The Self-Regulation Assessment (SeRA) questionnaire: development and exploratory analyses of a new patient-reported outcome measure for rehabilitation.

PURPOSE: To develop and explore underlying dimensions of the Self-Regulation Assessment (SeRA) and psychometric features of potential components. Further, to identify associations between the SeRA and disability-management self-efficacy, type of diagnosis, and type of rehabilitation. MATERIALS AND METHODS: Based on a previously developed model of self-regulation, expert and patient opinions, and cognitive interviews, a list of 22 items on self-regulation (the SeRA) was constructed. The SeRA was included in a cross-sectional survey among a multi-diagnostic group of 563 former rehabilitation patients. Exploratory analyses were conducted. RESULTS: Respondents had a mean age of 56.5 (SD 12.7) years. The largest diagnostic groups were chronic pain disorder and brain injury. Four components were found within the SeRA, labelled as "insight into own health condition," "insight into own capabilities," "apply self-regulation," and "organization of help." Cronbach's alpha was high (total scale: 0.93, subscales: range 0.85-0.89). Only scores on the first subscale showed a ceiling effect. Subscale three showed the highest correlation with a self-efficacy measure. Small differences in SeRA total scores (range 71.6-78.1) were found between different diagnostic groups. CONCLUSION: The SeRA is a new self-regulation measure with four subscales. Further research is needed to establish the validity and reliability of the SeRA. IMPLICATIONS FOR REHABILITATIONThe Self-Regulation Assessment (SeRA) was developed to provide a comprehensive measurement of self-regulation among rehabilitation populations.The SeRA could potentially be used to identify persons with self-regulation problems at the start of rehabilitation treatment and measure outcomes of rehabilitation for self-regulation.The SeRA could potentially be used to help analyse outcomes of rehabilitation practice as well as evaluate interventions on self-regulation.

The relation between cognitive-behavioural responses to symptoms in patients with long term medical conditions and the outcome of cognitive behavioural therapy for fatigue - A secondary analysis of four RCTs.

BACKGROUND: Cognitive behavioural therapy (CBT) is effective in reducing fatigue across long-term conditions (LTCs). This study evaluated whether cognitive and behavioural responses to symptoms: 1) differ between LTCs and 2) moderate and/or mediate the effect of CBT on fatigue. METHOD: Data were used from four Randomized Controlled Trials testing the efficacy of CBT for fatigue in Chronic Fatigue Syndrome/ME (N = 240), Multiple Sclerosis (N = 90), Type 1 Diabetes Mellitus (N = 120) and Q-fever fatigue syndrome (N = 155). Fatigue severity, assessed with the Checklist Individual Strength, was the primary outcome. Differences in fatigue perpetuating factors, assessed with the Cognitive Behavioural Responses to Symptoms Questionnaire (CBRQ), between diagnostic groups were tested using ANCOVAs. Linear regression and mediation analyses were used to investigate moderation and mediation by CBRQ scores of the treatment effect. RESULTS: There were small to moderate differences in CBRQ scores between LTCs. Patients with higher scores on the subscales damage beliefs and avoidance/resting behaviour at baseline showed less improvement following CBT, irrespective of diagnosis. Reduction in fear avoidance, catastrophising and avoidance/resting behaviour mediated the positive effect of CBT on fatigue across diagnostic groups. DISCUSSION: The same cognitive-behavioural responses to fatigue moderate and mediate treatment outcome across conditions, supporting a transdiagnostic approach to fatigue.

Ten-year disease progression in multiple sclerosis: walking declines more rapidly than arm and hand function.

