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. SETTING: Research institutions in Pittsburgh PA, Birmingham AL, and Bronx NY. METHODS: Data were collected from 60 MWUs with SCI who followed a structured activity protocol while wearing an ActiGraph activity monitor on their dominant wrist and portable metabolic cart which measured criterion PA intensity. Data was used to assess published models as well as develop and assess custom models using recall, specificity, precision, as well as normalized Mathew's correlation coefficient (nMCC). RESULTS: All the models performed well for predicting sedentary vs non-sedentary activity, yielding an nMCC of 0.87-0.90. However, all models demonstrated inadequate performance for predicting moderate to vigorous PA (MVPA) with an nMCC of 0.76-0.82. CONCLUSIONS: The mean absolute deviation (MAD) cutoff threshold yielded the best performance for predicting sedentary vs non-sedentary PA and may be used for tracking daily sedentary activity. None of the models displayed strong performance for MVPA vs non-MVPA. Future studies should investigate combining physiological measures with accelerometry to yield better prediction accuracies for MVPA.

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. METHODS: Eight participants who were over 18 years of age with chronic SCI and used a wheelchair for mobility were enrolled. Seven able-bodied participants were used for normal seated balance comparative values. Participants with chronic SCI received supervised EAW training using a powered exoskeleton (ReWalkTM) for a median 30 sessions (range from 7 to 90 sessions). Before and after EAW training, seated balance testing outcomes were collected using computerized dynamic posturography, providing measurements of endpoint excursion (EPE), maximal excursion (MXE), and directional control (DCL). Modified functional reach test (MFRT) and the sub-scales of physical functioning and role limitations due to physical health from the Short Form (36) Health Survey (SF-36) were used to identify changes in functional activities. RESULTS: After EAW training, seated balance significantly improved in total-direction EPE and MXE (P < 0.01 and P < 0.017 respectively). The results of MFRT and sub-scales of physical functioning and role limitations due to physical health improved after EAW training but were not statistically significant. CONCLUSIONS: EAW training may have the potential to improve seated balance for persons with chronic motor complete SCI. Due to the limitations of the study, such as small sample size and lack of a control group, further studies are needed to clarify the effect of improving seated balance through EAW training.

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. PARTICIPANTS: Persons (N=8) with chronic (>6mo) SCI between 18 and 65 years old who weighed less than 100 kg. INTERVENTIONS: Overground ambulation training using a powered exoskeleton (ReWalk) for 40 sessions, with each session lasting up to 2 hours, with participants training 3 times per week. MAIN OUTCOME MEASURE(S): Dual-energy x-ray absorptiometry (DXA) was used to measure lean mass (LM) and fat mass (FM) from the whole body, arms, legs and trunk. DXA was also used to assess visceral adipose tissue (VAT). Walking performance was measured by 6-minute walk test. RESULTS: Participants significantly lost total body FM (-1.8±1.2kg, P=.004) with the loss of adiposity distributed over several regional sites. Six of the 8 participants lost VAT, with the average loss in VAT trending toward significance (-0.141kg, P=.06). LM for the group was not significantly changed. CONCLUSIONS: Sustained and weekly use of powered exoskeletons in persons with SCI has the potential to reduce FM with inferred improvements in health.

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. Measurements over the course of a 60-session training program, approximately 20 sessions apart. SETTING: James J. Peters Bronx Veterans Affairs Medical Center, Center for the Medical Consequences of Spinal Cord Injury Research Center. PARTICIPANTS: The participants' demographics (N=5) were 37-61 years old, body mass index (calculated as weight in kilograms divided by height in meters squared) of 22.7-28.6, level of injury from T1-T11, and 2-14 years since injury. INTERVENTIONS: Powered EAW. MAIN OUTCOME MEASURES: Oxygen consumption per unit time (V˙O2, mL/min/kg), velocity (m/min), cost of transport (V˙O2/velocity), and rating of perceived exertion (RPE). RESULTS: With training: EAW velocity significantly improved (Pre: 51±51m; 0.14±0.14m/s vs Post: 99±42m; 0.28±0.12m/s, P=.023), RPE significantly decreased (Pre: 13±6 vs Post: 7±4, P=.001), V˙O2 significantly improved (Pre: 9.76±1.23 mL/kg/m vs Post: 12.73±2.30 mL/kg/m, P=.04), and CT was reduced from the early to the later stages of training (3.66±5.2 vs 0.87±0.85 mL/kg/m). CONCLUSIONS: The current study suggests that EAW training improves oxygen uptake efficiency and walking velocities, with a lower perception of exertion.

