Clinical trial NCT02770300: Effect of Personalized Robotic Therapy
Official title: Effect of an Automatic Personalized Robot-assisted Rehabilitation on Cortical Organization and Clinical Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: automatic
personalized
robotic therapy
Lead sponsor: Wearable Robotics srl.
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Geneva
name: Azienda Ospedaliero, Universitaria Pisana
name: Ecole Polytechnique Fédérale de Lausanne
First posted: 2016-05-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety evaluated through the number of adverse events
timeFrame: 2 years
measure: Efficacy evaluated through Fugl-Meyer
timeFrame: 2 years
Secondary outcomes:
measure: Efficacy of personalized therapy evaluated through Fugl-Meyer
timeFrame: 2 years
Other outcomes:
measure: Neurobiomechanical state evaluated through kinematics
timeFrame: 2 years
measure: Neurobiomechanical state evaluated through muscle activity measured with electromyography (EMG)
timeFrame: 2 years
measure: Neurobiomechanical state evaluated through brain activity measured with electroencephalography (EEG)
timeFrame: 2 years
measure: Neurobiomechanical state evaluated through brain activity measured with functional Magnetic Resonance Imaging (fMRI)
timeFrame: 2 years
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Adrian Guggisberg, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Universitaria Pisana
name: Carmelo Chisari, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Ecole Polytechnique Fédérale de Lausanne
name: Silvestro Micera, Prof.
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Pierella C, Pirondini E, Kinany N, Coscia M, Giang C, Miehlbradt J, Magnin C, Nicolo P, Dalise S, Sgherri G, Chisari C, Van De Ville D, Guggisberg A, Micera S. A multimodal approach to capture post-stroke temporal dynamics of recovery. J Neural Eng. 2020 Jul 10;17(4):045002. doi: 10.1088/1741-2552/ab9ada.