Navigating an unfamiliar world - Parents' experiences of having a child with post COVID-19.

BACKGROUND: Post COVID-19 diagnosis in children has been difficult as there has been a lack of knowledge within the healthcare system, leading to uncertainty concerning how these children should be assessed and treated. To understand the aspects of how parents experience seeking care for their child with an array of symptoms and how the child's symptoms affect their everyday life and family situation, we need to listen to the parents' stories about having a child living with post COVID-19. PURPOSE: To describe parents' experiences of seeking professional care for their child with post COVID-19 symptoms and what kinds of impacts there are on their children's daily life. DESIGN AND METHODS: A qualitative study with an inductive and exploratory approach including seventeen parents of children with post COVID-19. Face-to-face interviews were conducted between October 2022 and March 2023 and analyzed with thematic analysis. RESULTS: The findings describe how the parents' constant struggle for their child and how the child's symptoms affect their daily life and their family situation in three themes: Navigating the unknown, Navigating life with post COVID-19, and Navigating between fear and hope for an uncertain future. CONCLUSIONS: This study corroborates the parents' struggle for acceptance of the children's problems in the health system. PRACTICE IMPLICATIONS: It is important that health care focuses on the everyday world and the problems that the child and parents express to understand the family's perspective and the problems that arise in everyday life.

Oculomotor screening and neuro-visual rehabilitation following pediatric brain tumor resection.

Visual difficulties are common after brain tumors, despite a lack of visual complaints at diagnosis. These include difficulties with eye movements, visual coordination, vergence, accommodation, and photophobia, in addition to more obvious problems such as visual field defects.This case report presents the results of a thorough neuro-visual evaluation in a boy with sequelae after a brain tumor including intermittent double vision that was not explained by routine visual examination. Subjective complaints included poor reading perseverance, intermittent blurred and double vision, headache around the eyes when performing near activities, less efficient eye movement behavior in reading tasks, and increased sensitivity to visual motion. The patient participated in a multidisciplinary visual rehabilitation program that included reading glasses with prism compensation and tinted glasses, as well as training with the aim of improving eye teaming, near vision functions, and perseverance in eye movements.The patient responded quickly to the vision therapy program, with positive changes after just four weeks. Repeated neuro-visual evaluations over eight months showed remarkable improvements that were stable over time. This encouraging case report supports the notion that neuro-visual evaluation and rehabilitation should be included in the follow-up of patients after brain tumors.

A Systematic Review of the Scientific Literature for Rehabilitation/Habilitation Among Individuals With Pediatric-Onset Spinal Cord Injury.

Objectives: To conduct a systematic review to examine the scientific literature for rehabilitation/habilitation among individuals with pediatric-onset spinal cord injury (SCI). Methods: A literature search of multiple databases (i.e., PubMed/MEDLINE, CINAHL, EMBASE, PsychINFO) was conducted and was filtered to include studies involving humans, published as full-length articles up to December 2020, and in English. Included studies met the following inclusion criteria: (1) ≥50% of the study sample had experienced a traumatic, acquired, nonprogressive spinal cord injury (SCI) or a nontraumatic, acquired, noncongenital SCI; (2) SCI onset occurred at ≤21 years of age; and (3) sample was assessed for a rehabilitation/habilitation-related topic. Studies were assigned a level of evidence using an adapted Sackett scale modified down to five levels. Data extracted from each study included author(s), year of publication, country of origin, study design, subject characteristics, rehabilitation/habilitation topic area, intervention (if applicable), and outcome measures. Results: One hundred seventy-six studies were included for review (1974-2020) with the majority originating from the United States (81.3%). Most studies were noninterventional observational studies (n = 100; 56.8%) or noninterventional case report studies (n = 5; 2.8%). Sample sizes ranged from 1 to 3172 with a median of 26 (interquartile range [IQR], 116.5). Rehabilitation/habilitation topics were categorized by the International Classification of Functioning, Disability and Health (ICF); most studies evaluated ICF Body Function. There were 69 unique clinical health outcome measures reported. Conclusion: The evidence for rehabilitation/habilitation of pediatric-onset SCI is extremely limited; nearly all studies (98%) are level 4-5 evidence. Future studies across several domains should be conducted with novel approaches to research design to alleviate issues related to sample sizes and heterogeneity.

