Effect of Personalized Robotic Therapy

Recruiting

Phase N/A Results N/A

Trial Description

The primary goal of this project is to test the safeness and clinical effectiveness of a novel exoskeleton for the upper limb (Arm Light Exoskeleton Rehab Station, ALEx RS) developed at Wearable Robotics srl, for the force assistance of stroke patients during robotic-rehabilitation.
The secondary study aim is to design and test an automatic personalized robot-based upper limb motor rehabilitation protocol targeting the specific kinematic performance of each patient.
Finally, the study also aims to define the "neuro-biomechanical state" of the patient and its evolution during the therapy by studying cortical signals and muscular synergies. This information will be used to improve the personalization of the robotic treatment by targeting not only the motor performance but also the cerebral and muscular activity of the patient.
The study is longitudinally designed in order to test the safeness and clinical effectiveness of ALEx RS over time, and to monitor the clinical effectiveness of the automatic personalized robotic therapy from the beginning until the end of the treatment. Moreover, in order to estimate the long-term clinical effectiveness of the treatment, the assessment methods proposed in the clinical trial will be repeated one month after the end of the treatment.

Conditions

Interventions

  • Arm Light Exoskeleton Rehab Station (ALEx RS) Device
    Intervention Desc: ALEx RS is a complete system specifically designed to support the rehabilitation of stroke patients. In particular, this system is equipped with a robotic arm exoskeleton conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. It is proven that the use of this type of devices in rehabilitation can provide high intensive, repetitive, task specific, and interactive treatment of the impaired arm and an objective and reliable mean for monitoring patients' progress.
    ARM 1: Kind: Experimental
    Label: Traditional robotic rehabilitation with ALEx RS
    Description: The rehabilitative task will be constituted of 3D reaching movements covering a sphere of fourteen centimeter of radius in front of the patient. The initial rehabilitative task will be the same for all the patients belonging to this group and the workspace will be extended accordingly to the therapist evaluation during the following training sessions. In order not to bias the comparisons of the effects of the different rehabilitative treatments, the therapist assisting this group during the rehabilitation will be the same for all the subjects belonging to this group and he/she will not take part in the rehabilitative treatment of the other groups. Initially, the patients will execute reaching movements in different directions in the horizontal plane. If the therapist will evaluate that the movements have been sufficiently recovered, reaching movements in the other planes will be proposed.
  • Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized Device
    Intervention Desc: ALEx RS is a complete system specifically designed to support the rehabilitation of stroke patients. In particular, this system is equipped with a robotic arm exoskeleton conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. It is proven that the use of this type of devices in rehabilitation can provide high intensive, repetitive, task specific, and interactive treatment of the impaired arm and an objective and reliable mean for monitoring patients' progress. The movements to be performed by the patient are automatically decided by the exoskeleton.
    ARM 1: Kind: Experimental
    Label: Automatic personalized robotic rehabilitation with ALEx RS

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety evaluated through the number of adverse events 2 years Yes
Primary Efficacy evaluated through Fugl-Meyer 2 years Yes
Secondary Efficacy of personalized therapy evaluated through Fugl-Meyer 2 years Yes

Sponsors