Tendon Vibrations Effect on Upper Limb Motor Recovery After Recent Stroke (VIBRAMOT)

August 7, 2020 updated by: Alain YELNIK, Centre Borelli UMR 9010

A Pilot Study of Proprioception Stimulation by Repeated Multi-site Tendon Vibrations, on Upper Limb Motor Skills Recovery After Recent Stroke

Stroke is the leading cause of severe acquired disabilities in adults. It can affect sensory and motor functions which are closely entangled. Among them, upper limb function is often strongly impaired. In this study the investigators are interested in the eventuality to improve motor recovery by the mean of stimulating the proprioception.

Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion.

Stimulation by tendinous vibrations, applied to the musculotendinous endings, has been already proposed in post stroke rehabilitation, but only at late stages. Thus the aim of our study is to observe the effects of repeated tendon vibrations, applied in the early post stroke phase, the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery (motor control and activities).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Stroke is the leading cause of severe acquired disabilities in adults. It can affect sensory and motor functions which are closely entangled. Among them, upper limb function is often strongly impaired. In this study the investigators are interested in the eventuality to improve motor recovery by the mean of stimulating the proprioception.

Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion.

Stimulation by tendinous vibrations, applied to the musculotendinous endings, has been already proposed in post stroke rehabilitation, but only at late stages.

Thus the aim of our study is to observe the effects of repeated tendon vibrations, applied in the early post stroke phase, the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery (motor control and activities).

Patients: 30 patients recruited after a first ever stroke whatever the cause and the site; age >18; stroke delay< 60 days; the maximum duration of participation for each patient is 3 months.

Protocol:

This rehabilitation protocol will be added to the usual rehabilitation program during inpatient rehabilitation.

Participants are randomized into two groups: experimental group and placebo group.

The experimental group benefits from upper limb tendon vibration sessions produced by small electromechanical vibrators on the elbow and the wrist. Frequency of the vibration is 80 Hz, two 15-minutes sessions per day scheduled for 10 days over a period of two weeks (2 x 5 days). During the sessions, the participant wearing opaque glasses, in a seating position, is asked to move if possible his/her arm in the opposite direction of the perceived movement.

The placebo group receives apparently the same treatment but with "sham" vibration.

Assessment:

Motor recovery will be assessed:

  • At the brain level by the efficiency of the primary motor pathway, measured by Motor Evoked Potentials recorded at the contralateral hand (main outcome criteria after 30 days from inclusion).
  • At the limb level by the motor control effectiveness measured by the Fugl Meyer scale, the Tardieu scale, the Action Research Arm Test (ARAT), the Box and Blocks Test (BBT) and the range of upper limb exploration with the ArmeoSpring, Hocoma brand.

The secondary objectives are:

  • To assess any impact on nerve fibers density on the main motor pathway by Magnetic Resonance Imaging.
  • To test the feasibility of such a rehabilitation protocol in a Physical Rehabilitation Medicine department

Four consultations are planned:

D0 (day 0): (before starting stimulation): Motor skills assessments, Motor Evoked Potentials (MEP) and Magnetic Resonance Imaging (MRI).

D15 (day 15): (as soon as stimulation ends): Motor skills assessments. D30 (day 30): Motor skills assessments and Motor Evoked Potentials (MEP) D90 (day 90): Motor skills assessments, Motor Evoked Potentials (MEP) and Magnetic Resonance Imaging (MRI).

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Île De France
      • Paris, Île De France, France, 75010
        • Recruiting
        • Physical and Rehabilitation Medicine department of Hôpital Fernand Widal
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alain YELNIK, MD, Prof
        • Sub-Investigator:
          • Marylène JOUSSE, MD, PhD
        • Sub-Investigator:
          • Nathtalie KUBIS, MD, Prof
        • Sub-Investigator:
          • Jean Pierre GUICHARD, MD
        • Sub-Investigator:
          • Emna JELILI, Engineer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1st ischemic or hemorrhagic stroke
  • Motor deficit of the upper limb (Fugl-Meyer between 0 and 50)
  • Delay since stroke <or = 60 days
  • Subject having given free and informed consent
  • Subject affiliated to the social security system

