Patient research priority setting partnership in human T-cell lymphotropic virus type I.

INTRODUCTION: Human T-cell lymphotropic virus type 1 (HTLV-1) is a chronic infection affecting 5-10 million people worldwide. Ten percent develop HTLV-1-associated diseases, and 3%-5% develop HTLV-1-associated myelopathy (HAM)/tropical spastic paraparesis. Low health-related quality of life (HRQoL) is a significant concern for those with HTLV-1, and little is known about how it impacts daily life or what patients need from healthcare services. To address this, we report on patient involvement workshops aimed at identifying research priorities for HTLV-1 health service provision. METHODS: Participants recruited through HTLV-1 clinics in England attended six 90-min virtual workshops over 10 months, and two 60-min consolidation workshops. Content developed iteratively from topic focussed group discussions. All workshops were video-recorded with consent, transcribed verbatim and thematically analysed. Using consensus voting rounds, participants individually ranked their top six and then collectively their top three research priorities from the themes inferred from the analysis. A final feedback session explored the experiences of participating in the workshops. FINDINGS: Twenty-seven people with HTLV-1 engaged with the workshops with up to 22 participants attending each meeting. The majority were diagnosed with HAM (n = 22). The top three research priorities were identified as understanding disease progression, psychosocial wellbeing, and information and knowledge. Participants valued being asked to set research priorities that directly addressed their needs and enjoyed the workshops. They stressed the importance of patient advocates for promoting research that positively impacts everyday life. CONCLUSION: This is the first of this type of research engagement with people with HTLV-1 in the United Kingdom. Participants identified several avenues of investigation that could lead to improvements in healthcare services and HRQoL. Participants believed the workshops signified the start of a conversation to progress person-centred and meaningful research in HTLV-1. PATIENT OR PUBLIC CONTRIBUTION: People living with HTLV-1 were involved in the iterative design, conduct, analysis, writing and dissemination of this project through the patient involvement workshops. As a result of this engagement, a patient led advisory group has been set up to assist with the dissemination of the findings.

Investigating psychometric properties of the arm activity measure - Thai version (ArmA-TH) sub-scales using the Rasch model.

BACKGROUND: This study investigated the ArmA-TH sub-scale measurement properties based on item response theory using the Rasch model. METHODS: Patients with upper limb hemiplegia resulting from cerebrovascular and other brain disorders were asked to complete the ArmA-TH questionnaire. Rasch analysis was performed to test how well the ArmA-TH passive and active function sub-scales fit the Rasch model by investigating unidimensionality, response category functioning, reliability of person and item, and differential item functioning (DIF) for age, sex, and education. RESULTS: Participants had stroke or other acquired brain injury (n = 185), and the majority were men (126, 68.1 %), with a mean age of 55 (SD 22). Most patients (91, 49.2 %) had graduated from elementary/primary school. For the ArmA-TH passive function scale, all items had acceptable fit statistics. The scale's unidimensionality and local independence were supported. The reliability was acceptable. A disordered threshold was found for five items, and none indicated DIF. For the ArmA-TH active function scale, one item was misfit and three were locally dependent. The reliability was good. No items showed DIF. All items had disordered thresholds, and the data fitted the Rasch model better after rescoring. CONCLUSIONS: Both sub-scales of ArmA-TH fitted the Rasch model and were valid and reliable. The disordered thresholds should be further investigated.

Relationships between prolonged physical and social isolation during the COVID-19 pandemic, reduced physical activity and disability in activities of daily living among people with advanced respiratory disease.

