Hemiplegia Clinical Trial
Official title:
Action-Observation Therapy (AOT) and Information and Communications Technologies (ICT) for Home Rehabilitation of Hemiplegia
A new rehabilitative approach, called AOT, based on the recent discovery of mirror neuron system (MNS), has been used with promising results on the Upper Limb (UL) function in some studies in children with Cerebral Palsy (CP).The purpose of the present trial is to provide evidence by a RCT that AOT is an effective rehabilitation tool in Children with Unilateral CP (UCP) and that its effects are greater than standard care. Assisting Hand Assessment is chosen as primary outcome measure and a sample size of 10 per group is required. The rehabilitation lasting 3 weeks will be provided at home by an ICT platform able to deliver, manage, monitor and measure a personalized AOT.
A waitlist control, evaluator-blinded, randomized trial (RCT) will be conducted according to
CONSORT guidelines. Each participant will be randomized to either:
1. Immediate intervention group (Experimental group). Children will receive immediately the
system for 3 weeks.
2. Waitlist delayed intervention (Control group). Children will continue standard care for
3 weeks and then will receive the system as the Experimental group.
As such, all participants will receive the AOT training. The system will provide an in-home,
individualized, intensive treatment based on the AOT. The system will be delivered at home
and the children will perform a 60-minute training session 5 days a week for 3 consecutive
weeks. For the Immediate intervention group, follow-up assessment (outcome measures) will be
conducted before (T0) and post-intervention at 3 weeks (T1), and then 8 and 24 weeks after
T1(T2 and T3). For the Waitlist group, the assessments will be conducted before T0 and 3
weeks after (T1) the standard care, then they will follow the same timeline of the first
group (T1 plus, after the AOT intervention) and 8 and 24 weeks after T1 Puls (T2 and T3). The
primary endpoint will be T1. Clinical assessments will be administered by a therapist blind
to group assignment in each center. Scoring of videotaped clinical outcome measures will be
performed by therapists blind to group allocation and assessment order.
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