StrokeNCT02770300

Effect of Personalized Robotic Therapy

A study testing Arm Light Exoskeleton Rehab Station (ALEx RS) and Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized in people with Stroke, run by Wearable Robotics srl. at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Stroke
What is being tested?: Arm Light Exoskeleton Rehab Station (ALEx RS) and Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteSwitzerland
Study dates: May 2016to 31 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

University Hospital of Geneva
Geneva, 1211

Other trials in Switzerland

About this study

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

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: Stroke
Being tested: Arm Light Exoskeleton Rehab Station (ALEx RS), Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized
Keywords: automatic, personalized, robotic therapy
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arm Light Exoskeleton Rehab Station (ALEx RS)Device
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 personalizedDevice
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.

Study groups in NCT02770300
Study group	Role	What they receive
Conventional therapy	No intervention	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.
Traditional robotic rehabilitation with ALEx RS	Experimental	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. Receives: Device: Arm Light Exoskeleton Rehab Station (ALEx RS)
Automatic personalized robotic rehabilitation with ALEx RS	Experimental	Not described Receives: Device: Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety evaluated through the number of adverse events
Measured: 2 years
Efficacy evaluated through Fugl-Meyer
Measured: 2 years

Secondary outcomes (1)

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
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201631 Dec 2020

First posted12 May 2016 (estimated)
Study startMay 2016
Primary completion31 Dec 2020
Study completion31 Dec 2020

Why it stopped: The study was prematurely terminated by the sponsor in both centers because the recruitment in the two centers was slow, and it stopped during COVID period.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02770300
Sponsor's protocol ID: 1_2016
Status last verified: May 2020
First submitted: 30 Mar 2016
Last updated: 17 Oct 2022
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 26801620
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.
PubMed 32410617
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, 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.
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.
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.
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.
PubMed 32516757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of an Automatic Personalized Robot-assisted Rehabilitation on Cortical Organization and Clinical Recovery After Stroke
ClinicalTrials.gov ID: NCT02770300
Acronym / sponsor ID: 1_2016
Conditions: Stroke
Keywords: automatic, personalized, robotic therapy
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was prematurely terminated by the sponsor in both centers because the recruitment in the two centers was slow, and it stopped during COVID period.
Enrolment: 28 participants (actual)
Lead sponsor: Wearable Robotics srl.Industry (pharma, biotech, devices)
Collaborators: University Hospital, Geneva, Azienda Ospedaliero, Universitaria Pisana, Ecole Polytechnique Fédérale de Lausanne
Study start: May 2016
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 12 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Conventional therapy	No intervention	–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.
Traditional robotic rehabilitation with ALEx RS	Experimental	Device: 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	Experimental	Device: Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Traditional robotic rehabilitation with ALEx RS
Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalizedALEx 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.	Device	Automatic personalized robotic rehabilitation with ALEx RS

Primary outcome

Safety evaluated through the number of adverse events
Time frame: 2 years
Efficacy evaluated through Fugl-Meyer
Time frame: 2 years

1 secondary outcome

Efficacy of personalized therapy evaluated through Fugl-Meyer
Time frame: 2 years

Results and safety

The study was stopped early (reason given: The study was prematurely terminated by the sponsor in both centers because the recruitment in the two centers was slow, and it stopped during COVID period.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
Background: PubMed 26801620Pirondini 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.
Background: PubMed 32410617Giang 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.
Background5th 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.
Background5th 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.
Background5th 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.
Background5th 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.
Background5th 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.
Background7th 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.
Derived from this study: PubMed 32516757Pierella 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.

Related trials for Stroke

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A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adrian Guggisberg, Md principal investigator

University Hospital, Geneva

Carmelo Chisari, Md principal investigator

Azienda Ospedaliera Universitaria Pisana

Silvestro Micera, Prof. study director

Ecole Polytechnique Fédérale de Lausanne

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety evaluated through the number of adverse events (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02770300, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.