Hagglund G, Wagner P Spasticity of the gastrosoleus muscle is related to the development of reduced passive dorsiflexion of the ankle in children with cerebral palsy: a registry analysis of 2,796 examinations in 355 children. Acta Orthop. 2011 Dec;82(6):744-8. doi: 10.3109/17453674.2011.618917. Epub 2011 Sep 6.
Ritterband-Rosenbaum A, Justiniano MD, Nielsen JB, Christensen MS Are sensorimotor experiences the key for successful early intervention in infants with congenital brain lesion? Infant Behav Dev. 2019 Feb;54:133-139. doi: 10.1016/j.infbeh.2019.02.001. Epub 2019 Feb 12.
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Spittle A, Orton J, Anderson PJ, Boyd R, Doyle LW Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD005495. doi: 10.1002/14651858.CD005495.pub4.
Tedroff K, Lowing K, Jacobson DN, Astrom E Does loss of spasticity matter? A 10-year follow-up after selective dorsal rhizotomy in cerebral palsy. Dev Med Child Neurol. 2011 Aug;53(8):724-9. doi: 10.1111/j.1469-8749.2011.03969.x. Epub 2011 May 18.
Willerslev-Olsen M, Lorentzen J, Sinkjaer T, Nielsen JB Passive muscle properties are altered in children with cerebral palsy before the age of 3 years and are difficult to distinguish clinically from spasticity. Dev Med Child Neurol. 2013 Jul;55(7):617-23. doi: 10.1111/dmcn.12124. Epub 2013 Mar 20.
Williams PTJA, Jiang YQ, Martin JH Motor system plasticity after unilateral injury in the developing brain. Dev Med Child Neurol. 2017 Dec;59(12):1224-1229. doi: 10.1111/dmcn.13581. Epub 2017 Oct 3.
Protocol of a Two-group Open-label Randomized Clinical Trial With Blinded Assessment for Prevention of Contractures in Infants With High Risk of Cerebral Palsy.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
