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. (VIBRATAC)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Fugl-Meyer Assessment (FMA); Other: Medical Research Concil (MRC); Other: 2 Minute Walk Test (2MWT); Other: Timed Up & Go Test; Other: Modified Ashworth Scale; Other: Postural Assessment Scale for Stroke; Device: posturographic recording; Other: vibration program; Other: sham program

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Centre Hospitalier Universitaire de Saint-Etienne
  • Saint-Priest-en-Jarez, France
    • Le Clos Champirol - Service de Médecine Physique et de Réadaptation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vibration program; 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	Other: Fugl-Meyer Assessment (FMA); 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; Other: Medical Research Concil (MRC); evaluation of muscular strength score from 0 to 5; Other: 2 Minute Walk Test (2MWT); Assess functional walking and aerobic abilities; Other: Timed Up & Go Test; measures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down; Other: Modified Ashworth Scale; score from 0 to 4 evaluation of spasticity; Other: Postural Assessment Scale for Stroke; score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position; Device: posturographic recording; analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform; Other: vibration program; 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 Comparator: sham program; a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.	Other: Fugl-Meyer Assessment (FMA); 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; Other: Medical Research Concil (MRC); evaluation of muscular strength score from 0 to 5; Other: 2 Minute Walk Test (2MWT); Assess functional walking and aerobic abilities; Other: Timed Up & Go Test; measures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down; Other: Modified Ashworth Scale; score from 0 to 4 evaluation of spasticity; Other: Postural Assessment Scale for Stroke; score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position; Device: posturographic recording; analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform; Other: sham program; a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
score of Fugl Meyer Assessment (lower limbs)	score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.	day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
score of Fugl Meyer Assessment (lower limbs)	score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.	day 0, day 15, day 30 and month 2
score of Medical Research Concil	score of 0 (absence of contraction) to 5 (normal force)	day 0, day 15, day 30 and month 2
assess functional walking ability	measured with 2 Minute Walk Test	day 0, day 15, day 30 and month 2
score of postural assessment scale for stroke	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)	day 0, day 15, day 30 and month 2
analysis of static equilibrium	with Winposturo platform	day 0, day 15, day 30 and month 2
positional measurement of the center of gravity	with Winposturo platform	day 0, day 15, day 30 and month 2

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Bruno FERNANDEZ, MD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: muscle vibration protocol; anterior tibia muscle; hemiplegic patient
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 20CH152; 2020-A03189-30 (Other Identifier: ANSM)

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