Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase

Stroke Clinical Trial

— VIBRAMAIN1  

Official title:

Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase : Vibramain1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296225
• Other study ID #: CHRO-2023-07
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Régional d'Orléans
• Contact: Aurelie DESPUJOLS
• Phone: 0238744071
• Email: aurelie.despujols[@]chu-orleans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase. The investigations will be carried out by a specialized physiotherapist from the neurology department. The experiment consists of three successive phases: - First : measurement of the maximum handgrip force before any vibratory stimulation and then after the three sessions of ten-minute vibration. - Second : Rest period - Third: control phase with measurement of the maximum grip force every ten minutes without vibration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age:18 to 85
• Acute stroke (less than 7 days)
• Paretic upper limb: 3 or 4 to the MRC score and able to obtain a value of at least 10 kilograms on the handgrip strength
• Able to sign a consent form
• Affiliated to a social insurance

Exclusion Criteria:

• Person under tutorship or curatorship,
• Sleepiness
• Pregnancy or breastfeeding woman

Related Conditions & MeSH terms

• Fatigue
• Stroke
• Stroke, Acute

Intervention

Device:
• Vibration
Grip strenght measurement will always be done in the same way : for each series, 3 measurements of maximum strength will be taken for each side. Participants will receive verbal encouragement. After initial both sides grip strength evaluation, all participant will first experiment the vibration situation using the device Vibramoov Physio (TechnoConcept, Manosque, France): the vibrations had a frequency of 100Hz, with an amplitude of 2mm, they will be applied to the anterior part of the forearm for 10 minutes, 3 times. At the end of each 10 minutes vibration session, handgrip strength will be assessed. Participants then have a one-hour rest period. Control situation: participants will have 4 series of grip strength measurements every 10 minutes. At the end of the 2 hours, the patient will be discharged from the study protocol.

Locations

Country	Name	City	State
France	CH de Chartres	Chartres
France	CHU d'ORLEANS	Orleans
France	Hopital Pitie Salpetriere	Paris
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (5)

Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13. — View Citation

Celletti C, Sinibaldi E, Pierelli F, Monari G, Camerota F. Focal Muscle Vibration and Progressive Modular Rebalancing with neurokinetic facilitations in post- stroke recovery of upper limb. Clin Ter. 2017 Jan-Feb;168(1):e33-e36. doi: 10.7417/CT.2017.1979. — View Citation

Shirato R, Shimanuki R, Shoji T, Mugikura M. Inhibitory Effects of Prolonged Focal Muscle Vibration on Maximal Grip Strength and Muscle Activity of Wrist and Extrinsic Finger Flexor Muscles. J Chiropr Med. 2023 Jun;22(2):107-115. doi: 10.1016/j.jcm.2023.03.003. Epub 2023 Apr 21. — View Citation

Souron R, Besson T, Millet GY, Lapole T. Correction to: Acute and chronic neuromuscular adaptations to local vibration training. Eur J Appl Physiol. 2018 Feb;118(2):483. doi: 10.1007/s00421-017-3776-9. — View Citation

Toscano M, Celletti C, Vigano A, Altarocca A, Giuliani G, Jannini TB, Mastria G, Ruggiero M, Maestrini I, Vicenzini E, Altieri M, Camerota F, Di Piero V. Short-Term Effects of Focal Muscle Vibration on Motor Recovery After Acute Stroke: A Pilot Randomized Sham-Controlled Study. Front Neurol. 2019 Feb 19;10:115. doi: 10.3389/fneur.2019.00115. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum handgrip strength measured by a digital dynamometer	Handgrip strength in kilograms	2 hours
Secondary	Fatigue evolution	Fatigue assessed with Borg Scale : Minimal score indicates no fatigue (Minimum : 0 - Maximum : 10)	2 hours
Secondary	Evolution of handgrip strength during the vibration session measured by a digital dynamometer	Handgrip strength in kilograms	30 minutes