Efficacy of Walking Adaptability Training on Walking Capacity in Ambulatory People With Motor Incomplete Spinal Cord Injury: A Multicenter Pragmatic Randomized Controlled Trial.

BACKGROUND AND OBJECTIVE: Balance and walking capacity are often impaired in people with motor incomplete spinal cord injury (iSCI), frequently resulting in reduced functional ambulation and participation. This study aimed to assess the efficacy of walking adaptability training compared to similarly dosed conventional locomotor and strength training for improving walking capacity, functional ambulation, balance confidence, and participation in ambulatory people with iSCI. METHODS: We conducted a 2-center, parallel-group, pragmatic randomized controlled trial. Forty-one people with iSCI were randomized to 6 weeks of (i) walking adaptability training (11 hours of Gait Real-time Analysis Interactive Lab (GRAIL) training-a treadmill in a virtual reality environment) or (ii) conventional locomotor and strength training (11 hours of treadmill training and lower-body strength exercises). The primary measure of walking capacity was maximal walking speed, measured with an overground 2-minute walk test. Secondary outcome measures included the Spinal Cord Injury Functional Ambulation Profile (SCI-FAP), the Activities-specific Balance Confidence (ABC) scale, and the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P). RESULTS: No significant difference in maximal walking speed between the walking adaptability (n = 17) and conventional locomotor and strength (n = 18) training groups was found 6 weeks after training at follow-up (-0.05 m/s; 95% CI = -0.12-0.03). In addition, no significant group differences in secondary outcomes were found. However, independent of intervention, significant improvements over time were found for maximal walking speed, SCI-FAP, ABC, and USER-P restrictions scores. Conclusions. Our findings suggest that walking adaptability training may not be superior to conventional locomotor and strength training for improving walking capacity, functional ambulation, balance confidence, or participation in ambulatory people with iSCI. TRIAL REGISTRATION: Dutch Trial Register; Effect of GRAIL training in iSCI.

Needs and wishes for the future lower limb exoskeleton: an interview study among people with spinal cord injury with community-based exoskeleton experience.

PURPOSE: Exoskeleton use by people with complete spinal cord injury (SCI) in daily life is challenging. To optimize daily exoskeleton use, a better understanding of the purpose of use and the accompanying improvements are needed. The perspective of experienced exoskeleton users could guide design improvements. METHODS: Face-to-face semi-structured interviews were held with 13 people with SCI with exoskeleton experience. Interviews were audio-taped, transcribed, and analysed thematically. RESULTS: Participants expressed three future purposes of exoskeleton use: for daily activities (e.g., stair climbing), exercise (e.g., staying healthy), and social interaction (e.g., standing at parties). Exoskeleton use during daily activities was the ultimate goal. Therefore, the future exoskeleton should be: easy to use, small and lightweight, tailor made, safe, comfortable, less distinctive, durable, and affordable. Improving the ease of use was relevant for all purposes, for all participants. The other suggestions for improvement varied depending on the purpose of use and the participant. CONCLUSION: Increasingly more advanced improvements are needed to transition from an exercise purpose to social interaction, and ultimately use during daily activities. In the current study, detailed suggestions for improvements have been made. Only when multiple of these suggestions are adjusted, can the exoskeleton be used to its full potential.IMPLICATIONS FOR REHABILITATIONThe use of an exoskeleton by people with a complete spinal cord injury in daily life is still in its infancy.To optimize daily exoskeleton use, a better understanding of the purpose of use and exoskeleton improvements is needed.More advanced improvements to future exoskeletons are needed to make a transition from use as an exercise device to use during social interaction and daily activities.Improving the ease of use of future exoskeletons is considered a priority by experienced users, followed by making the exoskeleton small, lightweight, and tailor made.

Improvement of quality of life after 2-month exoskeleton training in patients with chronic spinal cord injury.

