Skip to main content
OpenTrials
Completed

NCT Number: NCT04737018

Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.

In about 40 percent of cases, after a stroke, neuromotor impairment leads to activity limitations and the development of chronic functional disorders, which have a significant impact on patient autonomy.

In the early subacute phase, motor deficit in foot lifters is one of the factors limiting standing posture and ambulation, which is ultimately difficult to rehabilitate due to the lack of available techniques for obtaining early onset of useful active voluntary contraction.

The use of muscular focal vibration therapy, applied to relaxed muscle, may be of interest due to the portability and availability of the system and the neuromotor benefits demonstrated in healthy subjects and in acute and chronic post-stroke patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Having had a stroke (with or without previous stroke) and being in the early subacute phase (between 14 days and 3 months of stroke).
  • Responsible for a motor deficit in the right or left lower limb.
  • No neurological history other than stroke.

Exclusion criteria

  • Multifocal stroke
  • Patient having received a botulinum toxin injection to the lower limb to be vibrated

Treatment and study plan

Fugl-Meyer Assessment (FMA)

Other

assessment of motor skills : measurement of the intensity of reflexes, as well as an assessment of voluntary movements and motor coordination Score from 0 to 34

Medical Research Concil (MRC)

Other

evaluation of muscular strength score from 0 to 5

2 Minute Walk Test (2MWT)

Other

Assess functional walking and aerobic abilities

Timed Up & Go Test

Other

measures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down

Modified Ashworth scale

Other

score from 0 to 4 evaluation of spasticity

Postural Assessment Scale for Stroke

Other

score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position

posturographic recording

Device

analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform

vibration program

Other

a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. The program will apply a frequency of 100 Hz, with an amplitude of 1 mm

Sham Program

Other

a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.

Primary outcomes

  1. score of Fugl Meyer Assessment (lower limbs)

    Time frame: day 30

    score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.

Secondary outcomes

  1. score of Fugl Meyer Assessment (lower limbs)

    Time frame: day 0, day 15, day 30 and month 2

    score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.

  2. score of Medical Research Concil

    Time frame: day 0, day 15, day 30 and month 2

    score of 0 (absence of contraction) to 5 (normal force)

  3. assess functional walking ability

    Time frame: day 0, day 15, day 30 and month 2

    measured with 2 Minute Walk Test

  4. score of postural assessment scale for stroke

    Time frame: day 0, day 15, day 30 and month 2

    measures the patient's ability to maintain stable postures, as well as balance in changes of position score of 0 (cannot perform the activity) to 36 (can perform the activity)

  5. analysis of static equilibrium

    Time frame: day 0, day 15, day 30 and month 2

    with Winposturo platform

  6. positional measurement of the center of gravity

    Time frame: day 0, day 15, day 30 and month 2

    with Winposturo platform

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: VIBRATAC

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2021
Registry last updated
Dec 27, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.