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. This cross-validation process was iterated for 1000 times to evaluate the stability of the thresholds on data corresponding to different proportions of sedentary, light intensity, and MVPA. MET values of 1.5 or lower were classified as sedentary behavior, MET values between 1.5 and 3 were classified as light intensity, and MET values of 3 or higher were classified as MVPA. The final thresholds were then validated on an out-of-sample independent dataset. PARTICIPANTS: MWUs (N=17) with SCI in the out-of-sample validation data set. INTERVENTIONS: Not applicable. SETTING: Research lab, community MAIN OUTCOME MEASURES: Accelerometer thresholds to classify sedentary, light intensity, and MVPA were obtained and their accuracy tested using cross-validation and an out-of-sample dataset. RESULTS: The threshold between sedentary and light intensity was 2057 counts-per-minute, and the threshold between light intensity and MVPA was 11,551 counts per minute. Based on the out-of-sample validation, the obtained thresholds had an overall accuracy of 85.6%, with a sensitivity and specificity of 95.3% and 97.4% for sedentary behavior, 87.8% and 84.5% for light intensity, 68.5% and 96.3% for MVPA, respectively. CONCLUSION: Accelerometer-based thresholds can be used to accurately identify sedentary behavior. However, thresholds may not provide accurate estimations of MVPA throughout the day when participants engage in more resistance-based activities.

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

Background: 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. Methods: A randomized clinical trial (RCT) was conducted across three sites, in persons with chronic (≥6 months) non-ambulatory SCI. Eligible participants were randomized (within site) to either the EAW arm first (Group 1), three times per week for 36 sessions, striving to be completed in 12 weeks or the usual activity arm (UA) first (Group 2), followed by a crossover to the other arm for both groups. The 10-meter walk test seconds (s) (10MWT), 6-min walk test meters (m) (6MWT), and the Timed-Up-and-Go (s) (TUG) were performed at 12, 24, and 36 sessions. To test walking performance in the exoskeletal devices, nominal velocities and distance milestones were chosen prior to study initiation, and were used for the 10MWT (≤ 40s), 6MWT (≥80m), and TUG (≤ 90s). All walking tests were performed with the exoskeletons. Results: A total of 50 participants completed 36 sessions of EAW training. At 12 sessions, 31 (62%), 35 (70%), and 36 (72%) participants achieved the 10MWT, 6MWT, and TUG milestones, respectively. By 36 sessions, 40 (80%), 41 (82%), and 42 (84%) achieved the 10MWT, 6MWT, and TUG criteria, respectively. Conclusions: It is feasible to train chronic non-ambulatory individuals with SCI in performance of EAW sufficiently to achieve reasonable mobility skill outcome milestones.

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

Background: 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. In this study, we assessed bi-planar dynamic stability margins for healthy adults during robot-assisted walking using EksoGT™, ReWalk™, and Indego® compared to independent overground walking at slow, self-selected, and fast speeds. Further, we examined the use of forearm crutches and its influence on dynamic gait stability margins. Methods: Kinematic data were collected at 60 Hz under several walking conditions with and without the robotic exoskeleton for six healthy controls. Outcome measures included (i) whole-body center of mass (CoM) and extrapolated CoM (XCoM), (ii) base of support (BoS), (iii) margin of stability (MoS) with respect to both feet and bilateral crutches. Results: Stability outcomes during exoskeleton-assisted walking at self-selected, comfortable walking speeds were significantly (p < 0.05) different compared to overground walking at self-selected speeds. Unlike overground walking, the control mechanisms for stability using these exoskeletons were not related to walking speed. MoSs were lower during the single support phase of gait, especially in the medial-lateral direction for all devices. MoSs relative to feet were significantly (p < 0.05) lower than those relative to crutches. The spatial location of crutches during exoskeleton-assisted walking pushed the whole-body CoM, during single support, beyond the lateral boundary of the lead foot, increasing the risk for falls if crutch slippage were to occur. Conclusion: Careful consideration of crutch placement is critical to ensuring that the margins of stability are always within the limits of the BoS to control stability and decrease fall risk.

Changes in bowel function following exoskeletal-assisted walking in persons with spinal cord injury: an observational pilot study.

