Exoskeletal-assisted walking combined with transcutaneous spinal cord stimulation to improve bone health in persons with spinal cord injury: study protocol for a prospective randomised controlled trial.

Introduction: Persons with non-ambulatory spinal cord injury (SCI) undergo immediate unloading of the skeleton and, as a result, have marked loss of bone mineral density below the level of lesion that is directly associated with increased risk of long-bone fractures. There is a paucity of research that has successfully implemented rehabilitation and/or exercise training interventions to mitigate bone loss after acute SCI or reverse bone loss that has already occurred in chronic SCI. This paper describes a research protocol to compare the effect of exoskeletal-assisted walking (EAW) alone versus EAW plus transcutaneous spinal cord stimulation (EAW+tSCS) on bone density, geometry and strength in a cohort of chronic SCI participants.

Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Enhances Recovery for Persons with Spinal Cord Injury-A Pilot Randomized Controlled Trial.

Spinal cord injury (SCI) negatively impacts individuals' functional independence, and motor and sensory function. Intense walking training has been shown to facilitate recovery for individuals with chronic SCI. Powered robotic exoskeletons provide therapists with a tool that allows them to conduct walking training with less therapist effort as compared to conventional walking training.

Use of an upright power wheelchair in spinal cord injury: a case series.

Objective: To explore independence, usability, and self-reported quality of life (QOL) in eligible persons with spinal cord injury (SCI) who used a standing powered wheelchair over a 12-week period. Setting: VA SCI research facility.

Participants: Four participants with chronic SCI who use a wheelchair as the primary means of mobility.

Health impacts reported in the Spinal Cord Injury COVID-19 Pandemic Experience Survey (SCI-CPES).

Context: In people with spinal cord injury (SCI), infections are a leading cause of death, and there is a high prevalence of diabetes mellitus, obesity, and hypertension, which are all comorbidities associated with worse outcomes after COVID-19 infection.

Objective: To characterize self-reported health impacts of COVID-19 on people with SCI related to exposure to virus, diagnosis, symptoms, complications of infection, and vaccination.

Methods: The Spinal Cord Injury COVID-19 Pandemic Experience Survey (SCI-CPES) study was administered to ask people with SCI about their health and other experiences during the COVID-19 pandemic.

Lack of improvement in anorectal manometry parameters after implementation of a pelvic floor/anal sphincter biofeedback in persons with motor-incomplete spinal cord injury.

Background: Effect of biofeedback on improving anorectal manometric parameters in incomplete spinal cord injury is unknown. A short-term biofeedback program investigated any effect on anorectal manometric parameters without correlation to bowel symptoms.

Methods: This prospective uncontrolled interventional study comprised three study subject groups, Group 1: sensory/motor-complete American Spinal Injury Association Impairment Scale (AIS) A SCI (n = 13); Group 2 (biofeedback group): sensory incomplete AIS B SCI (n = 17) (n = 3), and motor-incomplete AIS C SCI (n = 8), and AIS D SCI (n = 6); and Group 3: able-bodied (AB) controls (n = 12).

Cardiometabolic risk factor clustering in persons with spinal cord injury: A principal component analysis approach.

Context/objective: To identify cardiometabolic (CM) measurements that cluster to confer increased cardiovascular disease (CVD) risk using principal component analysis (PCA) in a cohort of chronic spinal cord injury (SCI) and healthy non-SCI individuals.

Approach: A cross-sectional study was performed in ninety-eight non-ambulatory men with chronic SCI and fifty-one healthy non-SCI individuals (ambulatory comparison group). Fasting blood samples were obtained for the following CM biomarkers: lipid, lipoprotein particle, fasting glucose and insulin concentrations, leptin, adiponectin, and markers of inflammation.

Development of the Spinal Cord Injury COVID-19 Pandemic Experience Survey (SCI-CPES).

Context: Early during the COVID-19 pandemic, rehabilitation providers received reports from people with spinal cord injury (SCI) of considerable disruptions in caregiver services, medical and nursing care, and access to equipment and supplies; concomitantly, the medical community raised concerns related to the elevated risk of acquiring the infection due to SCI-specific medical conditions. Due to the novel nature of the pandemic, few tools existed to systematically investigate the outcomes and needs of people with SCI during this emergency.

