Action Observation in Children With Diplegic Cerebral Palsy

Status Not yet recruiting

Clinical Trial Summary

A new rehabilitative approach, called AOT, based on the 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 an RCT, preceded by a pilot study, that customized and home based AOT training is an effective rehabilitation tool in children with diplegic CP (DCP) and that its effects are greater than standard care. Both Hands Assessment (BoHA) is chosen as primary outcome measure and a sample size of 27 per group is required. The rehabilitation lasting 8 weeks will be provided at home by an ICT platform able to deliver, manage, monitor and measure a personalized AOT.

Clinical Trial Description

A two-arm, evaluator-blinded, randomized trial (RCT), preceded by a pilot study, will be conducted according to CONSORT guidelines. Each participant will be randomized to either: 1. Intervention group (Experimental group). Children will receive immediately the system for 8 weeks. 2. Standard care group (Control group). Children will continue standard care At the end of the project, if the study results will be positive, children enrolled in the control group will be able to have the same treatment as the experimental group, if necessary. 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 at least 5 days a week for 8 consecutive weeks (total of 40 hours). Follow-up assessment (outcome measures) will be conducted before (T0) and post-intervention at 1 weeks (T1), and then 8 and 24 weeks after the AOT intervention/standard care (T2 and T3). The primary endpoint will be T1. Clinical assessments will be administered by a therapist blind to group assignment in each centre. Scoring of videotaped clinical outcome measures will be performed by therapists blind to group allocation and assessment order. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05223257
Study type	Interventional
Source	IRCCS Fondazione Stella Maris
Contact	Giuseppina Sgandurra, Dr.
Phone	+393392472874
Email	g.sgandurra@fsm.unipi.it
Status	Not yet recruiting
Phase	N/A
Start date	June 1, 2022
Completion date	September 16, 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.