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.

Stroke Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04737018
• Other study ID #: 20CH152
• Secondary ID: 2020-A03189-30
• Status: Completed
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 15, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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
• Medical Research Concil (MRC)
evaluation of muscular strength score from 0 to 5
• 2 Minute Walk Test (2MWT)
Assess functional walking and aerobic abilities
• 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
• Modified Ashworth Scale
score from 0 to 4 evaluation of spasticity
• 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 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Saint-Etienne	Saint-Etienne
France	Le Clos Champirol - Service de Médecine Physique et de Réadaptation	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	score of Medical Research Concil	score of 0 (absence of contraction) to 5 (normal force)	day 0, day 15, day 30 and month 2
Secondary	assess functional walking ability	measured with 2 Minute Walk Test	day 0, day 15, day 30 and month 2
Secondary	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
Secondary	analysis of static equilibrium	with Winposturo platform	day 0, day 15, day 30 and month 2
Secondary	positional measurement of the center of gravity	with Winposturo platform	day 0, day 15, day 30 and month 2