Validity and reliability of the 2-minute walk test in individuals with spinal cord injury.

STUDY DESIGN: Multicentre-observational study. OBJECTIVES: The 6-minute walk test (6mWT) is an established assessment of walking function in individuals with spinal cord injury (SCI). However, walking 6 min can be demanding for severely impaired individuals. The 2-minute walk test (2mWT) could be an appropriate alternative that has already been validated in other neurological disorders. The aim of this study was to assess construct validity and test-rest reliability of the 2mWT in individuals with SCI. In addition, the influence of walking performance on sensitivity to change of the 2mWT was assessed. SETTING: Swiss Paraplegic Center Nottwil, Switzerland; Balgrist University Hospital, Zürich, Switzerland. METHODS: Fifty individuals (aged 18-79) with SCI (neurological level of injury: C1-L3, AIS: A-D) were assessed on two test days separated by 1 to 7 days. The first assessment consisted of a 2mWT familiarization, followed by a 2mWT and 10-meter walk test (10MWT) (including the Walking Index for Spinal Cord Injury (WISCI II)) in randomized order. The second assessment consisted of 2mWT and 6mWT in randomized order. Tests were separated by at least 30 min of rest. RESULTS: The interclass correlation coefficient between the 2mWT assessed on the first and second test day was excellent (r = 0.980, p < 0.001). The 2mWT correlated very strongly with the 6mWT (r = 0.992, p < 0.001) and the 10MWT (r = 0.964, p < 0.001), and moderately with the WISCI II (r = 0.571, p < 0.001). Sensitivity to change was slightly affected by walking performance. CONCLUSION: The 2mWT is a valid and reliable alternative to the 6mWT to measure walking function in individuals with SCI. TRIAL REGISTRATION: NCT04555759.

Validation of Non-Restrictive Inertial Gait Analysis of Individuals with Incomplete Spinal Cord Injury in Clinical Settings.

Inertial Measurement Units (IMUs) have gained popularity in gait analysis and human motion tracking, and they provide certain advantages over stationary line-of-sight-dependent Optical Motion Capture (OMC) systems. IMUs appear as an appropriate alternative solution to reduce dependency on bulky, room-based hardware and facilitate the analysis of walking patterns in clinical settings and daily life activities. However, most inertial gait analysis methods are unpractical in clinical settings due to the necessity of precise sensor placement, the need for well-performed calibration movements and poses, and due to distorted magnetometer data in indoor environments as well as nearby ferromagnetic material and electronic devices. To address these limitations, recent literature has proposed methods for self-calibrating magnetometer-free inertial motion tracking, and acceptable performance has been achieved in mechanical joints and in individuals without neurological disorders. However, the performance of such methods has not been validated in clinical settings for individuals with neurological disorders, specifically individuals with incomplete Spinal Cord Injury (iSCI). In the present study, we used recently proposed inertial motion-tracking methods, which avoid magnetometer data and leverage kinematic constraints for anatomical calibration. We used these methods to determine the range of motion of the Flexion/Extension (F/E) hip and Abduction/Adduction (A/A) angles, the F/E knee angles, and the Dorsi/Plantar (D/P) flexion ankle joint angles during walking. Data (IMU and OMC) of five individuals with no neurological disorders (control group) and five participants with iSCI walking for two minutes on a treadmill in a self-paced mode were analyzed. For validation purposes, the OMC system was considered as a reference. The mean absolute difference (MAD) between calculated range of motion of joint angles was 5.00°, 5.02°, 5.26°, and 3.72° for hip F/E, hip A/A, knee F/E, and ankle D/P flexion angles, respectively. In addition, relative stance, swing, double support phases, and cadence were calculated and validated. The MAD for the relative gait phases (stance, swing, and double support) was 1.7%, and the average cadence error was 0.09 steps/min. The MAD values for RoM and relative gait phases can be considered as clinically acceptable. Therefore, we conclude that the proposed methodology is promising, enabling non-restrictive inertial gait analysis in clinical settings.

Reliability of patient-specific gait profiles with inertial measurement units during the 2-min walk test in incomplete spinal cord injury.