Objective: To develop a multidimensional assessment tool for surveying the experience of the COVID-19 pandemic on physical and psychological health, employment, caregiving services, medical supplies and equipment, and the delivery of medical care for people with SCI.

Generation of a Reference Dataset to Permit the Calculation of T-scores at the Distal Femur and Proximal Tibia in Persons with Spinal Cord Injury.

Persons with traumatic spinal cord injury (SCI) have severe bone loss below the level of lesion with the distal femur (DF) and proximal tibia (PT) being the skeletal regions having the highest risk of fracture. While a reference areal bone mineral density (aBMD) database is available at the total hip (TH) using the combined National Health and Nutrition Examination Survey (NHANES) III study and General Electric (GE) combined (GE/NHANES) to calculate T-score (T-score), no such reference database exists for aBMD of the DF, and PT. The primary objectives of this study were (1) to create a reference dataset of young-healthy able-bodied (YHAB) persons to calculate T-score (T-score) values at the DF and PT, (2) to explore the impact of time since injury (TSI) on relative bone loss in the DF and PT regions using the two computation models to determine T-score values, and (3) to determine agreement between T-score values for a cohort of persons with SCI using the (T-score) and (T-score) reference datasets.

Predicting physical activity intensity using raw accelerometer signals in manual wheelchair users with spinal cord injury.

Study Design: Cross-sectional validation study.

Objectives: The performance of previously published physical activity (PA) intensity cutoff thresholds based on proprietary ActiGraph counts for manual wheelchair users (MWUs) with spinal cord injury (SCI) was initially evaluated using an out-of-sample dataset of 60 individuals with SCI. Two types of PA intensity classification models based on raw accelerometer signals were developed and evaluated.

Predicting Cardiometabolic Risk From Visceral Abdominal Adiposity in Persons With Chronic Spinal Cord Injury.

Persons with spinal cord injury (SCI) have increased adiposity that may predispose to cardiovascular disease compared to those who are able-bodied (AB). The purpose of this study was to determine the relationships between dual energy X-ray absorptiometry (DXA)-derived visceral adipose tissue (VAT) and biomarkers of lipid metabolism and insulin resistance in persons with chronic SCI. A prospective observational study in participants with chronic SCI and age- and gender-matched AB controls.

The Effect of Exoskeletal-Assisted Walking on Spinal Cord Injury Bowel Function: Results from a Randomized Trial and Comparison to Other Physical Interventions.

Bowel function after spinal cord injury (SCI) is compromised because of a lack of voluntary control and reduction in bowel motility, often leading to incontinence and constipation not easily managed. Physical activity and upright posture may play a role in dealing with these issues. We performed a three-center, randomized, controlled, crossover clinical trial of exoskeletal-assisted walking (EAW) compared to usual activity (UA) in people with chronic SCI.

The Addition of Transdermal Delivery of Neostigmine and Glycopyrrolate by Iontophoresis to Thrice Weekly Bowel Care in Persons with Spinal Cord Injury: A Pilot Study.

Persons with spinal cord injury (SCI) have neurogenic bowel disorders characterized by difficulty with evacuation (DWE), fecal incontinence, and discoordination of defecation. Six medically stable in-patients with SCI with a mean age of 57 ± 10 years (range: 39-66 years) and time since injury of 18 ± 17 years (range: 3-47 years) were investigated. Standard of care (SOC) for bowel care was followed by two weeks of SOC plus neostigmine (0.

Exoskeletal-assisted walking may improve seated balance in persons with chronic spinal cord injury: a pilot study.

Study Design: Pre-post intervention.

Objective: To explore the potential effect of exoskeletal-assisted walking (EAW) on seated balance for persons with chronic motor complete spinal cord injury (SCI).

Setting: A SCI research center.

Dynamic Margins of Stability During Robot-Assisted Walking in Able-Bodied Individuals: A Preliminary Study.

Gait analysis studies during robot-assisted walking have been predominantly focused on lower limb biomechanics. During robot-assisted walking, the users' interaction with the robot and their adaptations translate into altered gait mechanics. Hence, robust and objective metrics for quantifying walking performance during robot-assisted gait are especially relevant as it relates to dynamic stability.