BACKGROUND AND AIMS: From a clinical perspective there is a difference in the decline of arm and hand function and leg function in patients with multiple sclerosis (PwMS). Therefore, this study investigated the course of walking and arm and hand functions in PwMS over the first 10 years after diagnosis, including whether any function declined earlier or faster. METHODS: A long-term prospective follow-up study of an incidence cohort of 156 patients with a definite diagnosis of MS, either non-relapse onset (n=28) or relapse onset (n=128) type. Participants were systematically examined immediately after definite diagnosis, at 6 months, and at 1, 2, 3, 6 and 10 years. Walking was determined with the fast 10-meter timed walk test (10mTWT), arm and hand function with the Action Research Arm test (ARAT) and the nine-hole peg test (9HPT). The 10-year trajectories of walking and arm and hand functions were compared using standardized z-scores. RESULTS: From 3 years onwards the z-scores of the arm and leg function were visually diverging, with a trend towards significance at 6 years, and at 10 years the 10mTWT z-score is significantly higher than the 9HPT. This difference is more pronounced in non-relapse onset patients than in patients with relapse onset type MS, but present in both groups over the first 10 years. In the non-relapse onset group a difference in z-scores at 10 years post-diagnosis between the 10m TWT and 9HPT was found of -12.94 (95% confidence interval (CI) -20.2 to -5.73) for the right and -10.14 (95% CI -17.3 to -2.93) for the left hand. In the relapse onset group there was a difference at 10 years post-diagnosis of -2.17 (95% CI -3.75 to -0.59) for the right and a difference of -2.29 (95% CI -3.87 to -0.71) for the left hand. CONCLUSION: This is the first longitudinal study that shows that walking declines earlier and more rapidly than arm and hand function in patients with MS. These results give important insights that can be linked to the pathophysiological disease process regarding the ascending order of deterioration in patients with MS.

Neuroprotective effects of exercise in people with progressive multiple sclerosis (Exercise PRO-MS): study protocol of a phase II trial.

BACKGROUND: Neurodegeneration, rather than inflammation, plays a key role in the progressive phase of multiple sclerosis (MS). Current disease modifying treatment options for people with progressive MS (PMS) do not specifically target neurodegeneration. Preliminary evidence suggests that exercise therapy might have neuroprotective effects. However, neuroprotective effect studies of exercise interventions in PMS are scarce and the possible mode of action underlying neuroprotective effects of exercise are unknown and need to be elucidated. The main aim of this phase II trial is to assess whether progressive resistance training (PRT) and high intensity interval training (HIIT), can slow down neurodegeneration in people with PMS. METHODS: In a single-blinded phase II clinical trial with an extended baseline period, 60 people with PMS will be randomly assigned to PRT or HIIT. The participants should have had a relapse onset of MS with confirmed disease progression, however still ambulatory. The duration of the study is 48 weeks, consisting of 16 weeks baseline period (no intervention), 16 weeks intervention and 16 weeks follow-up. Patient-tailored training will be performed 3 times per week for one hour in groups, led by an experienced physiotherapist. The primary outcome measure is neurodegeneration, measured as whole brain atrophy on magnetic resonance imaging (MRI). Secondary outcome parameters will include other biomarkers associated with neurodegeneration (i.e. regional brain atrophy, lesion load, white matter integrity, resting state functional connectivity, blood biomarkers (brain derived neurotrophic factor (BDNF) and serum neurofilament light (sNFL)), patient functioning (physical and cognitive) and cardiovascular risk factors. DISCUSSION: Besides the primary outcome measures, this study will examine a large variety of biomarkers associated with neurodegeneration after an exercise intervention. Combining outcome parameters may help to elucidate the mode of action underlying neuroprotective effects of exercise. TRIAL REGISTRATION: This trial is prospectively registered at the Dutch Trial Registry (number NL8265, date 06-01-2020).

Three distinct physical behavior types in fatigued patients with multiple sclerosis.

BACKGROUND: Multiple sclerosis often leads to fatigue and changes in physical behavior (PB). Changes in PB are often assumed as a consequence of fatigue, but effects of interventions that aim to reduce fatigue by improving PB are not sufficient. Since the heterogeneous nature of MS related symptoms, levels of PB of fatigued patients at the start of interventions might vary substantially. Better understanding of the variability by identification of PB subtypes in fatigued patients may help to develop more effective personalized rehabilitation programs in the future. This study aimed to identify PB subtypes in fatigued patients with multiple sclerosis based on multidimensional PB outcome measures. METHODS: Baseline accelerometer (Actigraph) data, demographics and clinical characteristics of the TREFAMS-ACE participants (n = 212) were used for secondary analysis. All patients were ambulatory and diagnosed with severe fatigue based on a score of ≥35 on the fatigue subscale of the Checklist Individual Strength (CIS20r). Fifteen PB measures were used derived from 7 day measurements with an accelerometer. Principal component analysis was performed to define key outcome measures for PB and two-step cluster analysis was used to identify PB types. RESULTS: Analysis revealed five key outcome measures: percentage sedentary behavior, total time in prolonged moderate-to-vigorous physical activity, number of sedentary bouts, and two types of change scores between day parts (morning, afternoon and evening). Based on these outcomes three valid PB clusters were derived. CONCLUSIONS: Patients with severe MS-related fatigue show three distinct and homogeneous PB subtypes. These PB subtypes, based on a unique set of PB outcome measures, may offer an opportunity to design more individually-tailored interventions in rehabilitation. TRIAL REGISTRATION: Clinical trial registration no ISRCTN 82353628 , ISRCTN 69520623  and  ISRCTN 58583714 .

Cognitive behavioural therapy for MS-related fatigue explained: A longitudinal mediation analysis.

BACKGROUND: Cognitive behavioural therapy (CBT) effectively reduces fatigue directly following treatment in patients with Multiple Sclerosis (MS), but little is known about the process of change during and after CBT. DESIGN: Additional analysis of a randomized clinical trial. OBJECTIVE: To investigate which psychological factors mediate change in fatigue during and after CBT. METHODS: TREFAMS-CBT studied the effectiveness of a 16-week CBT treatment for MS-related fatigue. Ninety-one patients were randomized (44 to CBT, 47 to the MS-nurse consultations). Mediation during CBT treatment was studied using assessments at baseline, 8 and 16weeks. Mediation of the change in fatigue from post-treatment to follow-up was studied separately using assessments at 16, 26 and 52weeks. Proposed mediators were: changes in illness cognitions, general self-efficacy, coping styles, daytime sleepiness, concentration and physical activity, fear of disease progression, fatigue perceptions, depression and physical functioning. Mediators were separately analysed according to the product-of-coefficients approach. Confidence intervals were calculated with a bootstrap procedure. RESULTS: During treatment the decrease in fatigue brought on by CBT was mediated by improved fatigue perceptions, increased physical activity, less sleepiness, less helplessness, and improved physical functioning. Post-treatment increases in fatigue levels were mediated by reduced physical activity, reduced concentration, and increased sleepiness. CONCLUSION: These results suggests that focusing on improving fatigue perceptions, perceived physical activity, daytime sleepiness, helplessness, and physical functioning may further improve the effectiveness of CBT for fatigue in patients with MS. Maintenance of treatment effects may be obtained by focusing on improving physical activity, concentration and sleepiness.

Community walking can be assessed using a 10-metre timed walk test.

BACKGROUND: A decline in mobility is a common feature of multiple sclerosis (MS). Community walking scales are used to categorize patients in their ability to move independently. The first purpose of this study was to determine which specific gait speed corresponded with the categories of the Modified Functional Walking Categories (MFWC). The second purpose was to determine the Minimally Important Change (MIC) in absolute gait speed using the MFWC and Expanded Disability Status Scale (EDSS) as external criteria. METHOD: MS patients were measured six times in 6 years. Gait velocity was measured with the 10-metre timed walk test (10-m TWT), the severity of MS was determined with the EDSS, and community walking was assessed with the MFWC. For each category of the MFWC, Receiver Operating Characteristic (ROC) curves were used to find the best possible cut-off point on the 10-m TWT. The MIC in absolute gait speed was determined using a change of one category on the MFWC or one point on the EDSS. RESULTS: A strong relationship was found between gait speed and the MFWC; all areas under the ROC curves (AUCs) were between 0.74 and 0.86. The MIC in absolute gait speed could not be determined, because the AUCs were below the threshold of 0.70 and changes in gait speed were small. CONCLUSIONS: Gait speed is related to community walking, but an MIC in absolute gait speed could not be determined using a minimally important change on the MFWC or the EDSS as external criteria.

Strong relationships between disease activity, foot-related impairments, activity limitations and participation restrictions in children with juvenile idiopathic arthritis.

