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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Stroke

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimanual group<br>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<br>* 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.<br>|
| Active Comparator: Unimanual group<br>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<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 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 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 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 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 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 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 | 
| 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 |