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
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