AOT and ICT for Hemiplegia (Tele-UPCAT)

IRCCS Fondazione Stella Maris

Status: Completed

Conditions: Hemiplegia; Hemiplegic Cerebral Palsy

Treatments: Other: Experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT03094455

GR-2011-02350053 AOT

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 5 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed diagnosis of spastic UCP
• age between 15 and 20 years
• predominant spasticity at upper limb upper limb
• minimal ability to grasp and hold objects, also passively, with affected hand (House functional classification score 2 or more)
• sufficient cooperation, cognitive and communicative understanding to perform assessments and participate in the intervention
• subjects and parents able to commit to the intensive therapy program for a period of 3 weeks

Exclusion criteria

• Children who had sustained previous orthopedic surgery or botulinum toxin A injection in the UL within 6 months prior to study entry were excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Experimental group

Experimental group

Description:

AOT is based on the observation of meaningful actions followed by their execution

Treatment:

Other: Experimental group

Control group

Other group

Description:

Children will continue standard care for 3 weeks and then will receive the AOT as the Experimental group

Treatment:

Other: Experimental group