A randomized controlled trial of a walking training with simultaneous cognitive demand (dual-task) in chronic stroke.

BACKGROUND AND PURPOSE: The aim was to evaluate the tolerability of, adherence to and efficacy of a community walking training programme with simultaneous cognitive demand (dual-task) compared to a control walking training programme without cognitive distraction. METHODS: Adult stroke survivors at least 6 months after stroke with a visibly obvious gait abnormality or reduced 2-min walk distance were included in a two-arm parallel randomized controlled trial of complex intervention with blinded assessments. Participants received a 10 week, bi-weekly, 30 min treadmill programme at an aerobic training intensity (55%-85% heart rate maximum), either with or without simultaneous cognitive demands. Outcome was measured at 0, 11 and 22 weeks. The primary assessment involved 2-min walk tests with and without cognitive distraction to investigate the dual-task effect on walking and cognition; secondary results were the Short Form Health Survey 36, EuroQol-5D-5L, the Physical Activity Scale for the Elderly (PASE) and step activity. RESULTS: Fifty stroke patients were included; 43 received allocated training and 45 completed all assessments. The experimental group (n = 26) increased their mean (SD) 2-min walking distance from 90.7 (8.2) to 103.5 (8.2) m, compared with 86.7 (8.5) to 92.8 (8.6) m in the control group, and their PASE score from 74.3 (9.1) to 89.9 (9.4), compared with 94.7 (9.4) to 77.3 (9.9) in the control group. Statistically, only the change in the PASE differed between the groups (P = 0.029), with the dual-task group improving more. There were no differences in other measures. CONCLUSIONS: Walking with specific additional cognitive distraction (dual-task training) might increase activity more over 12 weeks, but the data are not conclusive.

A protocol for a randomised double-blind placebo-controlled feasibility study to determine whether the daily consumption of flavonoid-rich pure cocoa has the potential to reduce fatigue in people with relapsing and remitting multiple sclerosis (RRMS).

BACKGROUND: Dietary interventions including consumption of flavonoids, plant compounds found in certain foods, may have the ability to improve fatigue. However, to date, no well-designed intervention studies assessing the role of flavonoid consumption for fatigue management in people with MS (pwMS) have been performed. The hypothesis is that the consumption of a flavonoid-rich pure cocoa beverage will reduce fatigue in pwMS. The aim of this study is to determine the feasibility and potential outcome of running a trial to evaluate this hypothesis. METHODS: Using a randomised (1:1) double-blind placebo-controlled feasibility study, 40 men and women (20 in each trial arm) with a recent diagnosis (< 10 years) of relapsing and remitting MS (RRMS) and who are over 18 years of age will be recruited from neurology clinics and throughout the Thames Valley community. During a 6-week nutrition intervention period, participants will consume the cocoa beverage, high flavonoid or low flavonoid content, at breakfast daily. At baseline, demographic factors and disease-related factors will be assessed. Fatigue, activity and quality of life, in addition to other measures, will be taken at three visits (baseline, week 3 and week 6) in a university setting by a researcher blinded to group membership. Feasibility and fidelity will be assessed through recruitment and retention, adherence and a quantitative process evaluation at the end of the trial.We will describe demographic factors (age, gender, level of education) as well as disease-related factors (disease burden scores, length of time diagnosed with MS) and cognitive assessment, depression and quality of life and general physical activity in order to characterise participants and determine possible mediators to identify the processes by which the intervention may bring about change. Feasibility (recruitment, safety, feasibility of implementation of the intervention and evaluation, protocol adherence and data completion) and potential for benefit (estimates of effect size and variability) will be determined to inform future planned studies. Results will be presented using point estimates, 95% confidence intervals and p values. Primary statistical analysis will be on an intention-to-treat basis and will use the complete case data set. DISCUSSION: We propose that a flavonoid-enriched cocoa beverage for the management of fatigue will be well received by participants. Further, if it is implemented early in the disease course of people diagnosed with RRMS, it will improve mobility and functioning by modifying fatigue. TRIAL REGISTRATION: Registered with ISRCTN Registry. Trial registration No: ISRCTN69897291; Date April 2016.