In people with advanced respiratory disease, we examined (i) the impact of COVID-19-related physical and social isolation on physical activity and (ii) relationships between time spent in isolation and disability in activities of daily living. Cross-sectional analysis was conducted in adults with advanced non-small cell lung cancer, chronic obstructive lung disease or interstitial lung disease. Measures included change in physical activity since physically and socially isolating (Likert scale) and disability (Barthel Index and Lawton-Brody IADL scale) or difficulty (World Health Organisation Disability Assessment Schedule-2.0) in daily activities. Multiple logistic regression was used to examine factors associated with disability in daily activities. 194/201 participants were isolating for a median [IQR] 5 [3-8]-month period, often leading to lower levels of physical activity at home (n = 94, 47%), and outside home (n = 129, 65%). 104 (52%) and 142 (71%) were not fully independent in basic and instrumental activities of daily living, respectively. 96% reported some degree of difficulty in undertaking daily activities. Prolonged physical and social isolation related to increased disability in basic (r = -0.28, p < 0.001) and instrumental (r = -0.24, p < 0.001) activities of daily living, and greater difficulty in daily activities (r = 0.22, p = 0.002). Each month spent in physical or social isolation was independently related to disability in basic activities of daily living (odds ratio [OR], 1.17 [95% CI: 1.03-1.33], p = 0.013). These findings suggest disability in daily activities is associated with prolonged physical or social isolation, which may present as difficulty in people who are fully independent. Post-isolation recovery and rehabilitation needs should be considered for all people deemed extremely clinically vulnerable.

Preliminary evaluation of the reliability, validity and feasibility of the arm activity measure - Thai version (ArmA-TH) in cerebrovascular patients with upper limb hemiplegia.

BACKGROUND: Upper limb hemiplegia following cerebrovascular diseases can result in significant functional limitation. To assess such functional disturbance requires a comprehensive, valid and reliable tool. The Arm Activity Measure (ArmA) is a comprehensive, valid and reliable self-report questionnaire to assess real-life function for upper limb hemiplegia. However, it has never been translated for use in different languages. The purpose of this study is to translate and cross-culturally adapt the Arm Activity Measure (ArmA) questionnaire into a Thai version and to evaluate content validity, internal consistency and feasibility. METHODS: The ArmA was translated and culturally adapted according to published cross-cultural adaptation guidelines resulting in the Thai version of ArmA (ArmA-TH). Forty Thai patients with upper limb hemiplegia resulting from cerebrovascular disorders participated in field-testing of the ArmA-TH. Its feasibility was evaluated. Content validity index for item (I-CVI) and score (S-CVI) were examined. Inter-rater reliability was evaluated by Gwet's AC2. Internal consistency was measured using Cronbach's alpha coefficient. RESULTS: Forty patients (29 males, 11 females) with upper limb spasticity due to stroke or TBI were included. The average age of patients was 54.5 years (SD 15.0). Twenty-seven patients (67.5%) completed the questionnaire within 5 min or less, average time taken was 4.45 (1.73) min. For both subscales, patients reported the ArmA-TH to be relevant (85%) and easy to use (67.5%). More than 80% of patients found the passive subscale useful, almost 80% found the active subscale useful. Overall S-CVI was 0.83, S-CVI for passive and active function subscale was 0.79 and 0.86 respectively. The inter-rater reliability coefficients for ArmA-TH was 0.81. Cronbach's alpha was 0.90 for the overall ArmA, 0.89 and 0.88 for the passive and active function subscales. CONCLUSIONS: The ArmA-TH was a feasible self-report questionnaire to assess hemiplegic upper limb function with good content validity, inter-rater reliability and internal consistency.

Common goal areas in the treatment of upper limb spasticity: a multicentre analysis.

OBJECTIVE: We aimed to develop a goal classification of individualised goals for spasticity treatment incorporating botulinum toxin intervention for upper limb spasticity to under-pin a more structured approach to future goal setting. DESIGN: Individualised goals for spasticity treatment incorporating botulinum toxin intervention for upper limb spasticity (n=696) were analysed initially from four studies published in 2008-2012, spanning a total of 18 centres (12 in the UK and 6 in Australia). Goals were categorised and mapped onto the closest matching domains of the WHO International Classification of Functioning. Confirmatory analysis included a further 927 goals from a large international cohort study spanning 22 countries published in 2013. RESULTS: Goal categories could be assigned into two domains, each subdivided into three key goal areas: Domain 1: symptoms/impairment n=322 (46%): a. pain/discomfort n=78 (11%), b. involuntary movements n=75 (11%), c. range of movement/contracture prevention n=162 (23%). Domain 2: Activities/function n=374 (54%): a. passive function (ease of caring for the affected limb) n=242 (35%), b active function (using the affected limb in active tasks) n=84 (12%), c. mobility n=11 (2%).Over 99% of the goals from the large international cohort fell into the same six areas, confirming the international applicability of the classification. CONCLUSIONS: Goals for management of upper limb spasticity, in worldwide clinical practice, fall into six main goal areas.

