Reducing the Number of Test Items of the Action Research Arm Test Poststroke: A Decision Tree Analysis✰.

OBJECTIVE: The present study aimed to create a shorter version of the Action Research Arm Test (ARAT) without compromising its measurement properties. DESIGN: Secondary analysis of stroke recovery cohorts that used the ARAT to measure upper limb impairment. SETTING: Rehabilitation centers. PARTICIPANTS: Patients with stroke from 5 different stroke recovery cohorts (N=1425). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A decision tree version of the ARAT (ARAT-DT) was developed using chi-square automated interaction detection. In an independent validation subset, criterion validity, agreement of ARAT-DT with original ARAT scores and score categories, and construct validity with the Fugl-Meyer Upper Extremity Scale score were determined. RESULTS: In total, 3738 ARAT measurements were available involving 1425 subjects. Chi-square automated interaction detection analysis in the development subset (n=2803) revealed an optimized decision tree with a maximum of 4 consecutive items. In the validation data set (n=935), the ARAT-DT differed by a mean of 0.19 points (0.3% of the total scale) from the original ARAT scores (limits of agreement=-5.67 to 6.05). The ARAT-DT demonstrated excellent criterion validity with the original ARAT scores (intraclass correlation coefficient=0.99 and ρ=0.99) and scoring categories (κw=0.97). The ARAT-DT showed very good construct validity with the Fugl-Meyer Upper Extremity Scale (ρ=0.92). CONCLUSION: A decision tree version of the ARAT was developed, reducing the maximum number of items necessary for ARAT administration from 19 to 4. The scores produced by the decision tree had excellent criterion validity with original ARAT scores.

Home-based Reach-to-Grasp training for people after stroke is feasible: a pilot randomised controlled trial.

OBJECTIVE: To determine feasibility of a randomised controlled trial (RCT) of home-based Reach-to-Grasp training after stroke. DESIGN: single-blind parallel group RCT. PARTICIPANTS: Residual arm deficit less than 12 months post-stroke. INTERVENTIONS: Reach-to-Grasp training in 14 one-hour therapist's visits over 6 weeks, plus one hour self-practice per day (total 56 hours). CONTROL: Usual care. MAIN MEASURES: Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), pre-randomisation, 7, 12, 24 weeks post-randomisation. RESULTS: Forty-seven participants (Reach-to-Grasp=24, usual care=23) were randomised over 17 months. Reach-to-Grasp participants received a median (IQR) 14 (13,14) visits, and performed 157 (96,211) repetitions per visit; plus 30 minutes (22,45) self-practice per day. Usual care participants received 10.5 (5,14) therapist visits, comprising 38.6 (30,45) minutes of arm therapy with 16 (6,24) repetitions of functional tasks per visit. Median ARAT scores in the reach-to-grasp group were 8.5 (3.0,24.0) at baseline and 14.5 (3.5,26.0) at 24 weeks compared to median of 4 at both time points (IQR: baseline (3.0,14.0), 24 weeks (3.0,30.0)) in the usual-care group. Median WMFT tasks completed at baseline and 24 weeks were 6 (3.0,11.5) and 8.5 (4.5,13.5) respectively in the reach-to-grasp group and 4 (3.0,10.0), 6 (3.0,14.0) in the usual care group. Incidence of arm pain was similar between groups. The study was stopped before 11 patients reached the 24 weeks assessment. CONCLUSIONS: An RCT of home-based Reach-to-Grasp training after stroke is feasible and safe. With ARAT being our preferred measure it is estimated that 240 participants will be needed for a future two armed trial.

Sensory dynamic orthoses in mild to moderate upper limb tremor in multiple sclerosis: a mixed methods feasibility study.

OBJECTIVE: To explore the feasibility of conducting a Phase III randomized controlled trial evaluating sensory dynamic orthoses for upper limb tremor in multiple sclerosis. DESIGN: Mixed methods: double blind randomized placebo controlled pilot study and semi-structured interviews. SETTING: Rehabilitation centre. SUBJECTS: A total of 21 people with multiple sclerosis with upper limb tremor. INTERVENTIONS: Participants received a sensory dynamic orthosis sleeve or a non-compressive sleeve (placebo) that they wore eight hours a day, for nine weeks. MAIN MEASURES: Outcomes were completed at baseline and nine weeks. The primary outcome measure was the Fahn-Tolosa-Marin (FAHN) Tremor Rating Scale. Secondary outcome measures included the: Action Research Arm Test, Canadian Occupational Performance Measure, Psychological Impact of Assistive Device Scale and the Nine-hole Peg Test. RESULTS: Both sleeves were acceptable, although achieving a good fit was an issue. There were no significant between-group differences for the primary outcome measure. The median ± interquartile range change scores were 0.5 ±6.5 and 2 ±8 for the placebo and treatment group, respectively. The median ± interquartile range Canadian Occupational Performance Measure (performance subscale) demonstrated significant improvements ( p = 0.01) for the placebo group (1.1 ±1.65) compared with the treatment group (0 ±1.2). There was no between-group differences in the satisfaction subscale. The primary outcome measure was sensitive to detect change; however the Action Research Arm Test was not responsive in this study population. CONCLUSION: Undertaking an randomized controlled trial would be feasible and a minimum of 200 participants would be needed for a fully powered, definitive randomized controlled trial.