How often is the diagnosis of the permanent vegetative state incorrect? A review of the evidence.

Some research suggests that 40% of people in the vegetative state are misdiagnosed. This review investigates the frequency, nature and causes of reported misdiagnosis of patients in the vegetative state, focusing on the nature of the error. It is a systematic review of all relevant literature, using references from key papers identified. The data are summarized in tables. Five clinical studies of the rate of misdiagnosis in practice were identified, encompassing 236 patients in the vegetative state of whom 80 (34%) were reclassified as having some awareness, often minimal. The studies often included patients in the recovery phase after acute injury, and were poorly reported. Five systematic reviews of signs and technologically based neurophysiological tests were identified, and they showed that most studies were small, lacked accurate or important details, and were subject to bias. Studies were not replicated. Many signs and tests did not differ between people in the vegetative state and in the minimally conscious state, and those that did were unable to diagnose an individual patient. The few single case reports suggest that failure to ensure an accurate diagnosis of the underlying neurological damage and dysfunction could, rarely, lead to significant misdiagnosis usually in patients who had brain-stem damage with little thalamic or cortical damage. Significant misdiagnosis of awareness, with an apparently 'vegetative' patient having good awareness, is rare. Careful neurological assessment of the cause and routine measurement of awareness using the Coma Recovery Scale - Revised should further reduce mistakes.

Dealing with a life changing event: The influence of spirituality and coping style on quality of life after survival of a cardiac arrest or myocardial infarction.

BACKGROUND: Survivors of a cardiac arrest often have cognitive and emotional problems. As a cardiac arrest is also an obvious life-threatening event, other psychological sequelae associated with surviving such as spirituality may also affect quality of life. OBJECTIVES: To determine the relationship between spirituality, coping and quality of life in cardiac patients both with and without a cardiac arrest. METHODS: In this retrospective cohort study, participants received a questionnaire by post. The primary outcome measure was quality of life (LiSat-9). Secondary outcome measures were spiritual well-being (FACIT-Sp12), coping style (UPCC), emotional well-being (HADS, IES), fatigue (FSS) and daily activities (FAI). Statistical analyses included multiple regression analyses. RESULTS: Data were available from 72 (60% response rate) cardiac arrest survivors and 98 (47%) patients with a myocardial infarction. Against our hypothesis, there were no differences in spirituality or other variables between the groups, with the exception of more depressive symptoms in patients with myocardial infarction without arrest. Analysis of the total data set (170 participants) found that a better quality of life was associated with higher levels of meaning and peace in life, higher levels of social and leisure activities, and lower levels of fatigue. CONCLUSIONS: Quality of life after a cardiac arrest and after a myocardial infarction without arrest are not different; fatigue, a sense of meaning and peace, and level of extended daily activities are factors related to higher life satisfaction.

Cardiovascular adaptation in people with multiple sclerosis following a twelve week exercise programme suggest deconditioning rather than autonomic dysfunction caused by the disease. Results from a randomized controlled trial.

BACKGROUND: Guidelines for optimal exercise doses in people with multiple sclerosis (MS) have to be established. We need to ascertain the basic physiological and perceptual response and adaptation to different exercise doses in this clinical population. AIM: The aim of this paper was to explore the response during maximal and sub-maximal exercise in people with MS prior to and following two different twelve week exercise programmes. DESIGN: Sub-analysis of per protocol exercise data of a two group, single blinded, randomised control trial. SETTING: Multicentre (community leisure and rehabilitation centres). POPULATION: Participants with MS assigned to a continuous (N.=12; mean±SE age=52.3±2.08; Barthel index median & range=19&13-20) or interval (N.=9; mean±SE age=49.3±3.5; Barthel index median & range=19&18-20) exercise programme. METHODS: Cardiovascular, respiratory and perceptual exercise response and adaption was measured at maximal and sub-maximal levels of physical exercise prior to and following a twelve week exercise programme, delivered at different intensities. RESULTS: Irrespective of the type of exercise programme followed, there was a significant increase in peak power (z=-1.98; P=0.05) and normalised oxygen uptake during unloaded cycling (z =-2.00; P=0.05). At discharge from the exercise programmes, the cardiovascular response to sub-maximal exercise had significantly changed (t(360) =-4.62; p<0.01). CONCLUSION: The response in people with MS at maximal and sub-maximal levels of physical exercise following a twelve week programme is analogous to non-diseased adults. CLINICAL REHABILITATION IMPACT: Cardiovascular adaptation in people with MS following a twelve week exercise programme suggests deconditioning rather than autonomic dysfunction caused by the disease.

