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 个研究点目标入组 30 人开始时间: 2016年5月27日最近更新: 2020年1月13日

试验速览

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•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 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.

发起方

Kerry Evans