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NCT Number: NCT06296225

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Fatigue Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke, Acute Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH de Chartres, Chartres, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Handgrip Strength

Primary outcomes

  1. Maximum handgrip strength measured by a digital dynamometer

    Time frame: 2 hours

    Handgrip strength in kilograms

Secondary outcomes

  1. Fatigue evolution

    Time frame: 2 hours

    Fatigue assessed with Borg Scale : Minimal score indicates no fatigue (Minimum : 0 - Maximum : 10)

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

    Time frame: 30 minutes

    Handgrip strength in kilograms

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: VIBRAMAIN1

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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