Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device. Final order.

The Food and Drug Administration (FDA) is classifying the vibratory counter-stimulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the vibratory counter-stimulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

[Efficiency of therapeutically applied physical factors for vibration disease caused by exposure to local vibration (review of literature).]

Important role in treatment and prophylaxis for vibration disease due to local vibration is played by physical factors. If high frequency components prevalent in occupational vibration, treatment with electric therapy, laser, magnetic fields, lymphatic drainage, hydrotherapy provides influence on leading chains of systemic microangiopathies pathogenesis - dysbalance of regulation influences by vegetative nervous system, vasoconstriction and intravascular changes, vascular permeability and microcirculation disorders. If low frequency coomponents prevalent in occupational vibration, treatment of polyneuropathies and locomotory disorders incorporates trophic processes activation: transcranial electroanalgesia, surface application of mineral waters, manual and subwater massage, ozone therapy, local spark discharges, peloids. Complex use of physical methods also increases human adaptational resources.

[Combined physical therapy: general information, interaction between physical factors]. / Sochetannaya fizioterapiya: obshchie svedeniya, vzaimodeistvie fizicheskikh faktorov.

The present article is devoted to problems pertaining to the combined (simultaneous) medical application of the therapeutic physical factors. The classification of the methods used in combined physical therapy is proposed, their advantages over the traditional therapeutic modalities are discussed, the general principles of simultaneous application of the medical physical factors are considered. The possible variants of interaction between such physical factors in the case of their combined application are theoretically determined, the criteria for their quantitative assessment (coefficients of synergism and effectiveness of combination) are offered, examples of their application for the evaluation of the efficiency of the selected combinations are provided.

The SCIRehab project: treatment time spent in SCI rehabilitation. Inpatient treatment time across disciplines in spinal cord injury rehabilitation.

BACKGROUND/OBJECTIVE: Length of stay (LOS) for rehabilitation treatment after spinal cord injury (SCI) has been documented extensively. However, there is almost no published research on the nature, extent, or intensity of the various treatments patients receive during their stay. This study aims at providing such information on a large sample of patients treated by specialty rehabilitation inpatient programs. METHODS: Six hundred patients with traumatic SCI admitted to six rehabilitation centers were enrolled. Time spent on various therapeutic activities was documented by each rehabilitation clinician after each patient encounter. Patients were grouped by neurologic level and completeness of injury. Total time spent by each rehabilitation discipline over a patient's stay and total minutes of treatment per week were calculated. Ordinary least squares stepwise regression models were used to identify patient and injury characteristics associated with time spent in rehabilitation treatment overall and within each discipline. RESULTS: Average LOS was 55 days (standard deviation 37), during which 180 (106) hours of treatment were received, or 24 (5) hours per week. Extensive variation was found in the amount of treatment received, between and within neurologic groups. Total hours of treatment provided throughout a patient's stay were primarily determined by LOS, which in turn was primarily predicted by medical acuity. Variation in minutes per week of treatment delivered by individual disciplines was predicted poorly by patient and injury characteristics. CONCLUSIONS: Variations between and within SCI rehabilitation patient groups in LOS, minutes of treatment per week overall, and for each rehabilitation discipline are large. Variation in treatment intensity was not well explained by patient and injury characteristics. In accordance with practice-based evidence methodology, the next step in the SCIRehab study will be to determine which treatment interventions are related with positive outcomes (at 1 year post injury), after controlling for patient and injury differences.

SCIRehab Project series: the therapeutic recreation taxonomy.

BACKGROUND/OBJECTIVE: Outcomes research of therapeutic recreation (TR) activities and interventions for spinal cord injury (SCI) rehabilitation is made more difficult by a lack of uniform descriptions and the absence of a formal treatments classification system (taxonomy). The objective of this study was to describe a taxonomy developed by Certified Therapeutic Recreation Specialists. METHODS: TR lead clinicians and researchers from 6 SCI rehabilitation centers developed a TR documentation system to describe the details of each TR session involving patients with SCI enrolled in the SCIRehab study. The SCIRehab study uses the practice-based evidence methodology, a rigorous observational methodology that examines current practice without introducing additional treatments, to capture details of each TR session for 1,500 SCI rehabilitation patients at 6 US inpatient SCI rehabilitation facilities. This may be the first attempt to document the many details of the TR rehabilitation process for patients with SCI. RESULTS: The TR taxonomy consists of 6 activities (eg, leisure education and counseling, outings, and leisure skill work in center) and activity-specific interventions, as well as time spent on each activity. Activity descriptions are enhanced with additional details that focus on assistance needs for each activity, patient ability to direct care, and patient/family involvement, which may help to determine TR activity selection. CONCLUSION: Development and application of a TR taxonomy, which is comprehensive for patients with SCI and efficient to use, are feasible despite significantly different TR programs at the 6 SCIRehab centers.