OBJECTIVES: To assess possible relationships between disease activity, foot-related impairments, activity limitations and participation restrictions in children with juvenile idiopathic arthritis (JIA). METHODS: Thirty-four children were studied. Disease activity was assessed with the Juvenile Arthritis Disease Activity Score in 71 joints (JADAS-71). Foot-related impairments, activity limitations and participation restrictions were measured with the Juvenile Arthritis Foot Disability Index (JAFI), the Childhood Health Assessment Questionnaire (CHAQ), self-reported or parent-reported and doctor-reported VAS scales. Relationships were quantified with Spearman's correlation coefficient. RESULTS: The mean age was 12.4±3.7 years, the median disease duration 1.5 years (interquartile range (IQR) 1.0-4.0), 88% were girls, and 76% had polyarticular disease course. The median JADAS-71 score (range 0-101) was 6 (IQR 1-13). On the JAFI sub-scores (range 0-4) 88% of the children reported some foot-related impairments (median 1.1, IQR 0.4-2.0); 82% reported some foot-related activity limitations (median 0.9, IQR 0.3-2.0), and 65% reported some foot-related participation restrictions (median 0.6, IQR 0-2.1). The median CHAQ score was 0.9 (IQR 0.1-1.8). The JADAS-71 correlated with all impairment, activity limitation and participation restriction variables (r=0.48-0.81, p<0.01). Most of the impairment variables correlated with activity limitation (r=0.39, p<0.05 to r=0.92, p<0.01) and participation restriction variables (r=0.44, p<0.05 to r=0.81, p<0.01). All activity limitation variables correlated with participation restriction variables (r=0.62-0.84, p<0.01). CONCLUSIONS: We observed strong relationships between disease activity, foot-related impairments, activity limitations and participation restrictions in children with JIA, and therefore suggest that standard screening for foot problems should be included in follow-up care for JIA patients.

Utilization of health care by patients with multiple sclerosis is based on professional and patient-defined health needs.

OBJECTIVE: This cross-sectional study investigates healthcare utilization, and determines which predisposing, enabling, and health factors are associated with healthcare utilization among 121 patients with multiple sclerosis (MS). METHODS: Data on patient-related predisposing, enabling, and health factors were collected by means of written questionnaires and a home visit from a well-trained physiotherapist. RESULTS: Of the 121 patients with MS (mean age 43 years, mean score on the Expanded Disability Status Scale 3.5, disease duration 6 years), 16% were hospitalized in the previous year; 62% consulted their general practitioner, and 69% consulted their neurologist in the previous 6 months. Other medical specialists were consulted in the 6-month period by 50% of the study population. In a 4-week period preceding the home visit, 41% of the patients were treated by an allied healthcare professional. Multivariate logistic regression analyses showed that consulting the general practitioner, the neurologist, other medical specialists, and allied healthcare professionals, and the use of equipment/aids by MS patients is primarily related to their health, either as perceived by the patients themselves or defined by the professional. CONCLUSIONS: MS patients in the Netherlands make appropriate use of healthcare facilities, because their utilization can predominantly be explained by health-related factors, and not by predisposing or enabling factors.

The usefulness of evaluative outcome measures in patients with multiple sclerosis.

To select the most useful evaluative outcome measures for early multiple sclerosis, we included 156 recently diagnosed patients in a 3-year follow-up study, and assessed them on 23 outcome measures in the domains of disease-specific outcomes, physical functioning, mental health, social functioning and general health. A global rating scale (GRS) and the Expanded Disability Status Scale (EDSS) were used as external criteria to determine the minimally important change (MIC) for each outcome measure. Subsequently, we determined whether the outcome measures could detect their MIC reliably. From these, per domain the outcome measure that was found to be most sensitive to changes (responsive) was identified. At group level, 11 outcomes of the domains of physical functioning, mental health, social functioning and general health could reliably detect the MIC. Of these 11, the most responsive measures per domain were the Medical Outcome Study 36 Short Form sub-scale physical functioning (SF36pf), the Disability and Impact Profile (DIP) sub-scale psychological, the Rehabilitation Activities Profile sub-scale occupation (RAPocc) and the SF36 sub-scale health, respectively. Overall, the most responsive measures were the SF36pf and the RAPocc. In individual patients, none of the measures could reliably detect the MIC. In sum, in the early stages of multiple sclerosis the most useful evaluative outcome measures for research are the SF36pf (physical functioning) and the RAPocc (social functioning).

The initial course of daily functioning in multiple sclerosis: a three-year follow-up study.

We studied the initial course of daily functioning in multiple sclerosis (MS). A cohort of 156 recently diagnosed patients was prospectively followed for three years (five measurements). Domains of interest were neurological deficits, physical functioning, mental health, social functioning and general health. An a priori distinction was made between a relapse onset group (n = 128) and a non-relapse onset group (n =28). At baseline, neurological deficits are relatively minor for most patients, 26.3% have aberrant physical functioning scores, 38.5% have aberrant social functioning scores, 9% have aberrant mental health scores and 25% have aberrant general health scores. The neurological deficits and physical functioning deteriorated significantly over time. This deterioration was more pronounced and clinically relevant in the non-relapse onset group only. Mental health showed a significant, but not clinically relevant deterioration over time. Social functioning and general health showed non-significant effects for time. It is concluded that in the initial stage of MS, when neurological deficits are relatively minor and mental health is relatively unaffected, patients in both groups experience limitations in daily functioning. Patients in the non-relapse onset group have progressive neurological symptoms that are accompanied by progressive limitations in physical functioning, but not by progressive limitations in the other domains.

