scholarly journals Quantitative Assessment of Clinician Assistance During Dynamic Rehabilitation Using Force Sensitive Resistors

2021 ◽  
Vol 2 ◽  
Author(s):  
Margaux B. Linde ◽  
Andrew R. Thoreson ◽  
Cesar Lopez ◽  
Megan L. Gill ◽  
Daniel D. Veith ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Contact Time ◽  
Functional Restoration ◽  
Applied Force ◽  
Lumbosacral Spinal Cord ◽  
Cord Injury ◽  
Phase Clinical Trial ◽  
Applied Forces ◽  
Magnitude Assessment

Background: Neuromodulation using epidural electrical stimulation (EES) has shown functional restoration in humans with chronic spinal cord injury (SCI). EES during body weight supported treadmill training (BWSTT) enhanced stepping performance in clinical trial participants with paraplegia. Unfortunately, tools are lacking in availability to quantify clinician assistance during BWSTT with and without EES. Force sensitive resistors (FSRs) have previously quantified clinician assistance during static standing; however, dynamic tasks have not been addressed.Objective: To determine the validity of FSRs in measurements of force and duration to quantify clinician assistance and participant progression during BWSTT with EES in participants with SCI.Design: A feasibility study to determine the effectiveness of EES to restore function in individuals with SCI.Methods: Two male participants with chronic SCI were enrolled in a pilot phase clinical trial. Following implantation of an EES system in the lumbosacral spinal cord, both participants underwent 12 months of BWSTT with EES. At monthly intervals, FSRs were positioned on participants' knees to quantity forces applied by clinicians to achieve appropriate mechanics of stepping during BWSTT. The FSRs were validated on the benchtop using a leg model instrumented with a multiaxial load cell as the gold standard. The outcomes included clinician-applied force duration measured by FSR sensors and changes in applied forces indicating progression over the course of rehabilitation.Results: The force sensitive resistors validation revealed a proportional bias in their output. Loading required for maximal assist training exceeded the active range of the FSRs but were capable of capturing changes in clinician assist levels. The FSRs were also temporally responsive which increased utility for accurately assessing training contact time. The FSRs readings were able to capture independent stance for both participants by study end. There was minimal to no applied force bilaterally for participant 1 and unilaterally for participant 2.Conclusions: Clinician assistance applied at the knees as measured through FSRs during dynamic rehabilitation and EES (both on and off) effectively detected point of contact and duration of forces; however, it lacks accuracy of magnitude assessment. The reduced contact time measured through FSRs related to increased stance duration, which objectively identified independence in stepping during EES-enabled BWSTT following SCI.

Further studies on free-radical pathology in the major central nervous system disorders: effect of very high doses of methylprednisolone on the functional outcome, morphology, and chemistry of experimental spinal cord impact injury

1982 ◽  
Vol 60 (11) ◽  
pp. 1415-1424 ◽  
Author(s):  
H. B. Demopoulos ◽  
E. S. Flamm ◽  
M. L. Seligman ◽  
D. D. Pietronigro ◽  
J. Tomasula ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Central Nervous System ◽  
Nervous System ◽  
Free Radical ◽  
Tissue Injury ◽  
Functional Restoration ◽  
Radical Reactions ◽  
Free Radical Reactions ◽  
Cord Injury

The hypothesis that pathologic free-radical reactions are initiated and catalyzed in the major central nervous system (CNS) disorders has been further supported by the current acute spinal cord injury work that has demonstrated the appearance of specific, cholesterol free-radical oxidation products. The significance of these products is suggested by the fact that: (i) they increase with time after injury; (ii) their production is curtailed with a steroidal antioxidant; (iii) high antioxidant doses of the steroidal antioxidant which curtail the development of free-radical product prevent tissue degeneration and permit functional restoration. The role of pathologic free-radical reactions is also inferred from the loss of ascorbic acid, a principal CNS antioxidant, and of extractable cholesterol. These losses are also prevented by the steroidal antioxidant. This model system is among others in the CNS which offer distinctive opportunities to study, in vivo, the onset and progression of membrane damaging free-radical reactions within well-defined parameters of time, extent of tissue injury, correlation with changes in membrane enzymes, and correlation with readily measurable in vivo functions.