STUDY DESIGN: Prospective, observational study. OBJECTIVE: To explore the effects of exoskeletal-assisted walking (EAW) on bowel function in persons with spinal cord injury (SCI). SETTING: Ambulatory research facility located in a tertiary care hospital. METHODS: Individuals 18-65 years of age, with thoracic vertebrae one (T1) to T11 motor-complete paraplegia of at least 12 months duration were enrolled. Pre- and post-EAW training, participants were asked to report on various aspects of their bowel function as well as on their overall quality of life (QOL) as related to their bowel function. RESULTS: Ten participants completed 25-63 sessions of EAW over a period of 12-14 weeks, one participant was lost to follow up due to early withdrawal after ten sessions. Due to the small sample size, each participant's results were presented descriptively in a case series format. At least 5/10 participants reported improvements with frequency of bowel evacuations, less time spent on bowel management per bowel day, fewer bowel accidents per month, reduced laxative and/or stool softener use, and improved overall satisfaction with their bowel program post-EAW training. Furthermore, 8/10 reported improved stool consistency and 7/10 reported improved bowel function related QOL. One participant reported worsening of bowel function post-EAW. CONCLUSION: Between 50 and 80% of the participants studied reported improvements in bowel function and/or management post-EAW training. EAW training appeared to mitigate SCI-related bowel dysfunction and the potential benefits of EAW on bowel function after SCI is worthy or further study.

Mechanisms for improving walking speed after longitudinal powered robotic exoskeleton training for individuals with spinal cord injury.

The goal of this study was to establish strideparameter gait models correlated to speed on individuals with chronic SCI and able-bodied controls walking with a powered robotic exoskeleton (EksoGT $^{\mathrm{ TM}}$). Longitudinal exoskeleton training $( >100$ hours) across eight individuals with SCI resulted in a 30% increase in walking speed. A simple linear regression between step length, stride length for given speed were very tightly correlated along a line of best fit $( \mathrm {p}<$.001). The temporal parameters of stride time, stance time and double support time depicted a non-linear exponentially decaying relationship for given walking speed. The research findings indicate that although longitudinal exoskeleton training reduces the temporal parameters, increases in spatial parameters are only marginal.

Multimodal cortical and subcortical exercise compared with treadmill training for spinal cord injury.

BACKGROUND AND PURPOSE: Spared fibers after spinal cord injury (SCI) tend to consist predominantly of subcortical circuits that are not under volitional (cortical) control. We aim to improve function after SCI by using targeted physical exercises designed to simultaneously stimulate cortical and spared subcortical neural circuits. METHODS: Participants with chronic motor-incomplete SCI enrolled in a single-center, prospective interventional crossover study. Participants underwent 48 sessions each of weight-supported robotic-assisted treadmill training and a novel combination of balance and fine hand exercises, in randomized order, with a 6-week washout period. Change post-intervention was measured for lower extremity motor score, soleus H-reflex facilitation; seated balance function; ambulation; spasticity; and pain. RESULTS: Only 9 of 21 enrolled participants completed both interventions. Thirteen participants completed at least one intervention. Although there were no statistically significant differences, multimodal training tended to increase short-interval H-reflex facilitation, whereas treadmill training tended to improve dynamic seated balance. DISCUSSION: The low number of participants who completed both phases of the crossover intervention limited the power of this study to detect significant effects. Other potential explanations for the lack of significant differences with multimodal training could include insufficient engagement of lower extremity motor cortex using skilled upper extremity exercises; and lack of skill transfer from upright postural stability during multimodal training to seated dynamic balance during testing. To our knowledge, this is the first published study to report seated posturography outcomes after rehabilitation interventions in individuals with SCI. CONCLUSION: In participants with chronic incomplete SCI, a novel mix of multimodal exercises incorporating balance exercises with skilled upper extremity exercises showed no benefit compared to an active control program of body weight-supported treadmill training. To improve participant retention in long-term rehabilitation studies, subsequent trials would benefit from a parallel group rather than crossover study design.

Training Persons with Spinal Cord Injury to Ambulate Using a Powered Exoskeleton.

Powered exoskeletons have become available for overground ambulation in persons with paralyses due to spinal cord injury (SCI) who have intact upper extremity function and are able to maintain upright balance using forearm crutches. To ambulate in an exoskeleton, the user must acquire the ability to maintain balance while standing, sitting and appropriate weight shifting with each step. This can be a challenging task for those with deficits in sensation and proprioception in their lower extremities. This manuscript describes screening criteria and a training program developed at the James J. Peters VA Medical Center, Bronx, NY to teach users the skills needed to utilize these devices in institutional, home or community environments. Before training can begin, potential users are screened for appropriate range of motion of the hip, knee and ankle joints. Persons with SCI are at an increased risk of sustaining lower extremity fractures, even with minimal strain or trauma, therefore a bone mineral density assessment is performed to reduce the risk of fracture. Also, as part of screening, a physical examination is performed in order to identify additional health-related contraindications. Once the person has successfully passed all screening requirements, they are cleared to begin the training program. The device is properly adjusted to fit the user. A series of static and dynamic balance tasks are taught and performed by the user before learning to walk. The person is taught to ambulate in various environments ranging from indoor level surfaces to outdoors over uneven or changing surfaces. Once skilled enough to be a candidate for home use with the exoskeleton, the user is then required to designate a companion-walker who will train alongside them. Together, the pair must demonstrate the ability to perform various advanced tasks in order to be permitted to use the exoskeleton in their home/community environment.

