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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)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fugl-Meyer Assessment (FMA)
Medical Research Concil (MRC)
2 Minute Walk Test (2MWT)
Timed Up & Go Test
Modified Ashworth Scale
Postural Assessment Scale for Stroke
posturographic recording
vibration program
sham program
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring muscle vibration protocol, anterior tibia muscle, hemiplegic patient

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Saint-EtienneRecruiting
  • Le Clos Champirol - Service de Médecine Physique et de Réadaptation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

vibration program

sham program

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
score of Medical Research Concil
score of 0 (absence of contraction) to 5 (normal force)
assess functional walking ability
measured with 2 Minute Walk Test
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)
analysis of static equilibrium
with Winposturo platform
positional measurement of the center of gravity
with Winposturo platform

Full Information

First Posted
January 28, 2021
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT04737018
Brief Title
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.
Acronym
VIBRATAC
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
muscle vibration protocol, anterior tibia muscle, hemiplegic patient

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vibration program
Arm Type
Experimental
Arm Description
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
Arm Title
sham program
Arm Type
Sham Comparator
Arm Description
a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.
Intervention Type
Other
Intervention Name(s)
Fugl-Meyer Assessment (FMA)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Medical Research Concil (MRC)
Intervention Description
evaluation of muscular strength score from 0 to 5
Intervention Type
Other
Intervention Name(s)
2 Minute Walk Test (2MWT)
Intervention Description
Assess functional walking and aerobic abilities
Intervention Type
Other
Intervention Name(s)
Timed Up & Go Test
Intervention Description
measures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down
Intervention Type
Other
Intervention Name(s)
Modified Ashworth Scale
Intervention Description
score from 0 to 4 evaluation of spasticity
Intervention Type
Other
Intervention Name(s)
Postural Assessment Scale for Stroke
Intervention Description
score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position
Intervention Type
Device
Intervention Name(s)
posturographic recording
Intervention Description
analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform
Intervention Type
Other
Intervention Name(s)
vibration program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
sham program
Intervention Description
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 Outcome Measure Information:
Title
score of Fugl Meyer Assessment (lower limbs)
Description
score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.
Time Frame
day 30
Secondary Outcome Measure Information:
Title
score of Fugl Meyer Assessment (lower limbs)
Description
score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.
Time Frame
day 0, day 15, day 30 and month 2
Title
score of Medical Research Concil
Description
score of 0 (absence of contraction) to 5 (normal force)
Time Frame
day 0, day 15, day 30 and month 2
Title
assess functional walking ability
Description
measured with 2 Minute Walk Test
Time Frame
day 0, day 15, day 30 and month 2
Title
score of postural assessment scale for stroke
Description
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)
Time Frame
day 0, day 15, day 30 and month 2
Title
analysis of static equilibrium
Description
with Winposturo platform
Time Frame
day 0, day 15, day 30 and month 2
Title
positional measurement of the center of gravity
Description
with Winposturo platform
Time Frame
day 0, day 15, day 30 and month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno FERNANDEZ, MD
Phone
04 77 12 77 57
Ext
+33
Email
bruno.fernandez@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno FERNANDEZ, MD
Organizational Affiliation
CHU Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno FERNANDEZ, MD
First Name & Middle Initial & Last Name & Degree
Agnés CONDEMINE, MD
First Name & Middle Initial & Last Name & Degree
Bérénice ZAGORDA, MD
First Name & Middle Initial & Last Name & Degree
Julia TOULY, MD
First Name & Middle Initial & Last Name & Degree
Hugo BESSAGUET, MD
Facility Name
Le Clos Champirol - Service de Médecine Physique et de Réadaptation
City
Saint-Priest-en-Jarez
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre BERTHOLON, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

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