SCIRehab Project series: the physical therapy taxonomy.

BACKGROUND/OBJECTIVE: Outcomes research is in need of a classification system of physical therapy (PT) interventions for acute traumatic spinal cord injury (SCI) rehabilitation in the United States. The objective of this study was to describe a taxonomy (system to categorize and classify interventions) to examine the effects of PT interventions on rehabilitation outcomes. METHODS: The SCIRehab study uses the rigorous observational practice-based evidence methodology to examine current treatment processes without changing existing practice. PT clinicians and researchers from 6 centers developed a taxonomy to describe details of each PT session. RESULTS: The PT taxonomy consists of 19 treatment activities (eg, bed mobility, transfers, wheelchair mobility, strengthening and stretching exercises) and supplementary information to describe the associated therapeutic interventions. Details that focus on patient assistance needs and family involvement are included as additional descriptors to help to describe and justify PT activity selection. Time spent on each activity is used as the measure of intensity. CONCLUSION: The detailed PT taxonomy documentation process, which offers efficiency in data collection, is being used for all PT sessions with 1,500 patients with acute traumatic SCI at the 6 participating centers. It might be the first attempt to document the many details of the PT rehabilitation process for patients with SCI in the United States.

SCIRehab Project series: the occupational therapy taxonomy.

BACKGROUND/OBJECTIVE: Lack of a classification system for occupational therapy (OT) rehabilitation interventions for traumatic spinal cord injury (SCI) rehabilitation in the United States makes conducting outcomes research difficult. This article describes an OT SCI rehabilitation taxonomy (system to categorize and classify treatments). METHODS: OT clinicians and researchers from 6 SCI rehabilitation centers developed a taxonomy to describe details of each OT session. This effort is part of the SCIRehab study, which uses the practice-based evidence, observational research methodology to examine current treatment processes without changing existing practice. RESULTS: The OT taxonomy consists of 26 OT activities (eg, training on activities of daily living, communication, home management skills, wheelchair mobility, bed mobility, transfers, balance, strengthening, stretching, equipment evaluation, and community reintegration). Time spent on each activity is documented along with therapeutic interventions used to facilitate the activity. Treatment descriptions are enhanced further with identification of assistance needs, patient direction of care, and family involvement, which help to describe and guide OT activity selection. The OT taxonomy documentation process includes all OT rehabilitation interventions for patients with SCI while maintaining efficiency in data collection. CONCLUSION: The electronic documentation system is being used at 6 centers for all OT sessions with 1,500 patients with acute traumatic SCI. It is the largest known attempt to document details of the comprehensive OT rehabilitation process for patients with SCI in the United States.

Feasibility of a classification system for physical therapy, occupational therapy, and sports therapy interventions for mobility and self-care in spinal cord injury rehabilitation.

OBJECTIVE: To test the feasibility of a classification system developed to record the contents of treatment sessions intended to improve mobility and self-care by persons with a spinal cord injury (SCI) in clinical rehabilitation. DESIGN: Descriptive study. SETTING: Three Dutch SCI facilities. PARTICIPANTS: Participants (N=36) as well as physical therapists (n=20), occupational therapists (n=14), and sports therapists (n=2). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Questionnaires to assess the clarity of the classification system, time needed to record 1 treatment session, and the distribution of categories and interventions. The classification system consisted of 28 categories at 3 levels of functioning: basic functions (eg, muscle power), basic activities (eg, transfers), and complex activities (eg, walking and moving around outside). RESULTS: Therapists used 1625 codes to record 856 treatment sessions of 142 patients. For 93% of the treatment sessions, the coding caused little or no doubt. The therapists were able to classify 86.3% of the treatment sessions within 3 minutes. The classification system was rated as useful and easy to use. CONCLUSIONS: The findings support the suitability of our classification system as a tool to record the contents of SCI treatment sessions in different settings and by different therapists.