scholarly journals Subcutaneous granulocyte colony-stimulating factor administration for subacute traumatic spinal cord injuries, report of neurological and functional outcomes: a double-blind randomized controlled clinical trial

2019 ◽  
Vol 30 (1) ◽  
pp. 19-30 ◽  
Author(s):  
Nazi Derakhshanrad ◽  
Hooshang Saberi ◽  
Mir Saeed Yekaninejad ◽  
Mohammad Taghi Joghataei
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Placebo Group ◽  
Spinal Cord Injuries ◽  
Functional Improvement ◽  
Granulocyte Colony Stimulating Factor ◽  
Double Blind ◽  
Cord Injury ◽  
The Mean ◽  
Stimulating Factor

OBJECTIVEGranulocyte-colony stimulating factor (G-CSF) is a major cytokine that has already been clinically verified for chronic traumatic spinal cord injuries (TSCIs). In this study, the authors set out to determine the safety and efficacy of G-CSF administration for neurological and functional improvement in subacute, incomplete TSCI.METHODSThis phase II/III, prospective, double-blind, placebo-controlled, parallel randomized clinical trial was performed in 60 eligible patients (30 treatment, 30 placebo). Patients with incomplete subacute TSCIs with American Spinal Injury Association Impairment Scale (AIS) grades B, C, and D were enrolled. Patients were assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale, Spinal Cord Independence Measure (SCIM-III) and International Association of Neurorestoratology Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS), just before intervention and at 1, 3, and 6 months, after 7 daily subcutaneous administrations of 300 μg/day of G-CSF in the treatment group and placebo in the control group.RESULTSAmong 60 participants, 28 patients (93.3%) in the G-CSF group and 26 patients (86.6%) in the placebo group completed the study protocol. After 6 months of follow-up, the AIS grade remained unchanged in the placebo group, while in the G-CSF group 5 patients (45.5%) improved from AIS grade B to C, 5 (45.5%) improved from AIS grade C to grade D, and 1 patient (16.7%) improved from AIS grade D to E. The mean ± SEM change in ISNCSCI motor score in the G-CSF group was 14.9 ± 2.6 points, which was significantly greater than in the placebo group (1.4 ± 0.34 points, p < 0.001). The mean ± SEM light-touch and pinprick sensory scores improved by 8.8 ± 1.9 and 10.7 ± 2.6 points in the G-CSF group, while those in the placebo group improved by 2.5 ± 0.60 and 1.2 ± 0.40 points, (p = 0.005 and 0.002, respectively). Evaluation of functional improvement according to the IANR-SCIFRS instrument revealed significantly more functional improvement in the G-CSF group (10.3 ± 1.3 points than in the placebo group (3.0 ± 0.81 points; p < 0.001). A significant difference was also observed between the 2 groups as measured by the SCIM-III instrument (29.6 ± 4.1 vs 10.3 ± 2.2, p < 0.001).CONCLUSIONSIncomplete subacute TSCI is associated with significant motor, sensory, and functional improvement after administration of G-CSF.Clinical trial registration no.: IRCT201407177441N3 (www.irct.ir)

scholarly journals Outcome Measures for Acute/Subacute Cervical Sensorimotor Complete (AIS-A) Spinal Cord Injury During a Phase 2 Clinical Trial

2012 ◽  
Vol 18 (1) ◽  
pp. 1-14 ◽  
Author(s):  
John Steeves ◽  
Daniel Lammertse ◽  
John Kramer ◽  
Naomi Kleitman,* ◽  
Sukhvinder Kalsi-Ryan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Outcome Measures ◽  
Phase 2 ◽  
Cord Injury ◽  
Phase 2 Clinical Trial

scholarly journals White matter regeneration induced by aligned fibrin nanofiber hydrogel contributes to motor functional recovery in canine T12 spinal cord injury

