[Show abstract][Hide abstract] ABSTRACT: Study design:Two randomized, double-blind, placebo-controlled trials.Objective:To evaluate the efficacy and safety of fampridine sustained-release tablets (fampridine-SR) 25 mg twice daily for moderate-to-severe spasticity in patients with chronic spinal cord injury (SCI).Setting:United States and Canada.Methods:Patients with incomplete chronic SCI were randomized to twice daily fampridine-SR 25 mg or placebo, with a 2-week single-blind placebo run-in, a 2-week titration, 12 weeks of stable dosing, 2 weeks of downward titration and 2 weeks of untreated follow-up. Co-primary end points were the change from baseline, averaged over the double-blind treatment period, for Ashworth score (bilateral knee flexors and extensors) and a 7-point Subject Global Impression of treatment (SGI; 1, terrible; 7, delighted). Secondary end points were: Penn Spasm Frequency Scale; the motor/sensory score from the International Standards for Neurological Classification of SCI; Clinician's Global Impression of Change of neurological status; and the International Index of Erectile Function (men) or the Female Sexual Function Index (women).Results:The populations were 212 and 203 patients in the two studies, respectively. Changes from baseline in Ashworth score were -0.15 (placebo) and -0.19 (fampridine-SR) in the first study, and -0.16 (placebo) and -0.28 (fampridine-SR) in the second study. The between-treatment difference was not significant for either the Ashworth score or the SGI and, with few exceptions, neither were the secondary end points. Fampridine-SR was generally well tolerated; treatment-emergent adverse events (TEAEs) and serious TEAEs were reported with similar frequency between treatments.Conclusion:Fampridine-SR was well tolerated. No significant differences were observed between treatment groups for the primary end points of Ashworth score and SGI.Spinal Cord advance online publication, 12 November 2013; doi:10.1038/sc.2013.137.
[Show abstract][Hide abstract] ABSTRACT: Study design:Administration of the walking index for SCI (WISCI) II is recommended to assess walking in spinal cord injury (SCI) patients. Determining the reliability and reproducibility of the WISCI II in acute SCI would be invaluable.Objectives:The objective of this study is to assess the reliability and reproducibility of the WISCI II in patients with traumatic, acute SCI.Design:Test-retest analysis and calculation of reliability and smallest real difference (SRD).Setting:SCI unit of a rehabilitation hospital.Methods:Thirty-three patients, median age 44 years, median time since onset of SCI 40 days. Level: 20 cervical, 8 thoracic, 5 lumbar; ASIA (American Spinal Injury Association) impairment scale (AIS) grade: 32 D/1 C. Assessment of maximum WISCI II levels by two trained, blinded raters to evaluate interrater (IRR) and intrarater reliability.Results:The intrarater reliability was 0.999 for therapists A and 0.979 for therapists B, for the maximum WISCI II level. The IRR for the maximum WISCI II score was 0.996 on day 1 and 0.975 on day 2. The SRD for the maximum WISCI II score was 1.147 for tetraplegics and 1.682 for paraplegics. These results suggest that a change of two WISCI II levels could be considered real.Conclusions:The WISCI II has high IRR and intrarater reliability and good reproducibility in the acute and subacute phase when administered by trained raters.Spinal Cord advance online publication, 22 October 2013; doi:10.1038/sc.2013.127.
