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.

Examining the role of intrinsic and reflexive contributions to ankle joint hyper-resistance treated with botulinum toxin-A.

BACKGROUND: Spasticity, i.e. stretch hyperreflexia, increases joint resistance similar to symptoms like hypertonia and contractures. Botulinum neurotoxin-A (BoNT-A) injections are a widely used intervention to reduce spasticity. BoNT-A effects on spasticity are poorly understood, because clinical measures, e.g. modified Ashworth scale (MAS), cannot differentiate between the symptoms affecting joint resistance. This paper distinguishes the contributions of the reflexive and intrinsic pathways to ankle joint hyper-resistance for participants treated with BoNT-A injections. We hypothesized that the overall joint resistance and reflexive contribution decrease 6 weeks after injection, while returning close to baseline after 12 weeks. METHODS: Nine participants with spasticity after spinal cord injury or after stroke were evaluated across three sessions: 0, 6 and 12 weeks after BoNT-A injection in the calf muscles. Evaluation included clinical measures (MAS, Tardieu Scale) and motorized instrumented assessment using the instrumented spasticity test (SPAT) and parallel-cascade (PC) system identification. Assessments included measures for: (1) overall resistance from MAS and fast velocity SPAT; (2) reflexive resistance contribution from Tardieu Scale, difference between fast and slow velocity SPAT and PC reflexive gain; and (3) intrinsic resistance contribution from slow velocity SPAT and PC intrinsic stiffness/damping. RESULTS: Individually, the hypothesized BoNT-A effect, the combination of a reduced resistance (week 6) and return towards baseline (week 12), was observed in the MAS (5 participants), fast velocity SPAT (2 participants), Tardieu Scale (2 participants), SPAT (1 participant) and reflexive gain (4 participants). On group-level, the hypothesis was only confirmed for the MAS, which showed a significant resistance reduction at week 6. All instrumented measures were strongly correlated when quantifying the same resistance contribution. CONCLUSION: At group-level, the expected joint resistance reduction due to BoNT-A injections was only observed in the MAS (overall resistance). This observed reduction could not be attributed to an unambiguous group-level reduction of the reflexive resistance contribution, as no instrumented measure confirmed the hypothesis. Validity of the instrumented measures was supported through a strong association between different assessment methods. Therefore, further quantification of the individual contributions to joint resistance changes using instrumented measures across a large sample size are essential to understand the heterogeneous response to BoNT-A injections.

Impaired foot placement strategy during walking in people with incomplete spinal cord injury.

BACKGROUND: Impaired balance during walking is a common problem in people with incomplete spinal cord injury (iSCI). To improve walking capacity, it is crucial to characterize balance control and how it is affected in this population. The foot placement strategy, a dominant mechanism to maintain balance in the mediolateral (ML) direction during walking, can be affected in people with iSCI due to impaired sensorimotor control. This study aimed to determine if the ML foot placement strategy is impaired in people with iSCI compared to healthy controls. METHODS: People with iSCI (n = 28) and healthy controls (n = 19) performed a two-minute walk test at a self-paced walking speed on an instrumented treadmill. Healthy controls performed one extra test at a fixed speed set at 50% of their preferred speed. To study the foot placement strategy of a participant, linear regression was used to predict the ML foot placement based on the ML center of mass position and velocity. The accuracy of the foot placement strategy was evaluated by the root mean square error between the predicted and actual foot placements and was referred to as foot placement deviation. Independent t-tests were performed to compare foot placement deviation of people with iSCI versus healthy controls walking at two different walking speeds. RESULTS: Foot placement deviation was significantly higher in people with iSCI compared to healthy controls independent of walking speed. Participants with iSCI walking in the self-paced condition exhibited 0.40 cm (51%) and 0.33 cm (38%) higher foot placement deviation compared to healthy controls walking in the self-paced and the fixed-speed 50% condition, respectively. CONCLUSIONS: Higher foot placement deviation in people with iSCI indicates an impaired ML foot placement strategy in individuals with iSCI compared to healthy controls.

Using Sensor Technology to Measure Gait Capacity and Gait Performance in Rehabilitation Inpatients with Neurological Disorders.

The aim of this study was to objectively assess and compare gait capacity and gait performance in rehabilitation inpatients with stroke or incomplete spinal cord injury (iSCI) using inertial measurement units (IMUs). We investigated how gait capacity (what someone can do) is related to gait performance (what someone does). Twenty-two inpatients (11 strokes, 11 iSCI) wore ankle positioned IMUs during the daytime to assess gait. Participants completed two circuits to assess gait capacity. These were videotaped to certify the validity of the IMU algorithm. Regression analyses were used to investigate if gait capacity was associated with gait performance (i.e., walking activity and spontaneous gait characteristics beyond therapy time). The ankle positioned IMUs validly assessed the number of steps, walking time, gait speed, and stride length (r ≥ 0.81). The walking activity was strongly (r ≥ 0.76) related to capacity-based gait speed. Maximum spontaneous gait speed and stride length were similar to gait capacity. However, the average spontaneous gait speed was half the capacity-based gait speed. Gait capacity can validly be assessed using IMUs and is strongly related to gait performance in rehabilitation inpatients with neurological disorders. Measuring gait performance with IMUs provides valuable additional information about walking activity and spontaneous gait characteristics to inform about functional recovery.

