Clinical trial NCT06666829: Multicenter Study That Offers New Solutions for Paediatric Rehabilitation by Proposing a Rehabilitation Plan Based on Each Child's Needs Using New Technological and Robotic Devices, Combined Among Them.
Official title: Innovative Paths to Paediatric Care: A Multicenter Study on the Efficacy of Multi-Domain Technological and Robotic Rehabilitation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromotor Impairments
Keywords: Children
Multidomain
Robotic rehabilitation
Technological rehabilitation
Innovative
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
Collaborators: name: IRCCS Eugenio Medea
name: Fondazione Don Carlo Gnocchi Onlus
name: Fondazione Mondino
name: Istituto Giannina Gaslini
First posted: 2024-10-31
Enrollment: 194
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to demonstrate the efficacy of multi domain robotic and technological rehabilitation on everyday life and satisfaction in children with neuromotor conditions. The main questions it aims to answer are:

* Will we have significant changes using the COPM in children taking part in the sperimental group?
* The children who will undergo the multidomain treatment will also experience functional improvements in individual areas?
* Thy type of treatment will improve motivation, active participation and satisfaction in children?

Researcher will compare the multidomain treatment to standard care proposed by the included clinical centers: single domain rehabilitation with one innovative device. Both groups will undergo also conventional multidomain therapy.

This will be done to see if using a holistic approach, and including every need of the child in the rehabilitation plan, can lead to greater improvements in quality of life compared to the control group.

Participant will:

* Be evaluated 3 times with clinical outcome measures
* Take part in a rehabilitation program, at least 20 x 2hours sessions treatment, organized in:

  * 4 weeks, 5 times per week
  * 7 weeks, 3 times per week

Detailed description: * The sample size was determined considering the primary outcome (the change in COPM): the superiority of robotic treatment compared to conventional treatment; a power of 80%; a number of groups equal to 2; a number of measurements equal to 3; and an effect size of 0.1. Based on these parameters, a sample size of 162 patients (81 per group) is obtained. Additionally, considering a dropout rate of 20%, a total sample size of 194 patients is required.
* For each recruited subject, a specific checklist (CRF) will be completed to collect the demographic, clinical, and technological data required by the study. All collected data will be pseudonymized (using a technique that modifies and masks personal and sensitive data to prevent it from being directly and easily attributed to an individual), in accordance with current privacy regulations. This will allow for regular monitoring of the study's progress, particularly regarding the number of subjects enrolled and recruited in the different phases, the evaluation tests conducted, adherence to the study, and the treatment protocols implemented.
* A high adherence to the study is anticipated, especially if the children involved receive treatment during the care period in rehabilitation facilities, in compliance with current regulations. To ensure the quality and consistency of the intervention, a careful assessment of adherence will be conducted. This assessment will be carried out by an independent team of clinical reviewers, who will regularly monitor treatment sessions. The reviewers will then implement targeted strategies to maintain and improve adherence, including periodic training sessions for the staff involved and timely feedback directed to the therapists in both study groups. A diary will also be maintained regarding the treatments performed by each patient to monitor adherence to the proposed treatment.
* Regarding the collection of data obtained from standardized clinical evaluations, each subject will be assigned a numeric ID code in accordance with current privacy regulations, allowing for the preservation and sharing of data in a completely anonymous form with other participating centers. The list linking the assigned code to each child's name will be kept by the principal investigator and stored in a locked cabinet. Only the principal investigator and other researchers involved in the project will have access to this information.

Similarly, information obtained during the rehabilitation phase from technological tools will be stored and shared with other participating centers in a completely anonymous manner, using the same numeric code previously defined. The data collected throughout the study, excluding the subject's name, will be recorded, processed, and stored for at least seven (7) years after the conclusion of the study, along with the assigned code, on password-protected hard drives stored in a physically secured location or within protected electronic archives (Research Electronic Data Capture (RedCap)), accessible only to the principal investigator and authorized researchers. After seven years, the data will be destroyed.

All collected information will not be processed or used for purposes other than those indicated in the study's objectives, nor for direct profit, and will not be communicated or transferred to unauthorized third parties.

Personal data will be collected and processed in accordance with the principle of data minimization and in compliance with all general principles outlined in Article 5 of the GDPR. Data, particularly personal and health-related data, will be processed only to the extent necessary in relation to the objectives of the trial, in accordance with EU Regulation 2016/679 (GDPR) and Legislative Decree No. 101 of August 10, 2018.