[Show abstract][Hide abstract] ABSTRACT: Study design:Literature review.Objective:To critically review all publications/internet sites that have described/used the Walking Index for Spinal Cord Injury (WISCI II), as a measure of impairment of walking function after spinal cord injury (SCI), in order to identify its psychometric properties, clarify its nature, specify misuse and incorporate the findings in an updated guide.Method:A systematic literature search was done of Ovid MEDLINE, CINAHL, PsychINFO, Cochrane Central Register of Controlled Trials, Scopus and electronic sites using key words: WISCI or WISCI II, SCI, paraplegia/ tetraplegia/ quadriplegia and ambulation/gait/walking. Among 1235 citations retrieved, 154 relevant articles/sites were identified, classified and examined by the authors; recommendations were made based on findings.Results and Discussion:The validity (face/concurrent/content/construct/convergent/criterion) and reliability of the WISCI II has been documented in clinical trials and clinical series, and considered adequate by systematic reviewers. In chronic SCI subjects, reliable determination of the maximum (as opposed to self-selected) WISCI II level requires more time and experience by the assessor. The correct use of WISCI II is clarified for testing acute/chronic phases of recovery after SCI, age of subjects, devices and settings. The WISCI II and walking speed measures may be performed simultaneously.Conclusion:The increased use of the WISCI II is attributed to its unique characteristics as a capacity measure of walking function and its strong metric properties. Appropriate use of the WISCI II was clarified and incorporated into a new guide for its use. Combining it with a walking speed measure needs further study.Sponsorship:This study was supported in part by grant #H133N000023 from the National Institute on Disability and Rehabilitation Research (NIDRR), Office of Special Education and Rehabilitative Services (OSERS), and US Department of Education, Washington, DC.Spinal Cord advance online publication, 5 March 2013; doi:10.1038/sc.2013.9.
[Show abstract][Hide abstract] ABSTRACT: Aggressive assessment and management of the secondary complications in the hours and days following spinal cord injury (SCI) leads to restoration of function in patients through intervention by a team of rehabilitation professionals. The recent certification of SCI physicians, newly validated assessments of impairment and function measures, and international databases agreed upon by SCI experts should lead to documentation of improved rehabilitation care. This chapter highlights recent advances in assessment and treatment based on evidence-based classification of literature reviews and expert opinion in the acute phase of SCI. A number of these reviews are the product of the Consortium for Spinal Cord Medicine, which offers clinical practice guidelines for healthcare professionals. Recognition of and early intervention for problems such as bradycardia, orthostatic hypotension, deep vein thrombosis/pulmonary embolism, and early ventilatory failure will be addressed although other chapters may discuss some issues in greater detail. Early assessment and intervention for neurogenic bladder and bowel function has proven effective in the prevention of renal failure and uncontrolled incontinence. Attention to overuse and disuse with training and advanced technology such as functional electrical stimulation have reduced pain and disability associated with upper extremity deterioration and improved physical fitness. Topics such as chronic pain, spasticity, sexual dysfunction, and pressure sores will be covered in more detail in additional chapters. However, the comprehensive and integrated rehabilitation by specialized SCI teams of physicians, nurses, therapists, social workers, and psychologists immediately following SCI has become the standard of care throughout the world.
Handbook of Clinical Neurology 01/2012; 109:181-95.
[Show abstract][Hide abstract] ABSTRACT: Blinded rank ordering.
To determine consumer preference in walking function utilizing the walking Index for spinal cord injury II (WISCI II) in individuals with spinal cord injury (SCI)from the Canada, the Italy and the United States of America.
In all, 42 consumers with incomplete SCI (25 cervical, 12 thoracic, 5 lumbar) from Canada (12/42), Italy (14/42) and the United States of America (16/42) ranked the 20 levels of the WISCI II scale by their individual preference for walking. Subjects were blinded to the original ranking of the WISCI II scale by clinical scientists. Photographs of each WISCI II level used in a previous pilot study were randomly shuffled and rank ordered. Percentile, conjoint/cluster and graphic analyses were performed.
All three analyses illustrated consumer ranking followed a bimodal distribution. Ranking for two levels with physical assistance and two levels with a walker were bimodal with a difference of five to six ranks between consumer subgroups (quartile analysis). The larger cluster (N=20) showed preference for walking with assistance over the smaller cluster (N=12), whose preference was walking without assistance and more devices. In all, 64% (27/42) of consumers ranked WISCI II level with no devices or braces and 1 person assistance higher than multiple levels of the WISCI II requiring no assistance. These results were unexpected, as the hypothesis was that consumers would rank independent walking higher than walking with assistance.
Consumer preference for walking function should be considered in addition to objective measures in designing SCI trials that use significant improvement in walking function as an outcome measure.
[Show abstract][Hide abstract] ABSTRACT: Traumatic spinal cord injury is a serious disorder in which early prediction of ambulation is important to counsel patients and to plan rehabilitation. We developed a reliable, validated prediction rule to assess a patient's chances of walking independently after such injury.
