A Single Dermatome Clinical Prediction Rule for Independent Walking 1 Year After Spinal Cord Injury.

OBJECTIVE: To derive and validate a simple, accurate CPR to predict future independent walking ability after SCI at the bedside that does not rely on motor scores and is predictive for those initially classified in the middle of the SCI severity spectrum. DESIGN: Retrospective cohort study. Binary variables were derived, indicating degrees of sensation to evaluate predictive value of pinprick and light touch variables across dermatomes. The optimal single sensory modality and dermatome was used to derive our CPR, which was validated on an independent dataset. SETTING: Analysis of SCI Model Systems dataset. PARTICIPANTS: Individuals with traumatic SCI. The data of 3679 participants (N=3679) were included with 623 participants comprising the derivation dataset and 3056 comprising the validation dataset. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Self-reported ability to walk both indoors and outdoors. RESULTS: Pinprick testing at S1 over lateral heels, within 31 days of SCI, accurately identified future independent walkers 1 year after SCI. Normal pinprick in both lateral heels provided good prognosis, any pinprick sensation in either lateral heel provided fair prognosis, and no sensation provided poor prognosis. This CPR performed satisfactorily in the middle SCI severity subgroup. CONCLUSIONS: In this large multi-site study, we derived and validated a simple, accurate CPR using only pinprick sensory testing at lateral heels that predicts future independent walking after SCI.

Non-invasive Transcutaneous Spinal Cord Stimulation Programming Recommendations for the Treatment of Upper Extremity Impairment in Tetraplegia.

OBJECTIVES: This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS) to effectively improve upper extremity function after chronic spinal cord injury (SCI). It proposes a framework to guide stimulation programming decisions for the successful translation of these techniques into the clinic. MATERIALS AND METHODS: Programming data from 60 participants who completed the Up-LIFT trial and from 17 participants who subsequently completed the LIFT Home trial were analyzed. All observations of stimulation amplitudes, frequencies, waveforms, and electrode configurations were examined. The incidence of adverse events and relatedness to stimulation parameters is reported. A comparison of parameter usage across the American Spinal Injury Association Impairment Scale (AIS) subgroups was conducted to evaluate stimulation strategies across participants with varying degrees of sensorimotor preservation. RESULTS: Active (cathodal) electrodes were typically placed between the C3/C4 and C6/C7 spinous processes. Most sessions featured return (anodal) electrodes positioned bilaterally over the anterior superior iliac spine, although clavicular placement was frequently used by 12 participants. Stimulation was delivered with a 10-kHz carrier frequency and typically a 30-Hz burst frequency. Biphasic waveforms were used in 83% of sessions. Average stimulation amplitudes were higher for biphasic waveforms. The AIS B subgroup required significantly higher amplitudes than did the AIS C and D subgroups. Device-related adverse events were infrequent, and not correlated with specific waveforms or amplitudes. Within the home setting, participants maintained their current amplitudes within 1% of the preset values. The suggested stimulation programming framework dictates the following hierarchical order of parameter adjustments: current amplitude, waveform type, active/return electrode positioning, and burst frequency, guided by clinical observations as required. CONCLUSIONS: This analysis summarizes effective stimulation parameters from the trials and provides a decision-making framework for clinical implementation of tSCS for upper extremity functional restoration after SCI. The parameters are aligned with existing literature and proved safe and well tolerated by participants.

Predicting Outdoor Walking 1 Year After Spinal Cord Injury: A Retrospective, Multisite External Validation Study.

