- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ArmeoP+real MV
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).
|
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).
|
Active Comparator: ArmeoP+ Sham MV
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). |
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl-Meyer Assessment of UL motor recovery after stroke -FMA
Time Frame: 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).
|
Six months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 42/2013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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