We undertook a longitudinal cohort study of adult patients with traumatic spinal cord injury, with early (within the first 15 days after injury) and late (1-year follow-up) clinical examinations, who were admitted to one of 19 European centres between July, 2001, and June, 2008. A clinical prediction rule based on age and neurological variables was derived from the international standards for neurological classification of spinal cord injury with a multivariate logistic regression model. Primary outcome measure 1 year after injury was independent indoor walking based on the Spinal Cord Independence Measure. Model performances were quantified with respect to discrimination (area under receiver-operating-characteristics curve [AUC]). Temporal validation was done in a second group of patients from July, 2008, to December, 2009.
Of 1442 patients with spinal cord injury, 492 had available outcome measures. A combination of age (<65 vs ≥65 years), motor scores of the quadriceps femoris (L3), gastrocsoleus (S1) muscles, and light touch sensation of dermatomes L3 and S1 showed excellent discrimination in distinguishing independent walkers from dependent walkers and non-walkers (AUC 0·956, 95% CI 0·936-0·976, p<0·0001). Temporal validation in 99 patients confirmed excellent discriminating ability of the prediction rule (AUC 0·967, 0·939-0·995, p<0·0001).
Our prediction rule, including age and four neurological tests, can give an early prognosis of an individual's ability to walk after traumatic spinal cord injury, which can be used to set rehabilitation goals and might improve the ability to stratify patients in interventional trials.
Internationale Stiftung für Forschung in Paraplegie.
The Lancet 03/2011; 377(9770):1004-10. · 39.06 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Retrospective, longitudinal analysis of motor recovery data from individuals with cervical (C4-C7) sensorimotor complete spinal cord injury (SCI) according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
To analyze the extent and patterns of spontaneous motor recovery over the first year after traumatic cervical sensorimotor complete SCI.
Datasets from the European multicenter study about SCI (EMSCI) and the Sygen randomized clinical trial were examined for conversion of American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade, change in upper extremity motor score (UEMS) or motor level, as well as relationships between these measures.
There were no overall differences between the EMSCI and Sygen datasets in motor recovery patterns. After 1 year, up to 70% of subjects spontaneously recovered at least one motor level, but only 30% recovered two or more motor levels, with lesser values at intermediate time points. AIS grade conversion did not significantly influence motor level changes. At 1 year, the average spontaneous improvement in bilateral UEMS was 10-11 motor points. There was only moderate relationship between a change in UEMS and a change in cervical motor level (r(2)=0.30, P<0.05). Regardless of initial cervical motor level, most individuals recover a similar number of motor points or motor levels.
Careful tracking of cervical motor recovery outcomes may provide the necessary sensitivity and accuracy to reliably detect a subtle, but meaningful treatment effect after sensorimotor complete cervical SCI. The distribution of the UEMS change may be more important functionally than the total UEMS recovered.
[Show abstract][Hide abstract] ABSTRACT: The Walking Index for Spinal Cord Injury II (WISCI II) is a hierarchical scale that measures improvements in walking following spinal cord injury (SCI). The WISCI II has good face validity, concurrent validity, and reliability following acute SCI; however, psychometric properties need to be determined for chronic SCI. Because prior studies have demonstrated a relationship between lower-extremity motor scores (LEMS) and walking, outcome measures for walking should demonstrate a linkage between the underlying impairment (weakness) and walking-convergent validity.
To determine convergent validity and reproducibility of the WISCI II.
Self-selected and maximum WISCI levels were assessed for 76 patients with chronic SCI (34 paraplegia, 42 tetraplegia); 10-m walking speeds were calculated. Convergent validity was assessed by correlating WISCI II levels to LEMS and walking speed. Reproducibility was assessed with the intraclass correlation coefficient (ICC) and the smallest real difference (SRD).
Convergent validity of the self-selected and maximum WISCI II with LEMS was moderate for paraplegia (ρ = 0.479 and ρ = 0.533) and strong for tetraplegia (ρ = 0.852 and ρ = 0.816). Tetraplegia, but not paraplegia, demonstrated convergent validity of walking speed at the self-selected and maximum WISCI levels with LEMS (ρ = 0.752 and ρ = 0.813). WISCI reproducibility was excellent (self-selected ICC = 0.994; maximum ICC = 0.995), resulting in SRDs of 0.785 (self-selected) and 0.597 (maximum), suggesting that a change of one WISCI level can be interpreted as real in a chronic patient.