Life after survival: long-term daily functioning and quality of life after an out-of-hospital cardiac arrest.

BACKGROUND: Information about long-term consequences of cardiac arrest is sparse. Because the survival rate is expected to increase, better knowledge of long-term functioning and quality of survival is essential. OBJECTIVES: To determine the level of functioning of out-of-hospital cardiac arrest survivors 1-6 years later, and to evaluate the predictive value of medical variables on long-term functioning. METHODS: A retrospective cohort study including 63 survivors of an out-of-hospital cardiac arrest, admitted to a Dutch University hospital between 2001 and 2006. Participants received a questionnaire by post. Primary outcome measures were: participation in society (Community Integration Questionnaire) and quality of life (SF-36). Secondary outcome measures were: physical, cognitive and emotional impairment, daily functioning and caregiver strain. Statistical analyses included multiple regression analyses. RESULTS: On average 3 years post-cardiac arrest, 74% of the patients experienced a low participation level in society compared with the general population. Over 50% reported severe fatigue, 38% feelings of anxiety and/or depression and 24% a decreased quality of life. Caregivers reported stress related responses, feelings of anxiety and lower quality of life. Seventeen percent of the caregivers reported high caregiver strain, which was associated with the patient's level of functioning. Gender, age, percutaneous coronary intervention (PCI) and therapeutic hypothermia contributed to outcome on at least one domain of long-term functioning. CONCLUSIONS: After surviving an out-of-hospital cardiac arrest, many patients and partners encounter extensive impairments in their level of functioning and quality of life. Gender, age, PCI and therapeutic hypothermia are associated with differences in long-term functioning of patients.

Rehabilitation interventions for foot drop in neuromuscular disease.

BACKGROUND: "Foot drop" or "Floppy foot drop" is the term commonly used to describe weakness or contracture of the muscles around the ankle joint. It may arise from many neuromuscular diseases. OBJECTIVES: To conduct a systematic review of randomised trials of treatment for footdrop resulting from neuromuscular disease. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Group Trials Register (July 2005), MEDLINE (January 1966 to July 2005), EMBASE (January 1980 to July 2005), AMED (January 1985 to July 2005) and CINAHL databases (January 1982 to July 2005). SELECTION CRITERIA: Randomised and quasi-randomised trials of physical, orthotic and surgical treatments for footdrop resulting from lower motor neuron or muscle disease and related contractures were included. People with primary joint disease were excluded. Interventions included a 'wait and see' approach, physiotherapy, orthotics, surgery and pharmacological therapy. The primary outcome measure was ability to walk whilst secondary outcome measures included dorsiflexor torque and strength, measures of 'activity' and 'participation' and adverse effects. DATA COLLECTION AND ANALYSIS: Methodological quality was evaluated by two authors using the van Tulder criteria. Three studies with altogether 139 participants were included in the review. Heterogeneity of the studies precluded pooling the data. MAIN RESULTS: Early surgery did not significantly affect walking speed in a trial including 20 children with Duchenne muscular dystrophy. After one year, the mean difference (MD) of the 28 feet walking time was 0.00 seconds (95% confidence interval (CI) -0.83 to 0.83) and the MD of the 150 feet walking time was -2.88 seconds, (95% CI -8.18 to 2.42). In a trial with altogether 26 participants with Charcot-Marie-Tooth disease (hereditary motor and sensory neuropathy), long-term strength training significantly increased walking speed on a 6 metre timed walk (MD -0.70 seconds, 95% CI -1.17 to -0.23) but not on a 50 metre timed walk (MD -1.9 seconds, 95% CI -4.09 to 0.29). In a trial of a 24-week strength training programme in 28 participants with myotonic dystrophy, there was no significant change in walking speed on either a 6 or 50 metre walk. AUTHORS' CONCLUSIONS: Using the primary outcome of ability to walk, only one study demonstrated a positive effect and that was an exercise programme for people with Charcot-Marie-Tooth disease. Surgery was not significantly effective in children with Duchenne Muscular Dystrophy. More evidence generated by methodologically sound trials is required.

