NCT04737018

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2021-05-14
• Primary completion: 2023-09-29
• Completion: 2023-12-15
• First posted: 2021-02-03
• Last updated: 2023-12-27

Locations

2 sites across 1 country: France