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

NCT05176600 | Unknown

• 1 other identifier: FDG_Birehab_2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events and description

  Number and description of adverse events related to the provided intervention

  through the study, an average of 10 months

Secondary Outcomes (18)

• Changes in EEG-based Interhemispheric coupling index

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

• Changes in EEG-based Interhemispheric coupling index

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

• Changes in EEG-based Interhemispheric coupling index

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

• Changes in EEG-based Connectivity index

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

• Changes in EEG-based Connectivity index

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

Study Arms (2)

Bimanual group

EXPERIMENTAL

In this group, patients will perform a robotic rehabilitation based on bimanual serious games

Device: Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games

Unimanual group

ACTIVE COMPARATOR

In this group, patients will perform a robotic rehabilitation based on unimanual serious games

Device: Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games

Interventions

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

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.

Bimanual group

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

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.

Unimanual group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Wearable Robotics srl.: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (1)

Fondazione Don Carlo Gnocchi

Rome, 00168, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 41179260 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Irene Aprile, MD, PhD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Aprile, MD, PhD

CONTACT

+390633086553; iaprile@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: January 4, 2022
• Study Start: January 10, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

IT (1)