Action Observation in Children With Diplegic Cerebral Palsy

IRCCS Fondazione Stella Maris

Status: Not yet enrolling

Conditions: Diplegic Cerebral Palsy

Treatments: Other: AOT

Study type: Interventional

Funder types: Other

Identifiers

NCT05223257

RF-2019-12370746

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of diplegic cerebral palsy (DCP) (GMFCS level I to IV - children may have been achieved an independent gait)
• age between 5 and 16 years
• MACS level I-IV
• sufficient cooperation and communicative understanding to perform assessments and participate in the intervention
• caregivers able to commit and collaborate in a rehabilitative intensive home
• subjects and parents able to commit to the intensive rehabilitation program for a period of 8 weeks.

Exclusion criteria

• Exclusion criteria will be uncontrolled seizures and UL botulinum injections or orthopaedic surgery in the previous 6 months or during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

54 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: AOT

Control group

No Intervention group

Description:

Children will continue standard care for 8 weeks Subject allocated to "standard care" group will have to continue what they normally do; they (if \> 13 years) or their parents will have to fill a diary in which they will write the rehabilitative activities they do, specifying their intensity and whether these activities are more focused on the lower limbs or upper limbs.