BACKGROUND AND PURPOSE: Predicting future outdoor walking ability after spinal cord injury (SCI) is important, as this is associated with community engagement and social participation. A clinical prediction rule (CPR) was derived for predicting outdoor walking 1 year after SCI. While promising, this CPR has not been validated, which is necessary to establish its clinical value. The objective of this study was to externally validate the CPR using a multisite dataset. METHODS: This was a retrospective analysis of US SCI Model Systems data from 12 centers. L3 motor score, L5 motor score, and S1 sensory score were used as predictor variables. The dataset was split into testing and training datasets. The testing dataset was used as a holdout dataset to provide an unbiased estimate of prediction performance. The training dataset was used to determine the optimal CPR threshold through a "leave-one-site-out" cross-validation framework. The primary outcome was self-reported outdoor walking ability 1 year after SCI. RESULTS: A total of 3721 participants' data were included. Using the optimal CPR threshold (CPR ≥ 33 threshold value), we were able to predict outdoor walking 1 year with high cross-validated accuracy and prediction performance. For the entire dataset, area under receiver operator characteristic curve was 0.900 (95% confidence interval: 0.890-0.910; P < 0.0001). DISCUSSION AND CONCLUSIONS: The outdoor walking CPR has been externally validated. Future research should conduct a clinical outcomes and cost-benefit impact analysis for implementing this CPR. Our results support that clinicians may use this 3-variable CPR for prediction of future outdoor walking ability.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A411 ).

Manual Wheelchair Configuration in Unilateral Upper- and Lower-Extremity Propulsion: A Randomized Crossover Study to Assess Effects of Rear Wheel Axle Position and Frame Type.

OBJECTIVE: To evaluate independence and exertion when using a lightweight wheelchair in comparison with ultra-lightweight wheelchairs (rigid and folding) for individuals with brain injury using a hemipropulsion technique. DESIGN: Randomized cross-over. SETTING: Rehabilitation hospital. PARTICIPANTS: Individuals diagnosed with brain injury resulting in hemiplegia using a hemipropulsion technique to mobilize in a manual wheelchair for at least 4 hours per day were recruited for this study. INTERVENTIONS: Eighteen participants were randomly assigned to complete skills and endurance testing in 3 different wheelchair configurations over a 3-week period: lightweight wheelchair; ultra-lightweight folding wheelchair; and ultra-lightweight rigid wheelchair. MAIN OUTCOME MEASURES: The primary outcome in this study was the percentage capacity score from the modified Wheelchair Skills Test 4.1. Secondary outcomes included the Wheelchair Propulsion Test, 100-m Push Test, heart rate, and rate of perceived exertion. RESULTS: Significant differences were found in the Wheelchair Skills Test (total score, low rolling resistance score, and the goal attainment score) favoring the ultra-lightweight wheelchairs over the lightweight wheelchair (P=.002, .001, and .016, respectively). Time to complete the 100-m push test was significantly faster for the ultra-lightweight rigid frame in comparison with the lightweight frame (P=.001; 30.89 seconds faster). Significance differences were not seen with the Wheelchair Propulsion Test measures across any of the wheelchair frames. Heart rate change and of perceived exertion were significantly lower for the ultra-lightweight rigid group in comparison with the lightweight group (P=.006 and .013, respectively). CONCLUSIONS: These data suggest that using an ultra-light weight wheelchair may lead to improved ability to complete wheelchair skills needed for successful mobility and a decrease in the actual and perceived physiological burden associated with propulsion in comparison to a lightweight wheelchair. A rigid frame may also enable faster mobility in comparison to a folding frame when hemi-propelling.

Barriers to driving and psychosocial outcomes after traumatic brain injury.

OBJECTIVE: Examine considerations and perceived barriers to return to driving, and their association with psychosocial outcomes among adults with traumatic brain injury (TBI) who were not driving. METHODS: 174 adults with moderate-to-severe TBI enrolled in the TBI Model System participated in this cross-sectional study. All participants were drivers prior to their TBI. Outcome measures included the Barriers to Driving Questionnaire, Disability Rating Scale, Patient Health Questionnaire-9, General Anxiety Disorder-7, and Satisfaction With Life Scale. Descriptive analyses examined considerations and barriers to driving, including differences associated with demographic characteristics. Moderation analyses investigated the extent to which disability moderated the relationship between barriers and psychosocial outcomes. RESULTS: Social barriers were the most strongly endorsed domain, whereas physical barriers were endorsed least. The profile of endorsements differed for men and women, and for Black and White participants, on both theoretical considerations in returning to drive and experiences of barriers in doing so. Disability level moderated the relationship between barriers to driving and depression and life satisfaction, but not anxiety. CONCLUSION: The experience of barriers to driving is differentially associated with psychosocial outcomes among nondriving adults with TBI. Adults with low disability appear to be at risk for distress, even compared to other nondrivers.

