Gustaaf J. Lankhorst

How to measure comorbidity. a critical review of available methods.

The object of this article was to systematically review available methods to measure comorbidity and to assess their validity and reliability. A search was made in Medline and Embase, with the keywords comorbidity and multi-morbidity, to identify articles in which a method to measure comorbidity was described. The references of these articles were also checked, and using a standardized checklist the relevant data were extracted from these articles. An assessment was made of the content, concurrent, predictive and construct validity, and the reliability. Thirteen different methods to measure comorbidity were identified: one disease count and 12 indexes. Data on content and predictive validity were available for all measures, while data on construct validity were available for nine methods, data on concurrent validity, and interrater reliability for eight methods, and data on intrarater reliability for three methods. The Charlson Index is the most extensively studied comorbidity index for predicting mortality. The Cumulative Illness Rating Scale (CIRS) addresses all relevant body systems without using specific diagnoses. The Index of Coexisting Disease (ICED) has a two-dimensional structure, measuring disease severity and disability, which can be useful when mortality and disability are the outcomes of interest. The Kaplan Index was specifically developed for use in diabetes research. The Charlson Index, the CIRS, the ICED and the Kaplan Index are valid and reliable methods to measure comorbidity that can be used in clinical research. For the other indexes, insufficient data on the clinimetric properties are available.

Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial

BACKGROUND We investigated the effects of different intensities of arm and leg rehabilitation training on the functional recovery of activities of daily living (ADL), walking ability, and dexterity of the paretic arm, in a single-blind randomised controlled trial. METHODS Within 14 days after stroke onset, 101 severely disabled patients with a primary middle-cerebral-artery stroke were randomly assigned to: a rehabilitation programme with emphasis on arm training; a rehabilitation programme with emphasis on leg training; or a control programme in which the arm and leg were immobilised with an inflatable pressure splint. Each treatment regimen was applied for 30 min, 5 days a week during the first 20 weeks after stroke. In addition, all patients underwent a basic rehabilitation programme. The main outcome measures were ability in ADL (Barthel index), walking ability (functional ambulation categories), and dexterity of the paretic arm (Action Research arm test) at 6, 12, 20, and 26 weeks. Analyses were by intention to treat. FINDINGS At week 20, the leg-training group (n=31) had higher scores than the control group (n=37) for ADL ability (median 19 [IQR 16-20] vs 16 [10-19], p<0.05), walking ability (4 [3-5] vs 3 [1-4], p<0.05), and dexterity (2 [0-56] vs 0 [0-2], p<0.01). The arm-training group (n=33) differed significantly from the control group only in dexterity (9 [0-39] vs 0 [0-2], p<0.01). There were no significant differences in these endpoints at 20 weeks between the arm-training and leg-training groups. INTERPRETATION Greater intensity of leg rehabilitation improves functional recovery and health-related functional status, whereas greater intensity of arm rehabilitation results in small improvements in dexterity, providing further evidence that exercise therapy primarily induces treatment effects on the abilities at which training is specifically aimed.

Forced Use of the Upper Extremity in Chronic Stroke Patients Results From a Single-Blind Randomized Clinical Trial

BACKGROUND AND PURPOSE Of all stroke survivors, 30% to 66% are unable to use their affected arm in performing activities of daily living. Although forced use therapy appears to improve arm function in chronic stroke patients, there is no conclusive evidence. This study evaluates the effectiveness of forced use therapy. METHODS In an observer-blinded randomized clinical trial, 66 chronic stroke patients were allocated to either forced use therapy (immobilization of the unaffected arm combined with intensive training) or a reference therapy of equally intensive bimanual training, based on Neuro-Developmental Treatment, for a period of 2 weeks. Outcomes were evaluated on the basis of the Rehabilitation Activities Profile (activities), the Action Research Arm (ARA) test (dexterity), the upper extremity section of the Fugl-Meyer Assessment scale, the Motor Activity Log (MAL), and a Problem Score. The minimal clinically important difference (MCID) was determined at the onset of the study. RESULTS One week after the last treatment session, a significant difference in effectiveness in favor of the forced use group compared with the bimanual group (corrected for baseline differences) was found for the ARA score (3.0 points; 95% CI, 1.3 to 4.8; MCID, 5.7 points) and the MAL amount of use score (0.52 points; 95% CI, 0.11 to 0.93; MCID, 0.50). The other parameters revealed no significant differential effects. One-year follow-up effects were observed only for the ARA. The differences in treatment effect for the ARA and the MAL amount of use scores were clinically relevant for patients with sensory disorders and hemineglect, respectively. CONCLUSIONS The present study showed a small but lasting effect of forced use therapy on the dexterity of the affected arm (ARA) and a temporary clinically relevant effect on the amount of use of the affected arm during activities of daily living (MAL amount of use). The effect of forced use therapy was clinically relevant in the subgroups of patients with sensory disorders and hemineglect, respectively.