Test-Retest Reliability of Kinematic and Temporal Outcome Measures for Clinical Gait and Stair Walking Tests, Based on Wearable Inertial Sensors.

It is important to assess gait function in neurological disorders. A common outcome measure from clinical walking tests is average speed, which is reliable but does not capture important kinematical and temporal aspects of gait function. An extended gait analysis must be time efficient and reliable to be included in the clinical routine. The aim of this study was to add an inertial sensor system to a gait test battery and analyze the test-retest reliability of kinematic and temporal outcome measures. Measurements and analyses were performed in the hospital environment by physiotherapists using customized software. In total, 22 healthy persons performed comfortable gait, fast gait, and stair walking, with 12 inertial sensors attached to the feet, shank, thigh, pelvis, thorax, and arms. Each person participated in 2 test sessions, with about 3-6 days between the sessions. Kinematics were calculated based on a sensor fusion algorithm. Sagittal peak angles, sagittal range of motion, and stride frequency were derived. Intraclass-correlation coefficients were determined to analyze the test-retest reliability, which was good to excellent for comfortable and fast gait, with exceptions for hip, knee, and ankle peak angles during fast gait, which showed moderate reliability, and fast gait stride frequency, which showed poor reliability. In stair walking, all outcome measures except shoulder extension showed good to excellent reliability. Inertial sensors have the potential to improve the clinical evaluation of gait function in neurological patients, but this must be verified in patient groups.

Pediatric spinal cord injury rehabilitation: A protocol for an international multicenter project (SINpedSCI).

PURPOSE: Children and adolescents (<18 years old) who sustain a spinal cord injury (SCI) should ideally be managed in specialized rehabilitation services. This project aims to describe the organization of pediatric SCI in ten rehabilitation units in seven countries and to qualitatively explore psychosocial aspects of adolescents living with SCI. METHODS: A multicenter cross-sectional project is planned, using quantitative (web survey) and qualitative (interview) methods in ten rehabilitation units from Norway, Sweden, United States, Israel, PR China, Russia and Palestine. Individual interviews will be conducted with ≥20 adolescents aged 13-17 years at least 6 months' post rehabilitation. RESULTS: Units involved will be described and compared, according to funding, attachment to an acute SCI unit, catchment area, number of beds, admittance and discharge procedures, availability of services, staff/patient ratio, content and intensity of rehabilitation programs, length of stay, measurement methods, follow-up services, health promotion services, and pediatric SCI prevention acts. The semi-structured interview guide will include experiences from acute care and primary rehabilitation, daily life, school, contact with friends, leisure time activities, peers, physical and psychological health, and the adolescents' plans for the future. CONCLUSION: Based on the present protocol, this project is likely to provide new insight and knowledge on pediatric SCI rehabilitation and increase the understanding of pediatric SCI in adolescents and their families internationally.

Organisation of services and systems of care in paediatric spinal cord injury rehabilitation in seven countries: a survey with a descriptive cross-sectional design.

STUDY DESIGN: International multicentre cross-sectional study. OBJECTIVES: To describe the organisation and systems of paediatric spinal cord injury (SCI) rehabilitation services in seven countries and compare them with available recommendations and key features of paediatric SCI. SETTING: Ten SCI rehabilitation units in seven countries admitting children and adolescents with SCI < 18 years of age. METHODS: An online survey reporting data from 2017. Descriptive and qualitative analysis were used to describe the data. RESULTS: The units reported large variations in catchment area, paediatric population and referrals, but similar challenges in discharge policy. Nine of the units were publicly funded. Three units had a paediatric SCI unit. The most frequent causes of traumatic injury were motor vehicle accidents, falls, and sports accidents. Unlike the other units, the Chinese units reported acrobatic dancing as a major cause. Mean length of stay in primary rehabilitation ranged between 18 and 203 days. Seven units offered life-long follow-up. There was a notable variation in staffing between the units; some of the teams were not optimal regarding the interdisciplinary and multiprofessional nature of the field. Eight units followed acknowledged standards and recommendations for specialised paediatric SCI rehabilitation and focused on family-centred care and rehabilitation as a dynamic process adapting to the child and the family. CONCLUSIONS: As anticipated, we found differences in the organisation and administration of rehabilitation services for paediatric SCI in the ten rehabilitation units in seven countries. This might indicate a need for internationally approved, evidence-based guidelines for specialised paediatric SCI rehabilitation.