Cost-effectiveness analysis of overground robotic training versus conventional locomotor training in people with spinal cord injury.

BACKGROUND: Few, if any estimates of cost-effectiveness for locomotor training strategies following spinal cord injury (SCI) are available. The purpose of this study was to estimate the cost-effectiveness of locomotor training strategies following spinal cord injury (overground robotic locomotor training versus conventional locomotor training) by injury status (complete versus incomplete) using a practice-based cohort. METHODS: A probabilistic cost-effectiveness analysis was conducted using a prospective, practice-based cohort from four participating Spinal Cord Injury Model System sites. Conventional locomotor training strategies (conventional training) were compared to overground robotic locomotor training (overground robotic training). Conventional locomotor training included treadmill-based training with body weight support, overground training, and stationary robotic systems. The outcome measures included the calculation of quality adjusted life years (QALYs) using the EQ-5D and therapy costs. We estimate cost-effectiveness using the incremental cost utility ratio and present results on the cost-effectiveness plane and on cost-effectiveness acceptability curves. RESULTS: Participants in the prospective, practice-based cohort with complete EQ-5D data (n = 99) qualified for the analysis. Both conventional training and overground robotic training experienced an improvement in QALYs. Only people with incomplete SCI improved with conventional locomotor training, 0.045 (SD 0.28), and only people with complete SCI improved with overground robotic training, 0.097 (SD 0.20). Costs were lower for conventional training, $1758 (SD $1697) versus overground robotic training $3952 (SD $3989), and lower for those with incomplete versus complete injury. Conventional overground training was more effective and cost less than robotic therapy for people with incomplete SCI. Overground robotic training was more effective and cost more than conventional training for people with complete SCI. The incremental cost utility ratio for overground robotic training for people with complete spinal cord injury was $12,353/QALY. CONCLUSIONS: The most cost-effective locomotor training strategy for people with SCI differed based on injury completeness. Conventional training was more cost-effective than overground robotic training for people with incomplete SCI. Overground robotic training was more cost-effective than conventional training for people with complete SCI. The effect estimates may be subject to limitations associated with small sample sizes and practice-based evidence methodology. These estimates provide a baseline for future research.

Enhancing Self-Advocacy After Traumatic Brain Injury: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the efficacy of a novel intervention aimed at enhancing self-advocacy in individuals living with traumatic brain injury (TBI). SETTING: Community. PARTICIPANTS: Sixty-seven (35 allocated to treatment, 32 to control) community-dwelling adults 9 months or more post-TBI (mean of 8.9 years postinjury); previously discharged from inpatient or outpatient TBI rehabilitation; able to travel independently in the community, indicating a level of independence needed to engage in self-advocacy. DESIGN: Longitudinal randomized 2-arm controlled trial (NCT no. 03385824). Computer-generated block randomization allocated participants to treatment/intervention or control/no-intervention. All outcome assessments completed by blinded study staff. INTERVENTION: A manualized group intervention, Self-Advocacy for Independent Life (SAIL), addressing the self-efficacy beliefs, knowledge, and skills for self-advocacy following TBI. MAIN OUTCOME MEASURES: The Self-Advocacy Scale (SAS) (primary); General Self-Efficacy Scale (GSE); Personal Advocacy Activity Scale (PAAS); Satisfaction With Life Scale (SWLS). RESULTS: The treatment group showed significantly greater improvement than controls from baseline to posttreatment on the primary measure (SAS) of self-efficacy specific to self-advocacy after TBI (effect size = 0.22). Similar improvements were found on secondary measures of general self-efficacy and satisfaction with life from baseline to posttreatment. However, significant between-groups gains for primary and secondary measures were not maintained over 6- and 12-week follow-up. CONCLUSIONS: Individuals living with chronic TBI sequelae can increase self-efficacy specific to self-advocacy, general self-efficacy, and satisfaction with life, through a TBI-specific intervention aimed at empowering individuals to advocate for their own needs and wishes. Sustaining gains over time may require ongoing community collaboration and support. This could involve community-based systems of self-advocacy education, resources, and peer support.

Feasibility of virtual reality and treadmill training in traumatic brain injury: a randomized controlled pilot trial.

