Effect of Personalized Robotic Therapy

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Device: Arm Light Exoskeleton Rehab Station (ALEx RS); Device: Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized

• Registration Number: NCT02770300
• Lead Sponsor: Wearable Robotics srl.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-30
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Status Verified: 2020-05
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• stroke patients
• right and left hand dominant
• cerebral lesion onset between 2-8 weeks
• able to participate in a session of about 30-60 minutes
• right-hemiplegic with at least 10° of motion in the treated joints (shoulder and elbow)
• age: more than 18 years old

Exclusion Criteria

• subjects with an active implantable device or wearing an active device (e.g., pacemakers, metallic objects in the brain, infusion pumps, etc.)
• persistent delirium or disturbed vigilance
• moderate or severe language comprehension deficits
• skull breach
• new stroke lesions during rehabilitation
• patients incapable of discernment
• subjects with reduced mobility due to previous injuries or abnormalities unrelated with the cerebral accident

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional robotic rehabilitation with ALEx RS	Arm Light Exoskeleton Rehab Station (ALEx RS)	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.
Automatic personalized robotic rehabilitation with ALEx RS	Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized	-

Primary Outcome Measures

Name	Time	Method
Efficacy evaluated through Fugl-Meyer	2 years
Safety evaluated through the number of adverse events	2 years

Secondary Outcome Measures

Name	Time	Method
Efficacy of personalized therapy evaluated through Fugl-Meyer	2 years	The secondary outcome of the study is the evaluation of the differences on the outcome for a personalized vs a standard robotic rehabilitation

Trial Locations

Locations (1)

University Hospital of Geneva; 🇨🇭 Geneva, Switzerland