Tendon Vibrations Effect on Upper Limb Motor Recovery After Recent Stroke

NCT04504214 | Unknown

• 1 other identifier: 015-A00559-40
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stroke/Brain Attack; Upper Extremity Paresis

Keywords

stroke; rehabilitation; proprioception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Motor recovery assessment at the upper limb level

  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

  at inclusion (first assessment, D0), 90 days after inclusion (D90)

• To test the feasibility of such a rehabilitation protocol in a PMR department

  After inclusions completion

Study Arms (2)

Experimental group (EG)

EXPERIMENTAL

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

Control Group (CG)

SHAM COMPARATOR

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

Interventions

Upper limb repeated multi-site tendon vibrations OTHER

Upper limb tendon vibration protocol will be added to the usual rehabilitation protocol performed during hospitalization

Control Group (CG); Experimental group (EG)

Eligibility Criteria

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

You may qualify if:

• st 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Borelli UMR 9010: lead
• Hopital Lariboisière: collaborator

Study Sites (1)

Physical and Rehabilitation Medicine department of Hôpital Fernand Widal

Paris, Île-de-France Region, 75010, France

RECRUITING

Related Publications (24)

• Reinkensmeyer DJ, Boninger ML. Technologies and combination therapies for enhancing movement training for people with a disability. J Neuroeng Rehabil. 2012 Mar 30;9:17. doi: 10.1186/1743-0003-9-17.

  PMID: 22463132 RESULT

• Kitago T, Krakauer JW. Motor learning principles for neurorehabilitation. Handb Clin Neurol. 2013;110:93-103. doi: 10.1016/B978-0-444-52901-5.00008-3.

  PMID: 23312633 RESULT

• Nudo RJ, McNeal D. Plasticity of cerebral functions. Handb Clin Neurol. 2013;110:13-21. doi: 10.1016/B978-0-444-52901-5.00002-2.

  PMID: 23312627 RESULT

• Edin BB, Johansson N. Skin strain patterns provide kinaesthetic information to the human central nervous system. J Physiol. 1995 Aug 15;487(1):243-51. doi: 10.1113/jphysiol.1995.sp020875.

  PMID: 7473253 RESULT

• Hagbarth KE, Eklund G. The muscle vibrator--a useful tool in neurological therapeutic work. Scand J Rehabil Med. 1969;1(1):26-34. No abstract available.

  PMID: 5406721 RESULT

• Goodwin GM, McCloskey DI, Matthews PB. Proprioceptive illusions induced by muscle vibration: contribution by muscle spindles to perception? Science. 1972 Mar 24;175(4028):1382-4. doi: 10.1126/science.175.4028.1382.

  PMID: 4258209 RESULT

• Roll JP, Vedel JP. Kinaesthetic role of muscle afferents in man, studied by tendon vibration and microneurography. Exp Brain Res. 1982;47(2):177-90. doi: 10.1007/BF00239377.

  PMID: 6214420 RESULT

• Roll JP, Albert F, Thyrion C, Ribot-Ciscar E, Bergenheim M, Mattei B. Inducing any virtual two-dimensional movement in humans by applying muscle tendon vibration. J Neurophysiol. 2009 Feb;101(2):816-23. doi: 10.1152/jn.91075.2008. Epub 2008 Dec 3.

  PMID: 19052107 RESULT

• Heath CJ, Hore J, Phillips CG. Inputs from low threshold muscle and cutaneous afferents of hand and forearm to areas 3a and 3b of baboon's cerebral cortex. J Physiol. 1976 May;257(1):199-227. doi: 10.1113/jphysiol.1976.sp011364.

  PMID: 820853 RESULT

• Forner-Cordero A, Steyvers M, Levin O, Alaerts K, Swinnen SP. Changes in corticomotor excitability following prolonged muscle tendon vibration. Behav Brain Res. 2008 Jun 26;190(1):41-9. doi: 10.1016/j.bbr.2008.02.019. Epub 2008 Feb 20.

  PMID: 18378327 RESULT

• Marconi B, Filippi GM, Koch G, Pecchioli C, Salerno S, Don R, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on motor cortical excitability induced by repeated muscle vibration during contraction in healthy subjects. J Neurol Sci. 2008 Dec 15;275(1-2):51-9. doi: 10.1016/j.jns.2008.07.025. Epub 2008 Aug 29.

  PMID: 18760809 RESULT

• Rosenkranz K, Rothwell JC. The effect of sensory input and attention on the sensorimotor organization of the hand area of the human motor cortex. J Physiol. 2004 Nov 15;561(Pt 1):307-20. doi: 10.1113/jphysiol.2004.069328. Epub 2004 Sep 23.