Can aerobic treadmill training reduce the effort of walking and fatigue in people with multiple sclerosis: a pilot study.

Impaired mobility in multiple sclerosis (MS) is associated with high-energy costs and effort when walking, gait abnormalities, poor endurance and fatigue. This repeated measures trial with blinded assessments investigated the effect of treadmill walking at an aerobic training intensity in 16 adults with MS. The intervention consisted of 12 sessions of up to 30 minutes treadmill training (TT), at 55-85% of age-predicted maximum heart rate. The primary outcome measure was walking effort, measured by oxygen consumption (mL/kg per metre), during treadmill walking at comfortable walking speed (CWS). Associated changes in gait parameters using the 'Gait-Rite' mat, 10-m time and 2-minute distance, and Fatigue Severity Scale were examined. Following training, oxygen consumption decreased at rest (P = 0.008), CWS increased (P = 0.002), and 10-m times (P = 0.032) and walking endurance (P = 0.020) increased. At increased CWS, oxygen consumption decreased (P = 0.020), with a decreased time spent in stance in the weaker leg (P = 0.034), and a greater stride distance with the stronger leg (P = 0.044). Reported fatigue levels remained the same. Aerobic TT presents the opportunity to alter a motor skill and reduce the effort of walking, whilst addressing cardiovascular de-conditioning, thereby, potentially reducing effort and fatigue for some people with MS.

Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis.

The object of this study was to monitor the safety and efficacy of long-term use of an oromucosal cannabis-based medicine (CBM) in patients with multiple sclerosis (MS). A total of 137 MS patients with symptoms not controlled satisfactorily using standard drugs entered this open-label trial following a 10-week, placebo-controlled study. Patients were assessed every eight weeks using visual analogue scales and diary scores of main symptoms, and were followed for an average of 434 days (range: 21 -814). A total of 58 patients (42.3%) withdrew due to lack of efficacy (24); adverse events (17); withdrew consent (6); lost to follow-up (3); and other (8). Patients reported 292 unwanted effects, of which 251 (86%) were mild to moderate, including oral pain (28), dizziness (20), diarrhoea (17), nausea (15) and oromucosal disorder (12). Three patients had five 'serious adverse events' between them--two seizures, one fall, one aspiration pneumonia, one gastroenteritis. Four patients had first-ever seizures. The improvements recorded and dosage taken in the acute study remained stable. Planned, sudden interruption of CBM for two weeks in 25 patients (of 62 approached) did not cause a consistent withdrawal syndrome, although 11 (46%) patients reported at least one of--tiredness, interrupted sleep, hot and cold flushes, mood alteration, reduced appetite, emotional lability, intoxication or vivid dreams. Twenty-two (88%) patients re-started CBM treatment. We conclude that long-term use of an oromucosal CBM (Sativex) maintains its effect in those patients who perceive initial benefit. The precise nature and rate of risks with long-term use, especially epilepsy, will require larger and longer-term studies.

A pilot randomised controlled trial of a home-based exercise programme aimed at improving endurance and function in adults with neuromuscular disorders.

AIM: To investigate the feasibility and effect of a home-based exercise programme on walking endurance, muscle strength, fatigue and function in people with neuromuscular disorders (NMDs). METHODS: 20 adults with NMDs recruited to a control (n = 11) or exercise (n = 9) group were assessed by blinded assessors at baseline and at week 8. Walking and strengthening exercises were given to the exercise group in an 8-week home exercise programme. A 2-min walk distance was the main outcome measurement; isometric muscle strength, fatigue and function were secondary measurements. RESULTS: 2-min walk distances were not found to change in either group (p>0.05; control: mean 14.50 (SD 22.06) m; exercise: mean 2.88 (SD 20.08) m), and no difference was observed in the change scores between groups (p>0.05). Leg muscle strength increased in the exercise group (p<0.05) but not in the control group (p>0.05). Significance was reached between the groups with respect to the difference in change in muscle strength scores in the right quadriceps (p<0.05; control: mean -2.82 (SD 4.87) kg; exercise: mean -7.08 (SD 2.82) kg). No change was observed in fatigue or function scores (p<0.05). CONCLUSIONS: A home-based approach aimed at improving endurance in adults with NMDs is feasible and further investigation on a larger sample is warranted.

