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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
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
Sponsored by
Wearable Robotics srl.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fondazione Don Carlo GnocchiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bimanual group

Unimanual group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of adverse events and description
Number and description of adverse events related to the provided intervention

Secondary Outcome Measures

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

Full Information

First Posted
November 10, 2021
Last Updated
April 22, 2022
Sponsor
Wearable Robotics srl.
Collaborators
Fondazione Don Carlo Gnocchi Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT05176600
Brief Title
Bimanual Robotic Exoskeletal Platform for the Treatment of the Upper Limb in Patients With Stroke. A Feasibility Study
Acronym
Birehab
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wearable Robotics srl.
Collaborators
Fondazione Don Carlo Gnocchi Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bimanual group
Arm Type
Experimental
Arm Description
In this group, patients will perform a robotic rehabilitation based on bimanual serious games
Arm Title
Unimanual group
Arm Type
Active Comparator
Arm Description
In this group, patients will perform a robotic rehabilitation based on unimanual serious games
Intervention Type
Device
Intervention Name(s)
Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of adverse events and description
Description
Number and description of adverse events related to the provided intervention
Time Frame
through the study, an average of 10 months
Secondary Outcome Measure Information:
Title
Changes in EEG-based Interhemispheric coupling index
Description
Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)
Time Frame
Before the intervention, after a 1-hour robotic rehabilitation session
Title
Changes in EEG-based Interhemispheric coupling index
Description
Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)
Time Frame
Before the intervention, after a 6-week robotic rehabilitation intervention
Title
Changes in EEG-based Interhemispheric coupling index
Description
Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)
Time Frame
Before the intervention, 1 week after the end of the 30-session robotic intervention
Title
Changes in EEG-based Connectivity index
Description
Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)
Time Frame
Before the intervention, after a 1-hour robotic rehabilitation session
Title
Changes in EEG-based Connectivity index
Description
Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)
Time Frame
Before the intervention, after a 6-week robotic rehabilitation intervention
Title
Changes in EEG-based Connectivity index
Description
Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)
Time Frame
Before the intervention, 1 week after the end of the 30-session robotic intervention
Title
Changes in Fugl-meyer Assessment Upper Extremity motor functioning
Description
It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).
Time Frame
Before the intervention, after a 6-week robotic rehabilitation intervention
Title
Changes in Fugl-meyer Assessment - Sensory functioning
Description
It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12points (best).
Time Frame
Before the intervention, after a 6-week robotic rehabilitation intervention
Title
Changes in Modified Ashworth Scale
Description
It is a validated measure of spasticity. It ranges from 0 (normal) to 4 (rigid limb).
Time Frame
Before the intervention, after a 6-week robotic rehabilitation intervention
Title
Changes in Motricity Index for upper extremity
Description
It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).
Time Frame
Before the intervention, after a 6-week robotic rehabilitation intervention
Title
Changes in Wolf Motor Function Test
Description
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.
Time Frame
Before the intervention, after a 6-week robotic rehabilitation intervention
Title
Changes in Action Research Arm Test (ARAT)
Description
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.
Time Frame
Before the intervention, after a 6-week robotic rehabilitation intervention
Title
Changes in Execution time (seconds) measured with the robot
Description
It is the time (in seconds) required to perform reaching movement using the robot
Time Frame
Before the intervention, after a 6-week robotic rehabilitation intervention
Title
Changes in Range of Motion (degrees) measured with the robot
Description
It is the range of motion (measured in degrees) of shoulder and elbow evaluated using the robot
Time Frame
Before the intervention, after a 6-week robotic rehabilitation intervention
Title
Changes in Number of velocity peaks measured with the robot
Description
It is a measure of movement smoothness while performing reaching movements with the robot.
Time Frame
Before the intervention, after a 6-week robotic rehabilitation intervention
Title
System Usability Scale
Description
It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.
Time Frame
After a 6-week robotic rehabilitation intervention
Title
Technology Acceptance Model (TAM)
Description
It is a self-administered questionnaire to evaluate the acceptance of the provided. It comprises several questions rated on a 7-point likert scale.
Time Frame
After a 6-week robotic rehabilitation intervention
Title
Likert for Satisfaction
Description
Satisfaction will be assessed using a 11-point likert scale. It ranges from 0 to 10. Higher scores mean higher satisfaction.
Time Frame
After a 6-week robotic rehabilitation intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Aprile, MD, PhD
Phone
+390633086553
Email
iaprile@dongnocchi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Aprile, MD, PhD
Organizational Affiliation
Fondazione Don Carlo Gnocchi Onlus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Don Carlo Gnocchi
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Aprile, MD, PhD
Phone
+390688036553
Email
iaprile@dongnocchi.it

12. IPD Sharing Statement

Learn more about this trial

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

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