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.

Not Applicable

Completed

• Conditions: Stroke
• Interventions: 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

• Registration Number: NCT04737018
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-03
• Study Start: 2021-05-14
• Primary Completion: 2023-09-29
• Status Verified: 2023-12
• Study Completion: 2023-12-15
• Last Update Submitted: 2023-12-26
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vibration program	Modified Ashworth Scale	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	Postural Assessment Scale for Stroke	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	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	Medical Research Concil (MRC)	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	2 Minute Walk Test (2MWT)	a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.
vibration program	Medical Research Concil (MRC)	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	2 Minute Walk Test (2MWT)	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	Fugl-Meyer Assessment (FMA)	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	Fugl-Meyer Assessment (FMA)	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	Timed Up & Go Test	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	Postural Assessment Scale for Stroke	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	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.
vibration program	Timed Up & Go Test	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	posturographic recording	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	Modified Ashworth Scale	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	posturographic recording	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 Measures

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

Secondary Outcome Measures

Name	Time	Method
assess functional walking ability	day 0, day 15, day 30 and month 2	measured with 2 Minute Walk Test
score of Fugl Meyer Assessment (lower limbs)	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.
score of Medical Research Concil	day 0, day 15, day 30 and month 2	score of 0 (absence of contraction) to 5 (normal force)
score of postural assessment scale for stroke	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)
analysis of static equilibrium	day 0, day 15, day 30 and month 2	with Winposturo platform
positional measurement of the center of gravity	day 0, day 15, day 30 and month 2	with Winposturo platform

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Saint-Etienne; 🇫🇷 Saint-Etienne, France

Le Clos Champirol - Service de Médecine Physique et de Réadaptation; 🇫🇷 Saint-Priest-en-Jarez, France