Robotic Hand Rehabilitation — RoHa-S  

Stroke Clinical Trial

Official title: Robotic Hand Rehabilitation in Stroke Patients

Status Not yet recruiting

Clinical Trial Summary

The performance of activities of daily living (ADL) depends to a large extent on the functionality of the upper limb and hand. Stroke is the leading cause of disability worldwide, with a significant individual, family and economic impact. After a stroke event, however, a large percentage of affected patients have a deficit of the hand and, six months after the acute event, 65% of patients with a deficit of the hand are unable to use and integrate the affected hand in activities of daily living, significantly reducing its quality. The impairment of strength, grip and general hand function makes it difficult to perform ADLs and affects the independence of functional activities, making the recovery of hand function an extremely challenging field in stroke rehabilitation.

Clinical Trial Description

Rehabilitation of the hand in stroke patients has changed substantially over the last decades, with an increasing interest in the use of robotic devices for the treatment of the upper limb. Indeed, the use of such systems makes it possible to increase the amount and intensity of therapy, to standardise treatment, to provide complex but controlled multisensory stimulation, and to support the patient while performing various tasks, preventing inappropriate movements. Moreover, through robotic systems it is possible to acquire kinematic and kinetic data that are processed to obtain quantitative indices in order to objectively evaluate the patient's motor performance before and after the rehabilitation treatment.

Amadeo® (Tyromotion, Austria) is an end-effector type robotic device, specifically designed for hand treatment, effective in reducing hand disability in stroke patients.

The aim of the study is to evaluate the effects of robotic rehabilitation with an Amadeo® hand end-effector robot (Tyromotion, Austria):

(i) in terms of improved hand function (assessed by clinical and instrumental scales); (ii) on fatigue and quality of life. 24 patients will be recruited at the UOS Post-Acute Rehabilitation, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome. Patients will be divided into two groups by randomization: one group (experimental group, GA) will perform specific rehabilitation for balance disorders using the end-effector robot Amadeo® (Tyromotion, Austria) 3 times a week, for 4 weeks (12 total sessions), for 45 minutes of treatment, in addition to the conventional treatment, and one group will perform only the conventional treatment (conventional group, GC), as a daily routine, as described below. ;

Related Conditions & MeSH terms

• Spasticity as Sequela of Stroke
• Stroke
• Upper Limb

• NCT number: NCT05983822
• Study type: Interventional
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Silvia Giovannini, MD, phD
• Phone: +390630154382
• Email: silvia.giovannini@policlinicogemelli.it
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Completion date: December 2025