Role of Armeo-Power and Muscle Vibration in Upper Limb Rehabilitation

April 6, 2017 updated by: Rocco Salvatore Calabrò, IRCCS Centro Neurolesi "Bonino-Pulejo"

Can Upper Limb Robotic Rehabilitation Plus Muscle Vibration Improve Motor Function? A Pilot Study

Muscle vibration (MV) has been suggested as a useful non-pharmacological approach to control spasticity. Armeo Power® (AP) is a robotic exoskeleton for rehabilitation allowing early rehabilitation treatment. The objective of our study was to determine whether AP training coupled with MV applied on antagonist muscles of the spastic upper limb (UL) can reduce the spasticity of agonist muscles. We enrolled 20 chronic post-stroke patients, who underwent 40 daily sessions of AP training. Ten subjects (group-A) received muscle MV (on triceps brachii, deltoid, and supraspinatus), whereas the other 10 (group-B) underwent a sham vibration.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a first ever supra-tentorial unilateral (left hemisphere) ischemic stroke experienced more than three months before the enrollment;
  • a deficit of shoulder abductor, arm flexor, and elbow extensor muscles ranging from 2 to 4 on the Medical Research Council scale (MRC);
  • a spasticity of biceps brachii (BB), pectoralis major (PM), and latissimus dorsi (LD) (namely, spastic agonist muscles) ranging from 1+ to 3 on the Modified Ashworth Scale (MAS);
  • age between 50 and 80 years; and (v) Caucasian ethnicity.

Exclusion Criteria:

  • history of concomitant neurodegenerative diseases or brain surgery;
  • severe cognitive (Mini-Mental State Examination score <23 points) or language impairment (Boston Disability Aphasia Quotient <4/5);
  • severe neglect (Catherine Bergego Scale >15/30);
  • systemic, bone, or joint disorders, tumors, changes in either central or peripheral sensitivity as well as visual impairments able to interfere with the aims and methods of the research;.(v) concomitant use of drugs for spasticity;
  • botulin toxin treatment in the last eight months;.(vii) TMS contraindications;
  • history of psychosis;
  • limited passive range of motion (shoulder abduction <60°, elbow extension <30°, specified by a goniometric assessment).

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ArmeoP+real MV
The patients underwent forty 1h Armeo-P training sessions (i.e. five times a week for eight consecutive weeks). During the first session, the device was adjusted to the patient's arm size and the angle of suspension. The working space and the exercises were selected once the UL had been fitted with the system. All the subjects in the arm received a focal belly-muscle vibration on the spastic antagonist muscles (i.e. triceps brachialis-TB, deltoid-DE, and supraspinatus-SS) during shoulder abduction and elbow extension. MV was delivered by a pneumatic vibrator powered by compressed air, wired to appropriate-muscle probe diameter (up to 2cm2). MV was set at a frequency of 80Hz and an individually adjusted vibration amplitude so that it was just below the threshold for perceiving an illusory movement. The investigators chose such set up to avoid any signs of muscle contraction potentially reflecting either possible voluntary movement or occurrence of the tonic vibration reflex (TVR).
Device: ArmeoP+real MV
All the subjects assigned to the experimental received a focal belly-muscle vibration on the spastic antagonist muscles (i.e. triceps brachialis-TB, deltoid-DE, and supraspinatus-SS) during shoulder abduction and elbow extension. MV was delivered by a pneumatic vibrator powered by compressed air (Vibraplus; @Circle, San Pietro in Casale, Italy) (fig. 2) wired to appropriate-muscle probe diameter (up to 2cm2). MV was set at a frequency of 80Hz and an individually adjusted vibration amplitude (approximately 2mm in indentation depth, mean pressure of 250mBar, which effectively induce inhibition of the monosynaptic reflex) so that it was just below the threshold for perceiving an illusory movement. We chose such set up to avoid any signs of muscle contraction potentially reflecting either possible voluntary movement or occurrence of the tonic vibration reflex (TVR).
Active Comparator: ArmeoP+ Sham MV

The patients underwent the same Armeo-P trainingas the experimental group. Only the vibration protocol was didderent. Indeed, in the control group a sham vibration was used, while in the experimental group, patients underwent a real one.

Sham vibration was delivered to the control group using the same procedure of the experimental group;however, vibration intensity was subthreshold (i.e. 50mBar below the threshold).
Device: ArmeoP+real MV
All the subjects assigned to the experimental received a focal belly-muscle vibration on the spastic antagonist muscles (i.e. triceps brachialis-TB, deltoid-DE, and supraspinatus-SS) during shoulder abduction and elbow extension. MV was delivered by a pneumatic vibrator powered by compressed air (Vibraplus; @Circle, San Pietro in Casale, Italy) (fig. 2) wired to appropriate-muscle probe diameter (up to 2cm2). MV was set at a frequency of 80Hz and an individually adjusted vibration amplitude (approximately 2mm in indentation depth, mean pressure of 250mBar, which effectively induce inhibition of the monosynaptic reflex) so that it was just below the threshold for perceiving an illusory movement. We chose such set up to avoid any signs of muscle contraction potentially reflecting either possible voluntary movement or occurrence of the tonic vibration reflex (TVR).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of spasticity-MAS
Time Frame: Six months
The primary outcomes consisted in the effects of MV and Armeo Power® on spasticity by a clinical (MAS from spastic agonist muscles causing arm adduction, inward rotation, and flexion, and forearm flexion)
Six months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment of UL motor recovery after stroke -FMA
Time Frame: Six months
The investigators measured the effects of MV and Armeo Power® on UL motor function impairment (measured by Fugl-Meyer Assessment of UL motor recovery after stroke -FMA).
Six months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Centro Neurolesi "Bonino-Pulejo"

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 42/2013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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