Quality, language, subdiscipline and promotion were associated with article accesses on Physiotherapy Evidence Database (PEDro).

OBJECTIVE: To quantify the relationship between the number of times articles are accessed on the Physiotherapy Evidence Database (PEDro) and the article characteristics. A secondary aim was to examine the relationship between accesses and the number of citations of articles. METHOD: The study was conducted to derive prediction models for the number of accesses of articles indexed on PEDro from factors that may influence an article's accesses. All articles available on PEDro from August 2014 to January 2015 were included. We extracted variables relating to the algorithm used to present PEDro search results (research design, year of publication, PEDro score, source of systematic review (Cochrane or non-Cochrane)) plus language, subdiscipline of physiotherapy, and whether articles were promoted to PEDro users. Three predictive models were examined using multiple regression analysis. Citation and journal impact factor were downloaded. RESULTS: There were 29,313 articles indexed in this period. We identified seven factors that predicted the number of accesses. More accesses were noted for factors related to the algorithm used to present PEDro search results (synthesis research (i.e., guidelines and reviews), recent articles, Cochrane reviews, and higher PEDro score) plus publication in English and being promoted to PEDro users. The musculoskeletal, neurology, orthopaedics, sports, and paediatrics subdisciplines were associated with more accesses. We also found that there was no association between number of accesses and citations. CONCLUSION: The number of times an article is accessed on PEDro is partly predicted by how condensed and high quality the evidence it contains is.

Chest physiotherapy with early mobilization may improve extubation outcome in critically ill patients in the intensive care units.

BACKGROUND: Extubation failure can lead to a longer intensive care unit (ICU) stay, higher mortality rate, and higher risk of requiring tracheostomy. Chest physiotherapy (CPT) can help patients in reducing the accumulation of airway secretion, preventing collapsed lung, improving lung compliance, and reducing comorbidities. Much research has investigated the correlation between CPT and respiratory system clearance. However, few studies have investigated the correlation between CPT and failed ventilator extubation. Therefore, this study aimed to investigate the use of CPT for reducing the rate of failed removal from mechanical ventilators. METHODS: This study was an intervention study with mechanical control. Subjects were divided into two groups. The control group, which received routine nursing chest care, was selected from a retrospective chart review. The intervention group was prospectively taken into the chest physiotherapy program. The chest physiotherapy treatment protocol consisted of inspiratory muscle training, manual hyperinflation, chest wall mobilization, secretion removal, cough function training, and early mobilization. RESULTS: A total of 439 subjects were enrolled in the intervention and control groups, with a mean age of 69 years. APACHE II score (P = .09) and GCS scores (P = .54) were similar between the two groups. Compared to the control group, patients in the intervention group had a significantly lower reintubation rate (8% vs 16%; P = .01). CONCLUSIONS: The results indicate that intensive chest physiotherapy could decrease extubation failure in mechanically ventilated patients in the ICU. In addition, chest physiotherapy could also significantly improve the rapid shallow breathing index score.

Preliminary examination of a proposed treatment-based classification system for patients receiving physical therapy interventions for neck pain.

BACKGROUND AND PURPOSE: Neck pain frequently is managed by physical therapists. The development of classification methods for matching interventions to subgroups of patients may improve clinical outcomes. The purpose of this study was to describe a proposed classification system for patients with neck pain by examining data for consecutive patients receiving physical therapy interventions. SUBJECTS AND METHODS: Standardized methods for collecting baseline and intervention data were used for all patients receiving physical therapy interventions for neck pain over 1 year. Outcome variables were the Neck Disability Index (NDI), numeric pain rating, and number of visits. Treatment was provided at the discretion of the physical therapist. After the completion of treatment, each patient was classified by use of baseline variables. The interventions received by the patient were categorized as being matched or not matched to the classification. Outcomes for patients who received matched interventions were compared with those for patients who received nonmatched interventions. The interrater reliability of the classification algorithm was examined with a subset of 50 patients. RESULTS: A total of 274 patients were included in this study (74% women; age [X+/-SD]=44.4+/-16.0 years). The most common classification was centralization (34.7%); next were exercise and conditioning (32.8%) and mobility (17.5%). The interrater reliability for classification decisions was high (kappa=.95, 95% confidence interval [CI]=0.87-1.0). A total of 113 patients (41.2%) received interventions matched to the classification. Receiving matched interventions was associated with greater improvements in the NDI (mean difference=5.6 points, 95% CI=2.6-8.6) and in pain ratings (mean difference=0.74 point, 95% CI=0.21-1.3) than receiving nonmatched interventions. DISCUSSION AND CONCLUSION: The development of classification methods for patients with neck pain may improve the outcomes of physical therapy intervention. This study was done to examine a previously proposed classification system for patients receiving physical therapy interventions for neck pain. Receiving interventions matched to the classification system was associated with better outcomes than receiving nonmatched interventions. Although the design of this study prohibited drawing conclusions about the effectiveness of the system, the results suggest that further research on the system may be warranted.