Initial psychometric evaluation of the Arm Activity Measure (ArmA): a measure of activity in the hemiparetic arm.

OBJECTIVE: To evaluate the psychometric properties of the Arm Activity Measure (ArmA), a patient-reported measure of active and passive function in the paretic upper limb. DESIGN: Psychometric evaluation study. SETTING: Two specialist rehabilitation and spasticity management services. METHOD: Patients (n = 92) with upper limb paresis were recruited from two specialist neurorehabilitation centres. Mean age 44.5 (SD 16.7). Diagnostic distribution: stroke 48 (52%); other brain injury 28 (31%); or other neurological condition 16 (17%). Evaluation of convergent and divergent validity; unidimensionality, scaling, reliability (internal consistency and test-retest); responsiveness to change and feasibility of the ArmA were undertaken. RESULTS: Expected convergent and divergent relationships were seen with the Leeds Adult Spasticity Impact Scale and the Disabilities of Arm Shoulder and Hand (DASH) (rho 0.5-0.63). Principal components analysis confirmed that active and passive function formed two separate constructs in each sub-scale. Mokken analysis corroborated the findings of the principal components analysis and demonstrated scaling using the monotone homogeneity model (Item H>0.5 for all items). Cronbach's alpha was 0.85 and 0.96, respectively, for the passive and active function subscales. Item level test-retest agreement ranged from 92-97.5% (quadratic-weighted Kappa 0.71-0.94). In the subgroup treated for spasticity with botulinum toxin (n = 58), the ArmA passive function scale identified a significant difference between responder and non-responder groups (Mann Whitney U = 0.85, p < 0.01). Respondents reported the ArmA to be relevant (77%), easy to use (90%) and timely to complete (83% under 10 minutes). CONCLUSION: The ArmA is a valid and reliable tool feasible for use in the evaluation of upper limb function in the context of treatment for spasticity.

Ultrasound image guided injection of botulinum toxin for the management of spasticity: A Delphi study to develop recommendations for a scope of practice, competency, and governance framework.

Objective: To establish a scope of practice, competency (through education) and governance framework for ultrasound image guided injection of botulinum toxin in the management of spasticity. Design: Delphi study. Setting: International, web-based survey. Participants: A purposively selected multidisciplinary (physicians, physiotherapists, occupational therapists) panel of experts (n=15) in the use of ultrasound image guided injection of botulinum toxin for management of spasticity. Panel members were predominantly based in the UK (11/15). Interventions: In round 1, open-ended questions were posed relating to potential scope of practice for 'ultrasound imaging in spasticity management'; (specifically relating to ultrasound image guided injection of Botulinum Toxin) education/competency and governance considerations. In round 2, respondents were asked to rate their level of agreement with the statements generated. Outcome measures: 5-point Likert scale used for rating the statements. Threshold for consensus agreement was set at 70% or above. Results: Three different scopes of practice relating to ultrasound imaging in spasticity management were accepted. The primary scope of practice was the use of ultrasound imaging to guide safe and accurate delivery of botulinum toxin. Relating to this primary scope, 7 competency requirements were agreed relating to areas including image optimization and interpretation, needle visualization and safety. A singular, broad governance statement was generated. Conclusion: Relating specifically to guided injection of botulinum toxin for management of spasticity, we present a scope of practice, competency, and governance framework. These are integrated within a framework approach to provide a mechanism for increased patient access to accurate, safe, and effective focal spasticity treatment. The framework supports focused training routes, greater inter-profession communication and wider clinical community engagement in spasticity management using this modality.

Predictors of increasing disability in activities of daily living among people with advanced respiratory disease: a multi-site prospective cohort study, England UK.

