Olfactory ensheathing cells transplanted into the injured spinal cord in animals promote regeneration and remyelination of descending motor pathways through the site of injury and the return of motor functions. In a single-blind, Phase I clinical trial, we aimed to test the feasibility and safety of transplantation of autologous olfactory ensheathing cells into the injured spinal cord in human paraplegia. Participants were three male paraplegics, 18-55 years of age, with stable, complete thoracic injuries 6-32 months previously, with stable spinal column, no implanted prostheses, and no syrinx. Olfactory ensheathing cells were grown and purified in vitro from nasal biopsies and injected into the region of damaged spinal cord. The trial design includes a matched injury group as a control for the assessors, who are blind to treatment status. Assessments, made before transplantation and at regular intervals subsequently, include MRI, medical, neurological and psychosocial assessments, and standard American Spinal Injury Association and Functional Independence Measure assessments. One year after cell implantation, there were no medical, surgical or other complications to indicate that the procedure is unsafe. There is no evidence of spinal cord damage nor of cyst, syrinx or tumour formation. There was no neuropathic pain reported by the participants, no change in psychosocial status and no evidence of deterioration in neurological status. Participants will be followed for 3 years to confirm long-term safety and to compare neurological, functional and psychosocial outcomes with the control group. We conclude transplantation of autologous olfactory ensheathing cells into the injured spinal cord is feasible and is safe up to one year post-implantation.
Olfactory ensheathing cells show promise in preclinical animal models as a cell transplantation therapy for repair of the injured spinal cord. This is a report of a clinical trial of autologous transplantation of olfactory ensheathing cells into the spinal cord in six patients with complete, thoracic paraplegia. We previously reported on the methods of surgery and transplantation and the safety aspects of the trial 1 year after transplantation. Here we address the overall design of the trial and the safety of the procedure, assessed during a period of 3 years following the transplantation surgery. All patients were assessed at entry into the trial and regularly during the period of the trial. Clinical assessments included medical, psychosocial, radiological and neurological, as well as specialized tests of neurological and functional deficits (standard American Spinal Injury Association and Functional Independence Measure assessments). Quantitative test included neurophysiological tests of sensory and motor function below the level of injury. The trial was a Phase I/IIa design whose main aim was to test the feasibility and safety of transplantation of autologous olfactory ensheathing cells into the injured spinal cord in human paraplegia. The design included a control group who did not receive surgery, otherwise closely matched to the transplant recipient group. This group acted as a control for the assessors, who were blind to the treatment status of the patients. The control group also provided the opportunity for preliminary assessment of the efficacy of the transplantation. There were no adverse findings 3 years after autologous transplantation of olfactory ensheathing cells into spinal cords injured at least 2 years prior to transplantation. The magnetic resonance images (MRIs) at 3 years showed no change from preoperative MRIs or intervening MRIs at 1 and 2 years, with no evidence of any tumour of introduced cells and no development of post-traumatic syringomyelia or other adverse radiological findings. There were no significant functional changes in any patients and no neuropathic pain. In one transplant recipient, there was an improvement over 3 segments in light touch and pin prick sensitivity bilaterally, anteriorly and posteriorly. We conclude that transplantation of autologous olfactory ensheathing cells into the injured spinal cord is feasible and is safe up to 3 years of post-implantation, however, this conclusion should be considered preliminary because of the small number of trial patients.
To determine the psychometric properties of the Moorong Self-Efficacy Scale (MSES). Design: Descriptive, correlational study. Participants: Persons with spinal cord injury. Main Outcome Measure: The MSES is a 16-item scale rating confidence in performing everyday activities on a 7-point Likert scale. Procedure: The MSES and other validating instruments were administered to outpatients (n ϭ 36) on 2 occasions; postacute patients undergoing rehabilitation (n ϭ 31) at 1, 3, and 6 months after mobilization; and a community sample (n ϭ 108) by mail. Results: The MSES is internally consistent, responsive, and stable, demonstrating good concurrent, convergent, and discriminant construct validity. Principal-components analysis extracted two factors, labeled Daily Activities and Social Functioning. Conclusions: Strong psychometric properties of the MSES make it a valuable clinical and research tool.