Treatment-based Classification System for Patients With Low Back Pain: The Movement Control Approach.

We present the movement control approach as part of the treatment-based classification system. This approach proposes a movement control schema that clarifies that movement control is a product of the interplay among multiple biopsychosocial components. The schema illustrates that for movement to occur in a dynamically controlled fashion, the lumbar spine requires both local mobility and global stability. Local mobility means that the lumbar spine and its adjacent regions possess adequate nerve and joint(s) mobility and soft tissue compliance (ie, the malleability of tissue to undergo elastic deformation). Global stability means that the muscles of the lumbar spine and its adjacent regions can generate activation that is coordinated with various joint movements and incorporated into activities of daily living. Local mobility and global stability are housed within the bio-behavioral and socio-occupational factors that should be addressed during movement rehabilitation. This schema is converted into a practical physical examination to help the rehabilitation provider to construct a clinical rationale as to why the movement impairment(s) exist. The examination findings are used to guide treatment. We suggest a treatment prioritization that aims to consecutively address neural sensitivity, joint(s) and soft tissue mobility, motor control, and endurance. This prioritization enables rehabilitation providers to better plan the intervention according to each patient's needs. We emphasize that treatment for patients with low back pain is not a static process. Rather, the treatment is a fluid process that changes as the clinical status of the patient changes. This movement control approach is based on clinical experience and indirect evidence; further research is needed to support its clinical utility.

Impact of intensity of practice after stroke: issues for consideration.

PURPOSE: The present debate paper addresses four relevant issues related to the impact of intensity of practice after stroke. First, the best way to define intensity of practice is discussed. Second, the paper describes the evidence that exists for a dose-response relationship in stroke rehabilitation. Third, the relevance of an appropriate patient selection for a meaningful intensive practice is explored. Finally, the paper raises the question of what it is that patients actually learn when they improve their functional skills. Search strategy. For this purpose articles from MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, PEDro, DARE and PiCarta and references presented in relevant publications were examined. DISCUSSION AND CONCLUSION: Although, there is strong evidence that early augmented exercise therapy time (expressed as time dedicated to practice) may enhance functional recovery, there is a discrepancy between the evidence for the benefits of intensive practice, on the one hand, and, the implementation of intensive rehabilitation treatment programmes in the current healthcare system on the other. Further emphasis should be given on a better understanding of the time-dependency of prognostic factors that determine the effectiveness of intensive practice in patients with stroke. In addition, a better understanding is needed of the neurophysiological and biomechanical mechanisms that underlie compensation-related learning of functional tasks after stroke.

Hypoxic brain injury improvement induced by coordination dynamics therapy; a comparison with normal CNS development.

A 13-year-old girl suffered a rather severe hypoxic CNS injury and was given up by the school medicine. Adequate therapy was rejected for the patient by a university clinic with the argument that there were only simple reflexes left. The patient underwent coordination dynamics therapy and could significantly improved; she now can sit, walk, eat, drink, count and speak a few words. During a 3-month intensive therapy, a 70% improvement in CNS functioning could be achieved, as quantified by the coordination dynamics, i.e. a similar improvement as could be achieved in patients after stroke and traumatic brain injury, and in cerebral palsy. The improvements in CNS functioning achieved were compared with changes occurring during development in pupils aged between 7 and 19 years. Similarities could be observed with respect to high-frequency exercising for improving CNS functioning, missing continuous concentration on a certain task, and the strong improvement of the coordination dynamics. In the Method section, the theory is presented of the Schalow coordination dynamics therapy.

[Usefulness of rehabilitation in inflammatory myopathies]. / Intérêt de la rééducation fonctionnelle au cours des myopathies inflammatoires.

Rehabilitation, for a long time not recommended, seems today to hold a prominent place within the therapeutic arsenal of inflammatory myopathies. The difficulty of its evaluation, apart from the low prevalence of these diseases, lies in a triple heterogeneity: first that distinguishing the different forms of inflammatory myopathies and the phase where they are active; second, that concerning the endpoint considered to assess the efficiency of the intervention; lastly, the diversity of the rehabilitation programs that can be undertaken. Between 1993 and 2016, about 30 studies estimating the rehabilitation of inflammatory myopathies have been published, among which five randomized controlled trials, four controlled trials, 15 open studies, and seven case reports. All these studies evidence the safety of rehabilitation and some show a significant improvement of the criteria estimating the activity of the disease, its functional impact or the impairment of quality of life and the limitation in daily life activities triggered by the disease. The rehabilitation, whether aerobic, anaerobic or mixed, must today systematically be associated with the pharmaceutic treatment proposed to patients affected by inflammatory myopathies. Other studies are necessary to optimize the rehabilitation methods, to understand their effects and action, and to quantify their impact and provide more trustworthy evidence.

ICF-based approach to evaluating functionality in cardiac rehabilitation patients after heart surgery.

BACKGROUND: Heart surgery is a frequent reason for admission to in-patient cardiac rehabilitation programmes. ICF approach has never been used to evaluate cardiac patients after major heart surgery. AIM: The aim was to evaluate and measure functionality in cardiac patients who have undergone heart surgery, using for the first time the ICF-based approach and to assess whether such approach can be feasible and useful in cardiac rehabilitation. DESIGN: Observational study. SETTING: In-patients cardiac Rehabilitation Unit in Milan. POPULATION: Fifty consecutively admitted patients who had undergone heart surgery (34 males, 16 females; mean age 65.7±12.5 years). METHODS: We prepared a ICF-core set short enough to be feasible and practical. Patients were individually interviewed by different healthcare professionals (randomly selected from a group of two physicians, two physiotherapists and two psychologists) at the beginning (T1) and end of cardiac rehabilitation (T2) RESULTS: The sum of the scores of each ICF body function, body structure, activity and participation code significantly decreased between T1 and T2 (P<0.001). The environmental code scores significantly decreased in the case of facilitators between T1 and T2 (P=0.0051), but not in the case of barriers. There were significant correlations between the ICF body function scores and Barthel's index (ρ=0.381; P=0.006), NYHA class (ρ=0.404; P=0.004) and plasma Cr-P levels (r=0.31; P=0.03), between the ICF body structure codes and the Conley scale (ρ=0.306; P=0.02), and between the activity/participation codes and SpO2 (ρ=0.319; P=0.04). There were no correlations between the ICF environmental codes and clinical parameters. CONCLUSION: The ICF-based data provided functional information that was consistent with the patients' clinical course. CLINICAL REHABILITATION IMPACT: The core set used allowed to quantify important body functions and activities, including some areas that are generally insufficiently considered by healthcare professionals during cardiac rehabilitation, and document their improvement.

Introduction to Special Issue: A Review of the International Classification of Functioning, Disability and Health and Physical Therapy over the Years.

BACKGROUND AND PURPOSE: The International Classification of Functioning, Disability and Health (ICF) of the World Health Organization was developed as a common framework to understand health and to describe the impact of health condition on functioning. The purpose of this paper is to summarize the literature on the use of the ICF in physical therapy practice and research. METHODS: We performed a scoping-narrative review and searched for relevant English language articles from 2001 to 2012 in multiple databases that included MEDLINE, PsycINFO, PubMed and Physiotherapy Evidence Database. Our keywords for the search consisted of ['physical therapy' OR 'physiotherapy'] AND ['ICF']. All types of articles were considered. RESULTS: We found 268 articles; out of which, 79 were reviewed. The years with most publications were 2011 (n = 16), 2008 (n = 15) and 2010 and 2012 (both with n = 13). Publications mostly came from the United States with 27% of the articles. The journal Physical Therapy leads with almost a third of ICF-related physical therapy publications. The ICF has been mostly used in studies of musculoskeletal and neuromuscular conditions. We found a wide array of application of the ICF in research, clinical practice and teaching (classroom and clinical education). Emerging topics included using the ICF in resource allocation and prevention and wellness. CONCLUSION: The use of the ICF in physical therapy practice and research is promising and continues to evolve. With recent developments in ICF-based measurement and integration in assessment tools for use in the clinics, research and teaching, the need to show the added value of using the ICF in practice and research remains.