An inertial sensor-based protocol for spinal range of motion measurements.

To develop a protocol for assessing spinal range of motion using an inertial sensor device. The baseline error of an inertial sensor was assessed using a bicycle wheel. Nineteen healthy subjects (12 females and 7 males, average age 18.2 ± 0.6 years) were then prospectively enrolled in a study to assess the reliability of an inertial sensor-based method for assessing spinal motion. Three raters each took three measurements of subjects' flexion/extension, right and left bending, and right and left rotation. Afterwards, one trial from each set of measurements was excluded. Correlations and the ICC (3,1) were used to assess intra-rater reliability, and ICC (3,2) was used to assess inter-rater reliability of the protocol. The baseline error of the sensor was 1.45°. Correlation and ICC (3,1) values for the protocol all exceeded 0.888, indicating high intra-rater reliability. ICC (3,2) values for the protocol exceed 0.87, indicating high inter-rater reliability. Our study presents both a paradigm for assessing the baseline error of inertial sensors and a protocol for assessing motion of the spine using an inertial sensing device.

Preclinical Bench Testing on a Novel Posterior Dynamic Deformity Correction Device for Scoliosis.

STUDY DESIGN: Biomechanical test. OBJECTIVE: To summarize the preclinical tests performed to assess the durability of a novel fusionless dynamic device for the treatment of adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: The minimal invasive deformity correction (MID-C) system is a distractible posterior dynamic deformity correction device designed to reduce scoliosis for AIS patients, to maintain curve correction, and to preserve spinal motion. To overcome the challenges of wear and fatigue of this procedure, the system has two unique features: polyaxial joints at the rod-screw interface and a ceramic coating of the moving parts. METHODS: Five biomechanical tests were performed: Static compression to failure, fatigue loading per ASTM F 1717 with 5.5-mm screws for 10 million cycles (MC) at 5 Hz, wear assessment, wear test of the polyaxial joint under 100 N load for 10 MC, and wear particle implantation in rabbits. RESULTS: The system failed through buckling of the rod with loads over 3000 N (400% of human body weight). Dynamically, the system maintained 700 N for 10 MC with 5.5 mm screws. The maximum total steady-state wear rate was 0.074 mg/MC (0.03 per polyaxial joint and 0.014 mg/MC for the ratchet mechanism). Histologic evaluation of the particle injection sites indicated no difference in the local tissue response between the control and test articles. At 3 and 6 months postinjection, there were neither adverse local effects nor systemic effects observed. CONCLUSIONS: The unique design features of the MID-C system, based on polyaxial joints and ceramic coating, resulted in favorable static, fatigue, and wear resistance properties. Wear properties were superior to those published for artificial spinal discs. Long-term outcomes from clinical use will be required to correlate these bench tests to the in vivo reality of clinical use. LEVEL OF EVIDENCE: Level V.

Examination and measurement of coping among adolescents with spinal cord injury.

STUDY DESIGN: Cross-sectional survey. OBJECTIVES: To describe coping strategy use in adolescents with spinal cord injury (SCI), to explore the underlying factor structure of a measure of coping among adolescents with SCI and to assess relationships between coping and psychosocial outcomes. SETTING: Multiple pediatric SCI centers in the United States. METHODS: One hundred and eighty-two participants aged 13-17 years who experienced an SCI completed measures including the Kidcope, Children's Depression Inventory, Revised Children's Manifest Anxiety Scale and the Pediatric Quality of Life Inventory. RESULTS: Participants reported that cognitive restructuring and resignation are the most used coping strategies, whereas social support, emotional regulation (calming) and cognitive restructuring are the most effective coping strategies. An exploratory factor analysis revealed that a three-factor solution provided the most parsimonious model for the relationships between the different coping strategies. However, only one of the three factors had acceptable internal consistency. This factor comprised escape-oriented coping strategies or an avoidant approach to coping with the sequelae of SCI. After controlling for demographic/injury-related factors, higher scores on the escape-oriented factor were associated with the lower quality of life and higher levels of depression and anxiety symptomatology. CONCLUSION: Escape-oriented coping is associated with maladaptive psychosocial outcomes in adolescents with SCI. These adolescents report that active coping strategies are most effective in reducing SCI-related distress. Coping strategy use may mediate psychosocial outcomes in adolescents with SCI and represent an intervention target in adolescents who overly rely on escape-oriented coping.

