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Clinical Trials/ACTRN12616000701426
ACTRN12616000701426
Completed
未知

A randomised controlled trial on the impact of the paediatric WalkAide 'Registered Trademark' (a drop-foot stimulator) and motor learning-based, gait focused physiotherapy on advanced motor skills and physical activity participation in children with hemiplegic cerebral palsy.

Kerry Evans0 sites30 target enrollmentStarted: May 27, 2016Last updated:

Overview

Phase
未知
Status
Completed
Sponsor
Kerry Evans
Enrollment
30

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
6 Years to 19 Years (—)
Sex
All

Inclusion Criteria

  • 1\) Children and young people aged 6\-19 years with a diagnosis of unilateral spastic hemiplegic cerebral palsy OR bilateral spastic cerebral palsy (if they present and are treated as an asymmetrical presentation; individuals who require treatment on both sides would be excluded), GMFCS level I or II (i.e., walk/run without any device other than an ankle or foot orthosis);
  • 2\) Able to cognitively understand the physiotherapy and WalkAide instructions;
  • 3\) Prepared to attend study appointments.
  • 4\) Willing to use the WalkAide device and gradually increase wear time over acclimcatisation period, aiming for \>6 hours/day wear time for 8 weeks.

Exclusion Criteria

  • Exclusion criteria are any of:
  • 1\) dystonia as primary contributor to their movement disorder;
  • 2\) skin allergies/reactions to adhesives/silicon;
  • 3\) lower limb Botulinum toxin or orthopaedic surgery in last 3 or 12 months respectively;
  • 4\) orthopaedic metalware around knee/leg on affected side;
  • 5\) uncontrolled seizure disorder;
  • 6\) passive ankle dorsiflexion range with knee extension of affected ankle of less than plantargrade;
  • 7\) score of 0 (no active) or 1 (EHL\+ \-EDL) on Selective Motor Control of dorsiflextion;
  • 8\) knee flexion contracture greater than 10 degrees flexion.

Investigators

Sponsor
Kerry Evans

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