Effects of Intensity of Rehabilitation After Stroke A Research Synthesis

BACKGROUND AND PURPOSE A research synthesis was performed to (1) critically review controlled studies evaluating effects of different intensities of stroke rehabilitation in terms of disabilities and impairments and (2) quantify patterns by calculating summary effect sizes. The influences of organizational setting of rehabilitation management, blind recording, and amount of rehabilitation on the summary effect sizes were calculated. METHODS A Medline literature search was performed for a critical review of the literature. The internal and external validity of the studies was evaluated. In addition, a meta-analysis was performed by applying the fixed (Hedgess g) effects model. RESULTS The effects of different intensities of rehabilitation were studied in nine controlled studies involving 1051 patients. Analysis of the methodological quality revealed scores varying from 14% to 47% of the maximum feasible score. Meta-analysis demonstrated a statistically significant summary effect size for activities of daily living (0.28 +/- 0.12). Lower summary effect sizes (0.19 +/- 0.17) were found for studies in which experimental and control groups were treated in the same setting compared with studies in which the two groups of patients were treated in different settings (0.40 +/- 0.19). Variables defined on a neuromuscular level (0.37 +/- 0.24) showed larger summary effect sizes than variables defined on a functional level (0.10 +/- 0.21). Weighting individual effect sizes for the difference in amount of rehabilitation between experimental and control groups resulted in larger summary effect sizes for activities of daily living and functional outcome parameters for studies that were not confounded by organizational setting. CONCLUSIONS A small but statistically significant intensity-effect relationship in the rehabilitation of stroke patients was found. Insufficient contrast in the amount of rehabilitation between experimental and control conditions, organizational setting of rehabilitation management, lack of blinding procedures, and heterogeneity of patient characteristics were major confounding factors.

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.

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.

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.

Relation between stimulation characteristics and clinical outcome in studies using electrical stimulation to improve motor control of the upper extremity in stroke

OBJECTIVE Electrical stimulation can be applied in a variety of ways to the hemiparetic upper extremity following stroke. The aim of this review is to explore the relationship between characteristics of stimulation and the effect of electrical stimulation on the recovery of upper limb motor control following stroke. METHODS A systematic literature search was performed to identify clinical trials evaluating the effect of electrical stimulation on motor control. The reported outcomes were examined to identify a possible relationship between the reported effect and the following characteristics: duration of stimulation, method of stimulation, setting of stimulation parameters, target muscles and stage after stroke. RESULTS Nineteen clinical trials were included, and the results of 22 patient groups were evaluated. A positive effect of electrical stimulation was reported for 13 patient groups. Positive results were more common when electrical stimulation was triggered by voluntary movement rather than when non-triggered electrical stimulation was used. There was no relation between the effect of electrical stimulation and the other characteristics examined. CONCLUSION Triggered electrical stimulation may be more effective than non-triggered electrical stimulation in facilitating upper extremity motor recovery following stroke. It appears that the specific stimulus parameters may not be crucial in determining the effect of electrical stimulation.

Therapeutic electrical stimulation to improve motor control and functional abilities of the upper extremity after stroke: a systematic review

Background: Therapeutic electrical stimulation (TES) is a therapeutic strategy aimed at improving impairments of the upper extremity in stroke. Objective: Assessment of the available evidence on the effect of TES of the affected upper extremity in improving motor control and functional abilities after stroke. Methods: A systematic literature search was performed to identify randomized controlled trials (RCTs) that have studied the effect of TES on motor control and functional abilities. The methodological quality of the studies was assessed systematically by two raters. The reported outcomes were examined to evaluate the effect of TES and to identify a possible relationship with patient characteristics, method of stimulation and methodological quality. When possible, effect sizes were calculated (Hedges’ g). Results: Six RCTs were included. The methodological scores ranged from 7 to 16 (maximum 19). All studies assessed the effect on motor control, and four reported a positive effect. Effect sizes calculated in three studies ranged from 0.55 to 1.46. Only two studies assessed the effect on functional ability, one reported a positive effect. Subgroup analyses in two studies suggest a better response to stimulation in less severely affected patients. Apart from this, no relationship between effect and patient characteristics, method of stimulation or methodological quality could be detected. Conclusions: The present review suggests a positive effect of electrical stimulation on motor control. No conclusions can be drawn with regard to the effect on functional abilities.

Clinical assessment of spasticity in children with cerebral palsy: a critical review of available instruments.

This study reviews the instruments used for the clinical assessment of spasticity in children with cerebral palsy, and evaluates their compliance with the concept of spasticity, defined as a velocity‐dependent increase in muscle tone to passive stretch. Searches were performed in Medline, Embase, and Cinahl, including the keywords ‘spasticity’, ‘child’, and‘cerebral palsy’, to identify articles in which a clinical method to measure spasticity was reported. Thirteen clinical spasticity assessment instruments were identified and evaluated using predetermined criteria. This review consists of reports on the standardization applied for assessment at different velocities, testing posture, and quantification of spasticity. Results show that most instruments do not comply with the concept of spasticity; standardization of assessment method is often lacking, and scoring systems of most instruments are ambiguous. Only the Tardieu Scale complies with the concept of spasticity, but this instrument has a comprehensive and time–consuming clinical scoring system.