Diagnostic accuracy of diffusion tensor imaging for pediatric cervical spinal cord injury.

STUDY DESIGN: Cross-sectional non-experimental study. OBJECTIVES: To examine diagnostic accuracy of diffusion tensor imaging (DTI) for pediatric spinal cord injury (SCI). SETTING: Pediatric Orthopedic Hospital. METHODS: Thirty-five subjects, 10 SCI and 25 controls, mean age 13.38 years underwent two scans with 3.0 T MR scanner. Fractional anisotropy (FA), axial diffusivity (AD) and radial diffusivity (RD) values were calculated. Subjects with SCI underwent examination of muscle strength, sensation and sacral sparing. Mean and s.d. values for FA, AD and RD were compared by group (controls, SCI with sacral sparing, SCI without sacral sparing) using analysis of variance for repeated measures. Comparisons were also made of DTI values at the injury site to values from cervical regions outside of the injury site. Specificity, sensitivity, receiver operating characteristics area under the curve (ROC AUC) and corresponding 95% confidence intervals were calculated. Resampling methods were used to validate the estimates from the final models. RESULTS: FA values differed among SCI subjects with intact sacral sparing, absent sacral sparing and controls, P<0.003 (adjusted). DTI values in combination showed the strongest diagnostic accuracy for predicting the presence of anal contraction (AD, RD; ROC AUC=0.90), deep anal pressure (FA; ROC AUC=0.88), S4-5 sensation (FA, RD; ROC AUC=0.93), motor level (FA, AD, RD; ROC AUC=0.92) and MRI level (FA, AD, RD; ROC AUC=0.92). Bootstrap and Jackknife median values indicated consistency of the parameter estimates. CONCLUSION: The predictive accuracy of DTI for sacral sparing end points and motor and MRI level of injury was good to strong.

Agreement of repeated motor and sensory scores at individual myotomes and dermatomes in young persons with spinal cord injury.

STUDY DESIGN: A prospective repeated measures multicenter study to determine reliability at individual spinal levels when applied to young persons with spinal cord injury (SCI). OBJECTIVES: To evaluate intra- and inter-rater agreement of repeated motor and sensory scores at individual spinal levels. SETTING: Shriners Hospitals for Children--Philadelphia and Chicago, USA. METHODS: A total 189 youth with complete and incomplete SCI underwent four neurological exams by two different raters. Agreement between and within raters for each myotome and dermatome was evaluated for complete and incomplete SCI separately. Intraclass correlation coefficients and 95% confidence intervals were calculated. RESULTS: Overall, both intra- and inter-rater agreement resulted in moderate-to-high agreement among myotomes. Subjects with complete SCI had moderate agreement for light touch (LT) and pin prick (PP) testing, whereas subjects with incomplete SCI had >60.0% of dermatomes resulting in poor agreement for PP testing. CONCLUSION: Overall, moderate-to-high agreement was found for muscle strength comparisons and moderate-to-poor agreement was found for PP and LT.

Autologous incubated macrophage therapy in acute, complete spinal cord injury: results of the phase 2 randomized controlled multicenter trial.

STUDY DESIGN: Randomized controlled trial with single-blinded primary outcome assessment. OBJECTIVES: To determine the efficacy and safety of autologous incubated macrophage treatment for improving neurological outcome in patients with acute, complete spinal cord injury (SCI). SETTING: Six SCI treatment centers in the United States and Israel. METHODS: Participants with traumatic complete SCI between C5 motor and T11 neurological levels who could receive macrophage therapy within 14 days of injury were randomly assigned in a 2:1 ratio to the treatment (autologous incubated macrophages) or control (standard of care) groups. Treatment group participants underwent macrophage injection into the caudal boundary of the SCI. The primary outcome measure was American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-B or better at ≥6 months. Safety was assessed by analysis of adverse events (AEs). RESULTS: Of 43 participants (26 treatment, 17 control) having sufficient data for efficacy analysis, AIS A to B or better conversion was experienced by 7 treatment and 10 control participants; AIS A to C conversion was experienced by 2 treatment and 2 control participants. The primary outcome analysis for subjects with at least 6 months follow-up showed a trend favoring the control group that did not achieve statistical significance (P=0.053). The mean number of AEs reported per participant was not significantly different between the groups (P=0.942). CONCLUSION: The analysis failed to show a significant difference in primary outcome between the two groups. The study results do not support treatment of acute complete SCI with autologous incubated macrophage therapy as specified in this protocol.