At the time of data collection, whether obtained from standardized clinical evaluations or from device reports, the Data Controllers will ensure that the collected data is pseudonymized by identifying the recruited subjects with codes or adopting other solutions compliant with point 5.4 of the Privacy Authority Provision No. 146/2019. The use of encryption techniques allows for the storage and processing of the data subject's information in a way that prevents identification by any external person. Only the Project Manager at each center and authorized personnel can link each code to the name of the participating subject.

•Regarding any events to be reported, the mode and timing of reporting will adhere to the obligations imposed by EU Regulation 2017/745 (Article 80) and the MDCG Guideline 2020-10/1 ("Safety reporting in clinical investigations of medical devices under Regulation (EU) 2017/745").

A specific insurance policy will be established, which will be activated immediately before the start of the clinical trial. Insurance quotes have been requested and are currently under evaluation. The policy will comply with the provisions of the Ministerial Decree of July 14, 2009, which guarantees specific coverage for damages caused to subjects by the trial activities throughout its duration, covering the civil liability of the investigator and the sponsor, without excluding damages unintentionally caused as a result of an accidental event and/or attributable to negligence, imprudence, or incompetence.

•The collected data will be presented using descriptive statistics, such as mean and standard deviation for numerical variables, and percentages for categorical variables.

The population will be defined to include patients in the multidomain treatment group or the control group (monodomain). The analyzable population will be defined by excluding patients who are not eligible for entry and those who do not receive the full treatment (due to treatment interruption for any reason). The primary endpoint at the end of treatment will be compared between the two treatment groups.

For the primary outcome, a planned subgroup analysis will be conducted to assess the presence of treatment effect modifiers. Continuous secondary outcomes will be analyzed in the population. All tests will be two-tailed with a significance level of 5%, and effect estimates will include a 95% confidence interval (CI).

Categorical outcomes will be reported as proportions with 95% CIs and compared using appropriate statistical tests. Similar analysis will be conducted to demonstrate any improvement in parameters measured during the follow-up (T2). This analysis will include subjects who completed the treatment, representing the population to be studied in the months following the completion of the treatment.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of developmental disorder and/or disability, either congenital or acquired;
* Age between 5 and 21 years at the time of recruitment;
* Verbal and/or non-verbal reasoning abilities \> 70 or \> 5th percentile, as assessed by standardized tests such as Colored Progressive Matrices (CPM), WISC-IV or WISC-V, WPPSI-III or WPPSI-IV, Leiter-3, Griffiths III.

Exclusion Criteria:

* Presence of severe comorbidities and/or behavioral/cognitive disorders that prevent adequate patient compliance with both conventional and robotic rehabilitation treatment (severe intellectual disability);
* Uncontrolled epilepsy;
* Presence of severe sensory deficits;
* Patients who have undergone orthopedic functional surgery or rhizotomy and/or botulinum toxin treatment in the last 6 months;
* Involvement of the peripheral nervous system

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
Secondary outcomes:
measure: Melbourne Assessment-2 (MA2)
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: ABILHAND-Kids.
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: Gross Motor Function Measure-88 (GMFM-88).
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: Six Minutes Walking Test (6MWT)
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: NEPSY-II inibition and auditory attention subtest
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: Leiter 3- Sustained attention subtest
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: VMI
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: Tower of London (ToL)
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: BVL 4-12
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: BVN 12-18 language, reading and writing subtest
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: MT-3 tests
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: BVSCO-3
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: HTA Questionnaires
timeFrame: Up to 7 weeks after the baseline (T1)
measure: 3D Gait Analysis: Joint kinematics
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: 3D Gait Analysis: Kinetics - Ground Reaction Force
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: 3D Gait Analysis: Kinetics - Joint moments
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: 3D Gait Analysis: Kinetics - Joint power
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
measure: 3D Gait Analysis: Spatiotemporal parameters
timeFrame: baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Eugenio Medea
state: Lecco
city: Calambrone
country: Italy
facility: IRCCS Fondazione Stella Maris
state: Pisa
city: Genova
country: Italy
facility: IRCCS Giannina Gaslini
city: Milano
country: Italy
facility: Fondazione Don Gnocchi IRCCS centro "Santa Maria Nascente"
city: Pavia
country: Italy
facility: IRCCS Istituto Neurologico Naz.le C.Mondino
city: Salerno
country: Italy
facility: Fondazione Don Gnocchi IRCCS centro "S.Maria al Mare"
Study officials:
References: