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Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled
Christine í Dali1, Flemming Juul Hansen, Søren Anker Pedersen
1Department of Paediatrics, Hvidovre Hospital, Denmark.
Insights
Threshold electrical stimulation (TES) did not significantly improve motor skills in children with cerebral palsy over 12 months. Objective measures showed no benefit, while subjective assessments were inconclusive, indicating no clear clinical effect.
Area of Science:
- Neurology
- Rehabilitation Medicine
- Pediatric Physical Therapy
Background:
- Cerebral palsy (CP) is a group of disorders affecting movement and posture, impacting motor skills in children.
- Threshold electrical stimulation (TES) is a therapeutic modality explored for potential benefits in motor function.
- Stable children with CP require effective interventions to enhance their functional abilities.
Purpose of the Study:
- To evaluate the efficacy of 12-month threshold electrical stimulation (TES) on motor skills in stable children with cerebral palsy.
- To assess the impact of TES on objective performance measurements, range of motion, spasticity, and muscle growth.
- To compare active TES with placebo treatment in a randomized, double-blind, controlled trial.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 82 stable children with cerebral palsy (mean age 10y 11m).
- Participants received either active or inactive (placebo) threshold electrical stimulators for 12 months.
- Primary outcomes included changes in motor function test summary indices, range of motion, spasticity, and CT-measured muscle growth.
Main Results:
- No significant differences were found between active TES and placebo groups in any tested motor function or secondary outcome measures.
- Objective performance indices showed a trend opposite to subjective visual and qualitative assessments, which favored TES.
- Fifty-seven out of 82 eligible outpatients completed the full 12-month treatment period.
Conclusions:
- Threshold electrical stimulation (TES) demonstrated no significant clinical effect on motor skills in stable children with cerebral palsy over a 12-month treatment period.
- The study did not support the use of TES as an effective intervention for improving motor function in this pediatric CP population.
- Further research may be needed to explore alternative therapeutic strategies or specific subpopulations within cerebral palsy.
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.