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

NCT03110718 | Completed FDA Device

• 1 other identifier: 42/2013
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Keywords

robotic rehabilitation; muscle vibration; combined approach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fugl-Meyer Assessment of UL motor recovery after stroke -FMA

  Six months

Study Arms (2)

ArmeoP+real MV

EXPERIMENTAL

The patients underwent forty 1h Armeo-P training sessions (i.e. five times a week for eight consecutive weeks). During the first session, the device was adjusted to the patient's arm size and the angle of suspension. The working space and the exercises were selected once the UL had been fitted with the system. All the subjects in the arm 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, wired to appropriate-muscle probe diameter (up to 2cm2). MV was set at a frequency of 80Hz and an individually adjusted vibration amplitude so that it was just below the threshold for perceiving an illusory movement. The investigators 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).

Device: ArmeoP+real MV

ArmeoP+ Sham MV

ACTIVE COMPARATOR

The patients underwent the same Armeo-P trainingas the experimental group. Only the vibration protocol was didderent. Indeed, in the control group a sham vibration was used, while in the experimental group, patients underwent a real one. Sham vibration was delivered to the control group using the same procedure of the experimental group;however, vibration intensity was subthreshold (i.e. 50mBar below the threshold).

Device: ArmeoP+real MV

Interventions

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).

ArmeoP+ Sham MV; ArmeoP+real MV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 1, 2017
• First Posted: April 12, 2017
• Study Start: January 2, 2015
• Primary Completion: June 2, 2015
• Study Completion: October 1, 2015
• Last Updated: April 12, 2017

Record last verified: 2017-04