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StrokeBirehabNCT05176600

Bimanual Robotic Exoskeletal Platform for the Treatment of the Upper Limb in Patients With Stroke. A Feasibility Study

A study testing Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games and Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games in people with Stroke, run by Wearable Robotics srl. at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the study is to test the technical functionality, safety, and feasibility of a bimanual robotic exoskeletal platform and associated serious games in order to offer information on technological and functional advances that will be included in the device's finalization. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games and Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
10 Jan 2022to Sep 2022
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • height between 150 and 190 cm;
  • weight not exceeding 130 kg;
  • ischemic injury;
  • first cortical and supra-tentorial event;
  • moderate motor deficit of the upper limb (score on the Fugl-Meyer Assessment - Upper Extremity between 29 and 42);
  • time since stroke event between 1 and 6 months;
  • trunk control test score greater than or equal to 48;
  • healthy bone density and skeleton that does not suffer from unhealed fractures.

Who cannot join

  • Relevant medical comorbidities (severe neurological diseases, cardiovascular diseases, diabetes / unstabilized hypertension);
  • Cognitive impairment that prevents understanding of the exercises administered;
  • Unavailability to provide informed consent;
  • Pregnant women;
  • Severe spasticity (Ashworth 4);
  • Major muscle contractures;
Show all 11Show fewer
  • Excessive asymmetry in the length of the arms;
  • Upper limb prostheses;
  • Excessive joint limitations that make it difficult or painful to use the device;
  • Use of pacemakers or implantation of active devices;
  • Patients who already participate in another clinical study or who are already undergoing another similar robotic rehabilitation treatment.

Trial locations and contacts

1 site in 1 country.

Irene Aprile, MD, PhD contact

+390633086553

iaprile@dongnocchi.it

Italy1 site, 1 recruiting

  • Fondazione Don Carlo Gnocchi

    Rome, 00168

    Irene Aprile, MD, PhD, +390688036553, iaprile@dongnocchi.it

    Recruiting

Other trials in Italy

About this study

Official title: Pilot Study on the Evaluation of the Functionality, Safety and Feasibility of a Bimanual Robotic Exoskeletal Platform for the Treatment of the Upper Limb in Patients With Stroke

The purpose of the study is to test the technical functionality, safety, and feasibility of a bimanual robotic exoskeletal platform and associated serious games in order to offer information on technological and functional advances that will be included in the device's finalization.

In addition, a secondary goal will be to assess the therapeutic effects of a rehabilitation therapy based on the bimanual configuration, comparing it to a unimanual treatment delivered on the same platform (using the specific configuration).

Conditions
Stroke
Being tested
Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games, Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games
Medical subject headings
Stroke

What participants receive

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

  • Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious gamesDevice

    Patients will undergo a bimanual 30-session robotic rehabilitation, using the robot ALEx RS with the bimanual configuration and the related serious games. Each session will last 45 minute. Daily sessions will be provided, five days a week.

  • Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious gamesDevice

    Patients will undergo a unimanual 30-session robotic rehabilitation, using the robot ALEx RS with the unimanual configuration and the related serious games.Daily sessions will be provided, five days a week.

Study groups in NCT05176600
Study groupRoleWhat they receive
Bimanual groupExperimentalIn this group, patients will perform a robotic rehabilitation based on bimanual serious games
Receives: Device: Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games
Unimanual groupActive comparatorIn this group, patients will perform a robotic rehabilitation based on unimanual serious games
Receives: Device: Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games

What is being measured

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

  1. Incidence of adverse events and description

    Number and description of adverse events related to the provided intervention

    Measured: through the study, an average of 10 months

Secondary outcomes (18)

  1. Changes in EEG-based Interhemispheric coupling index

    Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)

    Measured: Before the intervention, after a 1-hour robotic rehabilitation session

  2. Changes in EEG-based Interhemispheric coupling index

    Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)

    Measured: Before the intervention, after a 6-week robotic rehabilitation intervention

  3. Changes in EEG-based Interhemispheric coupling index

    Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)

    Measured: Before the intervention, 1 week after the end of the 30-session robotic intervention

  4. Changes in EEG-based Connectivity index

    Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)

    Measured: Before the intervention, after a 1-hour robotic rehabilitation session

  5. Changes in EEG-based Connectivity index

    Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)

    Measured: Before the intervention, after a 6-week robotic rehabilitation intervention

  6. Changes in EEG-based Connectivity index

    Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)

    Measured: Before the intervention, 1 week after the end of the 30-session robotic intervention

  7. Changes in Fugl-meyer Assessment Upper Extremity motor functioning

    It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).

    Measured: Before the intervention, after a 6-week robotic rehabilitation intervention

  8. Changes in Fugl-meyer Assessment - Sensory functioning

    It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12points (best).

    Measured: Before the intervention, after a 6-week robotic rehabilitation intervention

  9. Changes in Modified Ashworth Scale

    It is a validated measure of spasticity. It ranges from 0 (normal) to 4 (rigid limb).

    Measured: Before the intervention, after a 6-week robotic rehabilitation intervention

  10. Changes in Motricity Index for upper extremity

    It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).

    Measured: Before the intervention, after a 6-week robotic rehabilitation intervention

  11. Changes in Wolf Motor Function Test

    It is a validated measure of upper extremity motor ability through timed and functional tasks.

    The scores ranges from 0 to 75; lower scores are indicative of lower functioning levels.

    Measured: Before the intervention, after a 6-week robotic rehabilitation intervention

  12. Changes in Action Research Arm Test (ARAT)

    It is a valid measure of upper-extremity functional limitation. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance.

    Measured: Before the intervention, after a 6-week robotic rehabilitation intervention

  13. Changes in Execution time (seconds) measured with the robot

    It is the time (in seconds) required to perform reaching movement using the robot

    Measured: Before the intervention, after a 6-week robotic rehabilitation intervention

  14. Changes in Range of Motion (degrees) measured with the robot

    It is the range of motion (measured in degrees) of shoulder and elbow evaluated using the robot

    Measured: Before the intervention, after a 6-week robotic rehabilitation intervention

  15. Changes in Number of velocity peaks measured with the robot

    It is a measure of movement smoothness while performing reaching movements with the robot.

    Measured: Before the intervention, after a 6-week robotic rehabilitation intervention

  16. System Usability Scale

    It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.

    Measured: After a 6-week robotic rehabilitation intervention

  17. Technology Acceptance Model (TAM)

    It is a self-administered questionnaire to evaluate the acceptance of the provided.

    It comprises several questions rated on a 7-point likert scale.

    Measured: After a 6-week robotic rehabilitation intervention

  18. Likert for Satisfaction

    Satisfaction will be assessed using a 11-point likert scale. It ranges from 0 to 10. Higher scores mean higher satisfaction.

    Measured: After a 6-week robotic rehabilitation intervention

Timeline

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

  1. First posted4 Jan 2022
  2. Study start10 Jan 2022
  3. Primary completionSep 2022 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05176600
Sponsor's protocol ID
FDG_Birehab_2021
Acronym
Birehab
Status last verified
Apr 2022
First submitted
10 Nov 2021
Last updated
29 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mauro MC, Fasano A, Germanotta M, Cortellini L, Insalaco S, Pavan A, Comanducci A, Guglielmelli E, Aprile IG. Aperiodic brain activity changes in patients with stroke following virtual reality-based upper limb robotic rehabilitation: a pilot Randomized Controlled Trial. Front Hum Neurosci. 2025 Oct 17;19:1671804. doi: 10.3389/fnhum.2025.1671804. eCollection 2025.

    PubMed 41179260

Questions about this trial

What is this clinical trial studying?

A study testing Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games and Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games in people with Stroke, run by Wearable Robotics srl. at 1 site in Italy.

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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 29 Apr 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 Italy. 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?

Results are not available in the source record.

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

Contact Irene Aprile, MD, PhD (+390633086553, iaprile@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events and description (time frame: through the study, an average of 10 months). 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 NCT05176600, which also lists 1 linked publication.

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 29 Apr 2022.

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