Disruption of sitting balance after stroke: influence of spoken output.

OBJECTIVES: To identify the extent of dual task interference between cognitive and motor tasks, (cognitive motor interference (CMI)) in sitting balance during recovery from stroke; to compare CMI in sitting balance between stroke and non-stroke groups; and to record any changes to CMI during sitting that correlate with functional recovery. METHOD: 36 patients from stroke rehabilitation settings in three NHS trusts. Healthy control group: 21 older volunteers. Measures of seated postural sway were taken in unsupported sitting positions, alone, or concurrently with either a repetitive utterance task or an oral word category generation task. Outcome measures were variability of sway area, path length of sway, and the number of valid words generated. RESULTS: Stroke patients were generally less stable than controls during unsupported sitting tasks. They showed greater sway during repetitive speech compared with quiet sitting, but did not show increased instability to posture between repetitive speech and word category generation. When compared with controls, stroke patients experienced greater dual task interferences during repetitive utterance but not during word generation. Sway during repetitive speech was negatively correlated with concurrent function on the Barthel ADL index. CONCLUSIONS: The stroke patients showed postural instability and poor word generation skills. The results of this study show that the effort of verbal utterances alone was sufficient to disturb postural control early after stroke, and the extent of this instability correlated with concomitant Barthel ADL function.

Treadmill training for individuals with multiple sclerosis: a pilot randomised trial.

This pilot study investigated whether 4 weeks of aerobic treadmill training in individuals with multiple sclerosis (MS) improved mobility and reduced fatigue. Individuals with MS were recruited to this prospective, randomised controlled trial. Individuals were assessed at baseline, week 7 and 12 with a 10 metre timed walk, a 2 minute walk, the Rivermead Mobility Index, and the Fatigue Severity Scale. After a pre-assessment familiarisation session and a baseline assessment, individuals were randomly allocated to an initial intervention or delayed intervention group. Treadmill training consisted of 4 weeks of supervised aerobic exercise delivered weeks 3-6 in the immediate group and 8-11 in the delayed group. Of the initial 19 recruits, 16 individuals completed the study. There was a significant difference in walking endurance between the delayed and immediate groups at baseline (p<0.05). On reassessment in week 7, decreases in 10 metre walk time were found in both groups, which was significant in the immediate group (p<0.05). The 2 minute walk distance significantly increased in both groups (p<0.05). In the training group, reassessed at week 12 after training ceased, there was a return towards baseline scores. No significant changes in fatigue scores were found. This study showed that in individuals with MS, aerobic treadmill training is feasible and well tolerated. Walking speed and endurance increased following training with no increase in reported fatigue. Detraining occurred in the period following training. A larger randomised clinical trial is warranted.

Multi-disciplinary rehabilitation for acquired brain injury in adults of working age.