Vertebral body stapling as an alternative in the treatment of idiopathic scoliosis.

OBJECTIVE: Unilateral vertebral body stapling as a fusionless alternative to control curvature progression in patients with idiopathic scoliosis (IS). INDICATIONS: Skeletally immature patients (Risser 0 or 1) with IS measuring 20-45° and correction of the curvature <20° on side-bending X-rays. CONTRAINDICATIONS: Congenital scoliosis, curvature above T4 or below L4, thoracic kyphosis >40°. SURGICAL TECHNIQUE: Unilateral disc-sparing staples are placed at the convex side. A thoracoscopic approach can be used for thoracic curves and a mini-open retroperitoneal approach for lumbar curves. POSTOPERATIVE MANAGEMENT: Early ambulation on postoperative day 1 is encouraged. There are no absolute activity restrictions, and no bracing beyond 4 weeks is required. RESULTS: A total of 28 patients (4 males, 24 females; average age at operation 9.4 years) met all inclusion criteria and had a minimum 2-year follow-up (range 2-5.3 years). The success rate (improvement or stabilization of the curvature) was 86% for thoracic curves <35° and all lumbar curves meeting the indications.

Effects of cycling and/or electrical stimulation on bone mineral density in children with spinal cord injury.

STUDY DESIGN: Randomized clinical trial. OBJECTIVES: To determine the effect of cycling and/or electrical stimulation on hip and knee bone mineral density (BMD) in children with spinal cord injury (SCI). SETTING: Children's hospital specializing in pediatric SCI. METHODS: A total of 30 children, aged 5-13 years, with chronic SCI were randomized to one of three interventions: functional electrical stimulation cycling (FESC), passive cycling (PC), and non-cycling, electrically stimulated exercise (ES). Each group exercised for 1 h, three times per week for 6 months at home. The hip, distal femur and proximal tibia BMD were examined via dual-energy X-ray absorptiometry (DXA) pre- and post-intervention. RESULTS: In all, 28 children completed data collection. The FESC group exhibited increases in hip, distal femur and proximal tibia BMD of 32.4, 6.62 and 10.3%, respectively. The PC group exhibited increases at the hip (29.2%), but no change at the distal femur (1.5%) or proximal tibia (-1.0%). The ES group had no change at the hip (-0.24%) and distal femur (3.3%), but a loss at the proximal tibia (-7.06%). There were no differences between groups or within groups over time. Significant negative correlations were found between baseline BMD and the amount of BMD change. CONCLUSION: Although not achieving statistical significance, hip BMD changes observed were greater than the reported 0.9-10% gains after exercise for children with and without disability. Thus, cycling with and without electrical stimulation may be beneficial for skeletal health in pediatric SCI, but further research is needed with a larger sample size.

Diffusion tensor imaging of the pediatric spinal cord at 1.5T: preliminary results.

BACKGROUND AND PURPOSE: Recent studies suggest that pediatric subjects as old as 8-years-of-age may have difficulty with the ISNCSCI examinations. Our aim was to investigate DTI parameters of healthy spinal cord in children with noncervical IS for comparison with children with SCI and to prospectively evaluate reliability measures of DTI and to correlate the measures obtained in children with SCI with the ISNCSCI. MATERIALS AND METHODS: Five controls with thoracic and lumbar IS and 5 children with cervical SCI were imaged twice by using a single-shot echo-planar diffusion-weighted sequence. Axial imaging was performed to cover the entire cervical spinal cord in controls. For the SCI subjects, 2 vertebral bodies above and below the injury were imaged. FA and D values were obtained at different levels of the cervical spinal cord. All subjects with SCI had undergone ISNCSCI clinical examinations. Statistical analysis was performed to access differences of the DTI indices between the controls and SCI subjects, reproducibility measurements, and correlations between DTI and ISNCSCI. RESULTS: Subjects with SCI showed reduced FA and increased D values compared with controls. Test-retest reproducibility showed good ICC coefficients in all the DTI index values among controls (≥0.9), while the SCI group showed moderate ICC (≥0.77). There were statistically significant correlations between the various DTI indices and ISNCSCI scores. CONCLUSIONS: Preliminary DTI indices in children were determined and showed good reproducibility. Reduced FA and increased D values were seen in children with SCI in comparison with controls and showed good clinical correlation with ISNCSCI examinations.

