The SCI-QoL BDS was originally developed by an international team of investigators to be used as part of the International SCI Data Sets and to assess quality life (QoL) across three dimensions: life as a whole, physical, psychological with scores on a Likert scale ranging from 0-10 for each dimension. Highest scores suggest better QoL. The purpose of this dataset is to standardized data collection about QoL that can be used comparatively across four countries and five sites: Australia, Brazil, Netherlands and USA (Colorado and Michigan). This presentation will address the potential use of the SCI-QoL BDS in clinical practice by examining the concept of clinical utility and the association of the SCI-QoL BDS and secondary conditions after spinal cord injury/disease (SCI/D). Spinal Cord Disease refers to spinal cord lesions of non-traumatic etiology.
Method: Cognitive interviews were conducted resulting in a fourth dimensions added to the dataset. In addition to the SCI-QoL BDS, the SCI Secondary Conditions Scale (SCI-SCS), a 16-item questionnaire, was used to measure secondary health conditions such as pressure sores, pain, spasms, bladder dysfunction, and others, during the past 4 weeks on a 0-4 response scale (not experienced or insignificant to a significant problem). Higher scores in the SCI-SCS suggest more secondary conditions. Both measures were translated using the recommended translation methods into Portuguese and Dutch. Descriptive statistics, Pearson correlations and ANOVAs were used to determine associations between the number of complications experienced and reported QoL across the four items listed above.
Results: The sample included 291 persons with traumatic (76%) and non-traumatic SCI/D (24%). Mean SCI-QoL BDS scores for the overall sample were: psychological health (7.1) followed by life as a whole (6.9) and social life (6.9) and lastly physical health (6.5). For the SCI-SCS the mean score was 12.1 with a range of 0-36. Significant and substantive associations (P<.0005) in the expected direction were found between the SCI-SCS and ratings on all 4 items of the SCI-QoL BDS: physical health (-.42); life as a whole (-.38); social life (-.37); and psychological health (-.32). Those reporting more secondary conditions also reported lower QoL; specially in the case with respect to physical health. Differences were also observed across sites and countries with Australia and Brazil indicating higher numbers of secondary conditions.
Conclusions: The SCI-QoL BDS may be a good indicator of poorer health and higher presence of secondary conditions after SCI. More work is needed to optimize the clinical utility of this data set by looking at differences across time and quantifying meaningful changes, by establishing minimal important differences for the four items of this data set.

Introduction:
Rapidly improving capabilities of powered exoskeletons now provide exciting prospects of neurorehabilitation early after injury. In addition to the physical restoration of movement, the concept of neural reconditioning via locomotion has evolved from animal and human studies focused on the neural plasticity of the spinal cord. The objective of this study is to examine the safety and efficacy of ambulation utilizing a completely novel and lightweight powered exoskeleton by spinal cord injury patients.

Methods:
This is a multi-center, open-label, prospective cohort study conducted across 3 rehabilitation facilities. A patient cohort of 40 individuals with SCI ranging from T4-L5 neurological levels were recruited into a 20-session training and assessment protocol consisting of level ground walking, varied surface walking, and transitional movement testing, utilizing the Suitx Phoenix exoskeleton from US Bionics. All patients were tested using 10-meter walk test (10MWT), 6-minute walk test (6MWT), and Timed up & Go test (TUG). Patient satisfaction, pain, exertion, and psychological changes after training were also reported using a satisfaction survey, Rated Perceived Exertion (RPE) scale and Positive and Negative Affect Schedule (PANAS). Safety outcomes, adverse patient events and device malfunctions were monitored and reported.

Results:
40 participants completed the multi-center study. There were no adverse events reported for the entire study. All study participants reported moderate to high levels of comfort and satisfaction whilst using the device. At final outcome assessment, all patients were able to achieve an independence level (as represented by the locomotion component score of the Functional Independence Measure on a 7-point ordinal scale) of 4 or better on all transitional movements and walking tasks. The neurological level of injury had a statistically significant association (p<0.05) with 10MWT FIM score, 10MWT speed, 10MWT time to completion, 6-minute-walk-test FIM score, WISCI-II score, carpet and concrete FIM score. Participants with an incomplete spinal cord injury had a higher mean FIM score (mean=4.75 vs. 4.42), faster speed (0.15 m/s vs. 0.10 m/s), and quicker time to completion (48.63s vs. 72.42s). Those with incomplete injuries had a higher FIM score for the 6-minute walk test (4.56 vs. 4.23), higher WISCI-II scores (9.69 vs. 7.88), carpet FIM scores (4.75 vs. 4.42), and concrete FIM scores (4.81 vs. 4.46). In terms of psychological effects of over-ground walking, there was an upward trend noted for the positive affect scores, and a downward trend for the negative affect scores. As a group, all study participants reported moderate to high levels of comfort and satisfaction whilst using the device.

Conclusion:
This is the first study to examine the safety and efficacy of the Suitx Phoenix exoskeleton for ambulation by spinal cord injury patients. We have shown that the Phoenix is efficacious in allowing patients to perform all walking tasks and transitional movements and comparable to other published exoskeleton trials. This study also demonstrated a high safety-profile of the device, with no falls, no adverse events, and relatively few minor complaints.

Introduction: In translational spinal cord injury (SCI) research, the proper definition of inclusion criteria decides to a large extent, whether the endpoints of a trial investigating a new intervention will be successfully met or not. One of the most important aspects is the selection of appropriate study participants. Since the number of eligible patients is limited, a detailed, comprehensive and well-balanced decision strategy for the inclusion is required. However, this is rather challenging since the population of patients with SCI is represented in a highly heterogeneous manner regarding the type and severity of injury and the potential for neurological or functional recovery over the course of rehabilitation in particular in respect to walking function. A special group of interest are patients with cervical injuries, in whom incomplete lesions are more frequent than in thoracolumbar injuries.

Objective: Identification and stratification of homogeneous study participant cohorts focusing on lower extremity function and understanding the underlying conditions of the identified cohorts.

Methods: Data from patients with cervical SCI from the European Multicenter study about Spinal Cord Injury (EMSCI) was analysed. An unbiased recursive partitioning conditional inference tree (URP CTREE) analysis was performed to provide a prediction-based outcome stratification algorithm. The 6-minute walking test (6minWT) at 6 months after injury was predicted using clinical assessments (ISNCSCI) collected 2 weeks after injury. Reliability and stability of the computed algorithm were validated using an independent, external dataset. Further, the underlying conditions (different available functional outcomes at 2 weeks, 1, 3 and 6 months after injury) were analysed in the stratified subgroups.

Results: Based on clinical assessments, URP CTREE predicted and stratified a given heterogeneous SCI population of 309 patients into 7 homogeneous cohorts in relation to the functional outcome 6minWT. Further analysis of the underlying conditions across the identified cohorts emphasized differences in the characteristics of the included functional outcomes (lower extremity motor score, spinal cord independence measure, 6minWT & 10-meter walking test) over the course of rehabilitation.
The external validation of the prediction algorithm provided similar distributions within all subgroups of the original prediction.

Conclusion: Homogeneous study participant cohorts, with a focus on lower extremity function, can be stratified using the method of URP CTREE. The subsequent analysis of the underlying conditions of the identified cohorts provides additional information, leading to a better understanding of the different recovery patterns. Based on modelled predictions, stratification rules and appreciation of underlying clinical conditions the inclusiveness in clinical trials can be enhanced by enabling parallel cohort designs.