Traumatic spinal cord injury (SCI) may result in tetraplegia (motor and/or sensory nervous system impairment of the arms, trunk and legs) or paraplegia (motor and/or sensory impairment of the trunk and/or legs only). The adverse effects of SCI on health, fitness and functioning are frequently compounded by profoundly sedentary behaviour. People with paraplegia (PP) and tetraplegia (TP) have reduced exercise capacity due to paralysis/paresis and reduced exercising stroke volume. TP often further reduces exercise capacity due to lower maximum heart-rate and respiratory function. There is strong, consistent evidence that exercise can improve cardiorespiratory fitness and muscular strength in people with SCI. There is emerging evidence for a range of other exercise benefits, including reduced risk of cardio-metabolic disease, depression and shoulder pain, as well as improved respiratory function, quality-of-life and functional independence. Exercise recommendations for people with SCI are: ≥30min of moderate aerobic exercise on ≥5d/week or ≥20min of vigorous aerobic ≥3d/week; strength training on ≥2d/week, including scapula stabilisers and posterior shoulder girdle; and ≥2d/week flexibility training, including shoulder internal and external rotators. These recommendations may be aspirational for profoundly inactive clients and stratification into "beginning", "intermediate" and "advanced" will assist application of the recommendations in clinical practice. Flexibility exercise is recommended to preserve upper limb function but may not prevent contracture. For people with TP, Rating of Perceived Exertion may provide a more valid indication of exercise intensity than heart rate. The safety and effectiveness of exercise interventions can be enhanced by initial screening for autonomic dysreflexia, orthostatic hypotension, exercise-induced hypotension, thermoregulatory dysfunction, pressure sores, spasticity and pain.
Study design: Retrospective, descriptive study. Objectives: To describe patients' length of stay (LOS), functional status and discharge setting after rehabilitation and how degree of impairment (complete/incomplete paraplegia/tetraplegia) impacts on these outcomes. To compare actual LOS with estimated LOS. Estimated LOS was based on an Australian model, the Australian National Sub-acute and Non-acute Patient Classification System (AN-SNAP), which classifies patients using admission Functional Independence Measure (FIMt) scores. To further describe outcomes for each AN-SNAP class by degree of impairment. Setting: Spinal Injuries Unit of major Metropolitan hospital in Brisbane, Australia. Methods: Retrospective chart review of 167 patients with traumatic spinal cord injury (SCI). Main outcome measures were rehabilitation LOS, discharge FIMt scores and discharge setting. Injury measures were degree of impairment, acute LOS and rehabilitation admission FIMt scores. Standard demographic measures were also collected. Results: The median rehabilitation LOS was 83 days and mean discharge FIMt scores 102 for all patients. These differed by impairment (incomplete paraplegia LOS 43, FIM 117; complete paraplegia LOS 96, FIM 109; incomplete tetraplegia LOS 64, FIM 100; complete tetraplegia LOS 206, FIM 78). Patients discharged to the community (noncare facility) ranged from 93% with incomplete paraplegia to 73% with complete tetraplegia. For patients in the three AN-SNAP classes with the lowest FIM scores, the actual LOS was up to twice the estimated LOS. A large variability in discharge outcomes was found within individual AN-SNAP classes, despite similar FIMt scores on admission. Conclusions: Rehabilitation outcomes differed substantially by impairment. The variability in outcomes for patients within the same AN-SNAP class questions the ability of this system to accurately predict LOS, and therefore cost of rehabilitation services, for patients with traumatic SCI in Australia.
While there is evidence to support consideration of client sexuality needs in the provision of rehabilitation services to people with spinal cord injury (SCI), the interdisciplinary team rarely receives training in this area. The current study aimed to examine the effectiveness of a consumer-driven sexuality training program in improving staff knowledge, comfort (general and personal) and attitudes. Using a local needs assessment to identify training needs and the Permission, Limited Information, Specific Suggestions and Intensive Therapy (PLISSIT) model as a training framework, a sexuality training program was developed in one Australian SCI service. A randomized controlled trial was conducted and significant improvement was found in all domains for the treatment group -Knowledge(χ 2 = 46.141, p < 0.001), Comfort (χ 2 = 23.338, p < 0.001), Approach(χ 2 = 23.925, p < 0.001) and Attitude (χ 2 = 15.235, p < 0.001) compared to the control group. Changes were found to be maintained at three month follow-up -Knowledge (Z = −5.116, p < 0.001), Comfort (Z = −3.953, p < 0.001), Approach (Z = −4.103, p < 0.001) and Attitudes (Z = −2.655, p < 0.001). These results support the use of an individualized needs-based sexuality training program in fostering staff knowledge, comfort and attitudinal change in an interdisciplinary SCI rehabilitation service.
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