The International Standards for Neurological Classification of Spinal Cord Injury: relationship between S4-5 dermatome testing and anorectal testing.

STUDY DESIGN: Prospective cross-sectional multicenter study. OBJECTIVE: To evaluate the correlation, sensitivity, specificity and predictive values of S4-5 dermatome and the anorectal examination for determination of sacral sparing in the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination. SETTING: Two tertiary hospitals that specialize in pediatric spinal cord injuries. METHODS: In all, 189 patients who were at minimum 3 month after spinal cord injury participated in complete ISNCSCI examinations. All examiners completed training for the proper completion of the ISNCSCI examination. Correlations and sensitivity/specificity analyses were conducted between S4-5 dermatome testing and the anorectal examination. Results were analyzed by age of patient, examiner, tetraplegia/paraplegia classification and injury level (T10-S3, L1-S3 and S3). RESULTS: The correlation between S4-5 dermatome and anorectal sensation was moderate (0.62, P<0.001). Using the anorectal examination as the gold standard, the sensitivity of S4-5 testing was 0.60 (0.49, 70) and specificity was 0.96 (0.90, 0.99). No single age group, tester, level, or type of injury differed from the overall result. CONCLUSION: In the pediatric population, the correlation between S4-5 and anorectal sensation was lower than anticipated. The sensitivity of 0.62 for S4-5 testing and diminished sensation between T10 and S3 suggests that anorectal testing may either be a more sensitive representation of S4-5 function or activate an alternative neuronal pathway that is perceived by the patient. Further investigation into the validity of the sacral sparing components of the ISNCSCI examination is warranted.

A phase 2 autologous cellular therapy trial in patients with acute, complete spinal cord injury: pragmatics, recruitment, and demographics.

STUDY DESIGN: Post hoc analysis from a randomized controlled cellular therapy trial in acute, complete spinal cord injury (SCI). OBJECTIVES: Description and quantitative review of study logistics, referral patterns, current practice patterns and subject demographics. SETTING: Subjects were recruited to one of six international study centers. METHODS: Data are presented from 1816 patients pre-screened, 75 participants screened and 50 randomized. RESULTS: Of the 1816 patients pre-screened, 53.7% did not meet initial study criteria, primarily due to an injury outside the time window (14 days) or failure to meet neurological criteria (complete SCI between C5 motor/C4 sensory and T11). MRIs were obtained on 339 patients; 51.0% were ineligible based on imaging criteria. Of the 75 participants enrolled, 25 failed screening (SF), leaving 50 randomized. The primary reason for SF was based on the neurological exam (51.9%), followed by failure to meet MRI criteria (22.2%). Of the 50 randomized subjects, there were no significant differences in demographics in the active versus control arms. In those participants for whom data was available, 93.8% (45 of 48) of randomized participants received steroids before study entry, whereas 94.0% (47 of 50) had spine surgery before study enrollment. CONCLUSION: The 'funnel effect' (large numbers of potentially eligible participants with a small number enrolled) impacts all trials, but was particularly challenging in this trial due to eligibility criteria and logistics. Data collected may provide information on current practice patterns and the issues encountered and addressed may facilitate design of future trials.

Agreement of repeated motor and sensory scores at individual myotomes and dermatomes in young persons with complete spinal cord injury.