Results suggest that the WISCI II should be a very useful outcome measure for detecting changes in walking function following chronic SCI.
Neurorehabilitation and neural repair 02/2011; 25(2):149-57. · 4.28 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The 10-m walk test (10MWT) and the 6-min walk test (6MWT) have been recommended for assessment of walking in spinal cord injury (SCI) patients. The study was designed on test-retest analysis of the 10MWT and 6MWT.
The objective of this study was to assess validity/reliability of different methods of performing the tests.
The study was set at an SCI unit of a rehabilitation hospital.
A total of 37 patients; whose median age was 58.5 years (interquartile range 40-66, full range 19-77); median time since onset of SCI was 24 months (interquartile range 16.25-70.5, full range 6-109). Non-traumatic etiology in 20 out of 37 patients; level: 12C, 14T and 11L; American Spinal Injury Association Impairment Scale grade: 35D/2C. Assessment with the 10MWT (with or without dynamic start) and the 6MWT (short or long track) by two blinded raters to evaluate inter/intra-rater reliabilities.
The 10MWT was performed in a median of 19 s (25th-75th interquartile range 13-28) with the dynamic start and of 18.4 s (25th-75th interquartile range 12.6-29.9) with the static start (P=0.092). The correlation between the results of the two methods was between 0.98 and 0.99. The inter- and intra-rater reliabilities were between 0.95 and 0.99 for both the methods. The 6MWT showed significant differences according to the track length: patients walked a median of 226.7 m (25th-75th interquartile range 123.2-319) on the longer track and of 187.6 m (25th-75th interquartile range 69.7-240.6) on the short one (P<0.001). The correlation between the results of the two methods was between 0.91 and 0.93. The inter- and intra-rater reliabilities were between 0.98 and 0.99.
The 10MWT shows high inter/intra-rater reliability and shows comparable results with both dynamic and static start. The different testing conditions of the 6MWT (track/turns) results in significant differences that need standardization for use in future trials.
[Show abstract][Hide abstract] ABSTRACT: The need to determine the beneficial effect of the treatment of spinal cord injury (SCI) requires clearly defined standardized measures of the severity of injury and how well the function is restored. Improved neurological recovery should be linked to increased capacity to perform tasks such as walking, reaching and grasping, which results in meaningful gains in mobility and self-care. Measurements of recovery, capacity, mobility and self-care are the outcomes used to determine the benefits from the treatment and have evolved over the last century with contributions by the mentors and protégés of Sir Ludwig Guttmann, whom we honor today. Randomized clinical trials in the past 20 years have taught us many lessons as to which outcome measures have the greatest validity and reliability. The International Standards for Neurological Classification of SCI have become the clinical gold standard for measurement of severity, but would benefit from pathophysiological surrogates to better understand the mechanisms of recovery. Measurements of walking capacity have emerged as valid/reliable/responsive and upper extremity measures are in development, which help distinguish neurological improvement from rehabilitation adaptation. Performance of self-care and mobility has been linked to capacity and severity outcomes. In addition, new partnerships between clinical trial entities, professional societies, industry and federal agencies should facilitate identification of priorities and uniformity of measurement standards. Our ultimate goal is to improve the quality of life of those individuals with SCI whom we serve, but we must focus our investigative efforts carefully, systematically and rigorously as clinical scientists.
[Show abstract][Hide abstract] ABSTRACT: To demonstrate the inter-/intrarater reliability of the Walking Index for Spinal Cord Injury version 2 scale and the repeatability of the time to walk 10 m in chronic subjects.
In this reliability study, 26 subjects from the United States and Italy with spinal cord injury/disorder were tested by two blinded raters on two separate days to determine self-selected and maximum Walking Index for Spinal Cord Injury levels and the time to complete a 10-m walk. Subjects were progressed from self-selected to maximum Walking Index for Spinal Cord Injury incrementally until they failed the higher level. Intraclass correlations were calculated for Walking Index for Spinal Cord Injury levels and repeatability coefficients for the 10-m time.