Mobility Skills With Exoskeletal-Assisted Walking in Persons With SCI: Results From a Three Center Randomized Clinical Trial.

Clinical exoskeletal-assisted walking (EAW) programs for individuals with spinal cord injury (SCI) have been established, but many unknown variables remain. These include addressing staffing needs, determining the number of sessions needed to achieve a successful walking velocity milestone for ambulation, distinguishing potential achievement goals according to level of injury, and deciding the number of sessions participants need to perform in order to meet the Food and Drug Administration (FDA) criteria for personal use prescription in the home and community. The primary aim of this study was to determine the number of sessions necessary to achieve adequate EAW skills and velocity milestones, and the percentage of participants able to achieve these skills by 12 sessions and to determine the skill progression over the course of 36 sessions.

Oxygen Uptake During Exoskeletal-Assisted Walking in Persons With Paraplegia.

Objective: To determine the cardiometabolic demands associated with exoskeletal-assisted walking (EAW) in persons with paraplegia. This study will further examine if training in the device for 60 sessions modifies cost of transport (CT).

Design: Prospective cohort study.

Effect of Exoskeletal-Assisted Walking on Soft Tissue Body Composition in Persons With Spinal Cord Injury.

Objective: To determine the effect of overground walking using a powered exoskeleton on soft tissue body composition in persons with spinal cord injury (SCI).

Design: A prospective, single group observational pilot study.

Setting: Medical center.

Administration of Denosumab Preserves Bone Mineral Density at the Knee in Persons With Subacute Spinal Cord Injury: Findings From a Randomized Clinical Trial.

Persons with neurologically motor-complete spinal cord injury (SCI) have a marked loss of bone mineral density (BMD) of the long bones of the lower extremities, predisposing them to fragility fractures, especially at the knee. Denosumab, a commercially available human monoclonal IgG antibody to receptor activator of nuclear factor-κB ligand (RANKL), may provide an immunopharmacological solution to the rapid progressive deterioration of sublesional bone after SCI. Twenty-six SCI participants with subacute motor-complete SCI were randomized to receive either denosumab (60 mg) or placebo at baseline (BL), 6, and 12 months.

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.

Estimation of Physical Activity Intensity in Spinal Cord Injury Using a Wrist-Worn ActiGraph Monitor.

Objectives: To derive accelerometer count thresholds for classifying time spent in sedentary, light intensity, and moderate-to-vigorous physical activity (MVPA) in manual wheelchair users (MWUs) with spinal cord injury (SCI).

Design: Participants completed 18 activities of daily living and exercises for 10 minutes each with a 3-minute break between activities while wearing a COSMED K4b2 portable metabolic cart and an ActiGraph activity monitor on the dominant wrist. A linear regression was computed between the wrist acceleration vector magnitude and SCI metabolic equivalent of task (MET) for 80% of the participants to obtain thresholds for classifying different activity intensities, and the obtained thresholds were tested for accuracy on the remaining 20% of participants.

Recommendations for evaluation of neurogenic bladder and bowel dysfunction after spinal cord injury and/or disease.

To provide an overview of clinical assessments and diagnostic tools, self-report measures (SRMs) and data sets used in neurogenic bladder and bowel (NBB) dysfunction and recommendations for their use with persons with spinal cord injury /disease (SCI/D). Experts in SCI/D conducted literature reviews, compiled a list of NBB related assessments and measures, reviewed their psychometric properties, discussed their use in SCI/D and issued recommendations for the National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) guidelines. Clinical assessments included 15 objective tests and diagnostic tools for neurogenic bladder and 12 for neurogenic bowel.

Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Leads to Motor and Functional Improvement in Persons With Spinal Cord Injury: A Pilot Study.

Objective: To explore the potential effects of incorporating exoskeletal-assisted walking (EAW) into spinal cord injury (SCI) acute inpatient rehabilitation (AIR) on facilitating functional and motor recovery when compared with standard of care AIR.

Design: A quasi-experimental design with a prospective intervention group (AIR with EAW) and a retrospective control group (AIR only).

Setting: SCI AIR facility.