Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase (VIBRAMAIN1)

October 14, 2024 updated by: Centre Hospitalier Régional d'Orléans

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Chartres, France
        • Ch de Chartres
      • Orleans, France, 45067
        • CHU d'Orléans
      • Paris, France
        • Hopital Pitie Salpetriere
      • Tours, France
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

Other Names:
  • Handgrip Strength

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum handgrip strength measured by a digital dynamometer
Time Frame: 2 hours
Handgrip strength in kilograms
2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Study Chair: Canan OZSANCAK, MD, CHU Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Actual)

August 20, 2024

Study Completion (Actual)

August 20, 2024

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2023-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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