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

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT03110718
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-02
• Primary Completion: 2015-06-02
• Study Completion: 2015-10-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-01
• Study First Submitted QC: 2017-04-06
• Last Update Submitted: 2017-04-06
• Study First Posted: 2017-04-12
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of spasticity-MAS	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 Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment of UL motor recovery after stroke -FMA	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).