PURPOSE: Disability in activities of daily living (ADL) is a common unmet need among people with advanced respiratory disease. Rehabilitation could help prolong independence, but indicators for timely intervention in this population are lacking. This study aimed to identify trajectories of disability in ADLs over time, and predicting factors, in advanced respiratory disease. METHOD: Multi-site prospective cohort study in people with advanced non-small cell lung cancer (NSCLC), chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD), recruited from hospital or community services, throughout England. Disability in basic (Barthel Index) and instrumental (Lawton-Brody IADL Scale) ADLs were assessed monthly over six months. Visual graphical analysis determined individual trajectories. Multivariate logistic regression examined predictors of increasing disability in basic and instrumental ADLs. FINDINGS: Between March 2020 and January 2021, we recruited participants with a diagnosis of NSCLC (n = 110), COPD (n = 72), and ILD (n = 19). 151 participants completed ≥3 timepoints and were included in the longitudinal analysis. Mobility limitation was an independent predictor of increasing disability in instrumental ADLs (odds ratio, 1⋅41 [CI: 1⋅14-1⋅74], p = 0⋅002). CONCLUSION: Mobility limitation could be used as a simple referral criterion across people with advanced respiratory disease to ensure timely rehabilitation that targets independence in ADLs.

To our knowledge this is the first prospective cohort study of trajectories of disability in activities of daily living (ADL) in advanced respiratory disease, including recruitment during the Covid-19 pandemic.It adds to existing evidence by identifying individual variability in trajectories of ADL disability which are undetected at group level.The identification of mobility limitation as a predictor of increasing ADL disability, while controlling for malignant or non-malignant respiratory disease, is novel and has practical utility.Our findings have implications for clinical care, as early identification of functional decline through use of mobility limitation tools could flag early referral to rehabilitation services, potentially preventing or delaying forthcoming functional decline and avoiding reactive crisis management.Mobility limitation is a predictor of increasing disability in activities of daily living in advanced disease, which could be used to flag early referral to rehabilitation services, to help prevent or delay forthcoming functional decline and avoid reactive crisis management.

Prolonged disorders of consciousness: identification using the UK FIM + FAM and cohort analysis of outcomes from a UK national clinical database.

PURPOSE: 1: To determine whether Total UK FIM + FAM scores can identify patients in VS/MCS. 2: Using the identified cut-off points, to examine outcomes from specialist rehabilitation. METHODS: Part 1: Retrospective analysis of a consecutive clinical cohort (n = 388) presenting to a single specialist PDOC evaluation programme 2007-2021. FIM + FAM scores were analysed by PDOC diagnosis to define cut-off points for vegetative (VS) and minimally conscious states (MCS). Part 2: Multicentre cohort analysis of prospectively-collected clinical outcomes data from the UK Rehabilitation Outcomes Collaborative database of adults in PDOC registered 2011-2020 (n = 2384 in 68 centres). RESULTS: Cut-off points of ≤31 and 32-35 in FIM + FAM total scores respectively identified patients in VS/MCS-Minus and MCS-Plus. Approximately 365 PDOC patients are admitted to specialist rehabilitation units in England each year. By discharge, 43% have emerged into consciousness and demonstrate a wide range of disability. A few reached full independence, but the majority remained severely dependent. Nevertheless, those who emerged generated mean net life-time savings of over £436,000 (£400 million for this cohort). CONCLUSION: In absence of a dedicated PDOC registry, FIM + FAM scores can identify patients in VS/MCS at population level. Identifying those who emerge and providing timely rehabilitation generates cost-savings well-exceeding the cost of the evaluation/rehabilitation programme.Implications for rehabilitationThe UK National Health Service currently collects no systematic data to identify patients in PDOC, so we have no accurate information on how many patients there are, where they are managed or what their outcomes are.In the absence of more direct data, total FIM + FAM scores of < =31 and 32-35 respectively can be used to identify patients in vegetative and minimally conscious states.Of the 365 or so patients admitted to specialist rehabilitation units per year, 43% emerge into consciousness leaving about 150 patients per year in PDOC states that are likely to be permanent.Identifying those who emerge and providing timely rehabilitation generates cost-savings that pay for the entire PDOC evaluation/rehabilitation programme many times over.

Clinical presentation of patients with lower limb spasticity undergoing routine treatment with botulinum toxin: baseline findings from an international observational study.