OBJECTIVE: To examine changes in quality of life (QoL) after an eight-week period of robotic exoskeleton training in a homogeneous group of patients with chronic complete spinal cord injury (SCI). DESIGN: Prospective single-group pre-post study. SETTING: Rehabilitation center. PARTICIPANTS: Patients with a chronic (>6 months) motor complete SCI (T1-L1). INTERVENTION: Twenty-four training sessions with the ReWalk exoskeleton over an eight-week period. MAIN OUTCOME MEASURE: QoL, assessed with the sum score of the Short Form-36 with Walk Wheel modification (SF-36ww). Secondary outcome measures were the eight SF-36ww subdomains, satisfaction with bladder and bowel management, lower extremity joint passive range of motion (pROM), and lower extremity spasticity. RESULTS: Twenty-one participants completed the training. QoL significantly improved after the training period (average SF-36 sum score 621 ± 90) compared to baseline (571 ± 133) (t(20)=-2.5, P=.02). Improvements were seen on the SF-36ww subdomains for pain (P=.003), social functioning (P=.03), mental health (P=.02), and general health perception (P=.01). Satisfaction with bladder management (range 1-5) improved from median 3 at baseline to 4 after exoskeleton training (P=0.01). No changes in satisfaction with bowel management (P=.11), pROM (hip-extension (P=.49), knee-extension (P=.36), ankle dorsiflexion (P=.69)), or spasticity (P=.94) were found. CONCLUSION: Even in patients with chronic motor complete SCI and a relatively high level of QoL at baseline, a short-term exoskeleton training improved their QoL, pain and satisfaction with bladder management; findings that warrant further controlled studies in this specific SCI population.

Predictors of exoskeleton motor learning in spinal cord injured patients.

PURPOSE OF THE ARTICLE: Learning to use an exoskeleton is time consuming and diverse between users. Knowledge about trainability of exoskeleton skills is relevant for planning and expectation management. The objective was to assess predictors of exoskeleton skill performance during and after exoskeleton training. MATERIALS AND METHODS: Twenty-four participants with a motor complete spinal cord injury were given 24 training sessions in 8 weeks. Nine potential predictors were identified: lesion level, age, gender, age at injury, time since injury, BMI, sport, active lifestyle, and anxiety. Univariate and multivariate linear regression analyses were performed to examine predictors of skill performance after 2, 4, 6, and 8 weeks. RESULTS AND CONCLUSIONS: Twenty participants completed the training. Univariate analysis revealed that positive predictors were: low lesion level and more active lifestyle after 2 weeks, whereas low age at injury, low BMI, and more active lifestyle were positive predictors after 6 weeks. Multivariate regression model explained 65% of the performance after 2 weeks (predictors: lesion level, anxiety, active lifestyle) and 66% after 6 weeks (predictors: BMI, active lifestyle, age). Lesion level was a predictor during the first 4 weeks, but did not influence participants' final skill level. BMI, age, and active lifestyle were predictors toward the end of the training period.Implications for rehabilitationWith the help of wearable exoskeletons people with a complete spinal cord injury can regain their standing and walking mobility.Learning to use an exoskeleton is time consuming and the number of training sessions required to walk independently differs greatly between users.This study shows that lesion level was an important predictor of exoskeleton motor learning in the first 4 weeks of training.BMI, age, and active lifestyle were predictors of exoskeleton skill performance toward the end of the 8 week training period.

Exoskeleton home and community use in people with complete spinal cord injury.

A consequence of a complete spinal cord injury (SCI) is the loss of gait capacity. Wearable exoskeletons for the lower extremity enable household and community ambulation in people with SCI. This study assessed the amount, purpose, and location of exoskeleton use in the home and community environment, without any restrictions. The number of steps taken was read from the exoskeleton software. Participants kept a daily logbook, and completed two user experience questionnaires (Quebec User Evaluation of Satisfaction with assistive Technology (D-QUEST) and System Usability Scale (SUS)). Fourteen people with a complete SCI used the ReWalk exoskeleton a median of 9 (range [1-15]) out of 16 ([12-21]) days, in which participants took a median of 3,226 ([330-28,882]) steps. The exoskeleton was mostly used for exercise purposes (74%) and social interaction (20%). The main location of use was outdoors (48%). Overall, participants were satisfied with the exoskeleton (D-QUEST 3.7 ± 0.4) and its usability (SUS 72.5 [52.5-95.0]). Participants with complete SCI report satisfaction with the exoskeleton for exercise and social interaction in the home and community, but report limitations as an assistive device during daily life.

Gait Stability Training in a Virtual Environment Improves Gait and Dynamic Balance Capacity in Incomplete Spinal Cord Injury Patients.