Assessment of In-Hospital Walking Velocity and Level of Assistance in a Powered Exoskeleton in Persons with Spinal Cord Injury.

BACKGROUND: Individuals with spinal cord injury (SCI) often use a wheelchair for mobility due to paralysis. Powered exoskeletal-assisted walking (EAW) provides a modality for walking overground with crutches. Little is known about the EAW velocities and level of assistance (LOA) needed for these devices. OBJECTIVE: The primary aim was to evaluate EAW velocity, number of sessions, and LOA and the relationships among them. The secondary aims were to report on safety and the qualitative analysis of gait and posture during EAW in a hospital setting. METHODS: Twelve individuals with SCI ≥ 1.5 years who were wheelchair users participated. They wore a powered exoskeleton (ReWalk; ReWalk Robotics, Inc., Marlborough, MA) with Lofstrand crutches to complete 10-meter (10 MWT) and 6-minute (6MWT) walk tests. LOA was defined as modified independence (MI), supervision (S), minimal assistance (Min), and moderate assistance (Mod). Best effort EAW velocity, LOA, and observational gait analysis were recorded. RESULTS: Seven of 12 participants ambulated ≥ 0.40 m/s. Five participants walked with MI, 3 with S, 3 with Min, and 1 with Mod. Significant inverse relationships were noted between LOA and EAW velocity for both 6 MWT (Z value = 2.63, Rho = 0.79, P = .0086) and 10 MWT (Z value = 2.62, Rho = 0.79, P = .0088). There were 13 episodes of mild skin abrasions. MI and S groups ambulated with 2-point alternating crutch pattern, whereas the Min and Mod groups favored 3-point crutch gait. CONCLUSIONS: Seven of 12 individuals studied were able to ambulate at EAW velocities ≥ 0.40 m/s, which is a velocity that may be conducive to outdoor activity-related community ambulation. The ReWalk is a safe device for in-hospital ambulation.

Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia.

UNLABELLED: Historically, persons with paralysis have limited options for overground ambulation. Recently, powered exoskeletons have become available, which are systems that translate the user's body movements to activate motors to move the lower limbs through a predetermined gait pattern. As part of an ongoing clinical study (NCT01454570), eight nonambulatory persons with paraplegia were trained to ambulate with a powered exoskeleton. Measurements of oxygen uptake (VO2) and heart rate (HR) were recorded for 6 min each during each maneuver while sitting, standing, and walking. The average value of VO2 during walking (11.2 +/- 1.7 mL/kg/min) was significantly higher than those for sitting and standing (3.5 +/- 0.4 and 4.3 +/- 0.9 mL/kg/min, respectively; p < 0.001). The HR response during walking was significantly greater than that of either sitting or standing (118 +/- 21vs 70 +/- 10 and 81 +/- 12 beats per minute, respectively: p < 0.001). Persons with paraplegia were able to ambulate efficiently using the powered exoskeleton for overground ambulation, providing potential for functional gain and improved fitness. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; NCT01454570; "The ReWalk Exoskeletal Walking System for Persons with Paraplegia (VA_ReWalk)"; https://clinicaltrials.gov/ct2/show/NCT01454570.

Acute changes in soleus H-reflex facilitation and central motor conduction after targeted physical exercises.

We tested the acute effect of exercises targeted simultaneously at cortical and brainstem circuits on neural transmission through corticobulbar connections. Corticobulbar pathways represent a potential target for rehabilitation after spinal cord injury (SCI), which tends to spare brainstem circuits to a greater degree than cortical circuits. To explore this concept, able-bodied volunteers (n=20) underwent one session each of three exercises targeted at different nervous system components: treadmill walking (spinal locomotor circuits), isolated balance exercise (brainstem and other pathways), and multimodal balance plus skilled hand exercise (hand motor cortex and corticospinal tract). We found that short-interval soleus H-reflex facilitation increased after one session of balance and multimodal exercise by 13.2±4.0% and 8.3±4.7%, and slightly decreased by 1.9±4.4% after treadmill exercise (p=0.042 on ANOVA across exercise type). Increases in long-interval H-reflex facilitation were not significantly different between exercises. Both balance and multimodal exercise increased central motor conduction velocity by 4.3±2.6% and 4.5±2.8%, whereas velocity decreased by 4.3±2.7% after treadmill exercise (p=0.045 on ANOVA across exercise type). In conclusion, electrophysiological transmission between the motor cortex and spinal motor neurons in able-bodied subjects increased more following one session of balance exercise than treadmill exercise.