Upper Limb Task-Oriented Rehabilitation With Robotic Exoskeleton for Hemiparetic Stroke Patients

NCT ID: NCT03319992

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-20
• Study Completion Date: 2018-11-30

Brief Summary

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.

Conditions

Cerebrovascular Accident (CVA); Chronic Disease; Stroke Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional treatment

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Robotic treatment

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.

Group Type: EXPERIMENTAL

Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)

Intervention Type: DEVICE

RH-LEXOS is a robotic exoskeleton device to support the rehabilitation of stroke patients. This system is conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. Passive, assisted and active mobilization of upper arm is provided through the use of the exoskeleton robotic device within high intensive, repetitive, task-oriented exercises and an objective and reliable mean for monitoring patients' progress.

Interventions

Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)

RH-LEXOS is a robotic exoskeleton device to support the rehabilitation of stroke patients. This system is conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. Passive, assisted and active mobilization of upper arm is provided through the use of the exoskeleton robotic device within high intensive, repetitive, task-oriented exercises and an objective and reliable mean for monitoring patients' progress.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: collaborator

Scuola Superiore Sant'Anna di Pisa

OTHER

Sponsor Role: lead

Responsible Party

Antonio Frisoli

Prof, Office of Research and Development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carmelo Carmelo, Carmelo

Role: STUDY_DIRECTOR

U.O. Neurorehabilitation Division, Azienda Ospedaliero-Universitaria Pisana (AOUP)

Locations

University Hospital of Pisa

Pisa, , Italy

Countries

Italy

References

Frisoli A, Barsotti M, Sotgiu E, Lamola G, Procopio C, Chisari C. A randomized clinical control study on the efficacy of three-dimensional upper limb robotic exoskeleton training in chronic stroke. J Neuroeng Rehabil. 2022 Feb 4;19(1):14. doi: 10.1186/s12984-022-00991-y.

Reference Type: DERIVED

PMID: 35120546 (View on PubMed)

Other Identifiers

RH-UL-LEXOS-10

Identifier Type: -

Identifier Source: org_study_id