Patients' Experiences of Self-Administered Electrotherapy for Spasticity in Stroke and Cerebral Palsy: A Qualitative Study.

OBJECTIVE: To explore patients' experiences of a self-administered electrotherapy treatment for muscle spasticity in cerebral palsy and stroke; the Exopulse Mollii Suit®. DESIGN: Qualitative design with an inductive approach Subjects: Fifteen patients with spasticity due to stroke or cerebral palsy, participating in a previous randomized controlled trial evaluating the treatment concept. METHODS: Information letters were sent to all potential participants (n = 27) in the previous study. Semi-structured interviews (21-57 min) were carried out with all subjects who volunteered (n = 15), administered by an experienced interviewer who was not involved in the previous study. Transcribed interviews were subject to content analysis. RESULTS: The 5 categories that emerged from the content analysis were "New method gives hope", experiences related to "Using the assistive technology", "Outcome from training with the assistive technology", "The assistive technology" and "Taking part in the study". Respondents felt hopeful when included in the previous study, motivated when experiencing a treatment effect, and disappointed when not. CONCLUSION: The qualitative approach used in this study elicited complementary information that was not evident from the previous randomized controlled trial. This included statements regarding increased mobility, reduced spasticity, reduced use of medication, and problems related to using the treatment concept.

Complications of intrathecal drug delivery therapy (ITDD): A retrospective study of 231 implantations between 1999 and 2014.

OBJECTIVE: Determination of types and frequencies of complications related to ITDD therapy, and assessment of possible risk factors for such complications. METHODS: Retrospective study (1999-2014) including all ITDD-implantations at one regional center in Sweden. Descriptors comprised: sex; age; medical condition; body weight index; preoperative ASA-grade; presence of indwelling urinary catheters, feeding tubes, and/or daily urinary or anal incontinence; primary or re-implantation; type of pump and catheter; drug delivered; weekday of surgery; surgical procedure time; surgeon; experience of surgeon; surgical theater; and type of antibiotic prophylaxis. All deaths during the study period were assessed as regards possible relation to ITDD. Data were analyzed with SPSS 25, using Chi2 test for correlations between descriptors and complications. RESULTS: 231 ITDD pump implantations/re-implantations occurred in 159 patients. Seventy-eight (34%) instances of complications were found: 33 catheter-associated; 6 pump-associated; and 29 infection-associated, where 16 were surgical site infections. A higher infection rate occurred in pump re-implantations, as compared to primary implantations (p = 0.002), and in patients with traumatic spinal cord injury (TSCI) as compared to other diagnoses (p = 0.02). Cloxacillin as antibiotic prophylaxis correlated with a higher infection risk (p = 0.005) relative to other antibiotic prophylaxis. Prolonged surgical procedure time in re-implantations correlated positively with increased catheter-associated complications (p = 0.006). CONCLUSION: Complications in ITDD therapy were common, comprising catheter-, infection-, and pump-associated mishaps. A comprehensive system of care needs to be present for managing complications. Future studies may show less complications due to improved protocols and equipment.

Dosing Patterns In Treatment of Disabling Spasticity With Intrathecal Baclofen.

PURPOSE: The aim of this study was to describe and analyze dosing patterns for patients with ITB treatment over time and to identify possible subgroups demonstrating diversity in patterns. DESIGN: A retrospective design. METHODS: For 81 patients from six different hospitals, baclofen doses from the first 2 years of treatment were identified using medical records. Line graphs of each patient's doses were analyzed and grouped based on similarities in dosing pattern. FINDINGS: The analyses of the dosing patterns resulted in four different subgroups classified as stable, slow increase, rapid increase, and fluctuating. CONCLUSION: The results highlight the clinical challenge of predicting dose development over time. CLINICAL RELEVANCE TO REHABILITATION NURSING: This study provides rehabilitation healthcare professionals with a better understanding of intrathecal baclofen dose development. Illustrations of the four subgroups can be used as an educational tool for patients, family, and caregivers.

Impact of spasticity on functioning in spinal cord injury: an application of graphical modelling.

OBJECTIVE: To identify the impact of moderate-to-severe spasticity on functioning in people living with spinal cord injury. DESIGN: Secondary analysis of cross-sectional survey data using graphical modelling. SUBJECTS: Individuals (n = 1,436) with spinal cord injury aged over 16 years with reported spasticity problems. METHODS: Spasticity and 13 other impairments in body functions were assessed using the spinal cord injury Secondary Conditions Scale. Impairments in mental functions were assessed using the Mental Health subscale of the 36-item Short Form (SF-36). Independence in activities was measured with the Spinal Cord Injury Independence Measure Self-Report. Restrictions in participation were measured with the Utrecht Scale for Evaluation Rehabilitation - Participation. RESULTS: Fifty-one percent of participants reported moderate-to-severe spasticity. Graphical modelling showed that Chronic pain, Contractures, Tiredness, Doing housework, and Respiratory functions were associated with spasticity and were the top 5 potential targets for interventions to improve the experience of spasticity. The associations and intervention targets were dependent on the level and completeness of the lesion. CONCLUSION: This is the first application of graphical modelling in studying spasticity in people living with spinal cord injury. The results can be used as a basis for studies aiming to optimize rehabilitation interventions in people with moderate-to-severe spasticity.

Inequalities in pharmacologic treatment of spasticity in Sweden - health economic consequences of closing the treatment gap.

BACKGROUND: The Swedish Healthcare Act states that patients should have equal access to healthcare. This study addresses at how this translates to pharmacological treatment of adult spasticity, including injections with botulinum toxin A (BoNT-A) and pumps for intrathecal baclofen (ITB). To address potential economic incentives for treatment differences, the results are also set into a health economic perspective. Thus, the current study provides a detailed and comprehensive overview for informed decision- and policymaking. METHODS: Botulinum toxin use was retrieved from sales data. Clinical practice regarding mean BoNT-A treatment dose and proportion used for spasticity indication were validated in five county councils, while the number of ITB pumps were mapped for all county councils. Published costs and quality of life data was used for estimating required responder rates for cost-balance or cost-effectiveness. RESULTS: The proportion of patients treated with BoNT-A varied between 5.8% and 13.6% across healthcare regions, with a mean of 9.2% on a national level. The reported number of ITB pumps per 100,000 inhabitants varied between 3.6 and 14.1 across healthcare regions, with a national mean of 6/100,000. The estimated incremental cost for reaching treatment equity was EUR 1,976,773 per year for BoNT-A and EUR 3,326,692 for ITB pumps. Based on expected cost-savings, responder rates ranging between 4% and 15% cancelled out the incremental cost for BoNT-A. Assuming no cost-savings, responder rates of 14% or 36% was required for cost-effectiveness. CONCLUSIONS: There is a marked variation in pharmacologic treatment of adult spasticity in Sweden. Overall, the results indicate an underuse of treatment and need for harmonisation of clinical practice. Furthermore, the incremental cost for reaching treatment equity is likely to be offset by spasticity-associated cost-savings.

A review and evaluation of patient-reported outcome measures for spasticity in persons with spinal cord damage: Recommendations from the Ability Network - an international initiative.