OBJECTIVE: Describe how people with lower limb spasticity present for treatment in routine clinical practice. METHODS: Prospective, observational study (Clinicaltrials.gov: NCT04050527) of ambulatory adult patients (≥ 18 years) with unilateral lower limb spasticity (able to take ≥ 5 steps with or without assistance) presenting for routine spasticity management, including treatment with abobotulinumtoxinA. RESULTS: The study population included 430 adults with lower limb spasticity. Despite their relatively young age (mean ± standard deviation 53.7 ± 13.9 years), only 20% of patients were employed. Most patients had an acquired brain injury due to cerebrovascular disease; 84.1% reported having concomitant upper limb spasticity. Using the Leg Activity Measure, most patients reported no or only mild difficulties in performing hygiene/positioning tasks, while 80.7% had at least mild difficulty with indoor ambulation and 90.5% had at least mild difficulty with walking outdoors. Sensory, communication and/or cognitive impairments were also common. At the first treatment cycle, 50.7% of patients set active function primary goals, including locomotion transferring or standing. CONCLUSION: These observations highlight the complexity of presentation that must be considered when setting treatment goals for lower limb spasticity and emphasize the types of impairment and activity (functional) limitations that treating teams may expect to encounter in their patients and should cover in their initial and follow-up assessments.

Trajectories of disability in activities of daily living in advanced cancer or respiratory disease: a systematic review.

INTRODUCTION: Advanced cancer and/or respiratory disease threaten a person's independence in activities of daily living (ADL). Understanding how disability develops can help direct appropriate and timely interventions. AIM: To identify different trajectories and associations of disability in ADL and appraise its measurement. METHODS: Medline, Embase, PsychINFO, and CINAHL databases were searched for cohort studies with measures of disability in ADL in advanced cancer or respiratory disease at three or more timepoints. Data were narratively synthesized to produce a typology of disability trajectories and a model of factors and outcomes associated with increasing disability. RESULTS: Of 5702 publications screened, 11 were included. Seventy-four disability trajectories were categorized into typologies of unchanging (n = 20), fluctuating (n = 21), and increasing disability (n = 33). Respiratory disease did not predict any particular disability trajectory. Advanced cancer frequently followed trajectories of increasing disability. Factors associated with increasing disability included: frailty, multi-morbidity, cognitive impairment, and infection. Increased disability led to recurrent hospital admissions, long-term care, and/or death. Methodological limitations included use of non-validated measures. CONCLUSIONS: Increasing disability trajectories in advanced cancer and/or respiratory disease is related to potentially modifiable personal and environmental factors. We recommend future studies using validated disability instruments.Implications for rehabilitationDisability in activities of daily living (ADL) is a common unmet need in advanced cancer or respiratory disease and represents an important outcome for patients, caregivers and health and social care services.Trajectories of ADL disability can be categorized into increasing, fluctuating, and unchanging disability, which could help planning of rehabilitation services in advanced cancer or respiratory disease.Increasing disability in advanced cancer or respiratory disease relates to personal and environmental factors as well as bodily impairments, which can all be modifiable by intervention.This review highlights implications for the measurement of ADL disability in advanced cancer or respiratory disease and recommends use of validated measures of ADL to understand what factors can be modified through rehabilitation interventions.

Stratified management of hemiplegic shoulder pain using an integrated care pathway: an 18-year clinical cohort analysis.

PURPOSE: Hemiplegic shoulder pain (HSP) is a common but heterogeneous complication of acquired brain injury. Integrated care pathways (ICPs) can support clinical decision-making, prompting timely intervention to improve quality of care. This 18-year cohort analysis of clinical data presents outcomes from an ICP for management of HSP in an inpatient rehabilitation unit. MATERIALS & METHODS: Consecutive data were extracted for all eligible patients admitted between 2000-2018 (n = 333). Patients were categorised according to presentation pattern ("Floppy-subluxed" (59%), "Painful-stiff" (21%) or Mixed/not categorised(20%)) to help guide early management. Pain was assessed using the Shoulder-Q with pain ratings/10 in three domains: rest, night-time and movement. Patients with pain reduction ≥3 points in any domain were designated 'responders'. RESULTS: Mean baseline pain scores were 4.7 (95%CI 4.5,5.0). They were higher on movement (6.1(5.8,6.3)) than at rest (4.7(4.3, 5.0)) or at night (5.7(5.2,5.9)). Pain reduced significantly in all three domains (p < 0.0001) with a 65% overall response rate and complete resolution of pain 21-41%. There was a significant relationship between category of presentation pattern and management protocol used (X2 = 31.2, p < 0.0001). CONCLUSION: These high pain-response rates compare favourably to the literature (14-27%), suggesting that this stratified and integrated approach to HSP guides more effective management in this heterogeneous clinical presentation.Implications for RehabilitationTwo-thirds of the patients demonstrated a clinically-significant reduction in pain when managed using the integrated care pathway. These results compare favourably with pain resolution rates of well under one-third cited in the literature and suggest that the integrated care pathway leads to reduced pain and improved patient outcomes.Hemiplegic shoulder pain can result from a range of different clinical problems. The diversity of presentation and the range of required treatments are confirmed in this 18-year cohort analysis.Heterogeneity in presentation of HSP poses a challenge for both management and the evaluation of outcome. The results of this study suggest that a stratified approach helps to guide more effective management.

