Upper Extremity Paresis Clinical Trial
— VIBRAMOTOfficial title:
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).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Physical and Rehabilitation Medicine department of Hôpital Fernand Widal | Paris | Île De France |
Lead Sponsor | Collaborator |
---|---|
Centre Borelli UMR 9010 | Hopital Lariboisière |
France,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Motor recovery assessment at the upper limb level | 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) | |
Secondary | To assess any impact on nerve fibers density on the main motor pathway by Magnetic Resonance Imaging | 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) | |
Secondary | To test the feasibility of such a rehabilitation protocol in a PMR department | 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 |
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