CompletedPhase 2ACTRN12614000949684

Functional electrical stimulation in children with unilateral spastic cerebral palsy: A study of the effects based on the international classification of functioning framework.


Sponsor

University of Western Australia

Enrollment

30 participants

Start Date

Jun 7, 2013

Study Type

Interventional

Conditions

Summary

To determine the effects of community applied functional electrical stimulation in ambulant children with unilateral spastic cerebral palsy. A device known as the Walk Aide will be given to the intervention group to wear daily for a period of 8 weeks. This controlled trial will determine the effects of using such a device on a range of outcome measures covering the International Classification of Functioning (child and youth version). The outcome of this trial will deepen our understanding of the effects of functional electrical stimulation in a paediatric population and shape our clinical recommendations based on the available evidence.


Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 18 Yearss

Inclusion Criteria1

  • Children with unilateral spastic hemiplegia, GMFCS I or II with at least 5 degrees of ankle dorsiflexion, 3 months post botulinum toxin, no knee flexion contracture and able to follow instructions required for assessment procedures.

Exclusion Criteria1

  • Uncontrolled seizure disorder, orthopaedic metalware around the knee and leg (site of electrical stimulation)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Community based functional electrical stimulation to the ankle dorsiflexors during the swing phase of gait. The electrical stimulation is applied through a device known as a Walk Aide which is strappe

Community based functional electrical stimulation to the ankle dorsiflexors during the swing phase of gait. The electrical stimulation is applied through a device known as a Walk Aide which is strapped to the leg just below the knee. The tilt sensor is programmed so that stimulation is turned on at the commencement of swing phase through to initial contact. The intensity of stimulation will vary according to each individual but all participants will have a frequency of 33Hz and a pulse width ranging from 25 to 300 micro seconds. The amplitude will be participant controlled by a dial. Participants are asked to use the Walk Aide for a minimum of 4 hours a day, 6 days a week over the 8 week intervention period. Weekly to fortnightly school and home visits will be conducted for each participant to monitor the intervention. The Walk Aide has an inbuilt usage log therefore at each visit, this data will be downloaded so that the participant and the family can receive feedback regarding adherence to the dosage. Families will also have direct access to the principle investigator via mobile text message and email if there are any queries or concerns.


Locations(1)

Princess Margaret Hospital - Subiaco

WA, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12614000949684