BACKGROUND: Evidence from systematic reviews demonstrates that multi-disciplinary rehabilitation is effective in the stroke population, where older adults predominate. However, the evidence base for the effectiveness of rehabilitation following acquired brain injury (ABI) in younger adults is not yet established, perhaps because there are different methodological challenges. OBJECTIVES: To assess the effects of multi-disciplinary rehabilitation following ABI in adults, 16 to 65 years. To explore approaches that are effective in different settings and the outcomes that are affected. SEARCH STRATEGY: We used a wide range of sources including: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966-2004), EMBASE (1988-2004), CINAHL (1983-2004), PsycLIT (1967-2004), AMED, the National Research Register 2004 and ISI Science Citation Index (1981-2004). SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing multi-disciplinary rehabilitation with either routinely available local services or lower levels of intervention; or trials comparing intervention in different settings or at different levels of intensity. Quasi-randomised and quasi-experimental designs were also included, providing they met pre-defined methodological criteria. DATA COLLECTION AND ANALYSIS: Trials were selected by two authors independently, and their methodological quality rated, again by two independent authors. A third reviewer arbitrated when disagreements could not be resolved by discussion. A 'best evidence' synthesis was performed by attributing levels of evidence, based on methodological quality. Trials were sub-divided in terms of severity of ABI and the setting and type of rehabilitation offered. MAIN RESULTS: Ten trials were identified of good methodological quality and four of lower quality. Within the subgroup of predominantly mild brain injury, 'strong evidence' suggested that most patients make a good recovery with provision of appropriate information, without additional specific intervention. For moderate to severe injury, there is 'strong evidence' of benefit from formal intervention. For patients with moderate to severe ABI already in rehabilitation, there is strong evidence that more intensive programmes are associated with earlier functional gains, and 'moderate evidence' that continued outpatient therapy can help to sustain gains made in early post-acute rehabilitation. There is 'limited evidence' that specialist in-patient rehabilitation and specialist multi-disciplinary community rehabilitation may provide additional functional gains, but the studies serve to highlight the particular practical and ethical restraints on randomisation of severely affected individuals for whom there are no realistic alternatives to specialist intervention. AUTHORS' CONCLUSIONS: Problems following ABI vary; different services are required to suit the needs of patients with different problems. Patients presenting acutely to hospital with moderate to severe brain injury should be routinely followed up to assess their need for rehabilitation. Intensive intervention appears to lead to earlier gains. The balance between intensity and cost-effectiveness has yet to be determined. Patients discharged from in-patient rehabilitation should have access to out-patient or community-based services appropriate to their needs. Those with milder brain injury benefit from follow-up, and appropriate information and advice. Not all questions in rehabilitation can be addressed by traditional research methodologies. There are important questions still to be answered and future research should employ the most appropriate methodology.

Family support for stroke: one year follow up of a randomised controlled trial.

BACKGROUND: There is evidence that family support can benefit carers of stroke patients, but not the patients themselves. OBJECTIVE: To extend the follow up of a single blind randomised controlled trial of family support for stroke patients and carers to one year to ascertain whether there were any late effects of the intervention. METHODS: The study was a randomised controlled trial. Patients admitted to hospital with acute stroke who had a close carer were assigned to receive family support or normal care. Families were visited at home by a researcher 12 months after the stroke, and a series of questionnaires was administered to patient and carer. RESULTS: The benefits to carers mostly persisted, though they were no longer statistically significant because some patients were lost to follow up. There was no evidence of any effects on patients. CONCLUSION: Family support is effective for carers, but different approaches need to be considered to alleviate the psychosocial problems of stroke patients.

Does reducing spasticity translate into functional benefit? An exploratory meta-analysis.

BACKGROUND: Spasticity and loss of function in an affected arm are common after stroke. Although botulinum toxin is used to reduce spasticity, its functional benefits are less easily demonstrated. This paper reports an exploratory meta-analysis to investigate the relationship between reduced arm spasticity and improved arm function. METHOD: Individual data from stroke patients in two randomised controlled trials of intra-muscular botulinum toxin were pooled. The Modified Ashworth Scale (elbow, wrist, fingers) was used to calculate a "Composite Spasticity Index". Data from the arm section of the Barthel Activities of Daily Living Index (dressing, grooming, and feeding) and three subjective measures (putting arm through sleeve, cleaning palm, cutting fingernails) were summed to give a "Composite Functional Index". Change scores and the time of maximum change were also calculated. RESULTS: Maximum changes in both composite measures occurred concurrently in 47 patients. In 26 patients the improvement in spasticity preceded the improvement in function with 18 showing the reverse. There was a definite relationship between the maximum change in spasticity and the maximum change in arm function, independent of treatment (rho = -0.2822, p = 0.0008, n = 137). There was a clear relationship between the changes in spasticity and in arm function in patients treated with botulinum toxin (Dysport) at 500 or 1000 units (rho = -0.5679, p = 0.0090, n = 22; rho = -0.4430, p = 0.0018, n = 47), but not in those treated with placebo or 1500 units. CONCLUSIONS: Using a targeted meta-analytic approach, it is possible to demonstrate that reducing spasticity in the arm is associated with a significant improvement in arm function.

