Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Not applicable

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 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-11-04
Last updated
2025-05-07

Condition(s) studied

Neuromotor Impairments

Investigational drug(s) / intervention(s)

Multidomain interventionSingle domain intervention

Multidomain intervention: 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.

Single domain intervention: 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.

Study 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

Eligibility

Sex
ALL
Min age
5 Years
Max age
21 Years
Healthy volunteers
No
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 outcome measure(s)

  • Canadian Occupational Performance Measure (COPM) — baseline(T0), up to 7 weeks (T1) and 2 months after the end of the training (T2)
    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.

Trial sites (6)

FacilityCityRegionStatus
IRCCS Giannina Gaslini Genova Genova Not Yet Recruiting
IRCCS Eugenio Medea Bosisio Parini Lecco Recruiting
Fondazione Don Gnocchi IRCCS centro "Santa Maria Nascente" Milan Milano Not Yet Recruiting
IRCCS Istituto Neurologico Naz.le C.Mondino Pavia Pavia Not Yet Recruiting
IRCCS Fondazione Stella Maris Calambrone Pisa Not Yet Recruiting
Fondazione Don Gnocchi IRCCS centro "S.Maria al Mare" Salerno Salerno Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06666829 on ClinicalTrials.gov ↗ ← All trials in Italy