Many patients with incomplete spinal cord injury (iSCI) have impaired gait and balance capacity, which may impact daily functioning. Reduced walking speed and impaired gait stability are considered important underlying factors for reduced daily functioning. With conventional therapy, patients are limited in training gait stability, but this can be trained on a treadmill in a virtual environment, such as with the Gait Real-time Analysis Interactive Lab (GRAIL). Our objective was to evaluate the effect of 6-weeks GRAIL-training on gait and dynamic balance in ambulatory iSCI patients. In addition, the long-term effect was assessed. Fifteen patients with chronic iSCI participated. The GRAIL training consisted of 12 one-hour training sessions during a 6-week period. Patients performed 2 minute walking tests on the GRAIL in a self-paced mode at the 2nd, and 3rd (baseline measurements) and at the 12th training session. Ten patients performed an additional measurement after 6 months. The primary outcome was walking speed. Secondary outcomes were stride length, stride frequency, step width, and balance confidence. In addition, biomechanical gait stability measures based on the position of the center of mass (CoM) or the extrapolated center of mass (XCoM) relative to the center of pressure (CoP) or the base of support (BoS) were derived: dynamic stability margin (DSM), XCoM-CoP distance in anterior-posterior (AP) and medial-lateral (ML) directions, and CoM-CoP inclination angles in AP and ML directions. The effect of GRAIL-training was tested with a one-way repeated measures ANOVA (α = 0.05) and post-hoc paired samples t-tests (α = 0.017). Walking speed was higher after GRAIL training (1.04 m/s) compared to both baseline measurements (0.85 and 0.93 m/s) (p < 0.001). Significant improvements were also found for stride length (p < 0.001) and stability measures in AP direction (XCoM-CoPAP (p < 0.001) and CoM-CoPAP-angle (p < 0.001)). Stride frequency (p = 0.27), step width (p = 0.19), and stability measures DSM (p = 0.06), XCoM-CoPML (p = 0.97), and CoM-CoPML-angle (p = 0.69) did not improve. Balance confidence was increased after GRAIL training (p = 0.001). The effects were remained at 6 months. Increased walking speed, stride length, AP gait stability, and balance confidence suggest that GRAIL-training improves gait and dynamic balance in patients with chronic iSCI. In contrast, stability measures in ML direction did not respond to GRAIL-training.

A Framework for Measuring the Progress in Exoskeleton Skills in People with Complete Spinal Cord Injury.

For safe application of exoskeletons in people with spinal cord injury at home or in the community, it is required to have completed an exoskeleton training in which users learn to perform basic and advanced skills. So far, a framework to test exoskeleton skills is lacking. The aim of this study was to develop and test the hierarchy and reliability of a framework for measuring the progress in the ability to perform basic and advanced skills. Twelve participants with paraplegia were given twenty-four training sessions in 8 weeks with the Rewalk-exoskeleton. During the 2nd, 4th, and 6th training week the Intermediate-skills-test was performed consisting of 27 skills, measured in an hierarchical order of difficulty, until two skills were not achieved. When participants could walk independently, the Final-skills-test, consisting of 20 skills, was performed in the last training session. Each skill was performed at least two times with a maximum of three attempts. As a reliability measure the consistency was used, which was the number of skills performed the same in the first two attempts relative to the total number. Ten participants completed the training program. Their number of achieved intermediate skills was significantly different between the measurements XF2(2) = 12.36, p = 0.001. Post-hoc analysis revealed a significant increase in the median achieved intermediate skills from 4 [1-7] at the first to 10.5 [5-26] at the third Intermediate-skills-test. The rate of participants who achieved the intermediate skills decreased and the coefficient of reproducibility was 0.98. Eight participants met the criteria to perform the Final-skills-test. Their median number of successfully performed final skills was 16.5 [13-20] and 17 [14-19] skills in the first and second time. The overall consistency of >70% was achieved in the Intermediate-skills-test (73%) and the Final-skills-test (81%). Eight out of twelve participants experienced skin damage during the training, in four participants this resulted in missed training sessions. The framework proposed in this study measured the progress in performing basic and advanced exoskeleton skills during a training program. The hierarchical ordered skills-test could discriminate across participants' skill-level and the overall consistency was considered acceptable.