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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 5Years - 21Years
All Genders
ID06666829

Study of New Robotic and Technological Rehabilitation Approaches for Children and Young Adults With Neuromotor Impairments Using Personalized Multidomain Treatment Plans

Led by IRCCS Fondazione Stella Maris · Updated on 2025-05-07

194

Participants Needed

6

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a multi-domain robotic and technological rehabilitation program for children with neuromotor impairments. The study aims to determine if this holistic approach improves everyday life activities, motivation, active participation, and satisfaction compared to standard care involving single-domain rehabilitation with one innovative device. This trial involves children aged 5 to 21 years with confirmed developmental disorders or disabilities. Participants are randomly assigned to one of two treatment groups. One group receives a multi-domain rehabilitation treatment combining two or more innovative technological or robotic devices alongside conventional multidomain therapy. The other group receives a single-domain treatment using only one innovative device combined with conventional therapy. Treatment sessions consist of at least 20 sessions of 2 hours each, organized over two periods 4 weeks with 5 sessions per week and 7 weeks with 3 sessions per week. Throughout the study, participants will be evaluated three times using clinical outcome measures including the Canadian Occupational Performance Measure COPM at baseline, up to 7 weeks, and 2 months after training ends. Additional assessments cover motor function, attention, gait analysis, and questionnaires. Data will be pseudonymized and securely stored. Adherence to treatment will be monitored by clinical reviewers, with diaries maintained for each patient. The study will assess functional improvements, motivation, and quality of life changes over time with safety and data privacy measures in place.

CONDITIONS

Brief Title

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.

Research Team

G

Giuseppina Sgandurra Prof.ssa Sgndurra

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