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

NCT03319992 | Completed Phase 2

• 1 other identifier: RH-UL-LEXOS-10
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

Robotics [H01.671.293.643]; Exoskeleton Device [E07.341]; Rehabilitation Research [H01.770.644.145.472]; Physical and Rehabilitation Medicine [H02.403.680]; Exercise Therapy [E02.779.483]; Patient Outcome Assessment [N05.715.360.575.575.399]

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment (FMA( Score

  The null hypothesis tested in this study was the change in motor function domain of the upper extremity portion of the Fugl-Meyer assessment in the Robotic Group (Robotic Treatment) would be the same as the one obtained by the Control Group (Conventional Treatment). The FMA outcome is further divided and analyzed in terms of sub-items. In particular, the motor FMA score is divided into proximal (shoulder and elbow movement, 36 points) and distal (hand and wrist movement, 24 points) sub-items.

  baseline and 6 weeks

Secondary Outcomes (4)

• Functional scale: Bimanual Activity Test (BAT)

  baseline and 6 weeks

• Modified Ashworth (MA) scale

  baseline and 6 weeks

• Robotic kinesiological assessment of movement: Execution Time

  At end of each session, during 6 weeks of enrollment in treatment

• Robotic kinesiological assessment of movement: Smoothness index

  At end of each session, during 6 weeks of enrollment in treatment

Study Arms (2)

Conventional treatment

NO INTERVENTION

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

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.

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

Interventions

Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS) 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.

Robotic treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Scuola Superiore Sant'Anna di Pisa: lead
• Azienda Ospedaliero, Universitaria Pisana: collaborator

Study Sites (1)

University Hospital of Pisa

Pisa, 56123, Italy

Location

Related Publications (1)

• 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.

  PMID: 35120546 DERIVED

MeSH Terms

Conditions

Stroke; Chronic Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmelo Carmelo, Carmelo

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, Office of Research and Development

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 24, 2017
• Study Start: July 20, 2016
• Primary Completion: October 20, 2018
• Study Completion: November 30, 2018
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

IT (1)