Action Observation in Children With Diplegic Cerebral Palsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Intervention group (Experimental group). Children will receive immediately the system for 8 weeks. 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.

Official Title
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Action Observation Tele-rehabilitation for Upper Limb in Children With Diplegic Cerebral Palsy

Conditions
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Diplegic Cerebral Palsy

Intervention / Treatment
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* Other: AOT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 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
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: AOT<br>* Observation of video sequences showing unimanual and bimanual goal-directed actions followed by the execution of the observed actions with upper limbs for unimanual and bimanual actions.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Both Hands Assessment (BoHA) | This assessment measures bimanual performance in children with bilateral CP, during a semi-structured session with specific toys or activities. | Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Melbourne Assessment 2 (MA2) | It is criterion-referenced test that measures unilateral upper extremity quality of movement in subjects with neurological impairments. | Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period) | 
| Changes in Box and Block Test (BBT) | 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 the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period) | 
| Changes in cognitive assessment | It will be done cognitive assessment with the Wechsler Intelligence Scale for Children (WISC) that is an individually administered intelligence test for children. | Baseline (T0, 1 week before beginning of the study) | 
| Changes in neuropsychological assessment (social perception domain) | It will be done neuropsychological assessment with NEPSY-2 social perception domains, that measures the ability to: understand social contexts, interpret non verbal communication, form impressions of others, use contextual information to make inferences about others and their behaviour. | Baseline (T0, 1 week before beginning of the study) | 
| Changes in neuropsychological assessment (sensory-motor domain) | It will be done neuropsychological assessment with NEPSY-2 sensory-motor domains, that consists of four tests that evaluate motor speed and precision, the ability to plan and execute movement sequences, bimanual and visuomotor coordination and imitation of movement. | Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T3 (24 weeks after the end of the training/control period) | 
| Changes in BRIEF P | The Behavior Rating Inventory of Executive Function (BRIEF) measures the executive function in daily life context of children from the parents point of view. BRIEF P is for pre-school children. | Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T3 (24 weeks after the end of the training/control period) | 
| Changes in BRIEF 2 | The Behavior Rating Inventory of Executive Function (BRIEF) measures the executive function in daily life context of children from the parents point of view. BRIEF 2 is for school children. | Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T3 (24 weeks after the end of the training/control period) | 
| Changes in ABILHAND-kids | A semi-structured item-response questionnaire that measures manual ability according to a caregiver's perceived difficulty performing daily bimanual tasks. | Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period) | 
| Changes in Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL -Child, 4-12 years) | This instrument is useful for evaluating interventions designed to improve the lives of children. | Baseline (T0) and T3 (24 weeks after the end of the training/control period) | 
| Changes in Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL -Teen, 13-18 years) | This instrument is useful for evaluating interventions designed to improve the lives of adolescents. | Baseline (T0) and T3 (24 weeks after the end of the training/control period) | 
| Changes in Participation and Environment Measure - Children and Youth (PEM-CY) | It is a measure that evaluates participation in the home, at school, and in the community, alongside environmental factors within each of these settings. | Baseline (T0) and T3 (16 weeks after T2) | 
| Changes in Canadian occupational performance measure (COPM) | It is a validated measure that aims to identify rehabilitation needs in daily life and changes by the subject or his family. | Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period) | 
| Changes in technological measurement of manual abilities by means of Virtual Reality Rehabilitation System (VRRS) | VRRS activities are aimed at estimating and evaluating the uni and bimanual activities, quantitatively through kinematic parameters. | Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period) | 
| Changes in technological measurement of manual abilities by means of Upper Limb TRAcker system (ULTRA +) | ULTRA+ is a sensorized biomechatronic system equipped with an articulated arm with seven degrees of freedom. Kinematic and grip strength parameters will be obtained, thanks to a real immersion in a three-dimensional virtual environment. | Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period) | 
| Feasibility questionnaire | In order to investigate the feasibility of the system and the compliance of children and their families, will be carried out a questionnaire ad hoc at the end of the T1 assessment training in the experimental group. | T1 (within 1 week after the end of the training) | 
| Changes in cerebral plasticity with fMRI (Functional Magnetic Resonance Imaging) | A subgroup of children, selected based on specific inclusion sub-criteria, will be asked to perform the fMRI examination before (T0) and immediately after the end of the experimental or standard treatment period (T1). The children will perform two tasks: Motor execution Action observation task In order to understand the feasibility of these tasks and the brain circuits involved during their execution, a group of typically developing children and healthy young adults will also be enrolled on a voluntary basis. The fMRI study will evaluate the difference in intensity and extension of brain activation in relation to the rehabilitation intervention, as well as to demonstrate the effectiveness of the experimental rehabilitation intervention compared to the control one. | Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period) | 
| Quantitative Changes in upper limbs activities detected with Actigraph GXT3+ during clinical assessment. | Actigraph GXT3+ worn during BoHA assessments | Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period) | 
| Changes in daily life activities detected with Actigraph GXT3+ | Quantitative measurement of daily manual activities | During training and/or standard period (from T0 to T1) (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period) | 

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