OBJECTIVE: To evaluate the safety and efficacy of treadmill training with virtual reality compared to treadmill training alone and standard of care balance and mobility treatment in chronic traumatic brain injury (TBI). PARTICIPANTS AND DESIGN: Thirty-one individuals with chronic TBI with self-reported and objective balance deficits participated in a 4-week 12 session intervention of treadmill training with virtual reality, treadmill training alone, or standard of care overground therapy. OUTCOME MEASURES: Primary measures included recruitment and enrollment rates, retention, tolerance to intervention, completeness of outcome measures, and adverse events. Secondary measures included the Community Balance and Mobility Scale, 10 Meter Walk Test, 6 Minute Walk Test, and Timed Up and Go. RESULTS: No serious adverse events were reported. All participants completed all training sessions and assessments at all time points. Recruitment, enrollment, and retention rates were high. All groups showed a trend toward improvement in all balance and mobility measures following treatment. CONCLUSION: Virtual reality and treadmill training are safe and feasibile for individuals with TBI. Participants show improvements on balance and mobility measures following a 4-week intervention. Future research is needed to evaluate the efficacy of this intervention compared to other modes of balance and mobility training.

Results From a Randomized Controlled Trial to Address Balance Deficits After Traumatic Brain Injury.

OBJECTIVE: To evaluate the efficacy of an in-home 12-week physical therapy (PT) intervention that utilized a virtual reality (VR) gaming system to improve balance in individuals with traumatic brain injury (TBI). SETTING: Home-based exercise program (HEP). PARTICIPANTS: Individuals (N=63; traditional HEP n=32; VR n=31) at least 1 year post-TBI, ambulating independently within the home, not currently receiving PT services. MAIN OUTCOME MEASURES: Primary: Community Balance and Mobility Scale (CB&M); Secondary: Balance Evaluation Systems Test (BESTest), Activities-Specific Balance Confidence Scale (ABC), Participation Assessment with Recombined Tools-Objective (PART-O). RESULTS: No significant between-group differences were observed in the CB&M over the study duration (P=.9983) for individuals who received VR compared to those who received a HEP to address balance deficits after chronic TBI nor in any of the secondary outcomes: BESTest (P=.8822); ABC (P=.4343) and PART-O (P=.8822). However, both groups demonstrated significant improvements in CB&M and BESTest from baseline to 6, 12, and at 12 weeks follow-up (all P's <.001). Regardless of treatment group, 52% of participants met or exceeded the minimal detectable change of 8 points on the CB&M at 24 weeks and 38% met or exceeded the minimal detectable change of 7.81 points on the BESTest. CONCLUSION: This study did not find that VR training was more beneficial than a traditional HEP for improving balance. However, individuals with chronic TBI in both treatment groups demonstrated improvements in balance in response to these interventions which were completed independently in the home environment.

Balance in chronic traumatic brain injury: correlations between clinical measures and a self-report measure.

OBJECTIVE: To assess associations among commonly used self-report and clinical measures of balance in chronic TBI. DESIGN: Cross-sectional analysis of balance in a convenience sample of individuals at least one year post TBI. MAIN OUTCOME MEASURES: Activities-Specific Balance Confidence Scale (ABC) (self-reported balance impairment), Community Balance and Mobility Scale (CB&M) (clinical measure validated in TBI), and Balance Evaluation Systems Test (BESTest) (clinical measure not validated in TBI). METHODS: Fifty-nine individuals (64% male, mean age 48.2 years) ambulating independently within the home participated in testing. Pearson correlation coefficients were used to quantify the direction and magnitude of the relationships among the three balance impairment measures. RESULTS: A significant positive correlation was noted between the ABC and CB&M (r = 0.42, p = 0.0008), between the ABC and BESTest (r = 0.46, p = 0.0002), and between the CB&M and BESTest (r = 0.86, p < 0.0001). CONCLUSIONS: This is the first study we are aware of in the chronic moderate to severe TBI population directly comparing patient's self-reported balance impairment with clinical measures. Positive correlations were found between the self-report measure and both clinical measures. Overall, individuals with chronic TBI tend to self-report less impaired balance than clinical measures indicate. These results provide preliminary evidence to support the need for validation of the BESTest in this population. ABBREVIATIONS: ABC: Activities-specific balance confidence scale; BESTest: balance evaluation systems test; BOS: base of support; COM: center of mass; CB&M: community balance and mobility scale; CI: confidence interval; IQR: interquartile range; PTs: physical therapists; SD: standard deviation; SE: standard error; TBI: traumatic brain injury.