A framework to aid adoption of automated rehabilitation devices into clinical practice: synthesising and Interpreting Language for Clinical Kinematics (SILCK).

The Synthesising and Interpreting Language for Clinical Kinematics (SILCK) is an informatic framework for developing software to control automated rehabilitation devices. It aids adoption of devices into rehabilitation practice, by bridging the gap between clinical practice and internal device operation. SILCK defines data entities and processes for capturing clinical observations of patients and their rehabilitation goals in formats which can be used to direct the tailoring of device parameters to the individual patient's needs.

Delirium in acute stroke: screening tools, incidence rates and predictors: a systematic review.

Delirium is a common complication in acute stroke yet there is uncertainty regarding how best to screen for and diagnose delirium after stroke. We sought to establish how delirium after stroke is identified, its incidence rates and factors predicting its development. We conducted a systematic review of studies investigating delirium in acute stroke. We searched The Cochrane Collaboration, MEDLINE, EMBASE, CINHAL, PsychINFO, Web of Science, British Nursing Index, PEDro and OT Seeker in October 2010. A total of 3,127 citations were screened, full text of 60 titles and abstracts were read, of which 20 studies published between 1984 and 2010 were included in this review. The methods most commonly used to identify delirium were generic assessment tools such as the Delirium Rating Scale (n = 5) or the Confusion Assessment Method (n = 2) or both (n = 2). The incidence of delirium in acute stroke ranged from 2.3-66%, with our meta-analysis random effects approach placing the rate at 26% (95% CI 19-33%). Of the 11 studies reporting risk factors for delirium, increased age, aphasia, neglect or dysphagia, visual disturbance and elevated cortisol levels were associated with the development of delirium in at least one study. The outcomes associated with the condition are increased morbidity and mortality. Delirium is found in around 26% of stroke patients. Difference in diagnostic and screening procedures could explain the wide variation in frequency of delirium. There are a number of factors that may predict the development of the condition.

A survey of community exercise programmes for stroke survivors in Scotland.

Stroke is the most common cause of complex disability in the community. Physical fitness is often reduced after stroke, but training can improve fitness and function. UK and international stroke clinical guidelines recommend long-term exercise participation for stroke survivors. However, there has been no previous research into what services are available to support this. In 2009, we conducted the first European survey of community Exercise after Stroke services. A link to our web-based survey was emailed to health, leisure service and stroke charity contacts in Scotland with email and telephone follow-up to non-respondents. The overall response rate was 64% (230/361). A total of 14 Exercise after Stroke services were identified, the majority of which were run by charity collaborations (7/14), followed by leisure centre services (4/14) and health services (3/14). We sought information on session content, referral and assessment processes, and the qualifications of exercise instructors. This information was cross-referenced with current clinical and exercise guidelines to determine whether existing resources were sufficient to meet stroke survivors' needs for safe, effective and sustainable access to exercise. The results indicated a shortage of stroke-specific community exercise programmes. Further service development is required to ensure appropriate instructor training and referral pathways are in place to enable stroke survivors to access exercise services in accordance with current guidelines.

BoTULS: a multicentre randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A.

OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A plus an upper limb therapy programme with the upper limb therapy programme alone. DESIGN: A multicentre open-label parallel-group randomised controlled trial and economic evaluation. SETTING: Twelve stroke services in the north of England, UK. PARTICIPANTS: Three hundred and thirty-three adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. INTERVENTIONS: The intervention group received botulinum toxin type A injection(s) plus a 4-week programme of upper limb therapy. The control group received the upper limb therapy programme alone. Participants were clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A injection(s) and/or therapy. MAIN OUTCOME MEASURES: The primary outcome was upper limb function 1 month after study entry measured by the Action Research Arm Test (ARAT). A successful outcome was defined as: (1) a change of three or more points on the ARAT scale for a participant whose baseline ARAT score was between 0 and 3, (2) a change of six or more points on the ARAT scale for a participant whose baseline ARAT score was between 4 and 51, or (3) a final ARAT score of 57 for a participant whose baseline ARAT score was 52-56. Outcome assessments were undertaken at 1, 3 and 12 months by an assessor who was blinded to the study group allocation. Upper limb impairment and activity limitation were assessed by: Modified Ashworth Scale; Motricity Index; grip strength; ARAT; Nine-Hole Peg Test; upper limb basic functional activity questions and the Barthel Activities of Daily Living (ADL) Index. Stroke-related quality of life/participation restriction was measured using the Stroke Impact Scale, European Quality of Life-5 Dimensions (EQ-5D) and the Oxford Handicap Scale. Upper limb pain was assessed using numerical rating scales. Participant-selected upper limb goal achievement (1 month only) was measured using the Canadian Occupational Performance Measure. Adverse events were compared. Health-care and social services resource use was compared during the first 3 months postrandomisation. EQ-5D data were used to calculate the quality-adjusted life-years (QALYs) associated with intervention and control treatments, and the incremental cost per QALY gained of botulinum toxin type A plus therapy compared with therapy alone was estimated. The sensitivity of the base-case results to alternative assumptions was investigated, and cost-effectiveness acceptability curves, which summarise the evidence of botulinum toxin type A plus therapy being cost-effective for a range of societal willingness to pay for a QALY values, are presented. RESULTS: Randomisation groups were well matched at baseline. There was no significant difference between the groups for the primary outcome of improved arm function at 1 month. This was achieved by 30/154 (19.5%) in the control group and 42/167 (25.1%) in the intervention group (p = 0.232). The relative risk of having a 'successful treatment' in the intervention group compared with the control group was 1.3 [95% confidence interval (CI) 0.9 to 2.0]. No significant differences in improved arm function were seen at 3 or 12 months. In terms of secondary outcomes, muscle tone/spasticity at the elbow was decreased in the intervention group compared with the control group at 1 month. The median change in the Modified Ashworth Scale was - 1 in the intervention group compared with zero in the control group (p < 0.001). No difference in spasticity was seen at 3 or 12 months. Participants treated with botulinum toxin type A showed improvement in upper limb muscle strength at 3 months. The mean change in strength from baseline (upper limb component of the Motricity Index) was 3.5 (95% CI 0.1 to 6.8) points greater in the intervention group compared with the control group. No differences were seen at 1 or 12 months. Participants in the intervention group were more likely to be able to undertake specific basic functional activities, e.g. dress a sleeve, clean the palm and open the hand for cutting fingernails. At 1 month, 109/144 (75.7%) of the intervention group and 79/125 (63.2%) of the control group had improved by at least one point on a five-point Likert scale for at least one of these tasks (p = 0.033). At 3 months the corresponding proportions were 102/142 (71.8%) of the intervention group and 71/122 (58.2%) of the control group (p = 0.027). Improvement was sustained at 12 months for opening the hand for cleaning the palm and opening the hand for cutting the nails but not for other activities. Pain rating improved by two points on a 10-point severity rating scale in the intervention group compared with zero points in the control group (p = 0.004) at 12 months, but no significant differences were seen at 1 or 3 months. There were a number of occasions when there were statistically significant differences in favour of the intervention group; however, these differences were small and of uncertain clinical relevance. These differences were: 3 months - upper limb function (change in ARAT score from baseline), pain (EQ-5D) and participation restriction (Oxford Handicap Scale); 12 months - anxiety/depression (EQ-5D) and participation restriction (Oxford Handicap Scale). No differences in grip strength, dexterity or the Barthel ADL Index were found at any time point. There were no differences between the groups for achievement of patient-selected goals. There was a higher incidence of general malaise/flu-like/cold symptoms in participants treated with botulinum toxin type A with a relative risk of 7.6 (95% CI 1.8 to 32.3). Only one serious adverse event (dysphagia) was potentially related to botulinum toxin type A. Time since stroke and severity of initial upper limb function were preplanned subgroup analyses. There was no significant difference in either subgroup for achievement of ARAT 'success' following treatment with botulinum toxin type A. The base-case incremental cost-effectiveness ratio was 93,500 pounds per QALY gained and estimation of the cost-effectiveness acceptability curve for botulinum toxin type A plus the upper limb therapy programme indicated that there was only a 0.36 probability of it being cost-effective at a threshold ceiling ratio of 20,000 pounds per QALY. CONCLUSIONS: The addition of botulinum toxin type A to an upper limb therapy programme to treat spasticity due to stroke did not enhance improvement in upper limb function when assessed by the prespecified primary outcome measure at 1 month. However, improvements were seen in muscle tone at 1 month, upper limb strength at 3 months, upper limb functional activities related to undertaking specific basic functional tasks at 1, 3 and 12 months, and upper limb pain at 12 months. Botulinum toxin was well tolerated and side effects were minor. The addition of botulinum toxin type A to an upper limb therapy programme for the treatment of upper limb spasticity due to stroke was not estimated to be cost-effective at levels of willingness to pay for a QALY set by NHS decision-makers. TRIAL REGISTRATION: ISRCTN78533119; EudraCT 2004-002427-40; CTA 17136/0230/001.

Biomechanical approaches applied to the lower and upper limb for the measurement of spasticity: a systematic review of the literature.

PURPOSE: To review and characterise biomechanical approaches for the measurement of spasticity as one component of the upper motor neurone syndrome. METHOD: Systematic literature searches based on defined constructs and a four-step review process of approaches used or described to measure spasticity, its association with function or associated phenomena. Most approaches were limited to individual joints and therefore, to reflect this trend, references were grouped according to which body joint(s) were investigated or whether it addressed a functional activity. For each joint, references were further sub-divided into the types of measurement method described. RESULTS: A database of 335 references was established for the review process. The knee, ankle and elbow joints were the most popular, perhaps reflecting the assumption that they are mono-planar in movement and therefore simpler to assess. Seven measurement methods were identified: five involving passive movement (manual, controlled displacement, controlled torque, gravitational and tendon tap) and two involving active movement (voluntary and functional). Generally, the equipment described was in an experimental stage and there was a lack of information on system properties, such as accuracy or reliability. Patient testing was either by cohort or case studies. The review also conveyed the myriad of interpretations of the concept of spasticity. CONCLUSIONS: Though biomechanical approaches provide quantitative data, the review highlighted several limitations that have prevented them being established as an appropriate method for clinical application to measure spasticity.

Theoretical and methodological considerations in the measurement of spasticity.

PURPOSE: To discuss the measurement of spasticity in the clinical and research environments, make recommendations based on the SPASM reviews of biomechanical, neurophysiological and clinical methods of measuring spasticity and indicate future developments of measurement tools. METHOD: Using the results of the systematic reviews of the biomechanical, neurophysiological and clinical approaches, methods were evaluated across three dimensions: (1) validity, reliability and sensitivity to change; (2) practical quality such as ease of use and (3) qualities specific to the measurement of spasticity, for example ability to be applied to different muscle groups. Methods were considered in terms of applicability to research and clinical applications. RESULTS: A hierarchy of measurement approaches was identified from highly controlled and more objective (but unrelated to function) to ecologically valid, but less objective and subject to contamination from other variables. The lack of a precise definition of spasticity may account for the problem of developing a valid, reliable and sensitive method of measurement. The reviews have identified that some tests measure spasticity per se, some phenomena associated with spasticity or consequential to it and others the effect of spasticity on activity and participation and independence. CONCLUSIONS: Methods appropriate for use in research, particularly into the mechanism of spasticity did not satisfy the needs of the clinician and the need for an objective but clinically applicable tool was identified. A clinical assessment may need to generate more than one 'value' and should include evaluation of other components of the upper motor neurone syndrome. There is therefore a need for standardized protocols for 'best practice' in application of spasticity measurement tools and scales.

Assessing motor deficits in neurological rehabilitation: patterns of instrument usage.

To describe current patterns in the use of clinical scales and measurement technology for the assessment of motor deficits in neurological rehabilitation. Questionnaire, sent to the 2,556 members of the World Forum for Neurological Rehabilitation, distributed over 75 countries. Sixty-eight questionnaires were returned. Generally, participants indicated that the centres where they were based used a number of different clinical assessment scales (median, three), most frequently with a small proportion of patients. The (Modified) Ashworth Scale, the FIM, and the Fugl-Meyer were used most frequently. Only 35 respondents stated that their centre used one or more scales in >75% of their patients, but the choice of such routinely applied instruments varied between centres. The application of measurement technology was restricted, with video and goniometry being used most frequently. The main barriers to more frequent use of assessment tools were perceived to be a lack of resources, information, and training. The (albeit limited) results from this survey suggest that the assessment of motor deficits in neurological rehabilitation is currently mostly qualitative and lacks standardisation. More resources and education are required to support a more routine application of assessment tools and to integrate measurement technology further in neurological rehabilitation to assist in the process of quantification of outcomes.