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

Not Applicable

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

• Registration Number: NCT05176600
• Lead Sponsor: Wearable Robotics srl.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-04
• Study Start: 2022-01-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-29
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unimanual group	Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games	In this group, patients will perform a robotic rehabilitation based on unimanual serious games
Bimanual group	Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games	In this group, patients will perform a robotic rehabilitation based on bimanual serious games

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events and description	through the study, an average of 10 months	Number and description of adverse events related to the provided intervention

Secondary Outcome Measures

Name	Time	Method
Changes in EEG-based Connectivity index	Before the intervention, 1 week after the end of the 30-session robotic intervention	Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)
Changes in EEG-based Interhemispheric coupling index	Before the intervention, 1 week after the end of the 30-session robotic intervention	Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)
Changes in Fugl-meyer Assessment Upper Extremity motor functioning	Before the intervention, after a 6-week robotic rehabilitation intervention	It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).
Changes in Wolf Motor Function Test	Before the intervention, after a 6-week robotic rehabilitation intervention	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 Fugl-meyer Assessment - Sensory functioning	Before the intervention, after a 6-week robotic rehabilitation intervention	It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12points (best).
Changes in Modified Ashworth Scale	Before the intervention, after a 6-week robotic rehabilitation intervention	It is a validated measure of spasticity. It ranges from 0 (normal) to 4 (rigid limb).
Changes in Motricity Index for upper extremity	Before the intervention, after a 6-week robotic rehabilitation intervention	It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).
Changes in Action Research Arm Test (ARAT)	Before the intervention, after a 6-week robotic rehabilitation intervention	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	Before the intervention, after a 6-week robotic rehabilitation intervention	It is the time (in seconds) required to perform reaching movement using the robot
Changes in Range of Motion (degrees) measured with the robot	Before the intervention, after a 6-week robotic rehabilitation intervention	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	Before the intervention, after a 6-week robotic rehabilitation intervention	It is a measure of movement smoothness while performing reaching movements with the robot.
System Usability Scale	After a 6-week robotic rehabilitation intervention	It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.
Technology Acceptance Model (TAM)	After a 6-week robotic rehabilitation intervention	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	After a 6-week robotic rehabilitation intervention	Satisfaction will be assessed using a 11-point likert scale. It ranges from 0 to 10. Higher scores mean higher satisfaction.

Trial Locations

Locations (1)

Fondazione Don Carlo Gnocchi; 🇮🇹 Rome, Italy