STUDY DESIGN: Prospective repeated measures. OBJECTIVES: Evaluate intra-rater agreement of repeated motor and sensory scores at individual spinal levels. SETTING: Non-profit pediatric rehabilitation center. METHODS: Fifty-eight youth with complete spinal cord injury undergoing two neurological exams. Agreement between exams for each myotome and dermatome was evaluated for four neurological groups: C1-C4 (N=9); C5-C8 (N=8); T1-T6 (N=22); T7-T12 (N=19). Kappa (k) and weighted k (k(w)) coefficients were calculated. RESULTS: Agreement between strength scores was 99 and 100% in subjects with tetraplegia and paraplegia, respectively. C1-C4: pin prick (PP)=absolute agreement (AA) in 57% dermatomes (D) (k range=0.10-0.83; k(w) range=0.36-0.93). Light touch (LT)=AA in 59% D (k range=0.35-0.77; k(w) range=0.34-0.84). C5-C8: PP=AA in 86% D (k range=0.28-0.78; k(w) range=0.43-0.93). LT=AA in 80% D (k range=0.10-0.80; k(w) range=0.12-0.91). T1-T6: PP=AA in 82% D (k range=0.36-0.83; k(w)=0.20-0.96). LT=AA in 77% D (k range=0.23-0.89; k(w) range=0.23-0.89). T7-T12: PP=AA in 82% D (k range=0.46-0.90; k(w) range=0.54-0.90). LT=AA in 84% D (k range=0.41-0.87; k(w) range=0.52-0.94). CONCLUSION: Overall, agreement was excellent for myotome comparisons. For the C5-C8, T1-T6 and T7-T12 groups, there are variations in sensory scores within three levels of the neurological level (NL). For the C1-C4 group, variation in sensation extended well caudal to the NL. The International Standards for Neurological Classification of Spinal Cord Injury is a good outcome measure for a single-site, one-rater study but differences in repeated sensory scores at individual D were found, which should be considered in the interpretation of results of outcome studies.

Motor scores on the functional independence measure after pediatric spinal cord injury.

STUDY DESIGN: Retrospective descriptive analysis. OBJECTIVES: The purpose of this study was to report the functional ability of children with spinal cord injury (SCI) as recorded on motor items of the functional independence measure (FIM) and to examine the factors associated with FIM motor admission and post-discharge gain scores. METHODS: Scores on FIM motor items were analyzed from 941 children (age range: 0-21 years; mean: 13 years 4 months; s.d.: 4 years 8 months) admitted in acute-to-chronic time periods post-SCI to Shriners Hospitals for Children (USA). FIM motor scores at admission and gains at discharge were examined along with neurological level, completeness of injury, age, etiology of injury, and length of time between injury and admission and admission and discharge. RESULTS: The FIM motor scores at admission were negatively correlated with age, neurological level and completeness of injury. Gain in FIM motor scores was significant across neurological levels, and was associated with lower admission FIM motor scores, lower neurological level, incomplete injury, traumatic injury and less time between injury and admission. CONCLUSIONS: The motor function of children after pediatric SCI depends on neurological level and completeness of injury, among other factors. FIM motor scores can improve with intervention even several years after the injury.

The International Standards for Neurological Classification of Spinal Cord Injury: reliability of data when applied to children and youths.

STUDY DESIGN: Intra-rater reliability study, cross-sectional design. OBJECTIVES: To determine reliability of the International Standards for Neurological Classification of Spinal Cord Injury (ISCSCI) motor and sensory exam in children. SETTING: Nonprofit pediatric hospital. METHODS: In all, 74 subjects had two trials of the motor and sensory exams. Intraclass correlation coefficients (ICC), 95% confidence intervals (CI) were generated for total motor (TM), pin prick (PP) and light touch (LT) scores for the entire sample, four age groups, severity and type of injury. Coefficients >0.90=high reliability; 0.75-0.90=moderate reliability and <0.75=inadequate reliability. RESULTS: Children 0.90 except for TM in complete injuries (0.808). CONCLUSION: The ISCSCI exams may have poor utility in children under 4 years. While reliability values for the motor and sensory exams met or exceeded recommended values, wide CI suggest poor precision of the motor exam in children under 15 years of age and sensory exams in children under 5 years.

Implantable FES system for upright mobility and bladder and bowel function for individuals with spinal cord injury.