Clinimetric properties of the motor activity log for the assessment of arm use in hemiparetic patients.

BACKGROUND AND PURPOSE: The Motor Activity Log (MAL) is a semistructured interview for hemiparetic stroke patients to assess the use of their paretic arm and hand (amount of use [AOU]) and quality of movement [QOM]) during activities of daily living. Scores range from 0 to 5. The following clinimetric properties of the MAL were quantified: internal consistency (Cronbach alpha), test-retest agreement (Bland and Altman method), cross-sectional construct validity (correlation between AOU and QOM and with the Action Research Arm [ARA] test), longitudinal construct validity (correlation of change on the MAL during the intervention with a global change rating [GCR] and with change on the ARA), and responsiveness (effect size). METHODS: Two baseline measurements 2 weeks apart and 1 follow-up measurement immediately after 2 weeks of intensive exercise therapy either with or without immobilization of the unimpaired arm (forced use) were performed in 56 chronic stroke patients. RESULTS: Internal consistency was high (AOU: alpha=0.88; QOM: alpha=0.91). The limits of agreement were -0.70 to 0.85 and -0.61 to 0.71 for AOU and QOM, respectively. The correlation with the ARA score (Spearman rho) was 0.63 (AOU and QOM). However, the improvement on the MAL during the intervention was only weakly related to the GCR and to the improvement on the ARA, Spearman rho was between 0.16 and 0.22. The responsiveness ratio was 1.9 (AOU) and 2.0 (QOM). CONCLUSIONS: The MAL is internally consistent and relatively stable in chronic stroke patients not undergoing an intervention. The cross-sectional construct validity of the MAL is reasonable, but the results raise doubt about its longitudinal construct validity.

Functional recovery after cardiac rehabilitation.

OBJECTIVE: To study the effect of a cardiac rehabilitation programme based on the guidelines of the Dutch Heart Association (DHA). DESIGN: Randomized controlled trial with a waiting list control group. SETTING: Outpatient clinic of Rehabilitation Centre Amsterdam. SUBJECTS: Forty patients with a first myocardial infarction. INTERVENTIONS: Immediately after randomization the experimental group started the rehabilitation programme; the waiting list control group started after six weeks. No other type of treatment was given during the waiting period. MAIN OUTCOME MEASURES: Physical recovery, tested by means of an exercise test on a bicycle ergometer, and feelings of well-being (MPVH-W), handicap (MPVH-H) and distress (MPVH-D), tested using a Dutch questionnaire: the Medische Psychologische Vragenlijst voor Hartpatiënten, MPVH (medical psychological questionnaire for cardiac patients). RESULTS: The adjusted treatment effects of the cardiac rehabilitation programme were 4.72% on the exercise test, 3.43 points on MPVH-W, -1.93 points on MPVH-H, and 0.12 points on MPVH-D. These effects were not statistically significant. CONCLUSION: Changes after a cardiac rehabilitation programme are relatively small, but are found in both the physical and the psychosocial domain.

Randomized trial of 4-aminopyridine in patients with chronic incomplete spinal cord injury.

OBJECTIVE: To test the efficacy of 4-aminopyridine (4-AP) on functional status, walking speed and vibration perception in patients with chronic, incomplete spinal cord injury. METHODS: Twenty SCI patients were randomized in a trial with a double-blind, crossover design to receive four weeks of orally administered 4-AP, followed by a two-week wash-out period and four weeks of placebo, or vice versa. The total daily dose of 4-AP during the four weeks of treatment was systematically increased to a maximum of 0.5 mg/kg body weight. Evaluation of (side-)effects took place at the beginning, after one week, and at the end of each four-week study period. RESULTS: No significant benefit was found on functional status (COOP-WONCA). A statistically significant treatment effect was found on the vibration perception threshold (VPT) in the left fingers, during the first study period. On average, patients receiving 4-AP treatment responded less favourably (mean increase in VPT of 0.29 (0.31) microm) than patients receiving placebo (mean decrease in VPT of 0.05 (0.35) microm) (p=0.04). Neither comfortable nor maximum walking speed altered significantly following 4-AP treatment. CONCLUSIONS: No statistically significant, functional benefit from 4-AP was found for patients in the present study. Furthermore, no support was found for the possibility that an a priory selection of responsive patients would have yielded more favourable results.

