AOT and ICT for Hemiplegia

Study Overview
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Brief Summary
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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.

Detailed Description
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A waitlist control, evaluator-blinded, randomized trial (RCT) will be conducted according to CONSORT guidelines. Each participant will be randomized to either: Immediate intervention group (Experimental group). Children will receive immediately the system for 3 weeks. 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.

Official Title
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Action-Observation Therapy (AOT) and Information and Communications Technologies (ICT) for Home Rehabilitation of Hemiplegia

Conditions
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Hemiplegia, Hemiplegic Cerebral Palsy

Intervention / Treatment
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* Other: Experimental group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It will be a parallel RCT with a waitlist design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>AOT is based on the observation of meaningful actions followed by their execution | Other: Experimental group<br>* Observation of video sequences showing uni¬manual or bimanual goal-directed actions followed by the execution of the observed actions either with plegic upper limb for unimanual or with both upper limbs for bimanual actions.<br>* Other names: AOT;|
| Other: Control group<br>Children will continue standard care for 3 weeks and then will receive the AOT as the Experimental group | Other: Experimental group<br>* Observation of video sequences showing uni¬manual or bimanual goal-directed actions followed by the execution of the observed actions either with plegic upper limb for unimanual or with both upper limbs for bimanual actions.<br>* Other names: AOT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Assisting Hand Assessment | This assessment measures upper limb function during bimanual activities. The test evaluates spontaneous use of assisting hand during a semi-structured session with specific toys or tasks with objects requiring bimanual handling | Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Box and Block Test | : it measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations from childhood to adults. | Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) | 
| Changes in Melbourne Assessment of Unilateral Upper Limb Function | It is criterion-referenced test that measures unilateral upper extremity quality of movement in subjects with neurological impairments | Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) | 
| Changes in ABILHAND-kids | a semi-structured item-response questionnaire that measures manual ability according to an caregiver's perceived difficulty performing daily bimanual tasks. | Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tele-rehabilitation, Action Observation, Mirror neurons, ICT