STUDY DESIGN: Postintervention. OBJECTIVES: To determine the effectiveness of the Praxis multifunctional implantable functional electrical stimulation (FES) system (Neopraxis Pty. Ltd, Lane Cove, NSW, Australia) to provide standing and stepping ability and bladder and bowel management for individuals with motor complete thoracic level spinal cord injuries (SCI). SETTING: Pediatric orthopedic hospital specializing in SCI. SUBJECTS: Three males, ages 17 and 21 years, with motor-complete thoracic level SCI and intact lower motor neurons to the muscles targeted for stimulation. METHODS: Each subject was successfully implanted with the Praxis FES system. All three subjects received electrodes for upright mobility and the first two subjects received additional electrodes for stimulated bladder and bowel management. Following training, subjects were evaluated in their ability to use FES for nine mobility activities. Acute and chronic experiments of the effect of stimulation on bowel and bladder function were also performed. RESULTS: All three subjects could independently stand up from the wheelchair and could walk at least 6 m using a swing through gait pattern. Two subjects were able to independently perform swing through gait for 6 min and one subject was able to independently ascend and descend stairs. Suppression of reflex bladder contractions by neuromodulation (subject 1) and stimulated contractions of the rectum (subject 2) were observed in acute experiments. When stimulation was applied over the course of several weeks, a positive effect on bowel function was measured. Stimulated bladder contractions were not achieved. CONCLUSION: The feasibility of using the Praxis FES system for upright mobility and aiding aspects of bladder and bowel function was demonstrated with three subjects with thoracic level SCI.

Patterns of lower extremity innervation in pediatric spinal cord injury.

STUDY DESIGN: Retrospective review. OBJECTIVES: To identify relationships between lower extremity innervation and level of injury, mechanism of injury, and age at injury in a pediatric population with spinal cord injury (SCI). Secondarily, relationships between innervation and completeness of injury, time since injury, race, and sex were evaluated. SETTING: Pediatric orthopedic referral hospital, Philadelphia, Pennsylvania. METHODS: Records of 190 subjects, ages 1-21 years, were reviewed. Data collected from the medical record included lower extremity muscle innervation, American Spinal Injury Association (ASIA) level and class, mechanism of injury, age at injury, time since injury, race, and sex. To determine innervation, lower extremity muscles had been tested using surface electrical stimulation and identified as being innervated or denervated. If a muscle responded weakly, strength duration testing was performed. For analysis via logistic regression, subjects were grouped based upon level and mechanism of injury. RESULTS: A relationship (P<0.0001) was found between ASIA level and lower extremity innervation of all muscles and between length of time since injury and lower extremity innervation for some muscles. Following multiple logistic regression, only ASIA level remained as an independent predictor of lower extremity innervation status. CONCLUSION: Our results show that lower extremity innervation does differ based on the level of the injury. Denervation began to be seen with injuries in the lower thoracic region and more predominantly with injuries in the lumbar region. This supports our hypothesis that the incidence of lower motor neuron injuries would increase as injuries became more caudal. Our hypotheses of a relationship between innervation status and mechanism of injury and age at injury were not supported. This information is important in determining treatment strategies, eligibility for electrical stimulation techniques, and potential regenerative strategies. SPONSORSHIP: This study was funded by Shriners Hospitals for Children, Grant #8530.

Implantation of the Freehand System during initial rehabilitation using minimally invasive techniques.

STUDY DESIGN: Series of four single subjects with and without intervention design. OBJECTIVES: To describe a minimally invasive surgical technique used to implant the Freehand System during initial spinal cord injury (SCI) rehabilitation and to report rehabilitation outcomes of four recently injured adolescents using the Freehand System. SETTING: Nonprofit children's hospital specializing in orthopedic and SCI care. METHODS: Four subjects with C5 tetraplegia between 13 and 16 years of age and between 9 and 16 weeks following traumatic SCI underwent implantation of the Freehand System using minimally invasive surgical techniques. Outcomes on muscle strength, pinch force, hand function, performance of activities of daily living and satisfaction with and without the Freehand System were collected. RESULTS: Each subject was successfully implanted with the Freehand System without perioperative complications and employed the Freehand System during therapy services and ad lib on the rehabilitation floor. At the last follow-up, every subject remained a motor candidate for the Freehand System. With the Freehand System, average lateral and palmar pinch force was 1.8 and 1.6 kg respectively; average pinch force without functional electrical stimulation (FES) was 0.29 kg. With the Freehand System, three subjects improved their rate of performance on The Upper Extremity Capabilities Questionnaire. All subjects increased their level of independence on The Quadriplegia Index of Function. On the Canadian Occupational Performance Measure (COPM) with the Freehand System, average performance and satisfaction scores improved for every patient. Three of the four subjects continued to use the system at home. CONCLUSION: This case series demonstrates that the Freehand System can vastly improve hand function and performance of rehabilitation activities within days after a minimally invasive implant procedure during initial SCI rehabilitation. Satisfaction with the Freehand System beyond initial rehabilitation is evidenced by continued use at home.

