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Clinical Trials/NCT03110718
NCT03110718
Completed
Not Applicable

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

IRCCS Centro Neurolesi "Bonino-Pulejo"0 sites20 target enrollmentJanuary 2, 2015
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
Enrollment
20
Primary Endpoint
Assessment of spasticity-MAS
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2015
End Date
October 1, 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rocco Salvatore Calabrò

Principal investigator

IRCCS Centro Neurolesi "Bonino-Pulejo"

Eligibility Criteria

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).

Outcomes

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(Six months)

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