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

Wearable Robotics

Status: Unknown

Conditions: Stroke

Treatments: 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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05176600

FDG_Birehab_2021

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Bimanual group

Experimental group

Description:

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

Treatment:

Device: Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games

Unimanual group

Active Comparator group

Description:

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

Treatment:

Device: Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games