The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury.

There are more than 300,000 estimated cases of spinal cord injury (SCI) in the United States, and approximately 27,000 of these are Veterans. Immobilization from SCI results in adverse secondary medical conditions and reduced quality of life. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care. Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints. Few studies have reported the safety and efficacy for use of these devices in the home and community environments, and none evaluated their impact on patient-centered outcomes through a randomized clinical trial (RCT). Absence of reported RCTs for powered exoskeletons may be due to a range of challenges, including designing, statistically powering, and conducting such a trial within an appropriate experimental framework. An RCT for the study of exoskeletal-assisted walking in the home and community environments also requires the need to address key factors such as: avoiding selection bias, participant recruitment and retention, training, and safety concerns, particularly in the home environment. These points are described here in the context of a national, multisite Department of Veterans Affairs Cooperative Studies Program-sponsored trial. The rationale and methods for the study design were focused on providing a template for future studies that use powered exoskeletons or other strategies for walking and mobility in people with immobilization due to SCI.

Effects of early introduction of non-invasive positive pressure ventilation based on forced vital capacity rate of change: Variation across amyotrophic lateral sclerosis clinical phenotypes.

PURPOSE: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease associated with high morbidity and mortality. We evaluated the ability of pulmonary function tests to predict disease progression by ALS clinical phenotypes, and the timing of the introduction of non-invasive positive pressure ventilation (NIPPV). MATERIALS AND METHODS: A cohort study was performed in all adult patients who fulfilled El Escorial criteria at a tertiary-care academic medical centre for veterans in the USA from 1 January 2010 to 31 December 2014. Eligible patients underwent sitting and supine forced vital capacity (FVC) and the FVC rate of change (RoC) per month was calculated. ALS Functional Rating Scale-Revised (ALSFRS-R) scores were collected. RESULTS: A total of 137 patients were included in our analysis. The average survival from ALS onset was 31.40 (±40.04) months. The general cohort median (IQR) RoC was -0.87 (-2.55 to 0.34)/-0.65 (-2.55 to 0.70) % per month (P = 0.81) of the sitting/supine FVC, respectively. However, mean monthly RoC varied among the ALS phenotypes, with higher variation among global ALS, where greater decline in RoC was noted. The average time from ALS onset to tracheostomy was 27.88 (±22.21) months. The average sitting/supine FVC RoC for subjects requiring tracheostomy was -2.86 (±3.77)/-3.63 (±3.75) at the time of tracheostomy, compared to -1.190 (±2.38)/-1.07 (±3.78) for those who did not require the procedure. Although NIPPV use did not result in statistically significant improvements in either the sitting or supine FVC %, it did slow the RoC decline of patients with global ALS phenotypes. CONCLUSIONS: Initiation of NIPPV based on decline in RoC rather than the absolute value of either sitting or supine FVC may result in early stabilisation of ALS patients' pulmonary deterioration for the global clinical phenotype, and thus may have the potential for prolonging survival until tracheostomy or death.

Managing Superficial Distal Medial Collateral Ligament Insufficiency in Primary Total Knee Arthroplasty Using Bone Staples.

Superficial medial collateral ligament (MCL) injury is an occasional intraoperative complication during total knee arthroplasty (TKA) that can lead to failure. Although previous studies have recommended complex repair or conversion to a constrained implant, the authors evaluated results of superficial distal MCL reapproximation using bone staples. Records of 31 patients who underwent staple reapproximation for superficial MCL avulsion from the tibial attachment during primary TKA from 2005 to 2015 were reviewed. They were compared with 685 patients who underwent uncomplicated TKA (primary control) and 18 who underwent revision TKA for instability (secondary control). Subjective knee instability was assessed with a patient questionnaire, and other end points included revision for instability or stiffness and manipulations under anesthesia. The authors prospectively collected Knee injury and Osteoarthritis Outcome Score (KOOS) and visual analog scale satisfaction scores. The mean follow-up was 2.6 years. No patients treated with staple repair required revision for instability, whereas two patients were revised in the primary control. Subjective instability was reported in 19.2% of staple repair patients compared with 24.2 and 46.2% of patients in the primary and secondary controls. The mean KOOS for the staple group was 71.7 points, 77.3 for the primary control, and 49.3 for the secondary. KOOSs for the staple group were 5.6 points lower than the primary control, but 22.4 points higher than the secondary. Staple reapproximation is a simple and effective method for repairing the superficial distal MCL in primary TKA. The rate of instability and functional outcomes was comparable to uncomplicated primary TKA.

A Robotic Hand Device Safety Study for People With Cervical Spinal Cord Injury.

