Upper Limb Task-Oriented Rehabilitation With Robotic Exoskeleton for Hemiparetic Stroke Patients (RH-LEXOS)

Scuola Superiore Sant'Anna di Pisa

Status and phase: Completed; Phase 2

Conditions: Chronic Disease; Stroke Rehabilitation; Cerebrovascular Accident (CVA)

Treatments: Device: Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03319992

RH-UL-LEXOS-10

Details and patient eligibility

About

The aim of this study is to evaluate the effects of an assisted rehabilitation treatment through a robotic exoskeleton device on the functional recovery in a group of patients with hemiparesis from lesion of the first motor neuron (post-stroke), compared with a group of patients subjected to a conventional rehabilitation treatment. The patients enrolled in the study are chronic stroke injured with right hemiparesis of moderate to severe degree, by the system injury pyramid, never undergoing rehabilitation treatment with robots.

Enrollment: 26 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• diagnosis of a first-ever left hemisphere ischemic or hemorrhagic stroke at least 6 months prior to entry into the study;
• minimum ability for shoulder humeral elevation;
• upper-extremity motor function Fugl-Meyer (FM) score ≥ 15(out of 66);
• absence of neurological or muscular disorders that interfere with neuromuscular function;
• absence of severe cognitive deficits that would limit patients' ability to complete the study;
• minimum score of 2 in the Modified Ashworth Scale;
• not participating in any experimental rehabilitation or drug studies at the same time
• no previous experience with robotic treatments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Conventional treatment

No Intervention group

Description:

The conventional treatment arm was conducted according to a set of exercises that were specifically designed in order to match the robotic treatment. Patients received both physical therapy (PT) and occupational therapy (OT) session, administered by the physiotherapists of the hospital. The therapist will provide a specific conventional treatment comparable with the robotic treatment in terms of session time and therapeutic goals.

Robotic treatment

Experimental group

Description:

The patients enrolled in the robotic arm are going to be undergone a series of passive, assisted and active mobilization in upper limb task-oriented exercises implemented in 3d virtual environments. Briefly speaking, these tasks promote the upper arm multi-joints coordination during the execution of reaching movements and grasping actions of fixed virtual objects displaced in the space.

Treatment:

Device: Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)