Context: Patient-reported outcome measures (PROMs) are valuable for capturing the impact of spasticity on health-related quality of life (HRQoL) in persons with spinal cord damage (SCD) and evaluating the efficacy of interventions. Objective: To provide practical guidance for measuring HRQoL in persons with spasticity following SCD. Methods: Literature reviews identified measures of HRQoL and caregiver burden, utilized in studies addressing spasticity in SCD. Identified measures were evaluated for clinical relevance and practicality for use in clinical practice and research. The PRISM, SCI-SET, EQ-5D and SF-36 instruments were mapped to the International Classification of Functioning, Disability and Health (ICF). The PRISM and SCI-SET were evaluated using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist. Results: Two spasticity-specific, five generic, and four preference-based measures were identified. ICF mapping and the COSMIN checklist supported the use of the PRISM and SCI-SET in SCD. The SF-36 is considered the most useful generic measure; disability-adapted versions may be more acceptable but further studies on psychometric properties are required. The SF-36 can be converted to a preference-based measure (SF-6D), or alternatively the EQ-5D can be used. While no measures specific to caregivers of people with SCD were identified, the Caregiver Burden Scale and the Zarit Burden Interview are considered suitable. Conclusion: Recommended measures include the PRISM and SCI-SET (condition-specific), SF-36 (generic), and Caregiver Burden Scale and Zarit Burden Interview (caregiver burden). Consideration should be given to using condition-specific and generic measures in combination; the PRISM or SCI-SET combined with SF-36 is recommended.

Experiences from intrathecal baclofen treatment based on medical records and patient- and proxy-reported outcome: a multicentre study.

PURPOSE: To investigate patient satisfaction with intrathecal baclofen treatment, complications from the treatment, and the impact of general expectations on treatment outcome in relation to satisfaction. METHODS: A multicentre study with cross-sectional design. Data were collected through questionnaires and patient records. Patients were recruited from six outpatient intrathecal baclofen clinics in Sweden. Eighty-three patients who had been treated with intrathecal baclofen for 1-4 years were included. For patients unable to communicate, data were collected through a proxy. The Patient Global Impression of Change was used to measure patients' general satisfaction with change from intrathecal baclofen treatment. The Life Orientation Test - revised, was used to measure general expectations/optimism. RESULTS: General satisfaction with intrathecal baclofen treatment was high; 51/77 patients reported "much improved" or "very much improved." There was no relationship between the two main outcomes (general satisfaction and general expectations/optimism) (rs = 0.12, p = 0.382). The two groups; those who could and those who could not communicate, did differ regarding personal characteristics and should be evaluated as such. CONCLUSIONS: Most patients/proxies reported a high level of satisfaction with intrathecal baclofen treatment. The reported satisfaction with intrathecal baclofen treatment was not dependent on general expectations. Implications for Rehabilitation Patients with intrathecal baclofen treatment report low levels of health and quality of life at the same time as they are highly satisfied with their treatment. Intrathecal baclofen should be equally offered to both optimistic and less optimistic patients. Patients who are able to/not able to communicate, differs in characteristics and should be informed and followed up in different ways in daily clinical practice.

Evaluation of a self-administered transcutaneous electrical stimulation concept for the treatment of spasticity: a randomized placebo-controlled trial.

