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Completed

NCT Number: NCT03319992

Upper Limb Task-Oriented Rehabilitation With Robotic Exoskeleton for Hemiparetic 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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)

Sponsors and collaborators

Lead sponsor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Other

Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

Registry information

Official study title

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

Acronym: RH-LEXOS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2017
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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