Standard set of network outcomes for traumatic spinal cord injury: a consensus-based approach using the Delphi method.

STUDY DESIGN: Consensus study. OBJECTIVES: The purpose of this study is to define a standardized (network) outcomes set for traumatic spinal cord injury (t-SCI), covering the patient journey from acute to chronic rehabilitation phase, including patient-relevant outcomes, adequate measurement instruments, as well as case-mix and risk factors. SETTING: Acute Spinal Cord Injury (ASCI) Unit Nijmegen, the Netherlands. METHODS: A modified Delphi method was performed, including a multidisciplinary panel of 19 health-care professionals with experience in t-SCI management. Formal consensus was reached after two web-based surveys, a face-to-face meeting, and a final confirmation round (threshold consensus: 70%). RESULTS: In the first two Delphi rounds, 18/19 invited panelists (94.7%) responded and 10 panelists participated in the final meeting. The prefinal set was confirmed by all panelists. The standard set encompasses the three-tiered outcome hierarchy and consists of patient-reported and clinician-reported outcome domains and measurement instruments. Consensus was reached to include survival, degree of health or recovery, time to recovery, and return to normal activities, disutility of care or treatment process, sustainability of health and nature of recurrences, and long-term consequences of therapy. A measurement schedule was defined as well as for proposed casemix and risk factors, including demographics, clinical status, and treatment process. CONCLUSION: A standard set of network outcomes is developed that could be implemented in hospitals and rehabilitation centers involved in the treatment of t-SCI. Using this standard set, comparison of the quality of care is possible and prognostic prediction of outcomes of treatment is feasible, so that each patient receives the right care at the right time in the right place.

Incidence of urinary tract infection following initiation of intermittent catheterization among patients with recent spinal cord injury in Germany and the Netherlands.

Objective: To assess incidence of urinary tract infection (UTI) among patients with recent spinal cord injury (SCI) who initiated intermittent catheterization (IC).Design: Retrospective chart review.Setting: Two European SCI rehabilitation centers.Participants: Seventy-three consecutive patients with recent SCI who initiated IC.Outcome measures: Incidence of UTI, using six different definitions, each based on microbiology ± symptomatology ± mention of UTI . Rates were expressed in terms of numbers of UTIs per 100 patient-months (PMs). Attention was focused on first-noted UTI during the three-month follow-up, as assessed with each of the six definitions.Results: Fifty-eight percent of patients (n = 33) met ≥1 definitions for UTI during follow-up (rate: 31.5 UTIs per 100 PMs), ranging from 14% (5.3 per 100 PMs; definition requiring bacteriuria, pyuria, and presence of symptoms) to 45% (22.7 per 100 PMs; definition requiring "mention of UTI"). Ten cases were identified using the definition that required bacteriuria, pyuria, and symptoms, whereas definitions that required bacteriuria and either pyuria or symptoms resulted in the identification of 20-25 cases. Median time to UTI ranged from 42 days ("mention of UTI") to 81 days (definition requiring bacteriuria and ≥100 leukocytes/mm3).Conclusion: Depending on definition, 14% to 45% of patients with recent SCI experience UTI within three months of initiating IC. Definitions requiring bacteriuria and either pyuria or symptoms consistently identified about twice as many cases as those that required all three conditions. Standardizing definitions may help improve detection, treatment, and prevention of UTI within this vulnerable population.

Assessment of the Shank-to-Vertical Angle While Changing Heel Heights Using a Single Inertial Measurement Unit in Individuals with Incomplete Spinal Cord Injury Wearing an Ankle-Foot-Orthosis.