BACKGROUND: Spasticity is a common consequence of injury to the central nervous system negatively affecting patient's everyday activities. Treatment mainly consists of training and different drugs, often with side effects. There is a need for treatment options that can be performed by the patient in their home environment. AIM: The objective of this study was to assess the effectiveness of an assistive technology (AT), Mollii®, a garment with integrated electrodes for multifocal transcutaneous electrical stimulation intended for self-treatment of spasticity, in study participants with spasticity due to stroke or CP. DESIGN: The study was a randomized, controlled, double-blind study with a cross-over design. SETTING: Participants were recruited from two rehabilitation clinics. Treatments were performed in participants' homes and all follow-ups were performed in the two rehabilitation clinics. POPULATION: Thirty-one participants were included in the study and 27 completed the study. Four participants discontinued the study. Two declined participation before baseline and two withdrew due to problems handling the garment. METHODS: Participants used the AT with and without electrical stimulation (active/non-active period) for six weeks each, followed by six weeks without treatment. Goal Attainment Scaling (GAS), change in mobility, arm-hand ability, spasticity and pain were measured at baseline and after 6, 12 and 18 weeks. RESULTS: Fifteen of the 27 participants fulfilled the treatment protocol in terms of recommended use. Deviations were frequent. No statistically significant differences in outcome were found between the active and the non-active treatment periods. During the active period, an improvement was seen in the 10-meter comfortable gait test, time and steps. An improvement was seen in both the active and non-active periods for the GAS. CONCLUSIONS: Compliance was low, partly due to deviations related to the garment, complicating the interpretation of the results. Further research should focus on identifying the target population and concomitant rehabilitation strategies. CLINICAL REHABILITATION IMPACT: The evaluated concept of multifocal transcutaneous electrical stimulation (TES) represents an interesting addition to the existing repertoire of treatments to alleviate muscle spasticity. The evaluated concept allows TES to be self-administered by the patient in the home environment. A more elaborate design of training activities directly related to patient's own rehabilitation goals is recommended and may increase the value of the evaluated concept.

Efficacy and safety of oral baclofen in the management of spasticity: A rationale for intrathecal baclofen.

Oral baclofen has long been a mainstay in the management of spasticity. This review looks at the clinical evidence for the efficacy and safety of oral baclofen in patients with spasticity of any origin or severity, to determine whether there is a rationale for the use of intrathecal baclofen. Results suggest that oral baclofen may be effective in many patients with spasticity, regardless of the underlying disease or severity, and that it is at least comparable with other antispasmodic agents. However, adverse effects, such as muscle weakness, nausea, somnolence and paraesthesia, are common with oral baclofen, affecting between 25% and 75% of patients, and limiting its usefulness. Intrathecal baclofen may be an effective alternative as the drug is delivered directly into the cerebrospinal fluid, thus bypassing the blood-brain barrier and thereby optimizing the efficacy of baclofen while minimizing drug-related side-effects. Intrathecal baclofen is a viable option in patients who experience intolerable side-effects or who fail to respond to the maximum recommended dose of oral baclofen.

Changes in body composition after spasticity treatment with intrathecal baclofen.

OBJECTIVE: To assess changes in body composition, body weight and resting metabolic rate in patients who received intrathecal baclofen therapy for spasticity. DESIGN: Prospective, longitudinal, quasi-experimental, with a pre/post design. PATIENTS: Twelve patients with spasticity, fulfilling study criteria, and due for pump implantation for intrathecal baclofen therapy, completed the study. METHODS: Data were obtained before, 6 months and 12 months after commencement of intrathecal baclofen therapy as regards body composition (by skinfold calliper), body weight, and resting metabolic rate (by resting oxygen consumption). Spasticity was assessed according to the Modified Ashworth Scale (MAS) and Penn Spasm Frequency Scale (PSFS). RESULTS: A reduction in spasticity according to MAS occurred. Mean fat body mass increased and mean lean body mass decreased. Mean body weight showed a non-significant increase and resting metabolic rate a non-significant decrease. CONCLUSION: This explorative study indicates that unfavourable changes in body composition might occur after intrathecal baclofen therapy. Since obesity and increased fat body mass contribute to an increased cardiovascular risk, these findings may indicate a need for initiation of countermeasures, e.g. increased physical activity and/or dietary measures, in conjunction with intrathecal baclofen therapy. Further studies, including larger study samples and control groups, are needed to corroborate these findings.

Optimizing the Management of Disabling Spasticity Following Spinal Cord Damage: The Ability Network-An International Initiative.