Activity-based therapy for recovery of walking in individuals with chronic spinal cord injury: results from a randomized clinical trial.

OBJECTIVE: To examine the effects of activity-based therapy (ABT) on neurologic function, walking ability, functional independence, metabolic health, and community participation. DESIGN: Randomized controlled trial with delayed treatment design. SETTING: Outpatient program in a private, nonprofit rehabilitation hospital. PARTICIPANTS: Volunteer sample of adults (N=48; 37 men and 11 women; age, 18-66y) with chronic (≥12mo postinjury), motor-incomplete (ASIA Impairment Scale grade C or D) spinal cord injury (SCI). INTERVENTIONS: A total of 9h/wk of ABT for 24 weeks including developmental sequencing; resistance training; repetitive, patterned motor activity; and task-specific locomotor training. Algorithms were used to guide group allocation, functional electrical stimulation utilization, and locomotor training progression. MAIN OUTCOME MEASURES: Neurologic function (International Standards for Neurological Classification of Spinal Cord Injury); walking speed and endurance (10-meter walk test, 6-minute walk test, and Timed Up and Go test); community participation (Spinal Cord Independence Measure, version III, and Reintegration to Normal Living Index); and metabolic function (weight, body mass index, and Quantitative Insulin Sensitivity Check). RESULTS: Significant improvements in neurologic function were noted for experimental versus control groups (International Standards for Neurological Classification of Spinal Cord Injury total motor score [5.1±6.3 vs 0.9±5.0; P=.024] and lower extremity motor score [4.2±5.2 vs -0.6±4.2; P=.004]). Significant differences between experimental and control groups were observed for 10-meter walk test speed (0.096±0.14m/s vs 0.027±0.10m/s; P=.036) and 6-minute walk test total distance (35.97±48.2m vs 3.0±25.5m; P=.002). CONCLUSIONS: ABT has the potential to promote neurologic recovery and enhance walking ability in individuals with chronic, motor-incomplete SCI. However, further analysis is needed to determine for whom ABT is going to lead to meaningful clinical benefits.

Activity-based therapy for recovery of walking in chronic spinal cord injury: results from a secondary analysis to determine responsiveness to therapy.

OBJECTIVE: To gain insight into who is likely to benefit from activity-based therapy (ABT), as assessed by secondary analysis of data obtained from a clinical trial. DESIGN: Secondary analysis of results from a randomized controlled trial with delayed treatment design. SETTING: Outpatient program in a private, nonprofit rehabilitation hospital. PARTICIPANTS: Volunteer sample of adults (N=38; 27 men; 11 women; age, 22-63y) with chronic (≥12mo postinjury), motor-incomplete (American Spinal Injury Association [ASIA] Impairment Scale [AIS] grade C or D) spinal cord injury (SCI). INTERVENTIONS: A total of 9h/wk of ABT for 24 weeks including developmental sequencing; resistance training; repetitive, patterned motor activity; and task-specific locomotor training. Algorithms were used to guide group allocation, functional electrical stimulation utilization, and locomotor training progression. MAIN OUTCOME MEASURES: Walking speed and endurance (10-meter walk test and 6-minute walk test) and functional ambulation (timed Up and Go test). RESULTS: This secondary analysis identified likely responders to ABT on the basis of injury characteristics: AIS classification, time since injury, and initial walking ability. Training effects were the most clinically significant in AIS grade D participants with injuries <3 years in duration. This information, along with information about preliminary responsiveness to therapy (gains after 12wk), can help predict the degree of recovery likely from participation in an ABT program. CONCLUSIONS: ABT has the potential to promote neurologic recovery and enhance walking ability in individuals with chronic, motor-incomplete SCI. However, not everyone with goals of walking recovery will benefit. Individuals with SCI should be advised of the time, effort, and resources required to undertake ABT. Practitioners are encouraged to use the findings from this trial to assist prospective participants in establishing realistic expectations for recovery.

