Effect of Personalized Robotic Therapy

Sponsor

Wearable Robotics srl. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02770300

Collaborator

University Hospital, Geneva (Other), Azienda Ospedaliero, Universitaria Pisana (Other), Ecole Polytechnique Fédérale de Lausanne (Other)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Arm Light Exoskeleton Rehab Station (ALEx RS) Device: Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of an Automatic Personalized Robot-assisted Rehabilitation on Cortical Organization and Clinical Recovery After Stroke

Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Conventional therapy The control group of patients will perform a conventional therapy without the use of the exoskeleton. The conventional therapy will consist in a traditional treatment of occupational therapy or physiotherapy without the use of the robotic device. The therapist will provide a specific conventional treatment comparable with the robotic treatment in terms of session time and therapeutic goals (i.e., 45 minutes per session, about 100, 150, 200 and 250 movements respectively for the first, second, third and fourth week). The level of difficulty of the exercises will be increased by the physiotherapist according to the degree of impairment of the patients. The muscle and cerebral activity during the execution of the conventional therapy could be acquired.
Experimental: Traditional robotic rehabilitation with 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.	Device: Arm Light Exoskeleton Rehab Station (ALEx RS) 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.
Experimental: Automatic personalized robotic rehabilitation with ALEx RS	Device: Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized 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

Intervention/Treatment

No Intervention: Conventional therapy

The control group of patients will perform a conventional therapy without the use of the exoskeleton. The conventional therapy will consist in a traditional treatment of occupational therapy or physiotherapy without the use of the robotic device. The therapist will provide a specific conventional treatment comparable with the robotic treatment in terms of session time and therapeutic goals (i.e., 45 minutes per session, about 100, 150, 200 and 250 movements respectively for the first, second, third and fourth week). The level of difficulty of the exercises will be increased by the physiotherapist according to the degree of impairment of the patients. The muscle and cerebral activity during the execution of the conventional therapy could be acquired.

Experimental: Traditional robotic rehabilitation with 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.

Device: Arm Light Exoskeleton Rehab Station (ALEx RS)

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.

Experimental: Automatic personalized robotic rehabilitation with ALEx RS

Device: Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized

Outcome Measures

Primary Outcome Measures

Safety evaluated through the number of adverse events [2 years]
Efficacy evaluated through Fugl-Meyer [2 years]

Secondary Outcome Measures

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

Other Outcome Measures

Neurobiomechanical state evaluated through kinematics [2 years]
Definition of the neurobiomechanical state of the patient and its evolution during the therapy
Neurobiomechanical state evaluated through muscle activity measured with electromyography (EMG) [2 years]
Definition of the neurobiomechanical state of the patient and its evolution during the therapy
Neurobiomechanical state evaluated through brain activity measured with electroencephalography (EEG) [2 years]
Definition of the neurobiomechanical state of the patient and its evolution during the therapy
Neurobiomechanical state evaluated through brain activity measured with functional Magnetic Resonance Imaging (fMRI) [2 years]
Definition of the neurobiomechanical state of the patient and its evolution during the therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Geneva	Geneva		Switzerland	1211

Sponsors and Collaborators

Wearable Robotics srl.
University Hospital, Geneva
Azienda Ospedaliero, Universitaria Pisana
Ecole Polytechnique Fédérale de Lausanne

Investigators

Principal Investigator: Adrian Guggisberg, Md, University Hospital, Geneva
Principal Investigator: Carmelo Chisari, Md, Azienda Ospedaliera Universitaria Pisana
Study Director: Silvestro Micera, Prof., Ecole Polytechnique Fédérale de Lausanne