SaGAS, the Short and Graphic Ability Score: an alternative scoring method for the motor components of the Multiple Sclerosis Functional Composite.

The timed performances of the 10-m timed walk (TMTW) and the nine-hole peg test (NHPT) of 881 consecutive patients with multiple sclerosis (MS) undergoing a rehabilitation stay, were expressed as a logarithmic function of time in two subscores to form a composite score called the Short and Graphic Ability Score (SaGAS). The subscores (sS) were constructed in such a way that any interval of 0.5 unit corresponds to a change of 25% in the tests. The SaGAS was computed as the mean of four subscores: SaGAS = (2 x TMTWsS + NHPTsS right hand + NHPTsS left hand). With the aid of a nomogram, the timed values of the tests are easily transformed into the corresponding subscores, which are then displayed graphically to facilitate follow-up over time. The correlation coefficients between the SaGAS and the two motor components of the MS Functional Composite (MSFC) (r = 0.987), the Expanded Disability Status Scale (EDSS)(r = -0.83), the Nottingham EADL Index (r = 0.80) and the Rivermead Mobility Index (RMI) (r = 0.90) were all statistically significant (P < 0.001), supporting the validity of the measure. SaGAS had a similar sensitivity to the RMI, but was significantly more sensitive than the EDSS in detecting changes occurring during the rehabilitation stay (14.9% versus 5.0%; P < 0.001) and over a one-year follow-up (35.3% versus 19.7%; P < 0.001). Compared with the motor components of the MSFC, with which it shares several features, SaGAS has several advantages: it does not depend on the stratification of the study population; it does not skew the results of the NHPT towards improvement at the lower end; and it offers an independent assessment of both hands. SaGAS is a simple, intuitive, nonphysician-based measure, which could provide consistent scoring in future clinical trials.

Evaluation of the Modified Jebsen Test of Hand Function and the University of Maryland Arm Questionnaire for Stroke.

OBJECTIVE: To examine the concurrent validity and test-retest reliability of the Modified Jebsen Test of Hand Function (MJT) and the University of Maryland Arm Questionnaire for Stroke (UMAQS). DESIGN: Individuals with acquired neurological disorders were retested within an average of 9.6 days after the first assessment. SETTING: Individuals were recruited from two specialist rehabilitation units, members of the Multiple Sclerosis Society and Headway Group. SUBJECTS: Twenty-six individuals with acquired neurological disorders; stroke (12), MS (7), head injury (4), tumour (3) with moderate to high functioning upper limbs were recruited for this study. MAIN OUTCOME MEASURES: Arm function was assessed using the MJT, the UMAQS, the Nine Hole Peg Test (NHPT) and grip strength, calculating the ratio between affected and unaffected arm. RESULTS: The MJT showed good concurrent validity. Pearson's correlation with the NHPT was 0.86 and 0.88, on T1 and T2 respectively. The UMAQS showed no significant correlation with grip strength, the NHPT and the MJT. Test-retest reliability of the MJT was high with a correlation of 0.95, and 95% limits of agreement of 0.02 +/- 0.14. Correlations over time of the dominant hand/nondominant hand of the UMAQS were 0.72 and 0.83, with limits of agreement of -2.92 +/- 13.28 and 1.73 +/- 11.53. CONCLUSIONS: The present study supports the use of the MJT as a measure of gross functional dexterity. More information is needed to evaluate the UMAQS.

Verbal fluency assessment of patients with multiple sclerosis: test-retest and inter-observer reliability.

