Stroke
Conditions
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).
Interventions
DEVICERobotic 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.
DEVICERobotic 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.
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Wearable Robotics srl.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in EEG-based Connectivity index | Before the intervention, after a 1-hour robotic rehabilitation session | Connectivity 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 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 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 EEG-based Interhemispheric coupling index | Before the intervention, after a 1-hour robotic rehabilitation session | Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG) |
| 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. |
| 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. |
Countries
Italy
Contacts
Primary ContactIrene Aprile, MD, PhD
Outcome results
None listed