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Cerebrovascular Accident (CVA)Phase 2RH-LEXOSNCT03319992

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

A Phase 2 study testing Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS) in people with Cerebrovascular Accident (CVA) and Chronic Disease, run by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteItaly
Study dates
20 Jul 2016to 30 Nov 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University Hospital of Pisa

    Pisa, 56123

Other trials in Italy

About this study

Official title: 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.

Being tested
Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)
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]
Medical subject headings
Stroke, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03319992
Study groupRoleWhat they receive
Conventional treatmentNo interventionThe 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 treatmentExperimentalThe 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.
Receives: Device: Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline and 6 weeks

Secondary outcomes (4)

  1. Functional scale: Bimanual Activity Test (BAT)

    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.

    Measured: baseline and 6 weeks

  2. Modified Ashworth (MA) scale

    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)

    Measured: baseline and 6 weeks

  3. Robotic kinesiological assessment of movement: Execution Time

    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.

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

  4. Robotic kinesiological assessment of movement: Smoothness index

    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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2017
  2. Study start20 Jul 2016
  3. Primary completion20 Oct 2018
  4. Study completion30 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03319992
Sponsor's protocol ID
RH-UL-LEXOS-10
Acronym
RH-LEXOS
Status last verified
Apr 2021
First submitted
20 Oct 2017
Last updated
13 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: De-identified individual participant data for all primary and secondary outcome measures will be made available

Publications

  • 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.

    PubMed 35120546

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS) in people with Cerebrovascular Accident (CVA) and Chronic Disease, run by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fugl-Meyer Assessment (FMA( Score (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03319992, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.

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