Impact of instrumental analysis of stiff knee gait on treatment appropriateness and associated costs in stroke patients.

BACKGROUND: Stiff Knee Gait (SKG) in stroke patients is typically treated by the inhibition of the rectus femoris (RF) with botulinum toxin (BoNT) after clinical evaluation, obtaining an average pooled recovery in knee flexion (KF) of 7 degrees. PURPOSE: Our hypothesis is that this limited recovery after BoNT could depend on the inadequacy in the selection of patients to be treated. The aim of this study was to assess the percentage of inappropriate treatments (PIT) that can be avoided when instrumental gait analysis (GA) is used, and to estimate the associated cost savings. METHODS: We retrospectively analyzed GA data from chronic stroke patients with SKG and clinically assessed knee extensors spasticity referred to our laboratory over a five-year period. Gait kinematics and dynamic electromyography data were used. Patients were considered unsuitable for RF inhibition when: their SKG was determined by inadequate ankle push-off (APO) rather than by a brake from knee extensors, based on a previously published algorithm using gait kinematics (PITKIN); when RF was not active during KF (PITEMG); and when a proximal braking mechanism was found, if this was not due to RF activity (PITGA). RESULTS: 160 patients, age 20-87 years, gait speed 9-77%height/s, KF peak -4-44 degrees, were included. Of these, in 119 cases poor APO was the main cause of SKG, thus leading to PITKIN = 74%. In 48 out of 107 non-obese subjects, RF spasticity was not involved in SKG, resulting in PITEMG = 45%. Finally, patients with a braking activity as the main cause and concurrent RF activity were 20/107 = 19%, resulting in PITGA = 81% SIGNIFICANCE: When treating SKG, proper use of GA can reduce the percentage of inappropriate treatments by BoNT at the RF up to 81%. Savings are in the order of €100k/year when considering centers treating 100 or more patients/year.

Clinical overview of dalfampridine: an agent with a novel mechanism of action to help with gait disturbances.

BACKGROUND: Medication used to treat multiple sclerosis (MS) can be categorized as disease-modifying therapies, symptomatic therapies, or treatment of acute exacerbations. Dalfampridine is the first symptomatic therapy approved by the Food and Drug Administration to improve walking in patients with MS. OBJECTIVE: This article reviews the pharmacology, pharmacodynamic properties, and pharmacokinetic properties of dalfampridine, as well as its clinical efficacy, safety profile, pharmacoeconomic considerations, and place in therapy. METHODS: Three PubMed searches were conducted for original articles published in English between 1966 and August 2012 with human study participants. Articles concerning the pharmacology, pharmacokinetic properties, pharmacodynamic properties, efficacy, and safety profile of dalfampridine were evaluated. RESULTS: Dalfampridine theoretically works to improve conduction and enhance walking by inhibiting potassium channels in the axonal membrane and by prolonging action potentials in demyelinated neurons. The efficacy of dalfampridine has been reported in 2 Phase III clinical trials in patients with MS. When comparing dalfampridine 10 mg twice daily with placebo, these studies found a statistically significant improvement in walking (42.9% vs 9.3% and 35% vs 8%; P < 0.001). However, clinical trials and postmarketing surveillance have shown an increased risk of seizures with dalfampridine use that appears to be dose related [corrected]. CONCLUSIONS: Dalfampridine has a unique mechanism of action, leading to its approval as the first symptomatic therapy for MS to improve walking speed. The increased risk of seizures can be a safety concern and will require health care providers to be diligent in monitoring patients and to ensure adequate patient education [corrected]. The addition of dalfampridine as symptomatic therapy for MS may lead to additional novel products in the future.

Social and economic burden of walking and mobility problems in multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is a chronic progressive neurological disease and the majority of patients will experience some degree of impaired mobility. We evaluated the prevalence, severity and burden of walking and mobility problems (WMPs) in 5 European countries. METHODS: This was a cross-sectional, patient record-based study involving 340 neurologists who completed detailed patient record forms (PRF) for patients (>18 years) attending their clinic with MS. Patients were also invited to complete a questionnaire (PSC). Information collected included demographics, disease characteristics, work productivity, quality of life (QoL; EuroQol-5D and Hamburg Quality of Life Questionnaire Multiple Sclerosis [HAQUAMS]) and mobility (subjective patient-reported and objectively measured using the timed 25 foot walk test [T25FW]). Relationships between WMPs and disease and other characteristics were examined using Chi square tests. Analysis of variance was used to examine relationships between mobility measures and work productivity. RESULTS: Records were available for 3572 patients of whom 2171 also completed a PSC. WMPs were regarded as the most bothersome symptom by almost half of patients who responded (43%; 291/683). There was a clear, independent and strong directional relationship between severity of WMPs (subjective and objective) and healthcare resource utilisation. Patients with longer T25FW times (indicating greater walking impairment) were significantly more likely to require additional caregiver support (p < 0.0001), visit a variety of healthcare professionals including their primary care physicians (p = 0.0044) and require more long-term non-disease modifying drugs (p = 0.0001). A similar pattern was observed when subjective reporting of the severity of WMPs was considered. Work productivity was also markedly impacted by the presence of WMPs with fewer patients working full time and a reduction in weekly working hours as T25FW times and the subjective severity of WMPs increased. CONCLUSIONS: In Europe, WMPs in MS represent a considerable personal and social burden both financially and in terms of quality of life. Interventions to improve mobility could have significant benefits for patients and society as a whole.

