Christopher Price

A review of the properties and limitations of the Ashworth and modified Ashworth Scales as measures of spasticity

Background: The Ashworth Scale and the modified Ashworth Scale are the primary clinical measures of spasticity. A prerequisite for using any scale is a knowledge of its characteristics and limitations, as these will play a part in analysing and interpreting the data. Despite the current emphasis on treating spasticity, clinicians rarely measure it. Objectives: To determine the validity and the reliability of the Ashworth and modified Ashworth Scales. Study design: A theoretical analysis following a structured literature review (key words: Ashworth; Spasticity; Measurement) of 40 papers selected from the BIDS-EMBASE, First Search and Medline databases. Conclusions: The application of both scales would suggest that confusion exists on their characteristics and limitations as measures of spasticity. Resistance to passive movement is a complex measure that will be influenced by many factors, only one of which could be spasticity. The Ashworth Scale (AS) can be used as an ordinal level measure of resistance to passive movement, but not spasticity. The modified Ashworth Scale (MAS) will need to be treated as a nominal level measure of resistance to passive movement until the ambiguity between the ‘1’ and ‘1+’ grades is resolved. The reliability of the scales is better in the upper limb. The AS may be more reliable than the MAS. There is a need to standardize methods to apply these scales in clinical practice and research.

DOES REPETITIVE TASK TRAINING IMPROVE FUNCTIONAL ACTIVITY AFTER STROKE? A COCHRANE SYSTEMATIC REVIEW AND META-ANALYSIS

OBJECTIVE To determine if repetitive task training after stroke improves functional activity. DESIGN Systematic review and meta-analysis of trials comparing repetitive task training with attention control or usual care. DATA SOURCES The Cochrane Stroke Trials Register, electronic databases of published, unpublished and non-English language papers; conference proceedings, reference lists, and trial authors. REVIEW METHODS Included studies were randomized/quasi-randomized trials in adults after stroke where an active motor sequence aiming to improve functional activity was performed repetitively within a single training session. We used Cochrane Collaboration methods, resources, and software. RESULTS We included 14 trials with 17 intervention-control pairs and 659 participants. Results were statistically significant for walking distance (mean difference 54.6, 95% confidence interval (95% CI) 17.5, 91.7); walking speed (standardized mean difference (SMD) 0.29, 95% CI 0.04, 0.53); sit-to-stand (standard effect estimate 0.35, 95% CI 0.13, 0.56), and activities of daily living: SMD 0.29, 95% CI 0.07, 0.51; and of borderline statistical significance for measures of walking ability (SMD 0.25, 95% CI 0.00, 0.51), and global motor function (SMD 0.32, 95% CI -0.01, 0.66). There were no statistically significant differences for hand/arm functional activity, lower limb functional activity scales, or sitting/standing balance/reach. CONCLUSION Repetitive task training resulted in modest improvement across a range of lower limb outcome measures, but not upper limb outcome measures. Training may be sufficient to have a small impact on activities of daily living. Interventions involving elements of repetition and task training are diverse and difficult to classify: the results presented are specific to trials where both elements are clearly present in the intervention, without major confounding by other potential mechanisms of action.

A biomechanical investigation into the validity of the modified Ashworth Scale as a measure of elbow spasticity

Objective: To investigate the criterion validity of the modified Ashworth Scale. Population: Volunteers from a stroke population admitted to a district general hospital stroke unit diagnosed with a first ever stroke less than 26 weeks previously. Outcome measures: Resistance to passive movement about the elbow was simultaneously quantified (biomechanically) and graded (modified Ashworth Scale). Passive range of movement and peak instantaneous velocity during passive movement were also measured. Analysis: Criterion validity was investigated as convergent construct validity (using the Spearmans correlation coefficient) and concurrent validity (using analysis of variance). Results: One hundred measurements were taken on 63 subjects. Correlation between the modified Ashworth Scale and resistance to passive movement was 0.511. Resistance to passive movement and velocity showed significant differences between the modified Ashworth score of ‘0’ and a modified Ashworth score greater than ‘0’ (p < 0.01). There were no significant differences between MAS ‘1’, ‘1+’ and ‘2’. Resistance to passive movement in the impaired arm was significantly higher than in the nonimpaired arm (p < 0.01). Conclusion: The modified Ashworth Scale does not provide a valid measure of spasticity at lower grades but it may provide a measure of resistance to passive movement.