Comparison of One-Year Postinjury Mobility Outcomes Between Locomotor Training and Usual Care After Motor Incomplete Spinal Cord Injury.

Objectives: To compare 1-year mobility outcomes of individuals with traumatic motor incomplete spinal cord injury (miSCI) who participated in standardized locomotor training (LT) within the first year of injury to those who did not. Methods: This retrospective case-control analysis conducted with six US rehabilitation hospitals used SCI Model Systems (SCIMS) data comparing 1-year postinjury outcomes between individuals with miSCI who participated in standardized LT to those who received usual care (UC). Participants were matched on age, gender, injury year, mode of mobility, and rehabilitation center. The primary outcome is the FIM Total Motor score. Other outcomes include the FIM Transfer Index, FIM Stairs, and self-reported independence with household mobility, community mobility, and stairs. Results: LT participants reported significantly better FIM Total Motor (difference = 2.812, 95% confidence interval [CI] = 5.896, 17.282) and FIM Transfer Index scores (difference = 0.958, 95% CI = 0.993, 4.866). No significant between-group differences were found for FIM Stairs (difference = 0.713, 95% CI = -0.104, 1.530) or self-reported household mobility (odds ratio [OR] = 5.065, CI = 1.435, 17.884), community mobility (OR = 2.933, 95% CI = 0.868, 9.910), and stairs (OR = 5.817, 95% CI = 1.424, 23.756) after controlling for multiple comparisons. Conclusion: LT participants reported significantly greater improvements in primary and secondary measures of mobility and independence (FIM Total Motor score; FIM Transfer Index) compared to UC participants. Self-reported mobility outcomes were not significant between groups.

Lesion characteristics are associated with bowel, bladder, and overall independence following cervical spinal cord injury.

CONTEXT/OBJECTIVE: There is a growing global interest in quantifying spinal cord lesions and spared neural tissue using magnetic resonance imaging (MRI) in individuals with spinal cord injury (SCI). The primary objective of this study was to assess the relationships between spinal cord lesion characteristics assessed on MRI and bowel, bladder, and overall independence following SCI. DESIGN: Retrospective, exploratory study. PARTICIPANTS: 93 individuals with cervical SCI who were enrolled in a local United States Model Systems SCI database from 2010 to 2017. METHODS: Clinical and MRI data were obtained for potential participants, and MRIs of eligible participants were analyzed. Explanatory variables, captured on MRIs, included intramedullary lesion length (IMLL), midsagittal ventral tissue bridge width (VTBW), midsagittal dorsal tissue bridge width (DTBW), and axial damage ratio (ADR). OUTCOME MEASURES: Bowel and bladder management scale of the Functional Independence Measure (FIM) and FIM total motor score. RESULTS: When accounting for all four variables, only ADR was significantly associated with bowel independence (OR = 0.970, 95% CI: 0.942-0.997, P = 0.030), and both ADR and IMLL were strongly associated with bladder independence (OR = 0.967, 95% CI: 0.936-0.999, P = 0.046 and OR = 0.948, 95% CI: 0.919-0.978, P = 0.0007, respectively). 32% of the variation in overall independence scores were explained by all four predictive variables, but only ADR was significantly associated with overall independence after accounting for all other predictive variables (ß = -0.469, 95% CI: -0.719, -0.218, P = 0.0004). CONCLUSIONS: Our results suggest that the MRI-measured extent of spinal cord lesion may be predictive of bowel, bladder, and overall independence following cervical SCI.

Prognostic value of tissue bridges in cervical spinal cord injury: a longitudinal, multicentre, retrospective cohort study.