Exclusion Criteria:

  • Neurological history responsible for sensory or motor impairment of the concerned upper limb
  • Surgical history concerning the nervous or locomotor system of the concerned upper limb
  • Uncontrolled epilepsy
  • Pace-maker
  • Ferro-magnetic intra-cranial clip and any other contraindication to MEP and MRI
  • Cochlear implants
  • Pregnancy
  • Guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group (EG)
An Experimental Group (EG) of post-stroke subjects having vibration stimulation sessions in addition to traditional rehabilitation
Other: Upper limb repeated multi-site tendon vibrations
Upper limb tendon vibration protocol will be added to the usual rehabilitation protocol performed during hospitalization
Sham Comparator: Control Group (CG)
A Control Group (WG) of post-stroke subjects having placebo/sham vibration sessions (same vibrators used but without the eccentric mass), in addition to traditional rehabilitation
Other: Upper limb repeated multi-site tendon vibrations
Upper limb tendon vibration protocol will be added to the usual rehabilitation protocol performed during hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor recovery assessment at the brain level by the efficiency of the primary motor pathway measured by Motor Evoked Potentials (MEP) recorded at the contralateral hand
Time Frame: 30 day after the first assessment session (D30)

Assessment of Motor recovery at the brain level by the efficiency of the primary motor pathway, measured by Motor Evoked Potentials (MEP) recorded at the contralateral hand:

Magnetic stimulation is provided on the motor cortex involved by the stroke. The MEP are recorded on the contralateral side on the hand interossei muscles, in a bandwidth of 20 to 1000 Hz.

The electromyographic activity is recorded continuously to ensure total relaxation of the patient before stimulation.

The main parameter recorded is:

the threshold defined by the minimum stimulation intensity capable of generating a MEP> 50 microvolts amplitude in at least 3 of 6 tests, while the muscle is fully relaxed. Same measurements are made after moderate contraction of the collecting muscles (finger spacing).
30 day after the first assessment session (D30)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor recovery assessment at the upper limb level
Time Frame: at inclusion (first assessment, D0), 15 days after inclusion (as soon as stimulations ends, D15), 30 days after inclusion (D30), 90 days after inclusion (D90)
Motor control effectiveness is measured by the Fugl Meyer scale, the Tardieu scale, the Action Research Arm Test (ARAT), the Box and Blocks Test (BBT) and the range of upper limb exploration with the ArmeoSpring (Hocoma)
at inclusion (first assessment, D0), 15 days after inclusion (as soon as stimulations ends, D15), 30 days after inclusion (D30), 90 days after inclusion (D90)
To assess any impact on nerve fibers density on the main motor pathway by Magnetic Resonance Imaging
Time Frame: at inclusion (first assessment, D0), 90 days after inclusion (D90)

The MRI is used to assess the possible impact of vibrations on nerve fibers density of the main motor pathway (corticospinal bundle).

Diffusion tensor and tractography sequences are used to outline the direction and the density of nerve fibers. The corticospinal tract is particularly highlighted The first MRI takes place before any stimulation. It is used to localize the stroke in relation to the corticospinal tracts and to measure its volume.

A first tractography is used to assess the initial disorganization of the fiber bundles.

A 3D analysis of the tractography allows a visual assessment of the number and the density of fibers compared to the normal side.

A second MRI will be conducted after 3 months with same method of tractography analysis.
at inclusion (first assessment, D0), 90 days after inclusion (D90)
To test the feasibility of such a rehabilitation protocol in a PMR department
Time Frame: After inclusions completion

To study the impact of the protocol on the organization and rehabilitation if it proved useful to usual care.

The feasibility will be achieved by recording:

Total daily duration of installation and stimulation Technical difficulties encountered
After inclusions completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Borelli UMR 9010

Collaborators

Hopital Lariboisière

Investigators

  • Study Director: Alain YELNIK, MD, Prof, Centre BORELLI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 7, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 015-A00559-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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