NCT03110718

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-01-02
• Primary completion: 2015-06-02
• Completion: 2015-10-01
• First posted: 2017-04-12
• Last updated: 2017-04-12

Regulatory

• FDA-regulated device study