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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

ArmeoP+real MV

Device

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).

Primary outcomes

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)

Secondary outcomes

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).

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Apr 12, 2017
Registry last updated: Apr 12, 2017

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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