Clinical trial NCT05176600: Bimanual Robotic Exoskeletal Platform for the Treatment of the Upper Limb in Patients With Stroke. A Feasibility Study
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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Wearable Robotics srl.
Sponsor class: INDUSTRY
Collaborators: name: Fondazione Don Carlo Gnocchi Onlus
First posted: 2022-01-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Incidence of adverse events and description
timeFrame: through the study, an average of 10 months
Secondary outcomes:
measure: Changes in EEG-based Interhemispheric coupling index
timeFrame: Before the intervention, after a 1-hour robotic rehabilitation session
measure: Changes in EEG-based Interhemispheric coupling index
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in EEG-based Interhemispheric coupling index
timeFrame: Before the intervention, 1 week after the end of the 30-session robotic intervention
measure: Changes in EEG-based Connectivity index
timeFrame: Before the intervention, after a 1-hour robotic rehabilitation session
measure: Changes in EEG-based Connectivity index
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in EEG-based Connectivity index
timeFrame: Before the intervention, 1 week after the end of the 30-session robotic intervention
measure: Changes in Fugl-meyer Assessment Upper Extremity motor functioning
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Fugl-meyer Assessment - Sensory functioning
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Modified Ashworth Scale
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Motricity Index for upper extremity
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Wolf Motor Function Test
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Action Research Arm Test (ARAT)
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Execution time (seconds) measured with the robot
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Range of Motion (degrees) measured with the robot
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Number of velocity peaks measured with the robot
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: System Usability Scale
timeFrame: After a 6-week robotic rehabilitation intervention
measure: Technology Acceptance Model (TAM)
timeFrame: After a 6-week robotic rehabilitation intervention
measure: Likert for Satisfaction
timeFrame: After a 6-week robotic rehabilitation intervention
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Don Carlo Gnocchi
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Irene Aprile, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: