Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07384143

Exploring Cognitive Recovery: the Impact of Sensor-based Robotic Rehabilitation in Neurological and Neurodegenerative Disorders

Led by IRCCS Centro Neurolesi Bonino Pulejo · Updated on 2026-02-03

189

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether sensor-based robotic upper limb rehabilitation combined with cognitive exercises can improve both cognitive and motor functions in adults with neurological and neurodegenerative disorders such as Parkinson's disease, multiple sclerosis, and stroke. The study aims to determine if this integrated approach leads to better improvements in attention, memory, executive functions, motor recovery, and daily activities compared to conventional therapy. The trial is a randomized controlled study designed to explore these outcomes in adults aged 18 to 75 years. Participants will be randomly assigned to one of two groups: an experimental group receiving upper limb rehabilitation using sensor-based robotic devices with virtual reality exercises and embedded cognitive tasks, and a control group receiving conventional physiotherapy focused on motor recovery without robotic assistance or cognitive training. Each participant will complete 25 training sessions lasting 60 minutes each, conducted 2 to 3 times per week over about 8 to 12 weeks. Therapy intensity and difficulty will be adjusted individually in the robotic group. During the study, participants will undergo neuropsychological assessments tailored to their condition and motor function tests before and after the intervention. These include tools like ACE-R, BRB-N, and RBANS for cognition, and Fugl-Meyer Assessment and Nine Hole Peg Test for motor skills. Researchers will measure changes in cognitive scores and motor function from baseline to the end of treatment. The study also evaluates the usability of the robotic devices and goal attainment, with safety and progress monitored throughout the trial's duration.

CONDITIONS

Brief Title

Cognitive Recovery Via Sensor-based Robotic Upper Limb Rehabilitation in Neurological Disorders

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-75 years
  • Upper limb motor function suitable for robotic rehabilitation devices or conventional therapy
  • Montreal Cognitive Assessment (MoCA) score of 20 or less
  • Diagnosed with Parkinson's disease, multiple sclerosis, or stroke
  • Able to participate in 25 rehabilitation sessions over 8 to 12 weeks
Not Eligible

You will not qualify if you...

  • Severe cognitive disorders
  • Behavioral disorders
  • Sensory disorders that affect participation or assessment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 8 to 12 weeks

Participants undergo 25 sessions of upper limb rehabilitation over 8 to 12 weeks. Depending on their group, they receive either sensor-based robotic rehabilitation combined with cognitive exercises or conventional therapy focused on motor recovery. Each session lasts about 60 minutes, with 2 to 3 sessions each week, personalized to individual performance.

25 sessions, 2 to 3 times per week

Trial Site Locations

Total: 1 location

1

IRCCS Centro Neurolesi Bonino-Pulejo

Messina, Maine, Italy, 98124

Actively Recruiting

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Research Team

D

Désirée Latella

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Goal Attainment Scaling in rehabilitation: An educational review providing a comprehensive didactical tool box for implementing Goal Attainment Scaling.

Rachel Bard-Pondarré, Claire Villepinte, Fabienne Roumenoff...

https://pubmed.ncbi.nlm.nih.gov/37317629

The brief repeatable battery of neuropsychological tests (BRB-N) version a: update of Italian normative data from the Italian Neuroimaging Network Initiative (INNI).

Nicolò Tedone, Carmen Vizzino, Alessandro Meani...

https://pubmed.ncbi.nlm.nih.gov/38060030

Quality of life in Parkinson's disease: Italian validation of the Parkinson's Disease Questionnaire (PDQ-39-IT).

Giovanni Galeoto, Francesca Colalelli, Perla Massai...

https://pubmed.ncbi.nlm.nih.gov/30088166

Regression-based normative data and equivalent scores for Trail Making Test (TMT): an updated Italian normative study.

Mattia Siciliano, Carlo Chiorri, Valeria Battini...

https://pubmed.ncbi.nlm.nih.gov/30535956

The Addenbrooke's Cognitive Examination Revised (ACE-R) and its sub-scores: normative values in an Italian population sample.

Mattia Siciliano, Simona Raimo, Dario Tufano...

https://pubmed.ncbi.nlm.nih.gov/26563847