Effect of Personalized Robotic Therapy

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02770300
• Other study ID #: 1_2016
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: Wearable Robotics srl.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva	Geneva

Sponsors (4)

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

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

5th International Conference on NeuroRehabilitation, Pisa, italy, October 16-20 2018, Evolution of cortical asymmetry with post-stroke rehabilitation: a pilot study, Miehlbradt J, Pierella C, Kinany N, Coscia M, Pirondini E, Vissani M, Mazzoni A, Magnin C, Nicolo P, Guggisberg A and Micera S.

5th International Conference on NeuroRehabilitation, Pisa, italy, October 16-20 2018, On the potential of EEG biomarkers to inform robot-assisted rehabilitation in stroke patients, Pirondini E, Pierella C, Kinany N, Coscia M, Miehlbradt J, Magnin C, Nicolo P, Guggisberg A, Micera S, Deouell L and Van de Ville D.

5th International Conference on NeuroRehabilitation, Pisa, italy, October 16-20 2018, personalizing exoskeleton-based upper limb rehabilitation using a statistical model: a pilot study, Pierella C, Giang C, Pirondini E, Kinany N, Coscia M, Miehlbradt J, Magnin C, Nicolo P, Guggisberg A and Micera S.

5th International Conference on NeuroRehabilitation, Pisa, italy, October 16-20 2018, Resting-state functional connectivity in stroke patients after upper limb robot-assisted therapy: a pilot study, Kinany N, Pierella C, Pirondini E, Coscia M, Miehlbradt J, Magnin C, Nicolo P, Van De Ville D, Guggisberg A and Micera S.

5th International Conference on NeuroRehabilitation, Pisa, italy, October 16-20 2018, Training muscle synergies to relearn movement: current perspectives and future trends, Coscia M, Pellegrino L, Pierella C, Pirondini E, Kinany N, Miehlbradt J, Magnin C, Nicolo P, Giannoni P, Marinelli L, Guggisberg A, Casadio M and Micera S.

7th IEEE RAS/EMBS International Conference on Biomedical Robotics and Biomechatronics, Enschede, Netherlands, August 26-29 2018. Motor intention decoding during active and robot-assisted reaching. Pastore A*, Pierella C*, Artoni F, Pirondini E, Coscia M, Casadio M, Micera S.

Giang C, Pirondini E, Kinany N, Pierella C, Panarese A, Coscia M, Miehlbradt J, Magnin C, Nicolo P, Guggisberg A, Micera S. Motor improvement estimation and task adaptation for personalized robot-aided therapy: a feasibility study. Biomed Eng Online. 2020 May 14;19(1):33. doi: 10.1186/s12938-020-00779-y. — View Citation

Pirondini E, Coscia M, Marcheschi S, Roas G, Salsedo F, Frisoli A, Bergamasco M, Micera S. Evaluation of the effects of the Arm Light Exoskeleton on movement execution and muscle activities: a pilot study on healthy subjects. J Neuroeng Rehabil. 2016 Jan 23;13:9. doi: 10.1186/s12984-016-0117-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurobiomechanical state evaluated through kinematics	Definition of the neurobiomechanical state of the patient and its evolution during the therapy	2 years
Other	Neurobiomechanical state evaluated through muscle activity measured with electromyography (EMG)	Definition of the neurobiomechanical state of the patient and its evolution during the therapy	2 years
Other	Neurobiomechanical state evaluated through brain activity measured with electroencephalography (EEG)	Definition of the neurobiomechanical state of the patient and its evolution during the therapy	2 years
Other	Neurobiomechanical state evaluated through brain activity measured with functional Magnetic Resonance Imaging (fMRI)	Definition of the neurobiomechanical state of the patient and its evolution during the therapy	2 years
Primary	Safety evaluated through the number of adverse events		2 years
Primary	Efficacy evaluated through Fugl-Meyer		2 years
Secondary	Efficacy of personalized therapy evaluated through Fugl-Meyer	The secondary outcome of the study is the evaluation of the differences on the outcome for a personalized vs a standard robotic rehabilitation	2 years

External Links

•   Website of Wearable Robotics srl