  PMID: 15388776 RESULT

• Noma T, Matsumoto S, Shimodozono M, Etoh S, Kawahira K. Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients: a proof-of-principle study. J Rehabil Med. 2012 Apr;44(4):325-30. doi: 10.2340/16501977-0946.

  PMID: 22402727 RESULT

• Celnik P, Hummel F, Harris-Love M, Wolk R, Cohen LG. Somatosensory stimulation enhances the effects of training functional hand tasks in patients with chronic stroke. Arch Phys Med Rehabil. 2007 Nov;88(11):1369-76. doi: 10.1016/j.apmr.2007.08.001.

  PMID: 17964875 RESULT

• Liepert J, Binder C. Vibration-induced effects in stroke patients with spastic hemiparesis--a pilot study. Restor Neurol Neurosci. 2010;28(6):729-35. doi: 10.3233/RNN-2010-0541.

  PMID: 21209488 RESULT

• Tavernese E, Paoloni M, Mangone M, Mandic V, Sale P, Franceschini M, Santilli V. Segmental muscle vibration improves reaching movement in patients with chronic stroke. A randomized controlled trial. NeuroRehabilitation. 2013;32(3):591-9. doi: 10.3233/NRE-130881.

  PMID: 23648613 RESULT

• Marconi B, Filippi GM, Koch G, Giacobbe V, Pecchioli C, Versace V, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on cortical excitability and motor recovery induced by repeated muscle vibration in chronic stroke patients. Neurorehabil Neural Repair. 2011 Jan;25(1):48-60. doi: 10.1177/1545968310376757. Epub 2010 Sep 12.

  PMID: 20834043 RESULT

• Conrad MO, Gadhoke B, Scheidt RA, Schmit BD. Effect of Tendon Vibration on Hemiparetic Arm Stability in Unstable Workspaces. PLoS One. 2015 Dec 3;10(12):e0144377. doi: 10.1371/journal.pone.0144377. eCollection 2015.

  PMID: 26633892 RESULT

• Ribot-Ciscar E, Butler JE, Thomas CK. Facilitation of triceps brachii muscle contraction by tendon vibration after chronic cervical spinal cord injury. J Appl Physiol (1985). 2003 Jun;94(6):2358-67. doi: 10.1152/japplphysiol.00894.2002. Epub 2003 Feb 14.

  PMID: 12588789 RESULT

• Kawahira K, Higashihara K, Matsumoto S, Shimodozono M, Etoh S, Tanaka N, Sueyoshi Y. New functional vibratory stimulation device for extremities in patients with stroke. Int J Rehabil Res. 2004 Dec;27(4):335-7. doi: 10.1097/00004356-200412000-00015.

  PMID: 15573001 RESULT

• Field-Fote E, Ness LL, Ionno M. Vibration elicits involuntary, step-like behavior in individuals with spinal cord injury. Neurorehabil Neural Repair. 2012 Sep;26(7):861-9. doi: 10.1177/1545968311433603. Epub 2012 Feb 9.

  PMID: 22328683 RESULT

• Schindler I, Kerkhoff G, Karnath HO, Keller I, Goldenberg G. Neck muscle vibration induces lasting recovery in spatial neglect. J Neurol Neurosurg Psychiatry. 2002 Oct;73(4):412-9. doi: 10.1136/jnnp.73.4.412.

  PMID: 12235310 RESULT

• Kamada K, Shimodozono M, Hamada H, Kawahira K. Effects of 5 minutes of neck-muscle vibration immediately before occupational therapy on unilateral spatial neglect. Disabil Rehabil. 2011;33(23-24):2322-8. doi: 10.3109/09638288.2011.570411. Epub 2011 Apr 12.

  PMID: 21486139 RESULT

• Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.

  PMID: 24842220 RESULT

Related Links

• epidemiological stroke data in France

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alain YELNIK, MD, Prof

  Centre BORELLI

  STUDY DIRECTOR

Central Study Contacts

Emna JELILI, engineer

CONTACT

+33 (0) 1 40 05 49 46; emna.jelili@aphp.fr

Marylène JOUSSE, MD, PhD

CONTACT

marylene.jousse@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, University Professor

Model Details: pilot, prospective, biomedical, randomized, controlled study with intent-to-treat analysis of a stroke subjects cohort

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: October 1, 2015
• Primary Completion: October 1, 2021
• Study Completion: December 31, 2021
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)