"I wanna live and not think about the future" what place for advance care planning for people living with severe multiple sclerosis and their families? A qualitative study.

BACKGROUND: Little is known about how people with multiple sclerosis (MS) and their families comprehend advance care planning (ACP) and its relevance in their lives. AIM: To explore under what situations, with whom, how, and why do people with MS and their families engage in ACP. METHODS: We conducted a qualitative study comprising interviews with people living with MS and their families followed by an ethical discussion group with five health professionals representing specialties working with people affected by MS and their families. Twenty-seven people with MS and 17 family members were interviewed between June 2019 and March 2020. Interviews and the ethical discussion group were audio-recorded and transcribed verbatim. Data were analysed using the framework approach. RESULTS: Participants' narratives focused on three major themes: (i) planning for an uncertain future; (ii) perceived obstacles to engaging in ACP that included uncertainty concerning MS disease progression, negative previous experiences of ACP discussions and prioritising symptom management over future planning; (iii) Preferences for engagement in ACP included a trusting relationship with a health professional and that information then be shared across services. Health professionals' accounts from the ethical discussion group departed from viewing ACP as a formal document to that of an ongoing process of seeking preferences and values. They voiced similar concerns to people with MS about uncertainty and when to initiate ACP-related discussions. Some shared concerns of their lack of confidence when having these discussions. CONCLUSION: These findings support the need for a whole system strategic approach where information about the potential benefits of ACP in all its forms can be shared with people with MS. Moreover, they highlight the need for health professionals to be skilled and trained in engaging in ACP discussions and where information is contemporaneously and seamlessly shared across services.

A synthesis and appraisal of clinical practice guidelines, consensus statements and Cochrane systematic reviews for the management of focal spasticity in adults and children.

OBJECTIVE: To identify and appraise the existing clinical practice guidelines, consensus statements and Cochrane systematic reviews for the management of adult and paediatric focal spasticity to generate a single synthesized guideline. METHODS: Systematic review of 12 electronic databases. Clinical practice guidelines, consensus statements and Cochrane systematic reviews for focal spasticity in adults and children. Included studies were appraised according to the AGREE II criteria. RESULTS: A total of 25 papers were included in this review, comprising 12 clinical practice guidelines, nine consensus statements and four Cochrane systematic reviews. The areas most strongly endorsed were: (1) management to be provided by a multi-disciplinary team, (2) therapy should be goal-directed, (3) goals to be developed in conjunction with the patient and family, and (4) importance of follow-up evaluations. There was a greater focus on activity outcomes and classification in the paediatric papers. The guidelines varied considerably in their quality, with AGREE II scores ranging from 52.8 to 97.1%. CONCLUSIONS: This systematic review has synthesized the key elements regarding principles of focal spasticity management, outcome measures, physical interventions and educational recommendations into a single, readily applied guideline available for clinical use. Despite considerable variability in the quality of the guidelines, several strong themes emerged.Implications for rehabilitationFocal spasticity management should be multi-disciplinary, patient-centred and goal-directed.Routine measurement of impairment and activity are strongly endorsed.Botulinum toxin A injection should only be provided as part of an integrated approach to focal spasticity management.

Do randomised controlled trials evaluating functional outcomes following botulinum neurotoxin-A align with focal spasticity guidelines? A systematic review.