This study of the FES Hand Glove 200 device suggests possible efficacy in enhancing range of motion of various wrist and finger joints.

Individual Placement and Support in Spinal Cord Injury: A Longitudinal Observational Study of Employment Outcomes.

OBJECTIVE: To determine the effects of a 24-month program of Individual Placement and Support (IPS) supported employment (SE) on employment outcomes for veterans with spinal cord injury (SCI). DESIGN: Longitudinal, observational multisite study of a single-arm, nonrandomized cohort. SETTING: SCI centers in the Veterans Health Administration (n=7). PARTICIPANTS: Veterans with SCI (N=213) enrolled during an episode of either inpatient hospital care (24.4%) or outpatient care (75.6%). More than half the sample (59.2%) had a history of traumatic brain injury (TBI). INTERVENTION: IPS SE for 24 months. MAIN OUTCOME MEASURE: Competitive employment. RESULTS: Over the 24-month period, 92 of 213 IPS participants obtained competitive jobs for an overall employment rate of 43.2%. For the subsample of participants without TBI enrolled as outpatients (n=69), 36 obtained competitive jobs for an overall employment rate of 52.2%. Overall, employed participants averaged 38.2±29.7 weeks of employment, with an average time to first employment of 348.3±220.0 days. Nearly 25% of first jobs occurred within 4 to 6 months of beginning the program. Similar employment characteristics were observed in the subsample without TBI history enrolled as outpatients. CONCLUSIONS: Almost half of the veterans with SCI participating in the 24-month IPS program as part of their ongoing SCI care achieved competitive employment, consistent with their expressed preferences at the start of the study. Among a subsample of veterans without TBI history enrolled as outpatients, employment rates were >50%. Time to first employment was highly variable, but quite long in many instances. These findings support offering continued IPS services as part of ongoing SCI care to achieve positive employment outcomes.

Opiates for chronic nonmalignant pain syndromes: can appropriate candidates be identified for outpatient clinic management?

OBJECTIVE: To better define patients appropriate for opiate management for chronic pain syndromes. DESIGN: Retrospective study of 65 patients with noncancerous pain syndromes who were on or being considered for opiates and who were transitioned into a structured outpatient clinic with close monitoring and management. Noncompliance with this outpatient pain management program was the primary outcome. Noncompliance was defined as (1) receipt of prescriptions from providers outside of this clinic, (2) increase in medication dosage without proper approval, (3) refusing toxicology screening on entrance into the program, (4) negative toxicology tests for prescribed medications, (5) positive toxicology tests for psychoactive medications not prescribed, or (6) discovery on toxicology tests of the presence of illicit substances. RESULTS: There were 24 cases of noncompliance (37%), with age <56 yrs old demonstrating significant (P = 0.02) association with persons who were noncompliant with the outpatient program. Forty-three percent of those younger than 56 yrs were noncompliant with program, yet no patient older than 56 yrs was noncompliant. Working status approached significance (P = 0.07) with those patients out of work demonstrating a greater likelihood of noncompliance. There were no correlations found between other patient characteristics and the level of compliance with the program. CONCLUSIONS: When considering opiates as a treatment option, pain clinics should have a heightened suspicion for younger and unemployed patients. Although these findings should be examined in larger studies, they suggest that nonmedical factors play a substantial role regarding success in such a structured opiate pain program.

Fatigue analysis before and after shaker exercise: physiologic tool for exercise design.

Recent studies suggest that the Shaker exercise induces fatigue in the upper esophageal sphincter (UES) opening muscles and sternocleidomastoid (SCM), with the SCMs fatiguing earliest. The aim of this study was to measure fatigue induced by the isometric portion of the Shaker exercise by measuring the rate of change in the median frequency (MF rate) of the power spectral density (PSD) function, which is interpreted as proportional to the rate of fatigue, from surface electromyography (EMG) of suprahyoid (SHM), infrahyoid (IHM), and SCM. EMG data compared fatigue-related changes from 20-, 40-, and 60-s isometric hold durations of the Shaker exercise. We found that fatigue-related changes were manifested during the 20-s hold. The findings confirm that the SCM fatigues initially and as fast as or faster than the SHM and IHM. In addition, upon completion of the exercise protocol, the SCM had a decreased MF rate, implying improved fatigue resistance, while the SHM and IHM showed increased MF rates, implying that these muscles increased their fatiguing effort. We conclude that the Shaker exercise initially leads to increased fatigue resistance of the SCM, after which the exercise loads the less fatigue-resistant SHM and IHM, potentiating the therapeutic effect of the Shaker exercise regimen with continued exercise performance.