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Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial

Published online by Cambridge University Press:  25 June 2002

Christine í Dali
Affiliation:
Department of Paediatrics, Hvidovre Hospital, Kettegaard alle 30. DK Hvidovre, Denmark.
Flemming Juul Hansen
Affiliation:
Department of Paediatrics, Rigshospitalet Copenhagen, Denmark.
Søren Anker Pedersen
Affiliation:
Department of Paediatrics, Hvidovre Hospital, Kettegaard alle 30. DK Hvidovre, Denmark.
Liselotte Skov
Affiliation:
Department of Paediatrics, Copenhagen County Hospital, Glostrup, Denmark.
Jørgen Hilden
Affiliation:
Department of Biostatistics, University of Copenhagen, Denmark.
Inge Bjørnskov
Affiliation:
Department of Radiology, Rigshospitalet Copenhagen, Denmark.
Charlotte Strandberg
Affiliation:
Department of Radiology, Hvidovre Hospital, Denmark.
Jette Christensen
Affiliation:
Copenhagen County Hospital, Glostrup, Denmark.
Ulla Haugsted
Affiliation:
Department of Paediatrics, Rigshospitalet Copenhagen, Denmark.
Grethe Herbst
Affiliation:
Department of Paediatrics, Hvidovre Hospital, Kettegaard alle 30. DK Hvidovre, Denmark.
Ulla Lyskjær
Affiliation:
Department of Paediatrics, Copenhagen County Hospital, Glostrup, Denmark.
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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.

Type
Original Articles
Copyright
© 2002 Mac Keith Press

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