2021 ◽  
Author(s):  
Zheng Cao ◽  
Weitao Man ◽  
Yuhui Xiong ◽  
Yi Guo ◽  
Shuhui Yang ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
White Matter ◽  
Nerve Regeneration ◽  
Spinal Cord Injuries ◽  
Diffusion Tensor ◽  
Nerve Fibers ◽  
Functional Restoration ◽  
Large Animal ◽  
Cord Injury

Abstract A hierarchically aligned fibrin hydrogel (AFG) that possesses soft stiffness and aligned nanofiber structure has been successfully proven to facilitate neuroregeneration in vitro and in vivo. However, its potential in promoting nerve regeneration in large animal models that is critical for clinical translation has not been sufficiently specified. Here, the effects of AFG on directing neuroregeneration in canine hemisected T12 spinal cord injuries were explored. Histologically obvious white matter regeneration consisting of a large area of consecutive, compact, and aligned nerve fibers is induced by AFG, leading to a significant motor functional restoration. The canines with AFG implantation start to stand well with their defective legs from 3 to 4 weeks postoperatively and even effortlessly climb the steps from 7 to 8 weeks. Moreover, high-resolution multi-shot diffusion tensor imaging illustrates the spatiotemporal dynamics of nerve regeneration rapidly crossing the lesion within 4 weeks in the AFG group. Our findings indicate that AFG could be a potential therapeutic vehicle for spinal cord injury by inducing rapid white matter regeneration and restoring locomotion, pointing out its promising prospect in clinic practice.

Olfactory Mucosal Auto-transplantation in Spinal Cord Injury: A Clinical Trial, Saudi Arabia

2021 ◽  
pp. 11
Author(s):  
Ahmad Najib Ashraf ◽  
Abdulaziz Shebreen
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Sensory Function ◽  
Cell Transplant ◽  
Loss Of Function ◽  
Neurological Improvement ◽  
Cord Injury ◽  
Distinctive Property ◽  
Independent Life

Introduction: Spinal cord injury (SCI) results in loss of nervous tissue and consequently loss of motor and sensory function. Despite significant improvements in the early medical and surgical management of SCI, there is no effective treatment available that restores the injury-induced loss of function to a degree that an independent life can be guaranteed. Restoration of function and reversal of paralysis following SCI is among the most daunting challenges in all of neuroscience research. Methodology: We decided to study the outcomes in chronic SCI (CSCI) after autologous olfactory mucosal transplantation into the spinal cord following detethering of the cord. The human surgical procedure of autologous olfactory mucosal transplantation was first developed by Carlos Lima and his colleagues. These investigators provided guidance for the surgical procedures in this study and the procedures on the first six participants were performed in their presence. Result: Patients were screened at different centers in the kingdom. A stringent inclusion and exclusion criteria were applied. Patients for this clinical trial were selected from individuals that suffered an SCI at least 12 months before their assessment and were chronically paraplegic or tetraplegic. The final twenty participants were selected after screening more than 125 patients.  While some of them were rejected for medical reasons, some refused to participate upon receiving a full briefing and some of them were unable to fulfill the required psychosocial criteria. Conclusion: The details of the patients and the changes observed in their conditions post olfactory mucosal auto-transplantation will be discussed in detail in oral presentation with graphic results with marked significant improvement in motor and sensory levels of SCI patients as compared to before transplantation of olfactory mucosa. Olfactory unsheathing cells (OECs) are glia cells and continuous axon extension and successful topographic targeting of the olfactory receptor neurons responsible for the sense of smell (olfaction). Due to this distinctive property, OECs have been trialed in human cell transplant therapies to assist in the repair of central nervous system injuries, particularly those of the spinal cord. Although many studies have reported neurological improvement, therapy remains inconsistent and requires further improvement.

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