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

NCT ID: NCT06296225

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2024-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Stroke, Acute Fatigue

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Vibration group

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.

Group Type EXPERIMENTAL

Vibration

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Handgrip Strength

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Canan OZSANCAK, MD

Role: STUDY_CHAIR

CHU ORLEANS

Locations

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CH de Chartres

Chartres, , France

Site Status

CHU d'ORLEANS

Orléans, , France

Site Status

Hopital Pitie Salpetriere

Paris, , France

Site Status

CHU de Tours

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 29218406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37346243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30873102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28240760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31730754 (View on PubMed)

Other Identifiers

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CHRO-2023-07

Identifier Type: -

Identifier Source: org_study_id

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