Optimizing the treatment of disabling spasticity in persons with spinal cord damage is hampered by a lack of consensus regarding the use of acceptable definitions of spasticity and disabling spasticity, and the relative absence of decision tools such as clinical guidelines and concise algorithms to support decision-making within the broader clinical community. Many people with spinal cord damage are managed outside specialist centers, and variations in practice result in unequal access to best practice despite equal need. In order to address these issues, the Ability Network-an international panel of clinical experts-was initiated to develop management algorithms to guide and standardize the assessment, treatment, and evaluation of outcomes of persons with spinal cord damage and disabling spasticity. To achieve this, consensus was sought on common definitions through facilitated, in-person meetings. To guide patient selection, an in-depth review of the available tools was performed and expert consensus sought to develop an appropriate instrument. Literature reviews are guiding the selection and development of tools to evaluate treatment outcomes (body functions, activity, participation, quality of life) as perceived by people with spinal cord damage and disabling spasticity, and their caregivers and clinicians. Using this approach, the Ability Network aims to facilitate treatment decisions that take into account the following: the impact of disabling spasticity on health status, patient preferences, treatment goals, tolerance for adverse events, and in cases of totally dependent persons, caregiver burden.

OnabotulinumtoxinA Improves Pain in Patients With Post-Stroke Spasticity: Findings From a Randomized, Double-Blind, Placebo-Controlled Trial.

CONTEXT: Patients with post-stroke spasticity (PSS) commonly experience pain in affected limbs, which may impact quality of life. OBJECTIVES: To assess onabotulinumtoxinA for pain in patients with PSS from the BOTOX(®) Economic Spasticity Trial, a multicenter, randomized, double-blind, placebo-controlled trial. METHODS: Patients with PSS (N = 273) were randomized to 22- to 34-week double-blind treatment with onabotulinumtoxinA + standard care (SC) or placebo injection + SC and were eligible to receive open-label onabotulinumtoxinA up to 52 weeks. Assessments included change from baseline on the 11-point pain numeric rating scale, proportion of patients with baseline pain ≥4 achieving ≥30% and ≥50% improvement in pain, and pain interference with work at Week 12, end of double-blind treatment, and Week 52. RESULTS: At baseline, most patients (74.3%) experienced pain and 47.4% had pain ≥4 (pain subgroup). Mean pain reduction from baseline at Week 12 was significantly greater with onabotulinumtoxinA + SC (-0.77, 95% CI -1.14 to -0.40) than placebo + SC (-0.13, 95% CI -0.51 to 0.24; P < 0.05). Higher proportions of patients in the pain subgroup achieved ≥30% and ≥50% reductions in pain at Week 12 with onabotulinumtoxinA + SC (53.7% and 37.0%, respectively) compared with placebo (28.8% and 18.6%, respectively; P < 0.05). Reductions in pain were sustained through Week 52. Compared with placebo + SC, onabotulinumtoxinA consistently reduced pain interference with work. CONCLUSION: This is the first randomized, placebo-controlled trial demonstrating statistically significant and clinically meaningful reductions in pain and pain interference with work with onabotulinumtoxinA in patients with PSS.

A new way of assessing arm function in activity using kinematic Exposure Variation Analysis and portable inertial sensors--A validity study.

Portable motion systems based on inertial motion sensors are promising methods, with the advantage compared to optoelectronic cameras of not being confined to a laboratory setting. A challenge is to develop relevant outcome measures for clinical use. The aim of this study was to characterize elbow and shoulder motion during functional tasks, using portable motion sensors and a modified Exposure Variation Analysis (EVA) and evaluate system accuracy with optoelectronic cameras. Ten healthy volunteers and one participant with sequel after stroke performed standardised functional arm tasks. Motion was registered simultaneously with a custom developed motion sensor system, including gyroscopes and accelerometers, and an optoelectronic camera system. The EVA was applied on elbow and shoulder joints, and angular and angular velocity EVA plots was calculated. The EVA showed characteristic patterns for each arm task in the healthy controls and a distinct difference between the affected and unaffected arm in the participant with sequel after stroke. The accuracy of the portable system was high with a systematic error ranging between -1.2° and 2.0°. The error was direction specific due to a drift component along the gravity vector. Portable motion sensor systems have high potential as clinical tools for evaluation of arm function. EVA effectively illustrates joint angle and joint angle velocity patterns that may capture deficiencies in arm function and movement quality. Next step will be to manage system drift by including magnetometers, to further develop clinically relevant outcome variables and apply this for relevant patient groups.