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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110718
• Other study ID #: 42/2013
• Status: Completed
• Phase: N/A
• First received: April 1, 2017
• Last updated: April 6, 2017
• Start date: January 2, 2015
• Est. completion date: October 1, 2015

Study information

• Verified date: April 2017
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2015
• Est. primary completion date: June 2, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of spasticity-MAS	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	Fugl-Meyer Assessment of UL motor recovery after stroke -FMA	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