title: Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial.
abstract: A randomized double-blind placebo-controlled clinical trial was carried out to determine whether a group of stable children with cerebral palsy (36 males, 21 females; mean age 10 years 11 months, range 5 to 18 years) would improve their motor skills after 12 months of threshold electrical stimulation (TES). Two thirds received active and one third received inactive stimulators. For the primary outcome we constructed a set of plausible motor function tests and studied the change in summary indices of the performance measurements. Tests were videotaped and assessed blindly to record qualitative changes that might not be reflected in performance measurements. We also judged range of motion, degree of spasticity, and muscle growth measured by CT. Fifty seven of 82 outpatients who were able to walk at least with a walker, completed all 12 months of treatment (hemiplegia n=25, diplegia n=32). There was no significant difference between active and placebo treatment in any of the tested groups, nor combined. Visual and subjective assessments favoured TES (ns), whereas objective indices showed the opposite trend. We conclude that TES in these patients did not have any significant clinical effect during the test period.
authors.affiliation: Department of Paediatrics, Hvidovre Hospital, Denmark.
authors.forename: Christine í
authors.initials: Cí
authors.lastname: Dali
authors.forename: Flemming Juul
authors.initials: FJ
authors.lastname: Hansen
authors.forename: Søren Anker
authors.initials: SA
authors.lastname: Pedersen
authors.forename: Liselotte
authors.initials: L
authors.lastname: Skov
authors.forename: Jørgen
authors.initials: J
authors.lastname: Hilden
authors.forename: Inge
authors.initials: I
authors.lastname: Bjørnskov
authors.forename: Charlotte
authors.initials: C
authors.lastname: Strandberg
authors.forename: Jette
authors.initials: J
authors.lastname: Christensen
authors.forename: Ulla
authors.initials: U
authors.lastname: Haugsted
authors.forename: Grethe
authors.initials: G
authors.lastname: Herbst
authors.forename: Ulla
authors.initials: U
authors.lastname: Lyskjaer
mesh_terms: D000293:Adolescent; D002547:Cerebral Palsy / Q000150:complications / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy; D005260:Female; D006801:Humans; D008297:Male; D019957:Motor Skills Disorders / Q000209:etiology / Q000628:therapy*; D018482:Muscle, Skeletal / Q000502:physiology; D010919:Placebos; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D010919:Placebos