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.

NCT06666829 | Recruiting

• 2 other identifiers: PNC0000007PNC0000007 - Fit4MedRob
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 6

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

Conditions

Neuromotor Impairments

Keywords

Children; Multidomain; Robotic rehabilitation; Technological rehabilitation; Innovative

Outcome Measures

Primary Outcomes (1)

• Canadian Occupational Performance Measure (COPM)

  Assessment tool used in occupational therapy to evaluate an individual's performance and satisfaction in both daily and personal activities. The COPM focuses on activities that are meaningful to the assessed person, allowing them to identify areas where they wish to improve their abilities or participation. This tool helps therapists better understand their patients' needs and desires, enabling them to plan targeted therapeutic interventions to enhance their quality of life and overall well-being.

  baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)

Secondary Outcomes (18)

• Melbourne Assessment-2 (MA2)

  baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)

• ABILHAND-Kids.

  baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)

• Gross Motor Function Measure-88 (GMFM-88).

  baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)

• Six Minutes Walking Test (6MWT)

  baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)

• NEPSY-II inibition and auditory attention subtest

  baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)

Study Arms (2)

Multidomain treatment group

EXPERIMENTAL

Participant will undergo a Multidomain rehabilitation treatment using the combination of two or more innovative technological and robotic devices.This will also be associated with the conventional rehabilitation

Other: Multidomain intervention

Single domain treatment group

ACTIVE COMPARATOR

Participant will undergo a Single domain rehabilitation treatment using only one innovative technological or robotic device.This will also be associated with the conventional rehabilitation

Device: Single domain intervention

Interventions

Multidomain intervention OTHER

treatment plan using combination of more than one technological or robotic devices, choosing from: Virtual Reality Rehabilitation System (VRSS), Khymeia TR; HomeKIT Khymeia; VRSS Khymeia EVO; Myro® Tyromotion; Diego Tyromotion; Tyrostation Tyromotion; Pablo® Tyromotion; Amadeo Tyromotion; Lexo® Tyromotion; Humaware MObile RoboT for upper Limb NeurOortho Rehabilitation (MOTORE); Humanware Upper Limb TRAcker(ULTRA+); Gloreha Sinfonia plus; C-Mill Motek; Gait Real Time Analysis Laboratory (GRAIL) Motek Medical; Nirvana BTS; Agilik; Armeo Spring pediatrico Hocoma; Lokomat ® Hocoma; Hand Tutor, Leg Tutor, Arm Tutor (MediTouch); Care Lab; Dessintey IVS3; Rehacom Hasomed; Hunova; GEO System (Kineo). In this way, the child will be taken care of holistically, considering their needs from a motor, cognitive, and speech therapy perspective. The treatment plan will also include a conventional multi-level rehabilitation program.

Multidomain treatment group

Single domain intervention DEVICE

Treatment plan using only one of these technological or robotic device: Virtual Reality Rehabilitation System (VRSS), Khymeia TR; HomeKIT Khymeia; VRSS Khymeia EVO; Myro® Tyromotion; Diego Tyromotion; Tyrostation Tyromotion; Pablo® Tyromotion; Amadeo Tyromotion; Lexo® Tyromotion; Humaware MObile RoboT for upper Limb NeurOortho Rehabilitation (MOTORE); Humanware Upper Limb TRAcker(ULTRA+); Gloreha Sinfonia plus; C-Mill Motek; Gait Real Time Analysis Laboratory (GRAIL) Motek Medical; Nirvana BTS; Agilik; Armeo Spring pediatrico Hocoma; Lokomat ® Hocoma; Hand Tutor, Leg Tutor, Arm Tutor (MediTouch); Care Lab; Dessintey IVS3; Rehacom Hasomed; Hunova; GEO System (Kineo). Technological rehabilitation will focus on the main specific need for the child, it'll be chosen individually. The treatment plan will also include a conventional multi-level rehabilitation program.

Single domain treatment group

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• IRCCS Eugenio Medea: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Fondazione Mondino: collaborator
• Istituto Giannina Gaslini: collaborator

Study Sites (6)

IRCCS Giannina Gaslini

Genova, Genova, 16147, Italy

NOT YET RECRUITING

IRCCS Eugenio Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

Fondazione Don Gnocchi IRCCS centro "Santa Maria Nascente"

Milan, Milano, 20148, Italy

NOT YET RECRUITING

IRCCS Istituto Neurologico Naz.le C.Mondino

Pavia, Pavia, 27100, Italy

NOT YET RECRUITING

IRCCS Fondazione Stella Maris

Calambrone, Pisa, 56128, Italy

NOT YET RECRUITING

Fondazione Don Gnocchi IRCCS centro "S.Maria al Mare"

Salerno, Salerno, 84131, Italy

NOT YET RECRUITING

Central Study Contacts

Giuseppina Sgandurra Prof.ssa Sgndurra

CONTACT

050886284; giuseppina.sgandurra@fsm.unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 31, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 7, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)