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

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games; Device: Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irene Aprile, MD, PhD; Phone Number: +390633086553; Email: iaprile@dongnocchi.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Don Carlo Gnocchi
    • Contact: Irene Aprile, MD, PhD; Phone Number: +390688036553; Email: iaprile@dongnocchi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bimanual group; 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; 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.
Active Comparator: Unimanual group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale	It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.	After a 6-week robotic rehabilitation intervention
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.	After a 6-week robotic rehabilitation intervention
Likert for Satisfaction	Satisfaction will be assessed using a 11-point likert scale. It ranges from 0 to 10. Higher scores mean higher satisfaction.	After a 6-week robotic rehabilitation intervention
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).	Before the intervention, after a 6-week robotic rehabilitation intervention
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.	Before the intervention, after a 6-week robotic rehabilitation intervention
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).	Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in EEG-based Interhemispheric coupling index	Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)	Before the intervention, after a 1-hour robotic rehabilitation session
Changes in EEG-based Interhemispheric coupling index	Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)	Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in EEG-based Interhemispheric coupling index	Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)	Before the intervention, 1 week after the end of the 30-session robotic intervention
Changes in EEG-based Connectivity index	Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)	Before the intervention, after a 1-hour robotic rehabilitation session
Changes in EEG-based Connectivity index	Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)	Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in EEG-based Connectivity index	Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)	Before the intervention, 1 week after the end of the 30-session robotic intervention
Changes in Fugl-meyer Assessment - Sensory functioning	It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12points (best).	Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Modified Ashworth Scale	It is a validated measure of spasticity. It ranges from 0 (normal) to 4 (rigid limb).	Before the intervention, after a 6-week robotic rehabilitation intervention
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.	Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Execution time (seconds) measured with the robot	It is the time (in seconds) required to perform reaching movement using the robot	Before the intervention, after a 6-week robotic rehabilitation intervention
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	Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Number of velocity peaks measured with the robot	It is a measure of movement smoothness while performing reaching movements with the robot.	Before the intervention, after a 6-week robotic rehabilitation intervention

Collaborators and Investigators

• Sponsor: Wearable Robotics srl.
• Collaborators: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: FDG_Birehab_2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No