BACKGROUND: The accuracy of prognostication in patients with cervical spinal cord injury (SCI) needs to be improved. We aimed to explore the prognostic value of preserved spinal tissue bridges-injury-spared neural tissue adjacent to the lesion-for prediction of sensorimotor recovery in a large, multicentre cohort of people with SCI. METHODS: For this longitudinal study, we included patients with acute cervical SCI (vertebrae C1-C7) admitted to one of three trauma or rehabilitation centres: Murnau, Germany (March 18, 2010-March 1, 2021); Zurich, Switzerland (May 12, 2002-March 2, 2019); and Denver, CO, USA (Jan 12, 2010-Feb 16, 2017). Patients were clinically assessed at admission (baseline), at discharge (3 months), and at 12 months post SCI. Midsagittal tissue bridges were quantified from T2-weighted images assessed at 3-4 weeks post SCI. Fractional regression and unbiased recursive partitioning models, adjusted for age, sex, centre, and neurological level of injury, were used to assess associations between tissue bridge width and baseline-adjusted total motor score, pinprick score, and light touch scores at 3 months and 12 months. Patients were stratified into subgroups according to whether they showed better or worse predicted recovery. FINDINGS: The cohort included 227 patients: 93 patients from Murnau (22 [24%] female); 43 patients from Zurich (four [9%] female); and 91 patients from Denver (14 [15%] female). 136 of these participants (from Murnau and Zurich) were followed up for up to 12 months. At 3 months, per preserved 1 mm of tissue bridge at baseline, patients recovered a mean of 9·3% (SD 0·9) of maximal total motor score (95% CI 7·5-11.2), 8·6% (0·8) of maximal pinprick score (7·0-10·1), and 10·9% (0·8) of maximal light touch score (9·4-12·5). At 12 months post SCI, per preserved 1 mm of tissue bridge at baseline, patients recovered a mean of 10·9% (1·3) of maximal total motor score (8·4-13·4), 5·7% (1·3) of maximal pinprick score (3·3-8·2), and 6·9% (1·4) of maximal light touch score (4·1-9·7). Partitioning models identified a tissue bridge cutoff width of 2·0 mm to be indicative of higher or lower 3-month total motor, pinprick, and light touch scores, and a cutoff of 4·0 mm to be indicative of higher and lower 12-month scores. Compared with models that contained clinical predictors only, models additionally including tissue bridges had significantly improved prediction accuracy across all three centres. INTERPRETATION: Tissue bridges, measured in the first few weeks after SCI, are associated with short-term and long-term clinical improvement. Thus, tissue bridges could potentially be used to guide rehabilitation decision making and to stratify patients into more homogeneous subgroups of recovery in regenerative and neuroprotective clinical trials. FUNDING: Wings for Life, International Foundation for Research in Paraplegia, EU project Horizon 2020 (NISCI grant), and ERA-NET NEURON.

Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial.

Cervical spinal cord injury (SCI) leads to permanent impairment of arm and hand functions. Here we conducted a prospective, single-arm, multicenter, open-label, non-significant risk trial that evaluated the safety and efficacy of ARCEX Therapy to improve arm and hand functions in people with chronic SCI. ARCEX Therapy involves the delivery of externally applied electrical stimulation over the cervical spinal cord during structured rehabilitation. The primary endpoints were safety and efficacy as measured by whether the majority of participants exhibited significant improvement in both strength and functional performance in response to ARCEX Therapy compared to the end of an equivalent period of rehabilitation alone. Sixty participants completed the protocol. No serious adverse events related to ARCEX Therapy were reported, and the primary effectiveness endpoint was met. Seventy-two percent of participants demonstrated improvements greater than the minimally important difference criteria for both strength and functional domains. Secondary endpoint analysis revealed significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and sensory abilities and self-reported increases in quality of life. These results demonstrate the safety and efficacy of ARCEX Therapy to improve hand and arm functions in people living with cervical SCI. ClinicalTrials.gov identifier: NCT04697472 .

A comparison of one year outcomes between standardized locomotor training and usual care after motor incomplete spinal cord injury: Community participation, quality of life and re-hospitalization.

