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.

NCT04737018 | Completed

• 2 other identifiers: 20CH1522020-A03189-30
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

muscle vibration protocol; anterior tibia muscle; hemiplegic patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• score of Fugl Meyer Assessment (lower limbs)

  day 0, day 15, day 30 and month 2

• score of Medical Research Concil

  day 0, day 15, day 30 and month 2

• assess functional walking ability

  day 0, day 15, day 30 and month 2

• score of postural assessment scale for stroke

  day 0, day 15, day 30 and month 2

• analysis of static equilibrium

  day 0, day 15, day 30 and month 2

Study Arms (2)

vibration program

EXPERIMENTAL

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); 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

sham program

SHAM COMPARATOR

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); 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: sham program

Interventions

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

sham program; vibration program

Medical Research Concil (MRC) OTHER

evaluation of muscular strength score from 0 to 5

sham program; vibration program

2 Minute Walk Test (2MWT) OTHER

Assess functional walking and aerobic abilities

sham program; vibration program

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

sham program; vibration program

Modified Ashworth Scale OTHER

score from 0 to 4 evaluation of spasticity

sham program; vibration program

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

sham program; vibration program

posturographic recording DEVICE

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

sham program; vibration program

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

vibration program

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.

sham program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (2)

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42055, France

Location

Le Clos Champirol - Service de Médecine Physique et de Réadaptation

Saint-Priest-en-Jarez, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruno FERNANDEZ, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 3, 2021
• Study Start: May 14, 2021
• Primary Completion: September 29, 2023
• Study Completion: December 15, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)