PURPOSE: The impact of botulinum neurotoxin-A (BoNT-A) on functional outcomes when managing focal muscle spasticity remains unclear. It is possible that randomised controlled trial (RCT) design and/or reporting may be a contributing factor. The objective of this review was to determine the extent to which RCTs evaluating functional outcomes following BoNT-A align with focal spasticity guidelines. MATERIALS AND METHODS: RCTs published from 2010 were included if they targeted focal spasticity, included BoNT-A, randomised a physical intervention to the upper/lower limb, or the primary outcome(s) related to the activity/participation domains of the International Classification of Functioning, Disability, and Health. Data extraction and quality appraisal using the Modified PEDro and Modified McMasters Tool were performed independently by two reviewers. General research practices were also extracted such as compliance with therapy reporting guidelines. RESULTS: Fifty-two RCTs were eligible. Individualised goal setting was uncommon (25%). Six studies (11.5%) included multi-disciplinary management, and five (9.6%) included patient/caregiver education. Four studies (7.7%) measured outcomes beyond 6 months. The Median Modified PEDro score was 11/15. CONCLUSIONS: Alignment with focal spasticity guidelines in RCTs was generally low. Our understanding of the impact of focal spasticity management on functional outcomes may be improved if RCT design aligned more closely with guideline recommendations.IMPLICATIONS FOR REHABILITATIONThe influence of BoNT-A on improved functional outcomes is yet to be determined.Individualised goal setting with a multi-disciplinary team is uncommon in an RCT design, despite it being a key guideline recommendation.Given the long-term nature of spasticity management, guidelines recommend short as well as long-term reviews following intervention however RCTs rarely assess beyond 6 months.

Worldwide Survey of Clinician Practice on use of Adjunctive Therapies Following Botulinum Toxin Injection for Spasticity.

OBJECTIVE: Non-pharmacological adjunctive therapies can be used alongside botulinum toxin injection to enhance its efficacy. The objective of this global study was to determine the current practice and perception among clinicians of the use of adjunctive therapies after botulinum toxin injections for the treatment of limb spasticity. METHODS: A questionnaire with 22 questions on clinical practice demographics, self-reported use and clinician opinion on barriers to the use of complementary therapies, and priorities for future research was translated into 7 languages and distributed worldwide through national and international professional associations concerning (neuro)rehabilitation. RESULTS: A total of 527 clinicians from 52 countries responded to the survey. Most commonly used physical interventions were: active exercise programmes at home (81%), stretching programmes at home (81%), and splinting (70%), followed by active movement exercises (65%) and within 30 min of botulinum toxin injection and constraint induced movement therapy (63%). The main barriers reported by clinicians to provision of these interventions were clinicians' lack of time, limited financial resources, and lack of evidence. Future research should focus primarily on immediate active movement exercises and passive stretching. CONCLUSION: Worldwide, clinicians often recommend adjunctive therapies after a botulinum toxin injection to reduce spasticity. The most commonly used physical interventions among clinicians were active exercises at home, stretching at home, and splinting. Lack of evidence, time and financial constraints were identified as barriers to providing these interventions.

The spasticity-related quality of life 6-dimensions instrument in upper-limb spasticity: Part I Development and responsiveness.

OBJECTIVE: To describe the development of the Spasticity-related Quality of Life 6-Dimensions instrument (SQoL-6D) and its sensitivity to clinical change (responsiveness). DESIGN: Multicentre, prospective, longitudinal cohort study at 8 UK sites (NCT03442660). PATIENTS: Adults (n = 104) undergoing focal treatment of upper limb spasticity. METHODS: No condition-specific health-related quality of life tool is available for upper-limb spasticity of any aetiology. The SQoL-6D was developed to fulfil this need, designed to complement the Upper Limb Spasticity Index (which incorporates the Goal Attainment Scaling evaluation of upper limb spasticity [GASeous] tool) with targeted standardised measures. The 6 dimensions of the SQoL-6D (score range 0-4) map onto common treatment goal areas identified in upper-limb spasticity studies. A Total score (0-100) provides overall spasticity-related health status. To assess responsiveness, the SQoL-6D, Global Assessment of Benefit scale and "GASeous" were administered at enrolment and 8 weeks. RESULTS: Significant differences in mean SQoL-6D Total score change and effect sizes across patients rating "some benefit" (0.51) and "great benefit" (0.88) supported responsiveness. CONCLUSION: The SQoL-6D is a promising new measure of health status in upper limb spasticity, that enables systematic assessment of the impact of this condition in relation to patients' priority treatment goals. A psychometric evaluation of SQoL-6D is presented separately.