Twenty-two of 26 subjects showed increases of one to eight levels from self-selected to maximum Walking Index for Spinal Cord Injury, whereas 10-m walking time remained relatively unchanged (n = 15) or increased markedly (n = 7). Inter- and intrarater reliabilities were 1.00 for the self-selected Walking Index for Spinal Cord Injury level. Intrarater reliability for the maximum level was 1.0; interrater reliability was 0.98. Repeatability coefficients for time to walk 10 m were smaller (better) at self-selected than at maximum Walking Index for Spinal Cord Injury and on the same day than on different days. On same-day assessments, repeatability coefficients were 18%-20% of 10-m walk time, excluding subjects with discrepant Walking Index for Spinal Cord Injury levels (n = 2). For different-day assessments, repeatability coefficients were 27%-35% of 10-m walk time.
The determination of both self-selected and maximum Walking Index for Spinal Cord Injury levels is highly reliable, whereas 10-m walking time is more variable. Walking "profiles" of speed at self-selected and maximum Walking Index for Spinal Cord Injury may better characterize walking ability than a single Walking Index for Spinal Cord Injury level.
American journal of physical medicine & rehabilitation / Association of Academic Physiatrists 01/2010; 89(1):7-15. · 1.56 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Study design:Review by the spinal cord outcomes partnership endeavor (SCOPE), which is a broad-based international consortium of scientists and clinical researchers representing academic institutions, industry, government agencies, not-for-profit organizations and foundations. Objectives:Assessment of current and evolving tools for evaluating human spinal cord injury (SCI) outcomes for both clinical diagnosis and clinical research studies. Methods:a framework for the appraisal of evidence of metric properties was used to examine outcome tools or tests for accuracy, sensitivity, reliability and validity for human SCI. Results:Imaging, neurological, functional, autonomic, sexual health, bladder/bowel, pain and psychosocial tools were evaluated. Several specific tools for human SCI studies have or are being developed to allow the more accurate determination for a clinically meaningful benefit (improvement in functional outcome or quality of life) being achieved as a result of a therapeutic intervention. Conclusion:Significant progress has been made, but further validation studies are required to identify the most appropriate tools for specific targets in a human SCI study or clinical trial.
[Show abstract][Hide abstract] ABSTRACT: The restoration of walking function following SCI is extremely important to consumers and has stimulated a response of new treatments by scientists, the pharmaceutical industry and clinical entrepreneurs. Several of the proposed interventions: (1) the use of functional electrical stimulation (FES) and (2) locomotor training have been examined in clinical trials and recent reviews of the scientific literature. Each of these interventions is based on research of human locomotion. Therefore, the systematic study of walking function and gait in normal individuals and those with injury to the spinal cord has contributed to the identification of the impairments of walking, the development of new treatments and how they will be measured to determine effectiveness. In this context gait research applied to interventions to improve walking function is of high clinical relevance. This research helps identify walking impairments to be corrected and measures of walking function to be utilized as endpoints for clinical trials. The most common impairments following SCI diagnosed by observational gait analysis include inadequate hip extension during stance, persistent plantar flexion and hip/knee flexion during swing and foot placement at heel strike. FES has been employed as one strategy for correcting these impairments based on analysis that range from simple measures of speed, cadence and stride length to more sophisticated systems of three- dimensional video motion analysis and multichannel EMG tracings of integrated walking. A recent review of the entire FES literature identified 36 studies that merit comment and the full range of outcome measures for walking function were used from simple velocity to the video analysis of motion. In addition to measures of walking function developed for FES interventions, the first randomized multicenter clinical trial on locomotor training in subacute SCI was recently published with an extensive review of these measures. In this study outcome measures of motor strength (impairment), balance, Walking Index for SCI (WISCI), speed, 5min walk (walking capacities) and locomotor functional independence measure (L-FIM), a disability measure all showed improvement in walking function based on the strategy of the response of activity based plasticity to step training. Although the scientific basis for this intervention will be covered in other articles in this series, the evolution of clinical outcome measures of walking function continues to be important for the determination of effectiveness in clinical trials.
Brain research bulletin 11/2008; 78(1):35-42. · 2.18 Impact Factor