Implanted functional electrical stimulation: an alternative for standing and walking in pediatric spinal cord injury.

STUDY DESIGN: Post intervention, repeated measures design, comparing two interventions. SETTING: Orthopedic pediatric hospital specializing in spinal cord injury. METHODS: Nine subjects, ages 7-20 years, received an eight-channel implanted lower extremity functional electrical stimulation (FES) system for standing and walking. Electrodes were placed to stimulate hip and knee extension, and hip abduction and adduction. Standing and walking were achieved through constant stimulation to the implanted muscles, allowing a swing through gait pattern with an assistive device. After training with FES and long leg braces (LLB), subjects were tested in eight upright mobility activities, which were scored based upon completion time and level of independence. RESULTS: Seven subjects completed data collection. These subjects completed four activities faster (P<0.02) and five activities more independently (P<0.025) with FES as compared to LLB. Transitions between sitting and standing, which were scored in isolation for two mobility activities, were achieved faster and with more independence with FES. In addition, subjects reported preferring FES for the majority of activities. No activity required more time or more assistance to complete with FES as compared to LLB. CONCLUSION: The implanted FES system provided these subjects with enhanced functional abilities over traditional LLB and decreased the need for physical assistance by a caregiver, suggesting that it is a realistic alternative for upright mobility in a pediatric population with spinal cord injury.

Multisurgeon assessment of surgical decision-making in adolescent idiopathic scoliosis: curve classification, operative approach, and fusion levels.

STUDY DESIGN: A multisurgeon assessment of curve classification, selection of operative approach, and fusion levels via a case study presentation. OBJECTIVES: To evaluate the ability of a group of scoliosis surgeons, not involved in the development of a new classification system, to accurately choose the corresponding curve classification of adolescent idiopathic scoliosis (AIS) cases and to evaluate the variability in the selection of operative approaches and both proximal and distal fusion levels in accordance with the new classification system in operative adolescent idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: Recent evaluations using the King method for classifying AIS has shown poor intraobserver and interobserver reliability. A new, comprehensive classification system of AIS has been developed, but the result of a scoliosis surgeon's ability to apply the objective classification is unknown. In the surgical treatment of AIS, there are three choices for the operative approach (anterior, posterior, or both) and multiple choices for the selection of fusion levels. METHODS: During an AIS roundtable discussion at a spinal surgery meeting, 28 scoliosis surgeons were presented seven cases of operative AIS via good quality slides. Standard preoperative radiographs and clinical photographs were presented, and the reviewers were asked to classify the cases by a new classification system, choose their preferred surgical approach, and classify both proximal and distal fusion levels. RESULTS: For the seven cases presented, 84% of the curve types, 86% of lumbar modifiers, and 90% of sagittal thoracic modifiers were classified by the reviewers as described in the new classification. The case study found widely variable operative approaches and fusion levels chosen by the reviewers. There was an average of five different proximal (range, 4-8) and four different distal (range, 3-5) fusion levels chosen by the reviewers for each case. CONCLUSIONS: This case study assessment found a relatively high rate (84-90%) of agreement in curve classification of the individual components of a new classification system of AIS. This suggests the ability of a group of scoliosis surgeons to identify the specific criteria necessary for this new classification system of AIS. In addition, the high variability in selection of both operative approach and fusion levels confirms the current lack of standardized treatment paradigms. This further reinforces the need for a method to critically and objectively evaluate these variable treatments to determine the "best" radiographic and clinical results.