Botulinum Toxin for the Upper Limb After Stroke (BoTULS) Trial Effect on Impairment, Activity Limitation, and Pain

Background and Purpose— Botulinum toxin is increasingly used to treat upper limb spasticity due to stroke, but its impact on arm function is unclear. We evaluated botulinum toxin for upper limb spasticity and function poststroke. Methods— Three hundred thirty-three patients with stroke with upper limb spasticity and reduced arm function participated in a multicenter randomized controlled trial. The intervention group received botulinum toxin type A injection(s) plus a 4-week therapy program. The control group received the therapy program alone. Repeat injection(s) and therapy were available at 3, 6, and 9 months. The primary outcome was upper limb function at 1 month (Action Research Arm Test). Secondary outcomes included measures of impairment, activity limitation, and pain at 1, 3, and 12 months. Outcome assessments were blinded and analysis was by intention to treat. Results— There was no significant difference in achievement of improved arm function (Action Research Arm Test) at 1 month (intervention group: 42 of 167 [25.1%], control group 30 of 154 [19.5%]; P=0.232). Significant differences in favor of the intervention group were seen in muscle tone at 1 month; upper limb strength at 3 months; basic arm functional tasks (hand hygiene, facilitation of dressing) at 1, 3, and 12 months; and pain at 12 months. Conclusions— Botulinum toxin type A is unlikely to be useful for improving active upper limb function (eg, reaching and grasping) in the majority of patients with spasticity after stroke, but it may improve basic upper limb tasks (hand hygiene, facilitation of dressing) and pain.

Does an early increased-intensity interdisciplinary upper limb therapy programme following acute stroke improve outcome?

Objective: To determine whether an early increased-intensity upper limb therapy programme following acute stroke improves outcome. Design: A randomized controlled trial. Setting: A stroke unit which provides acute care and rehabilitation for all stroke admissions. Subjects: One hundred and twenty-three patients who had had a stroke causing upper limb impairment within the previous 10 days. Intervention: The intervention group received stroke unit care plus enhanced upper limb rehabilitation provided jointly by a physiotherapist and occupational therapist, commencing within 10 days of stroke, and available up to 30 minutes/day, five days/week for six weeks. The control group received stroke unit care. Main outcome measures: The primary outcome measure was the Action Research Arm Test (ARAT) three months after stroke. Secondary outcome measures: Motricity Index; Frenchay Arm Test; upper limb pain; Barthel ADL Index; Nottingham E-ADL Scale; and costs to health and social services at three and six months after stroke. Results: There were no differences in outcomes between the intervention and control groups three and six months after stroke. During the intervention period the intervention group received a median of 29 minutes of enhanced upper limb therapy per working day as inpatients. The total amount of inpatient physiotherapy and occupational therapy received by the intervention group was a median of 52 minutes per working day during the intervention period and 38 minutes per working day for the control group (p = 0.001). There were no differences in service costs. Conclusions: An early increased-intensity interdisciplinary upper limb therapy programme jointly provided by a physiotherapist and occupational therapist did not improve outcome after stroke. The actual difference in the amount of therapy received by intervention and control groups was less than planned due to a competitive therapy bias.

Protocol and pilot data for establishing the Australian Stroke Clinical Registry

Background Disease registries assist with clinical practice improvement. The Australian Stroke Clinical Registry aims to provide national, prospective, systematic data on processes and outcomes for stroke. We describe the methods of establishment and initial experience of operation. Methods Australian Stroke Clinical Registry conforms to new national operating principles and technical standards for clinical quality registers. Features include: online data capture from acute public and private hospital sites; opt-out consent; expert consensus agreed core minimum dataset with standard definitions; outcomes assessed at 3 months post-stroke; formal governance oversight; and formative evaluations for improvements. Results Qualitative feedback from sites indicates that the web-tool is simple to use and the user manuals, data dictionary, and training are appropriate. However, sites desire automated data-entry methods for routine demography variables and the opt-out consent protocol has sometimes been problematic. Data from 204 patients (median age 71 years, 54% males, 60% Australian) were collected from four pilot hospitals from June to October 2009 (mean, 50 cases per month) including ischaemic stroke (in 72%), intracerebral haemorrhage (16%), transient ischaemic attack (9%), and undetermined (3%), with only one case opting out. Conclusion Australian Stroke Clinical Registry has been well established, but further refinements and broad roll-out are required before realising its potential of improving patient care through clinician feedback and allowance of local, national, and international comparative data.

Randomized Controlled Trial to Evaluate the Effect of Surface Neuromuscular Electrical Stimulation to the Shoulder After Acute Stroke

Background and Purpose— Surface neuromuscular electrical stimulation (sNMES) after stroke aims to improve upper limb function and reduce shoulder pain, but current evidence of effectiveness is inconclusive. We have undertaken a randomized controlled trial to evaluate sNMES to the shoulder after acute stroke. Methods— One hundred seventy-six patients, within 10 days of stroke onset, were randomized to receive sNMES or placebo in addition to stroke unit care. The primary outcome measure was upper limb function measured by the Action Research Arm Test (ARAT) 3 months after stroke. Secondary outcome measures included other measures of upper limb function, upper limb impairment, pain, disability, and global health status. Outcome assessments were blinded. Results— There was no difference in arm function between groups in terms of the primary outcome measure. The median ARAT at 3 months was 50 in the intervention group and 55.5 in the control group (P=0.068). Significant differences were seen at 3 months in favor of the control group for other measures of arm function and impairment: grasp and gross movement subsections of the ARAT, Frenchay Arm Test, and the arm subsection of the Motricity Index. Secondary analysis suggested that these differences were most marked in subjects with severe initial upper limb weakness. Conclusions— A 4-week program of sNMES to the shoulder after acute stroke does not improve functional outcome and may worsen arm function in severely impaired stroke patients. “Routine” use of sNMES to the proximal affected upper limb after acute stroke cannot be recommended.

Systematic review of stroke thrombolysis service configuration

Intravenous recombinant tissue plasminogen activator is a highly effective treatment for acute ischemic stroke, but routine provision is challenging. We compared the activity, safety and response times of five service configurations: local services, redirection of selected or all suspected stroke patients by emergency medical services (EMS) to stroke centers and the use of telemedicine with and without secondary transfer to a stroke center. In total, 59 relevant service descriptions were identified. Pooled treatment rates (mean ± standard deviation [SD]) per 100 confirmed stroke patients were: local service design, 2.5 ± 2.5 (n = 21417); EMS redirection of only patients potentially eligible for thrombolysis, 3.9 ± 1.2 (n = 1872); EMS redirection of all suspected stroke patients, 3.8 ± 1.1 (n = 5427); telemedicine with secondary transfer, 6.9 (no pooled SD; n = 749); and telemedicine without secondary transfer, 3.4 (no pooled SD; n = 6610). A comprehensive stroke patient register was completed for only five regional collaborations, resulting in pooled ischemic stroke treatment rates of 5.7 (95% confidence interval: 4.6–6.9; n = 7815) compared with 3.1 (95% confidence interval: 2.1–4.1; n = 31411) for local services. Pooled symptomatic hemorrhage rates were similar for all service designs (range: 3.9–5.1%). Average door–needle times exceeded 60 min in most studies. We conclude that regional collaborations achieve higher rates of thrombolysis than local services working in isolation. Stroke services should continue to publish thrombolysis activity and safety data in a recommended format in order to determine the most suitable configuration for different settings.

A Time Series Evaluation of the FAST National Stroke Awareness Campaign in England

Objective In February 2009, the Department of Health in England launched the Face, Arm, Speech, and Time (FAST) mass media campaign, to raise public awareness of stroke symptoms and the need for an emergency response. We aimed to evaluate the impact of three consecutive phases of FAST using population-level measures of behaviour in England. Methods Interrupted time series (May 2007 to February 2011) assessed the impact of the campaign on: access to a national stroke charitys information resources (Stroke Association [SA]); emergency hospital admissions with a primary diagnosis of stroke (Hospital Episode Statistics for England); and thrombolysis activity from centres in England contributing data to the Safe Implementation of Thrombolysis in Stroke UK database. Results Before the campaign, emergency admissions (and patients admitted via accident and emergency [A&E]) and thrombolysis activity was increasing significantly over time, whereas emergency admissions via general practitioners (GPs) were decreasing significantly. SA webpage views, calls to their helpline and information materials dispatched increased significantly after phase one. Website hits/views, and information materials dispatched decreased after phase one; these outcomes increased significantly during phases two and three. After phase one there were significant increases in overall emergency admissions (505, 95% CI = 75 to 935) and patients admitted via A&E (451, 95% CI = 26 to 875). Significantly fewer monthly emergency admissions via GPs were reported after phase three (−19, 95% CI = −29 to −9). Thrombolysis activity per month significantly increased after phases one (3, 95% CI = 1 to 6), and three (3, 95% CI = 1 to 4). Conclusions Phase one had a statistically significant impact on information seeking behaviour and emergency admissions, with additional impact that may be attributable to subsequent phases on information seeking behaviour, emergency admissions via GPs, and thrombolysis activity. Future campaigns should be a0ccompanied by evaluation of impact on clinical outcomes such as reduced stroke-related morbidity and mortality.

Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): results from the pilot randomised controlled trial

Background High blood pressure (BP) during acute stroke is associated with poorer stroke outcome. Trials of treatments to lower BP have not resulted in improved outcome, but this may be because treatment commenced too late. Emergency medical service staff (paramedics) are uniquely placed to administer early treatment; however, experience of prehospital randomised controlled trials (RCTs) is very limited. Methods We conducted a pilot RCT to determine the feasibility of a definitive prehospital BP-lowering RCT in acute stroke. Paramedics were trained to identify, consent and deliver a first dose of lisinopril or placebo to adults with suspected stroke and hypertension while responding to the emergency call. Further treatment continued in hospital. Study eligibility, recruitment rate, completeness of receipt of study medication and clinical data (eg, BP) were collected to inform the design of a definitive RCT. Results In 14 months, 14 participants (median age=73 years, median National Institute of Health Stroke Scale=4) were recruited and received the prehospital dose of medication. Median time from stroke onset (as assessed by paramedic) to treatment was 70 min. Four participants completed 7 days of study treatment. Of ambulance transported suspected stroke patients, 1% were both study eligible and attended by a PIL-FAST paramedic. Conclusions It is possible to conduct a paramedic initiated double-blind RCT of a treatment for acute stroke. However, to perform a definitive RCT in a reasonable timescale, a large number of trained paramedics across several ambulance services would be needed to recruit the number of patients likely to be required. Clinical trial registration http://www.clinicaltrials.gov. Unique identifier: NCT01066572.