CONTEXT/OBJECTIVE: Spinal cord injury (SCI) often results in a significant loss of mobility and independence coinciding with reports of decreased quality of life (QOL), community participation, and medical complications often requiring re-hospitalization. Locomotor training (LT), the repetition of stepping-like patterning has shown beneficial effects for improving walking ability after motor incomplete SCI, but the potential impact of LT on psychosocial outcomes has not been well-established. The purpose of this study was to evaluate one year QOL, community participation and re-hospitalization outcomes between individuals who participated in a standardized LT program and those who received usual care (UC). DESIGN/SETTING/PARTICIPANTS: A retrospective (nested case/control) analysis was completed using SCI Model Systems (SCIMS) data comparing one year post-injury outcomes between individuals with traumatic motor incomplete SCI who participated in standardized LT to those who received UC. OUTCOME MEASURES: Outcomes compared include the following: Satisfaction with Life Scale (SWLS™), Craig Handicap Assessment and Reporting Technique-Short Form (CHART-SF™), and whether or not an individual was re-hospitalized during the first year of injury. RESULTS: Statistically significant improvements for the LT group were found in the following outcomes: SWLS (P = 0.019); and CHART subscales [mobility (P = <0.001)]; occupation (P = 0.028); with small to medium effects sizes. CONCLUSION: Individuals who completed a standardized LT intervention reported greater improvements in satisfaction with life, community participation, and fewer re-hospitalizations at one year post-injury in comparison to those who received UC. Future randomized controlled trials are needed to verify these findings.

Improving Upper Extremity Strength, Function, and Trunk Stability Using Wide-Pulse Functional Electrical Stimulation in Combination With Functional Task-Specific Practice.

Objectives: To evaluate upper extremity (UE) function, strength, and dynamic sitting balance in individuals with spinal cord injury (SCI) who received an intensive outpatient therapy program focused on UE training augmented with wide pulse/high frequency functional electrical stimulation (WPHF-FES). Methods: This prospective case series was conducted in an outpatient (OP) clinic in an SCI-specific rehabilitation hospital. Participants were a convenience sample (N = 50) of individuals with tetraplegia receiving OP therapy focused on UE recovery. Individuals participated in 60 minutes of UE functional task-specific practice (FTP) in combination with WPHF-FES 5 times/week for an average of 72 sessions. The primary outcome for this analysis was the Capabilities of Upper Extremity Test (CUE-T). Secondary outcomes include UE motor score (UEMS) and the modified functional reach (MFR). Results: Fifty individuals (13 motor complete; 37 motor incomplete SCI) completed an OP UE training program incorporating WPHF-FES and were included in this analysis. On average, participants demonstrated significant improvements in the total CUE-T score of 14.1 (SD = 10.0, p < .0001) points; significant changes were also noted in UEMS and MFR, improving an average of 4.6 (SD = 5.2, p < .0001) points and 13.6 (SD = 15.8, p < .0001) cm, respectively. Conclusion: Individuals with tetraplegia demonstrated significant improvements in UE strength, function, and dynamic sitting trunk balance after receiving UE training augmented with WPHF-FES. Future comparative effectiveness studies need to be completed to guide efficacious treatment interventions in OP therapy.

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury.

Objective: To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCS) on upper and lower extremity function in individuals with chronic spinal cord injury (SCI). Design: Prospective case series. Setting: SCI specific rehabilitation hospital. Participants: A convenience sample (N = 7) of individuals with tetraplegia who had previously been discharged from outpatient therapy due to a plateau in progress. Interventions: Individuals participated in 60 min of upper extremity (UE) functional task-specific practice (FTP) in combination with TSCS and 60 min of locomotor training in combination with TSCS 5x/week. Main Outcome Measures: The primary outcome for this analysis was the Capabilities of Upper Extremity Test (CUE-T). Secondary outcomes include UE motor score (UEMS), LE motor score (LEMS), sensation (light touch and pin prick), Nine-Hole Peg Test, 10 meter walk test, 6 min walk test, and 5 min stand test. Results: Seven individuals (four motor complete; three motor incomplete) completed 20-80 sessions UE and LE training augmented with TSCS and without any serious adverse events. Improvements were reported on the CUE-T in all seven individuals. Two individuals improved their ASIA impairment scale (AIS) classification (B to C; C to D) and two individuals improved their neurologic level of injury by one level (C4-C5; C5-C6). Sensation improved in five individuals and all four who started out with motor complete SCIs were able to voluntarily activate their LEs on command in the presence of stimulation. Conclusion: Individuals with chronic SCI who had previously demonstrated a plateau in function after an intensive outpatient therapy program were able to improve in a variety of UE and LE outcomes in response to TSCS without any adverse events. This was a small pilot study and future fully powered studies with comparative interventions need to be completed to assess efficacy.