Most established clinical walking tests assess specific aspects of movement function (velocity, endurance, etc.) but are generally unable to determine specific biomechanical or neurological deficits that limit an individual's ability to walk. Recently, inertial measurement units (IMU) have been used to collect objective kinematic data for gait analysis and could be a valuable extension for clinical assessments (e.g., functional walking measures). This study assesses the reliability of an IMU-based overground gait analysis during the 2-min walk test (2mWT) in individuals with spinal cord injury (SCI). Furthermore, the study elaborates on the capability of IMUs to distinguish between different gait characteristics in individuals with SCI. Twenty-six individuals (aged 22-79) with acute or chronic SCI (AIS: C and D) completed the 2mWT with IMUs attached above each ankle on 2 test days, separated by 1 to 7 days. The IMU-based gait analysis showed good to excellent test-retest reliability (ICC: 0.77-0.99) for all gait parameters. Gait profiles remained stable between two measurements. Sensor-based gait profiling was able to reveal patient-specific gait impairments even in individuals with the same walking performance in the 2mWT. IMUs are a valuable add-on to clinical gait assessments and deliver reliable information on detailed gait pathologies in individuals with SCI.Trial registration: NCT04555759.

Deep brain stimulation for locomotion in incomplete human spinal cord injury (DBS-SCI): protocol of a prospective one-armed multi-centre study.

INTRODUCTION: Spinal cord injury (SCI) is a devastating condition with immediate impact on the individual's health and quality of life. Major functional recovery reaches a plateau 3-4 months after injury despite intensive rehabilitative training. To enhance training efficacy and improve long-term outcomes, the combination of rehabilitation with electrical modulation of the spinal cord and brain has recently aroused scientific interest with encouraging results. The mesencephalic locomotor region (MLR), an evolutionarily conserved brainstem locomotor command and control centre, is considered a promising target for deep brain stimulation (DBS) in patients with SCI. Experiments showed that MLR-DBS can induce locomotion in rats with spinal white matter destructions of >85%. METHODS AND ANALYSIS: In this prospective one-armed multi-centre study, we investigate the safety, feasibility, and therapeutic efficacy of MLR-DBS to enable and enhance locomotor training in severely affected, subchronic and chronic American Spinal Injury Association Impairment Scale C patients in order to improve functional recovery. Patients undergo an intensive training programme with MLR-DBS while being regularly followed up until 6 months post-implantation. The acquired data of each timepoint are compared with baseline while the primary endpoint is performance in the 6-minute walking test. The clinical trial protocol was written in accordance with the Standard Protocol Items: Recommendations for Interventional Trials checklist. ETHICS AND DISSEMINATION: This first in-man study investigates the therapeutic potential of MLR-DBS in SCI patients. One patient has already been implanted with electrodes and underwent MLR stimulation during locomotion. Based on the preliminary results which promise safety and feasibility, recruitment of further patients is currently ongoing. Ethical approval has been obtained from the Ethical Committee of the Canton of Zurich (case number BASEC 2016-01104) and Swissmedic (10000316). Results will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: NCT03053791.

Energy expenditure during an exercise training session for cardiac patients.

Increasing energy expenditure (EE) in cardiac patients remains a challenge. Exercise approaches in cardiac rehabilitation/secondary prevention programs (CR/SP) have consistently resulted in minimal weight loss, due in part to the low exercise-related EE. The purpose of this study was to measure the EE among patients participating in a routine exercise session of Phase III maintenance CR/SP, where a recreational activity was introduced. Twelve overweight/obese male patients with coronary artery disease (aged 62.6 ± 8.5 years) had their total EE measured during a combined aerobic (circuit workout (ACW) and recreational activity) and resistance training (RT) session using a portable gas analyzer. Subjects were instructed to exercise at 60%-70% of heart rate reserve. Activity EE was calculated from total EE and resting EE. The duration of the session was 75.3 ± 1.5 min, of which 59.7 ± 8.8 min were above moderate intensity (3-6 METs). Activity EE was 309 ± 76 kcal, concurring to a total EE of 457 ± 80 kcal (3.9 ± 0.8 METs-h). ACW, recreational activity, and RT fulfilled 34.4% ± 6.4%, 25.0% ± 5.3%, and 14.2% ± 2.7% of the activity EE, respectively. Absolute intensities (METs) were significantly different between the RT (3.9 ± 1.0) and the ACW (6.9 ± 1.8) and recreational activity (5.9 ± 0.8). In conclusion, a combined aerobic and resistance training following standard exercise prescription practices, coupled with a recreational activity, is an effective tool to promote exercise above moderate intensity in male coronary artery disease patients. Clinicians can adopt concepts from recreational activity to develop CR/SP sessions.