The spasticity-related quality of life 6-dimensions instrument in upper-limb spasticity: Part II A first psychometric evaluation.

OBJECTIVE: Psychometric evaluation of the Spasticity-related Quality of Life 6-Dimensions instrument (SQoL-6D). DESIGN: A clinimetric evaluation conducted in a multicentre, prospective, longitudinal cohort study at 8 UK sites. PATIENTS: Adult patients (n=104) undergoing focal treatment of upper-limb spasticity. METHODS: The SQoL-6D was administered in the clinic at enrolment and at 8 weeks, then 1-4 days later at home to assess test-retest reliability. RESULTS: The SQoL-6D demonstrated adequate construct validity and unidimensionality of the scale, allowing the calculation of a Total score. Cronbach's alpha (0.74) supported the internal consistency reliability, while the intraclass correlation coefficient supported test-retest reliability (0.82). Correlation coefficients with established instruments supported convergent validity, while significant differences between known-groups (of differing clinical severity) in SQoL-6D Total score confirmed its sensitivity to both cross-sectional and longitudinal differences. CONCLUSION: The SQoL-6D is a promising new measure to assess health status for patients with upper-limb spasticity of any aetiology. Further investigation and exploration of the allocation of weights to convert the SQoL-6D to a health-related quality of life utility index, are required.

Early Identification, Intervention and Management of Post-stroke Spasticity: Expert Consensus Recommendations.

Stroke patients with spasticity usually require long-lasting care and interventions but frequently report that outpatient and community treatment is limited, reflecting a significant unmet need in health and social care provision. Rehabilitation and spasticity management services are essential for patient recovery, with improvements in both activity and participation reducing the burden on patients, family and society. Current clinical guidance provides scope for improvements in both post-stroke management and spasticity prevention. However, access to specialist services can be limited and the patient journey does not always match national recommendations. Identification of spasticity and its predictors and lack of subsequent referral to rehabilitation or specialist spasticity services are key issues in the management of post-stroke spasticity. Implementation of a traffic light classification system prioritises patients at an increased risk of spasticity and promotes early and consistent management across the spectrum of primary and secondary care. The proposed system is based on clinical evidence, expert consensus and recent clinical guidelines. It provides simple and straightforward criteria for management, multidisciplinary consultation and referral to specialist spasticity services, with patients allocated by monitoring requirements and a low (green/periodic monitoring), medium (amber/routine referral) or high risk (red/urgent referral) of spasticity.

The Leg Activity measure, a new measure of passive and active function and impact on quality of life; informing goal setting and outcome evaluation in leg spasticity.

PURPOSE: Application of the Leg Activity measure in acquired brain injury spasticity intervention to identify areas for goal setting prior to treatment, document the treatments applied and evaluate outcome. METHODS: A prospective cohort from three specialist spasticity management centres was used. Primary outcome measures were, Leg Activity Measure, Modified Ashworth Scale and Goal Attainment Scaling - light. Measurement was completed at baseline, 6 and 12 weeks. The Leg-Therapy recording Schedule was used to record physical therapy intervention. RESULTS: Participants (n = 64) included had a mean age of 51 (18-84) years, half (n = 32) were men. Significant changes were demonstrated over the 12-week period in MAS (Xr2 = 35.4; p < 0.001), the Leg Activity passive function scale (Xr2 = 32.2; p < 0.001) (e.g., improved ease of dressing, hygiene) and Leg Activity impact on quality of life scale (Xr2 = 32.2; p < 0.001). No change was identified in the Leg Activity active function scale. Goal achievement was demonstrated at 6 weeks and further improved at 12 weeks (Xr2 = 65.7; p < 0.001) and was associated with change in the relevant scale. Physical interventions were captured at each time-point. DISCUSSION: Significant gains in passive-function and quality-of-life were recorded by the Leg Activity measure scales at 6 weeks, and at 12 weeks post-injection in the context of on-going physical treatment, primarily by self-management.Implications for rehabilitationThe Leg Activity measure is able to detected changes in passive function and impact on quality of life.Measurement of change in active function is also likely to be detected, but was not seen in the cohort studied.The Leg Activity measure was effective in this study in identifying problem areas to enable setting of treatment goals and planning of treatment intervention.