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

April 8, 2021 updated by: Antonio Frisoli, Scuola Superiore Sant'Anna di Pisa

Robotic Assisted Task-Oriented Rehabilitation of Upper Limb for Chronic Stroke Patients

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pisa, Italy, 56123
        • University Hospital of Pisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer Assessment (FMA( Score
Time Frame: baseline and 6 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional scale: Bimanual Activity Test (BAT)
Time Frame: baseline and 6 weeks

The BAT is a functional scale designed to quantify the contribution of patient's affected upper limb to execute 25 common Activities of Daily Living such as Loosen and tighten the cap of a bottle , or unscrew a bolt. The elapsed time for accomplishing each task is measured and the therapist also give a score (ranging from 1 to 4) about the quality of each movement.

The BAT data is analyzed also in terms of sub-items, divided into pinch-tasks and power-tasks collecting those items requiring fine and gross manipulation motor skills respectively.

baseline and 6 weeks
Modified Ashworth (MA) scale
Time Frame: baseline and 6 weeks
The MA scale (Bohannon and Smith, 1987) is used to evaluate spasticity of the upper limb and to assess abnormal muscle tone at the shoulder and elbow. The MA scale is a 6-point scale: scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement. MA scores were averaged across the two joints and across testing directions (flexion, extension) to estimate abnormal muscle tone in the upper extremity (Zackowski, Dromerick et al., 2004)
baseline and 6 weeks
Robotic kinesiological assessment of movement: Execution Time
Time Frame: At end of each session, during 6 weeks of enrollment in treatment

This measure is evaluated only in the group of patients performing robotic training, at the end of each session through the analysis of their performance during the execution of an evaluation exercise without robotic assistance.The patients are instructed to reach different targets positioned in front of them and placed around a vertical circumference at 12 equally spaced locations.

The robotic measure is extracted for each outgoing (from the center to the target) movement. The execution time is measured as the elapsed time (measure in seconds) for accomplishing each movement, measured from the time of grasping of the virtual object at the start position to the release time at the target position.

At end of each session, during 6 weeks of enrollment in treatment
Robotic kinesiological assessment of movement: Smoothness index
Time Frame: At end of each session, during 6 weeks of enrollment in treatment

This measure is evaluated only in the group of patients performing robotic training, at the end of each session through the analysis of their performance during the execution of an evaluation exercise without robotic assistance.The patients are instructed to reach different targets positioned in front of them and placed around a vertical circumference at 12 equally spaced locations.

The robotic measure is extracted for each outgoing (from the center to the target) movement.

The smoothness index is computed in the same interval period by counting the number of peaks in the velocity profile of movement, namely the Number of Movements Units (NMU) (Fasoli S, Krebs J Neurosci 2002)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Carmelo Carmelo, Carmelo, U.O. Neurorehabilitation Division, Azienda Ospedaliero-Universitaria Pisana (AOUP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2016

Primary Completion (Actual)

October 20, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 20, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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