caused the smaller compensatory motions detected when the powered stance control knee ankle foot orthosis was used. CONCLUSION: The new powered SCKAFO facilitated controlled knee flexion and extension during ambulation for a volunteer poliomyelitis person.

Reciprocal gait orthoses and powered gait orthoses for walking by spinal cord injury patients.

BACKGROUND: Using mechanical orthoses have some limitations for walking in paraplegic patients. The development of powered orthoses could potentially overcome some of the limitations of those currently available. OBJECTIVES: The aim of this review was to compare the evidence of the effect of powered gait orthoses (PGOs) when compared to reciprocating gait orthoses (RGOs) and also hip guidance orthoses (HGOs) in improving gait parameters and the energy efficiency of walking by spinal cord injury (SCI) patients. STUDY DESIGN: Literature review. METHODS: Using the PRISMA method, and based on selected keywords and their composition, a search was performed in PubMed, Science Direct, and ISI Web of Knowledge databases. Eight articles were selected for final evaluation. RESULTS: The results of the analysis demonstrated that there is lack of evidence to show that currently-developed powered orthoses improve the walking parameters of SCI patients when compared to RGOs and HGOs. CONCLUSIONS: The changes offered by PGOs are not substantial enough for such orthoses to be currently considered preferable by SCI subjects for ambulatory purposes. Clinical relevance The development of powered orthoses is still in its infancy and progress needs to be made to improve their functionality and performance envelopes.

Neuromuscular orthotics in the treatment of craniomandibular dysfunction and the effects on patients with multiple sclerosis: a pilot study.

The purpose of this pilot study was to identify, measure and document an effect on the subjective multiple sclerosis symptoms and compare it to any objective data changes in the neuromuscular system of the head and neck, following the correction of the jaw position using a neuromuscular orthotic. The hope is to provide clinical evidence of improvement in the disease long-term without relying on the subjective evidence of remissions and exacerbations reported by the patient. The evidence found in the current pilot study measured improvement of head position, jaw position, jaw function, and airway in the neuromuscular bite position, which correlated with the improvement of subjective symptoms of craniomandibular dysfunction and multiple sclerosis. Studies show that the bite affects blood flow in the brain, which may explain the improvement of the patients in the current study.

The effects of three different types of orthoses on the range of motion of the lumbar spine during 15 activities of daily living.

STUDY DESIGN: Prospective cohort study. OBJECTIVE: To quantify which 3 common lumbar orthoses of varying rigidity restrict both full, active range of motion (ROM) and functional ROM required for activities of daily living (ADL). SUMMARY OF BACKGROUND DATA: Spinal orthoses are implemented to restrict lumbar motion. Despite widespread prevalence of lumbar bracing, the efficacy of these appliances for immobilizing the spine has not been definitively established. METHODS: The full, active ROM of 10 asymptomatic individuals was quantified using an electrogoniometer that registered maximum rotation in all planes. Subjects subsequently completed 15 simulated ADLs during which time their functional ROM was measured; performed without a brace and while wearing a corset, semirigid lumbosacral orthosis (LSO), and rigid custom-molded LSO. RESULTS: For flexion/extension, the mean percentage decreases (with SDs) in full, active ROM that were recorded with corset, semirigid, and a custom orthosis were 24.1 ± 7.9%, 46.8 ± 7.1%, and 64.7 ± 8%, respectively (P < 0.001 relative to no brace). In the coronal plane, motion was restricted by 33.9 ± 8.8%, 51.9 ± 9.4%, and 49.1 ± 11.8%, respectively (P < 0.001). Finally, rotation was limited by 39.6 ± 8.8%, 59.2 ± 10.2%, and 70.6 ± 5.4%, respectively (P < 0.001). There were no significant discrepancies between the ROM recorded in the semirigid and custom LSOs for the ADLs. Likewise, functional ROM associated with corset and semirigid LSOs were only different for 2 ADLs whereas significant disparities between values with corset and custom LSOs were observed for 4 simulations. CONCLUSION: The full, active ROM allowed by lumbar braces evaluated was greater than employed during ADLs in absence of any brace. The motion decrease beyond actual restriction of the braces suggests they will act primarily as proprioceptive guides to regulate movement.

A Cochrane review of the evidence for non-surgical interventions for flexible pediatric flat feet.

The pediatric flat foot is a frequent presentation in clinical practice, a common concern to parents and continues to be debated within professional ranks. As an entity, it is confused by varied classifications, the notion of well-intended prevention and unsubstantiated, if common, treatment. The available prevalence estimates are all limited by variable sampling, assessment measures and age groups and hence result in disparate findings (0.6-77.9%). Consistently, flat foot has been found to normally reduce with age. The normal findings of flat foot versus children's age estimates that approximately 45% of preschool children, and 15% of older children (average age 10 years) have flat feet. Few flexible flat feet have been found to be symptomatic. Joint hypermobility and increased weight or obesity may increase flat foot prevalence, independently of age. Most attempts at classification of flat foot morphology include the arch, heel position and foot flexibility. Usual assessment methods are footprint measures, X-rays and visual (scaled) observations. There is no standardized framework from which to evaluate the pediatric flat foot. The pediatric flat foot is often unnecessarily treated, being ill-defined and of uncertain prognosis. Contemporary management of the pediatric flat foot is directed algorithmically within this review, according to pain, age, flexibility; considering gender, weight, and joint hypermobility. When foot orthoses are indicated, inexpensive generic appliances will usually suffice. Customised foot orthoses should be reserved for children with foot pain and arthritis, for unusual morphology, or unresponsive cases. Surgery is rarely indicated for pediatric flat foot (unless rigid) and only at the failure of thorough conservative management. The assessment of the pediatric flatfoot needs to be considered with reference to the epidemiological findings, where there is consensus that pediatric flexible flat foot reduces with age and that most children are asymptomatic. Globally, there is need for a standard by which the pediatric flat foot is assessed classified and managed. Until then, assessment should utilize the available evidence-based management model, the p-FFP Future research needs to evaluate the pediatric flat foot from representative samples, of healthy and known disease-group children prospectively, and using validated assessment instruments. The preliminary findings of the benefits of foot exercises, and discrete investigation into the effects of shoes and footwear use are also warranted.

Soft and rigid collars provide similar restriction in cervical range of motion during fifteen activities of daily living.

STUDY DESIGN: Prospective cohort study. OBJECTIVE: To evaluate the relative efficacies of soft and rigid collars for restricting both the full, active and functional ranges of motion (ROM) of the cervical spine during 15 activities of daily living (ADLs). SUMMARY OF BACKGROUND DATA: Cervical collars are frequently used for the purpose of limiting cervical motion after surgical procedures or as a treatment for certain injuries. Rigid collars are generally believed to reduce cervical motion to a greater extent than soft collars but the latter are often preferred by patients because of their greater comfort. Although there are some data to suggest that soft collars restrict full, active ROM (i.e., the extremes of motion) to a lesser degree than rigid braces, there are currently no comparative studies that have assessed the effects of these 2 types of cervical collars on the functional ROM that is required to perform multiple ADLs. METHODS: In this investigation, a previously validated electrogoniometer device was used to quantify both the full, active ROM of 10 subjects as well as the functional ROM they exhibited during a series of 15 ADLs. For each individual, these ROM measurements were repeated after the application of both a soft collar and a rigid orthosis. RESULTS: The soft collar limited flexion/extension, lateral bending, and rotation by 27.1%+/-9.9% (mean+/-standard deviation), 26.1%+/-4.8%, and 29.3%+/-10.3%, respectively. The corresponding reductions in ROM with a rigid collar were 53.7%+/-7.2%, 34.9%+/-6%, and 59.2%+/-5.3%, respectively. The rigid collar resulted in significantly lower full, active ROM in both the sagittal and axial planes but not in the lateral bending plane. Compared with the soft collar, the rigid collar afforded no difference in motion during 13 of the 15 simulated ADLs. Greater motion was only noted with backing up a car and sitting from a standing position. CONCLUSION: Although subjects exhibited less full, active ROM of the cervical spine when immobilized in a rigid collar than when they were placed in a soft collar, the motion recorded during various functional tasks was not significantly different for nearly all of the ADLs in this study, regardless of which cervical device was applied. One potential explanation for this finding is that both collars may serve as proprioceptive guides, which allow patients to regulate their own cervical motion based on their level of comfort. Given the paucity of data supporting the use of postoperative bracing, especially after procedures which incorporate internal fixation, this study indicates that a rigid orthosis may be unnecessary in many cases because even a soft collar seems to be sufficient for restricting motion during routine activities until the normal, physiologic ROM of the cervical spine has been restored.

[Orthotic management in cerebral palsy]. / Beyin felcinde ortez uygulamalari.

Children with cerebral palsy (CP) may have many musculoskeletal deformities depending on the type of CP. These deformities may result from (i) lack of motor control, (ii) abnormal biomechanical alignment, (iii) impairment in timing of muscle activation, (iv) impairment in normal agonist/antagonist muscle balance, (v) lack of power generation, and (vi) balance disorder. Rehabilitation, orthopedic surgical intervention, and additional orthotic management can prevent and correct these deformities. In this review, mainly lower extremity orthoses are described, with brief explanation on upper and spinal orthotic applications.

Proper sling selection and application while using patient lifts.

In response to staff shortages, an aging clinical workforce, and research on safe patient handling, manufacturers have provided an extensive array of patient-lifting technology, including ceiling, floor-based, and sit-to-stand lifts as well as slings that are required for their use. Expanded choice, however, may pose challenges to both healthcare facilities and individual clinicians. These challenges, if not successfully resolved, can preclude the consistent, safe, and efficient use of patient-handling devices. This article provides nurses and other direct patient care providers with a heightened awareness of the challenges to appropriate sling and lift use in rehabilitation and other clinical settings. A new way to categorize slings is introduced, and guidelines for safely evaluating and using slings for different patient-handling tasks are offered.