OBJECTIVE: To establish the reliability and validity of verbal fluency testing in patients with multiple sclerosis (MS). DESIGN: Each patient was assessed twice 7-14 days apart on a test of phonological fluency and again 7-14 days later when half of the patients were assessed for phonological fluency by a second assessor while the other half was assessed by the first assessor using a test of semantic fluency. SETTING: A specialist young disabled unit. SUBJECTS: Thirty-five patients with multiple sclerosis. MEASURES: Phonological fluency (PF) was tested giving the patient 60 seconds to generate words starting with 'F' 'A' and 'S'; semantic fluency (SF) with names of animals and fruits. Also used were the Short Orientation-Memory-Concentration Test and the Barthel ADL Index. RESULTS: On the first occasion 31/35 patients could be tested, and the average (SD) score of the PF was 21.9 (12.1), median 18. The test-retest reliability (n = 30/35) of the PF was good (Pearson r = 0.85). The score difference between the first two occasions ranged from +17 to -15 (median -3, mean -2.9, SD 6.7). The inter-observer reliability (n = 13/16) of the PF was good (Pearson r = 0.90). The difference of the score between the two assessors ranged from -9 to +6 (median 0, mean -1.2, SD 4.9). The correlation (Pearson) of the PF score with the SF, Barthel and SOMC was respectively r = 0.59, r = 0.27 and r = 0.63. CONCLUSIONS: Phonological fluency testing is reliable in people with MS.

Postoperative hypoxia is a contributory factor to cognitive impairment after cardiac surgery.

OBJECTIVE: Cognitive dysfunction and postoperative hypoxia are common sequelae of coronary artery bypass grafting, but there has been no study to determine whether there is any relationship between them. METHODS: Arterial blood gas measurements were performed before surgical intervention and on the second and fifth postoperative day, and neuropsychological assessments were performed before surgical intervention and 5 days and 3 months postoperatively by using a battery of 10 psychometric tests in 175 patients undergoing coronary artery bypass grafting. An estimate of overall performance on the battery at each assessment point was provided by a simple aggregate cognitive index score calculated from the mean z scores of 4 normally distributed test variables. Multiple regression analysis was performed by using the cognitive index score at day 5 as the dependent variable, with age, sex, duration of the operation, presence or absence of cardiopulmonary bypass, preoperative cognitive index score, and arterial oxygenation and percentage of saturation at day 5 as independent variables. RESULTS: The mean cognitive index score decreased significantly in 115 (66%) patients who agreed to neuropsychological test battery assessment on the fifth postoperative day but improved significantly beyond baseline at 3 months. Mean arterial oxygen tension and percentage of saturation decreased significantly 2 days after the operation and, although improving over the following 3 days, remained decreased at day 5. Decreased cognitive index scores at day 5 strongly predicted cognitive impairment at 3 months (r = 0.36). The only significant independent predictors of the day 5 cognitive index score in the multiple regression analysis were preoperative cognitive index score and arterial oxygenation tension at day 5 (r = 0.24, P <.03). CONCLUSIONS: We report a significant correlation between postoperative cognitive dysfunction and hypoxia 5 days after coronary artery bypass grafting. This finding might have therapeutic implications because early postoperative cognitive dysfunction influences long-term impairment.

Neuroprotection during cardiac surgery: a randomised trial of a platelet activating factor antagonist.

OBJECTIVE: To assess platelet activating factor (PAF) antagonists, potent neuroprotective agents in experimental cerebral dysfunction, in clinical practice. DESIGN: Double blind, minimised, placebo controlled trial of low and high dose PAF antagonist (lexipafant). SETTING: Cardiac surgery unit. PATIENTS: 150 patients undergoing coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass. INTERVENTIONS: Randomisation to placebo, low dose (10 mg) or high dose (100 mg) lexipafant. MAIN OUTCOME MEASURES: Incidence of impairment on four established cognitive tests, undertaken before, five days, and three months after CABG, examined by three methods for defining impairment. RESULTS: The three groups were similar with respect to preoperative and intraoperative factors. Observed levels of cognitive impairment were less than had been predicted from previous studies. There was no difference in the groups in cognitive change scores at five days or three months. Group mean analysis showed significant time factors for all four tests but not for interactions or for the lexipafant group. A composite cognitive index, based on the aggregate of four normally distributed tests, showed a significant effect for timing of the test but not for the lexipafant group or interaction. Age, but not duration of bypass, was the most important determinant of postoperative cognitive impairment. CONCLUSIONS: The neuroprotective PAF antagonist lexipafant did not differentially reduce the level of cognitive impairment after CABG as determined by power estimates derived from published studies. The strongest predictors of cognitive impairment were age and timing of the test after operation.