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

NCT06296225 | Completed DMC

• 1 other identifier: CHRO-2023-07
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Stroke; Stroke, Acute; Fatigue

Keywords

Stroke; vibration; Handgrip strength; Fatigue

Outcome Measures

Primary Outcomes (1)

• Maximum handgrip strength measured by a digital dynamometer

  Handgrip strength in kilograms

  2 hours

Secondary Outcomes (2)

• Fatigue evolution

  2 hours

• Evolution of handgrip strength during the vibration session measured by a digital dynamometer

  30 minutes

Study Arms (1)

Vibration group

EXPERIMENTAL

Patients with acute stroke less than 7 days with only one paretic upper limb will be assessed for eligibility. Patient will undergo 8 grip strength evaluation and 30 minutes of forehand muscles vibration.

Device: Vibration

Interventions

Vibration DEVICE

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.

Also known as: Handgrip Strength

Vibration group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (4)

CH de Chartres

Chartres, France

Location

CHU d'ORLEANS

Orléans, 45067, France

Location

Hopital Pitie Salpetriere

Paris, France

Location

CHU de Tours

Tours, France

Location

Related Publications (5)

• 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.

  PMID: 29218406 BACKGROUND

• 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.

  PMID: 37346243 BACKGROUND

• 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.

  PMID: 30873102 BACKGROUND

• 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.

  PMID: 28240760 BACKGROUND

• 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.

  PMID: 31730754 BACKGROUND

MeSH Terms

Conditions

Stroke; Fatigue

Condition Hierarchy (Ancestors)

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

Study Officials

• Canan OZSANCAK, MD

  CHU ORLEANS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 6, 2024
• Study Start: March 5, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)