Guidelines and best practices for appropriate use of dalfampridine in managed care populations.

Multiple sclerosis (MS) is a complex chronic, progressing disease that contributes to poor quality of life (QOL) for patients and high costs for managed care organizations. Currently, disease-modifying treatments (DMTs) constitute the platform pharmacotherapy for MS patients. Despite their efficacy, for many patients taking DMTs there is little evidence of their effect on QOL in general or symptom management. Impaired mobility contributes to direct and indirect costs. Annual direct medical costs for MS with gait impairment average nearly $21,000 per patient. Decreased mobility is also associated with higher absenteeism rates, thus raising indirect costs. Dalfampridine has been shown to improve walking in patients with MS. The effects of dalfampridine can complement those of DMTs by improving walking ability as a key component of overall mobility and a primary concern among many MS patients. Improved walking could potentially help contain some of the direct and indirect costs associated with MS care.

Use of physical and occupational therapy by Medicare beneficiaries within five conditions: 1994-2001.

OBJECTIVE: To examine the use of physical therapy and occupational therapy among Medicare beneficiaries nationwide before and after the 1997 Balanced Budget Act, which introduced prospective payment for rehabilitation services. DESIGN: We analyzed responses from the longitudinal Medicare Current Beneficiary Survey, merged with Medicare claims, to track physical therapy and occupational therapy rates and intensity (units of service) from 1994 through 2001. This observational study focused on elderly and disabled Medicare beneficiaries within five conditions: stroke, acute myocardial infarction, chronic obstructive pulmonary disease, arthritis, and lower-limb mobility problems. We used cubic smoothing spline functions to describe trends in service intensity over time and generalized estimating equations to assess changes in service intensity. RESULTS: Controlling for demographic characteristics, adjusted mean level of physical therapy and occupational therapy intensity rose significantly between 1994 and 2001 for all five conditions. Service intensity leveled off in 1999 for occupational therapy and 2000 for physical therapy. With few exceptions, physical therapy and occupational therapy intensity was not significantly associated with patients' demographic characteristics. CONCLUSIONS: Medicare beneficiaries with conditions that can potentially benefit from physical therapy or occupational therapy or both continued to get these services at similar-and sometimes increasing-intensity during years after passage of the Balanced Budget Act.

Tailored psychotherapy for patients with functional neurological symptoms: a pilot study.

OBJECTIVE: The objective of this study was to assess whether individually tailored psychotherapy for patients with functional neurological symptoms is associated with improvements in patient-centered measures of emotional well-being, quality of life, as well as somatic symptoms and whether this treatment modality is likely to be cost-effective. METHODS: We conducted an uncontrolled prospective pilot study of consecutive patients with functional symptoms referred from neurology outpatient clinics to a single psychotherapist using validated questionnaires [Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), Short Function (SF)-36 Health Survey, and Patient Health Questionnaire (PHQ)-15]. Patients had a median of 6 treatment sessions (range=1-24). Ninety-one patients completed questionnaires at referral, 63 did at the end of treatment, and 34 did at follow-up after 6 months. Significant improvements were seen on all measures and were maintained at follow-up (CORE-OM, P=.003; SF-36, P<.001; PHQ-15, P=.001). Significance was not lost in an intention-to-treat analysis. Of all the patients, 49.2% improved by at least 1 S.D. in at least one of the measures. The number of patients needed to be treated to see an improvement of at least 1 S.D. in one of the three outcome measures was 2; that in two measures, 3.9; and that in all measures, 7. The mean cost of the intervention was pound231; the cost per quality-adjusted life year was estimated as pound5,328. RESULTS: Psychotherapy was associated with significant improvements in patient-centered measures, which seemed to be achieved at a comparatively low cost. CONCLUSIONS: The results indicate that psychotherapy may be a cost-effective intervention for patients presenting with functional neurological symptoms. The findings warrant further assessment of this treatment with a randomized and controlled trial.

Feasibility of robotic-assisted locomotor training in children with central gait impairment.

Intensive, task-specific training enabled by a driven gait orthosis (DGO) may be a cost-effective means of improving walking performance in children. A paediatric DGO has recently been developed. This study was the first paediatric trial aimed to determine the feasibility of robotic-assisted treadmill training in children with central gait impairment (n=26; 11 females, 15 males; mean age 10 y 1 mo [SD 4 y]; range 5 y 2 mo-19 y 5 mo). Diagnoses of the study group included cerebral palsy (n=19; Gross Motor Function Classification System Levels I-IV), traumatic brain injury (n=1), Guillain-Barré syndrome (n=2), incomplete paraplegia (n=2), and haemorrhagic shock (n=1), and encephalopathy (n=1). Sixteen children were in-patients and 10 were outpatients. Twenty-four of the 26 patients completed the training which consisted of a mean of 19 sessions (SD 2.2; range 13-21) in the in-patient group and 12 sessions (SD 1.0; range 10-13) in the outpatient group. Gait speed and 6-Minute Walking Test increased significantly (p<0.01). Functional Ambulation Categories and Standing dimension (in-patient group p<0.01; outpatient group p<0.05) of the Gross Motor Function Measure improved significantly. DGO training was successfully integrated into the rehabilitation programme and findings suggest an improvement of locomotor performance.