Previous research showed that an Inertial Measurement Unit (IMU) on the anterior side of the shank can accurately measure the Shank-to-Vertical Angle (SVA), which is a clinically-used parameter to guide tuning of ankle-foot orthoses (AFOs). However, in this context it is specifically important that differences in the SVA are detected during the tuning process, i.e., when adjusting heel height. This study investigated the validity of the SVA as measured by an IMU and its responsiveness to changes in AFO-footwear combination (AFO-FC) heel height in persons with incomplete spinal cord injury (iSCI). Additionally, the effect of heel height on knee flexion-extension angle and internal moment was evaluated. Twelve persons with an iSCI walked with their own AFO-FC in three different conditions: (1) without a heel wedge (refHH), (2) with 5 mm heel wedge (lowHH) and (3) with 10 mm heel wedge (highHH). Walking was recorded by a single IMU on the anterior side of the shank and a 3D gait analysis (3DGA) simultaneously. To estimate validity, a paired t-test and intraclass correlation coefficient (ICC) between the SVAIMU and SVA3DGA were calculated for the refHH. A repeated measures ANOVA was performed to evaluate the differences between the heel heights. A good validity with a mean difference smaller than 1 and an ICC above 0.9 was found for the SVA during midstance phase and at midstance. Significant differences between the heel heights were found for changes in SVAIMU (p = 0.036) and knee moment (p = 0.020) during the midstance phase and in SVAIMU (p = 0.042) and SVA3DGA (p = 0.006) at midstance. Post-hoc analysis revealed a significant difference between the ref and high heel height condition for the SVAIMU (p = 0.005) and knee moment (p = 0.006) during the midstance phase and for the SVAIMU (p = 0.010) and SVA3DGA (p = 0.006) at the instant of midstance. The SVA measured with an IMU is valid and responsive to changing heel heights and equivalent to the gold standard 3DGA. The knee joint angle and knee joint moment showed concomitant changes compared to SVA as a result of changing heel height.

Bed Sensor Technology for Objective Sleep Monitoring Within the Clinical Rehabilitation Setting: Observational Feasibility Study.

BACKGROUND: Since adequate sleep is essential for optimal inpatient rehabilitation, there is an increased interest in sleep assessment. Unobtrusive, contactless, portable bed sensors show great potential for objective sleep analysis. OBJECTIVE: The aim of this study was to investigate the feasibility of a bed sensor for continuous sleep monitoring overnight in a clinical rehabilitation center. METHODS: Patients with incomplete spinal cord injury (iSCI) or stroke were monitored overnight for a 1-week period during their in-hospital rehabilitation using the Emfit QS bed sensor. Feasibility was examined based on missing measurement nights, coverage percentages, and missing periods of heart rate (HR) and respiratory rate (RR). Furthermore, descriptive data of sleep-related parameters (nocturnal HR, RR, movement activity, and bed exits) were reported. RESULTS: In total, 24 participants (12 iSCI, 12 stroke) were measured. Of the 132 nights, 5 (3.8%) missed sensor data due to Wi-Fi (2), slipping away (1), or unknown (2) errors. Coverage percentages of HR and RR were 97% and 93% for iSCI and 99% and 97% for stroke participants. Two-thirds of the missing HR and RR periods had a short duration of ≤120 seconds. Patients with an iSCI had an average nocturnal HR of 72 (SD 13) beats per minute (bpm), RR of 16 (SD 3) cycles per minute (cpm), and movement activity of 239 (SD 116) activity points, and had 86 reported and 84 recorded bed exits. Patients with a stroke had an average nocturnal HR of 61 (SD 8) bpm, RR of 15 (SD 1) cpm, and movement activity of 136 (SD 49) activity points, and 42 reported and 57 recorded bed exits. Patients with an iSCI had significantly higher nocturnal HR (t18=-2.1, P=.04) and movement activity (t18=-1.2, P=.02) compared to stroke patients. Furthermore, there was a difference between self-reported and recorded bed exits per night in 26% and 38% of the nights for iSCI and stroke patients, respectively. CONCLUSIONS: It is feasible to implement the bed sensor for continuous sleep monitoring in the clinical rehabilitation setting. This study provides a good foundation for further bed sensor development addressing sleep types and sleep disorders to optimize care for rehabilitants.

Feasibility of a Sensor-Based Technological Platform in Assessing Gait and Sleep of In-Hospital Stroke and Incomplete Spinal Cord Injury (iSCI) Patients.

Recovery of the walking function is one of the most common rehabilitation goals of neurological patients. Sufficient and adequate sleep is a prerequisite for recovery or training. To objectively monitor patients' progress, a combination of different sensors measuring continuously over time is needed. A sensor-based technological platform offers possibilities to monitor gait and sleep. Implementation in clinical practice is of utmost relevance and has scarcely been studied. Therefore, this study examined the feasibility of a sensor-based technological platform within the clinical setting. Participants (12 incomplete spinal cord injury (iSCI), 13 stroke) were asked to wear inertial measurement units (IMUs) around the ankles during daytime and the bed sensor was placed under their mattress for one week. Feasibility was established based on missing data, error cause, and user experience. Percentage of missing measurement days and nights was 14% and 4%, respectively. Main cause of lost measurement days was related to missing IMU sensor data. Participants were not impeded, did not experience any discomfort, and found the sensors easy to use. The sensor-based technological platform is feasible to use within the clinical rehabilitation setting for continuously monitoring gait and sleep of iSCI and stroke patients.

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.