Sample sizes and statistical methods in interventional studies on individuals with spinal cord injury: A systematic review

Prevalence and incidence of spinal cord injury (SCI) are low. However, sample sizes have not been systematically examined yet, although this might represent useful information for study planning and power considerations. Therefore, our objective was to determine the median sample size in clinical trials on SCI individuals. Moreover, within small‐sample size studies, statistical methods and awareness of potential problems regarding small samples were examined.

[1]  P. London.  Injury , 1969, Definitions.

[2]  L. Hsu,et al.  Random sampling, randomization, and equivalence of contrasted groups in psychotherapy outcome research. , 1989, Journal of consulting and clinical psychology.

[3]  S. Quine,et al.  Prevalence of spinal cord injury: an international comparison. , 1995, Neuroepidemiology.

[4]  M. Devivo,et al.  Recent trends in mortality and causes of death among persons with spinal cord injury. , 1999, Archives of physical medicine and rehabilitation.

[5]  E. Brunner,et al.  The Nonparametric Behrens‐Fisher Problem: Asymptotic Theory and a Small‐Sample Approximation , 2000 .

[6]  A. Hicks,et al.  Exercise Research Issues in the Spinal Cord Injured Population , 2005, Exercise and sport sciences reviews.

[7]  J. Ioannidis.  Why Most Published Research Findings Are False , 2005, PLoS medicine.

[8]  M. Craggs,et al.  Aberrant reflexes and function of the pelvic organs following spinal cord injury in man , 2006, Autonomic Neuroscience.

[9]  K. Krishnamoorthy,et al.  A parametric bootstrap approach for ANOVA with unequal variances: Fixed and random models , 2007, Comput. Stat. Data Anal..

[10]  J. Ioannidis,et al.  The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration , 2009, Annals of Internal Medicine [serial online].

[11]  D. Moher,et al.  Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement , 2009, BMJ : British Medical Journal.

[12]  D. Cadotte,et al.  A series of systematic reviews on the treatment of acute spinal cord injury: a foundation for best medical practice. , 2011, Journal of neurotrauma.

[13]  G. Biondi-Zoccai,et al.  In Intensive Care Cardiovascular Anesthesia Review Article the Rough Guide to Systematic Reviews and Meta-analyses , 2022 .

[14]  F. Cruz,et al.  Spinal Cord Injury and Bladder Dysfunction: New Ideas about an Old Problem , 2011, TheScientificWorldJournal.

[15]  Alan Agresti,et al.  Categorical Data Analysis , 2003 .

[16]  E. Sierra.  Methodology to development to prior studies to the project in The Palacio del Infantado in Guadalajara , 2012 .

[17]  M. Bracken.  Steroids for acute spinal cord injury. , 2012, The Cochrane database of systematic reviews.

[18]  Mónica Alcobendas-Maestro,et al.  Lokomat Robotic-Assisted Versus Overground Training Within 3 to 6 Months of Incomplete Spinal Cord Lesion , 2012, Neurorehabilitation and neural repair.

[19]  M. Fehlings,et al.  Incidence and Prevalence of Spinal Cord Injury in Canada: A National Perspective , 2012, Neuroepidemiology.

[20]  Bram Koopman,et al.  The effect of impedance-controlled robotic gait training on walking ability and quality in individuals with chronic incomplete spinal cord injury: an explorative study , 2014, Journal of NeuroEngineering and Rehabilitation.

[21]  J. Kõrv,et al.  Mortality and causes of death after traumatic spinal cord injury in Estonia , 2013, The journal of spinal cord medicine.

[22]  Brian A. Nosek,et al.  Power failure: why small sample size undermines the reliability of neuroscience , 2013, Nature Reviews Neuroscience.

[23]  A. Forbes,et al.  A Lactobacillus casei Shirota probiotic drink reduces antibiotic-associated diarrhoea in patients with spinal cord injuries: a randomised controlled trial , 2013, British Journal of Nutrition.

[24]  Win Min Oo.  Efficacy of addition of transcutaneous electrical nerve stimulation to standardized physical therapy in subacute spinal spasticity: a randomized controlled trial. , 2014, Archives of physical medicine and rehabilitation.

[25]  Jaynie F. Yang,et al.  Repetitive Mass Practice or Focused Precise Practice for Retraining Walking After Incomplete Spinal Cord Injury? A Pilot Randomized Clinical Trial , 2014, Neurorehabilitation and neural repair.

[26]  T. Little,et al.  Exercise for everyone: a randomized controlled trial of project workout on wheels in promoting exercise among wheelchair users. , 2014, Archives of physical medicine and rehabilitation.

[27]  Tingbao Zhao,et al.  Novel medical bathing with traditional Chinese herb formula alleviates paraplegia spasticity. , 2014, International journal of nursing practice.

[28]  Arun Jayaraman,et al.  Daily intermittent hypoxia enhances walking after chronic spinal cord injury , 2013, Neurology.

[29]  L. Goetz,et al.  Effectiveness of supported employment for veterans with spinal cord injury: 2-year results. , 2014, Archives of physical medicine and rehabilitation.

[30]  H. Gabr,et al.  Autologous Bone Marrow-Derived Cell Therapy Combined with Physical Therapy Induces Functional Improvement in Chronic Spinal Cord Injury Patients , 2014, Cell transplantation.

[31]  D. Ditor,et al.  Effects of FES-Ambulation Training on Locomotor Function and Health-Related Quality of Life in Individuals With Spinal Cord Injury. , 2014, Topics in spinal cord injury rehabilitation.

[32]  Paula M Ludewig,et al.  Effectiveness of home exercise on pain, function, and strength of manual wheelchair users with spinal cord injury: a high-dose shoulder program with telerehabilitation. , 2014, Archives of physical medicine and rehabilitation.

[33]  S. Hutchins,et al.  Influence of orthotic gait training with powered hip orthosis on walking in paraplegic patients , 2014, Disability and rehabilitation. Assistive technology.

[34]  D. Berlowitz,et al.  The effect of singing training on voice quality for people with quadriplegia. , 2014, Journal of voice : official journal of the Voice Foundation.

[35]  Michael G Fehlings,et al.  Global prevalence and incidence of traumatic spinal cord injury , 2014, Clinical epidemiology.

[36]  S. Hutchins,et al.  Comparison of gait between healthy participants and persons with spinal cord injury when using a powered gait orthosis-a pilot study , 2014, Spinal Cord.

[37]  Kristan A. Leech,et al.  Effects of serotonergic medications on locomotor performance in humans with incomplete spinal cord injury. , 2014, Journal of neurotrauma.

[38]  Yasuo Ito,et al.  Multicenter Prospective Nonrandomized Controlled Clinical Trial to Prove Neurotherapeutic Effects of Granulocyte Colony-Stimulating Factor for Acute Spinal Cord Injury: Analyses of Follow-up Cases After at Least 1 Year , 2014, Spine.

[39]  Peng Yu,et al.  Effects of electroacupuncture combined with clean intermittent catheterization on urinary retention after spinal cord injury: a single blind randomized controlled clinical trial. , 2015, International journal of clinical and experimental medicine.

[40]  M. Ferguson-Pell,et al.  Pressure changes under the ischial tuberosities during gluteal neuromuscular stimulation in spinal cord injury: a comparison of sacral nerve root stimulation with surface functional electrical stimulation. , 2015, Archives of physical medicine and rehabilitation.

[41]  Duncan J. Macfarlane,et al.  Sitting Tai Chi Improves the Balance Control and Muscle Strength of Community-Dwelling Persons with Spinal Cord Injuries: A Pilot Study , 2015, Evidence-based complementary and alternative medicine : eCAM.

[42]  Y. Höller,et al.  Descending motor pathways and cortical physiology after spinal cord injury assessed by transcranial magnetic stimulation: a systematic review , 2015, Brain Research.

[43]  Frédéric Lofaso,et al.  Evaluation of 3 pushrim-activated power-assisted wheelchairs in patients with spinal cord injury. , 2015, Archives of physical medicine and rehabilitation.

[44]  M. Popovic,et al.  Trunk control impairment is responsible for postural instability during quiet sitting in individuals with cervical spinal cord injury. , 2015, Clinical biomechanics.

[45]  Reliability of the sit-up test in individuals with spinal cord injury , 2015, The journal of spinal cord medicine.

[46]  T. Pithon-Curi,et al.  Effects of DHA-rich fish oil supplementation on the lipid profile, markers of muscle damage, and neutrophil function in wheelchair basketball athletes before and after acute exercise. , 2015, Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme.

[47]  M. Ashraf,et al.  Effects of Human Erythropoietin on Functional Outcome of Patients with Traumatic Cervical Cord Injury; A Pilot Randomized Clinical Trial. , 2015, Bulletin of emergency and trauma.

[48]  Functional impact of multidisciplinary outpatient program on patients with chronic complete spinal cord injury , 2015, Spinal Cord.

[49]  Functional impact of multidisciplinary outpatient program on patients with chronic complete spinal cord injury , 2015, Spinal Cord.

[50]  Solomon W. Harrar,et al.  Parametric and nonparametric bootstrap methods for general MANOVA , 2015, J. Multivar. Anal..

[51]  A. Heinemann,et al.  Efficacy of venlafaxine XR for the treatment of pain in patients with spinal cord injury and major depression: a randomized, controlled trial. , 2015, Archives of physical medicine and rehabilitation.

[52]  R. Heshmat,et al.  Omega-3 fatty acids’ effect on leptin and adiponectin concentrations in patients with spinal cord injury: A double-blinded randomized clinical trial , 2015, The journal of spinal cord medicine.

[53]  A. Berardelli,et al.  Intradetrusorial Botulinum Toxin in Patients with Multiple Sclerosis: A Neurophysiological Study , 2015, Toxins.

[54]  Neuromuscular electrical stimulation training increases intermuscular fascial length but not tendon cross-sectional area after spinal cord injury. , 2015, Topics in spinal cord injury rehabilitation.

[55]  K. Phan,et al.  Surgery for spinal tuberculosis: a multi-center experience of 582 cases. , 2015, Journal of spine surgery.

[56]  Clare Hartigan,et al.  Acute Cardiorespiratory and Metabolic Responses During Exoskeleton-Assisted Walking Overground Among Persons with Chronic Spinal Cord Injury. , 2015, Topics in spinal cord injury rehabilitation.

[57]  Jiayi Guo,et al.  Comparison of therapeutic effects of anterior decompression and posterior decompression on thoracolumbar spine fracture complicated with spinal nerve injury , 2015, Pakistan journal of medical sciences.

[58]  J. Steeves,et al.  Evidence-based scientific exercise guidelines for adults with spinal cord injury: an update and a new guideline , 2017, Spinal Cord.

[59]  Randomized controlled trials in status epilepticus: Size matters , 2017, Epilepsia.

[60]  Edgar Brunner,et al.  Permuting longitudinal data in spite of the dependencies , 2017, J. Multivar. Anal..

[61]  L. Saltuari,et al.  Abnormal cortical neuroplasticity induced by paired associative stimulation after traumatic spinal cord injury: A preliminary study , 2018, Neuroscience Letters.