The responsiveness of the Action Research Arm test and the Fugl-Meyer Assessment scale in chronic stroke patients.

The responsiveness of the Action Research Arm (ARA) test and the upper extremity motor section of the Fugl-Meyer Assessment (FMA) scale were compared in a cohort of 22 chronic stroke patients undergoing intensive forced use treatment aimed at improvement of upper extremity function. The cohort consisted of 13 men and 9 women, median age 58.5 years, median time since stroke 3.6 years. Responsiveness was defined as the sensitivity of an instrument to real change. Two baseline measurements were performed with a 2-week interval before the intervention, and a follow-up measurement after 2 weeks of intensive forced use treatment. The limits of agreement, according to the Bland-Altman method, were computed as a measure of the test-retest reliability. Two different measures of responsiveness were compared: (i) the number of patients who improved more than the upper limit of agreement during the intervention; (ii) the responsiveness ratio. The limits of agreement, designating the interval comprising 95% of the differences between two measurements in a stable individual, were -5.7 to 6.2 and -5.0 to 6.6 for the ARA test and the FMA scale, respectively. The possible sum scores range from 0 to 57 (ARA) and from 0 to 66 (FMA). The number of patients who improved more than the upper limit were 12 (54.5%) and 2 (9.1%); and the responsiveness ratios were 2.03 and 0.41 for the ARA test and the FMA scale, respectively. These results strongly suggest that the ARA test is more responsive to improvement in upper extremity function than the FMA scale in chronic stroke patients undergoing forced use treatment.

The intra- and interrater reliability of the action research arm test: a practical test of upper extremity function in patients with stroke.

OBJECTIVES: To determine the intra- and interrater reliability of the Action Research Arm (ARA) test, to assess its ability to detect a minimal clinically important difference (MCID) of 5.7 points, and to identify less reliable test items. DESIGN: Intrarater reliability of the sum scores and of individual items was assessed by comparing (1) the ratings of the laboratory measurements of 20 patients with the ratings of the same measurements recorded on videotape by the original rater, and (2) the repeated ratings of videotaped measurements by the same rater. Interrater reliability was assessed by comparing the ratings of the videotaped measurements of 2 raters. The resulting limits of agreement were compared with the MCID. PATIENTS: Stratified sample, based on the intake ARA score, of 20 chronic stroke patients (median age, 62yr; median time since stroke onset, 3.6yr; mean intake ARA score, 29.2). MAIN OUTCOME MEASURES: Spearman's rank-order correlation coefficient (Spearman's rho); intraclass correlation coefficient (ICC); mean difference and limits of agreement, based on ARA sum scores; and weighted kappa, based on individual items. RESULTS: All intra- and interrater Spearman's rho and ICC values were higher than .98. The mean difference between ratings was highest for the interrater pair (.75; 95% confidence interval, .02-1.48), suggesting a small systematic difference between raters. Intrarater limits of agreement were -1.66 to 2.26; interrater limits of agreement were -2.35 to 3.85. Median weighted kappas exceeded .92. CONCLUSION: The high intra- and interrater reliability of the ARA test was confirmed, as was its ability to detect a clinically relevant difference of 5.7 points.

Exercise therapy for arm function in stroke patients: a systematic review of randomized controlled trials.

OBJECTIVE: Assessment of the available evidence for the effectiveness of exercise therapy to improve arm function in patients who have suffered from a stroke. METHODS: A systematic search of bibliographical databases and reference checking were performed to identify publications on randomized controlled trials (RCTs) which evaluated the effect of exercise therapy on arm function in stroke patients. The methodological quality was assessed systematically by two raters, based on a standardized list of methodological criteria. Study characteristics, such as the chronicity and severity of impairment of the patient population, the amount and duration of interventions, and specific methodological criteria, were related to reported effects. RESULTS: Thirteen RCTs were identified, six of which reported positive results on an arm function test. In five of these six studies there was a contrast in amount or duration of exercise therapy between groups. Methodological scores ranged from 5 to 15 (maximum possible score: 19 points). CONCLUSION: Insufficient evidence made it impossible to draw definitive conclusions about the effectiveness of exercise therapy on arm function in stroke patients. The difference in results between studies with and without contrast in the amount or duration of exercise therapy between groups suggests that more exercise therapy may be beneficial.

Measuring subluxation of the hemiplegic shoulder: reliability of a method.

OBJECTIVE: Subluxation of the shoulder after stroke can be measured according to the method described by Van Langenberghe and Hogan. METHODS: To evaluate the reliability of this method, the shoulder radiographs of 25 patients were available for this study. Two independent raters each assessed these radiographs twice. RESULTS: The intrarater reliability was good: percentage of agreement was 88 and 84%, weighted kappa, 0.69 [95% confidence interval (CI), 0.38-1.0] and 0.78 (95% CI, 0.60-0.95) for raters 1 and 2, respectively. The interrater reliability was poor: percentage of agreement was 36 and 28%, kappa, 0.11 (95% CI, 0.0-0.31) and 0.09 (95% CI, 0.0-0.23) in sessions 1 and 2, respectively. Subsequently the original method was adjusted by combining two categories (no subluxation and beginning subluxation) into one ("no clinically important subluxation"). CONCLUSIONS: After this adjustment of the categories, the interrater reliability improved [percentage of agreement, 72%, and kappa, 0.49 (95% CI, 0.18-0.80)], but did not reach acceptable values.

Smallest real difference, a link between reproducibility and responsiveness.

The aim of this study is to show the relationship between test-retest reproducibility and responsiveness and to introduce the smallest real difference (SRD) approach, using the sickness impact profile (SIP) in chronic stroke patients as an example. Forty chronic stroke patients were interviewed twice by the same examiner, with a 1-week interval. All patients were interviewed during the qualification period preceding a randomized clinical trial. Test-retest reproducibility has been quantified by the intraclass correlation coefficient (ICC). the standard error of measurement (SEM) and the related smallest real difference (SRD). Responsiveness was defined as the ratio of the clinically relevant change to the SD of the within-stable-subject test-retest differences. The ICC for the total SIP was 0.92, whereas the ICCs for the specified SIP categories varied from 0.63 for the category 'recreation and pastime' to 0.88 for the category 'work'. However, both the SEM and the SRD far more capture the essence of the reproducibility of a measurement instrument. For instance, a total SIP score of an individual patient of 28.3% (which is taken as an example, being the mean score in the study population) should decrease by at least 9.26% or approximately 13 items, before any improvement beyond reproducibility noise can be detected. The responsiveness to change of a health status measurement instrument is closely related to its test-retest reproducibility. This relationship becomes more evident when the SEM and the SRD are used to quantify reproducibility, than when ICC or other correlation coefficients are used.

Effect of triamcinolone acetonide injections on hemiplegic shoulder pain : A randomized clinical trial.

UNLABELLED: Background and Purpose-Hemiplegic shoulder pain is not uncommon after stroke. Its origin is still unknown, and although many different methods of treatment are applied, none have yet been proved to be effective. We sought to study the efficacy of 3 injections of intra-articular triamcinolone acetonide on pain and arm function in stroke patients with hemiplegic shoulder pain. METHODS: -In a multicenter, randomized, placebo-controlled clinical trial, patients with hemiplegic shoulder pain received either 3 intra-articular injections of 40 mg triamcinolone acetonide or 1 mL physiological saline solution (placebo). Primary outcomes were pain measured according to 3 visual analogue scales (score range, 0 to 10), and arm function was measured by means of the Action Research Arm test and the Fugl-Meyer assessment scale; secondary outcomes were passive external rotation of the shoulder and general functioning measured according to Barthel Index and the Rehabilitation Activities Profile. RESULTS: -In the triamcinolone group (n=18), the median decrease in pain, 3 weeks after the last injection, was 2.3 (interquartile range, 0.3 to 4.3) versus 0.2 (interquartile range, -0.5 to 2.2) in the placebo group. This result was not statistically significant. The change in the other outcome measures did not differ significantly between the 2 treatment groups. Twenty-five patients reported side effects. CONCLUSIONS: -In the 37 participants included in this study, triamcinolone injections seemed to decrease hemiplegic shoulder pain and to accelerate recovery, but this effect was not statistically significant. Therefore, on the basis of the results of this study, these injections cannot be recommended for the treatment of patients with hemiplegic shoulder pain.