Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients.

NARecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

March 12, 2024

Primary Completion Date

January 7, 2027

Study Completion Date

May 15, 2027

Conditions
Stroke Rehabilitation
Interventions
DEVICE

Vibration

The program will take place over 40 sessions : 5 sessions per week, for 2 months (40 sessions in total over 8 weeks during the hospitalization in the department); this group will benefit from an effective vibration of a frequency of 100Hz

DEVICE

Sham vibration

The program will take place over 40 sessions: 5 sessions per week, for 2 months (40 sessions in total over 8 weeks during hospitalization in the department); this group will not benefit from effective vibration.

OTHER

10 meters Walk Test

Short-distance ambulation speed is measurement between 2 markers on the ground 10 meters apart in a corridor with flat ground, the patient starting his walk 3 meters before to have a launched march disregarding markers, and ends 3 meters After. The stopwatch is started when the markers are crossed.

OTHER

2 Minute Walk Test (2MWT)

Long-distance ambulation speed is measured from a standing start and the test involves asking the patient to walk as far as possible in 2 minutes.

OTHER

Fugl-Meyer (FMA-LE)

The Fugl-Meyer (FMA-LE) 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

Modified Ashworth scale

The modified Ashworth scale allows the measurement of spasticity, that is to say the measurement of muscle tone by mobilizing the segment of the lower limb and by evaluating the resistance to stretching of the muscles. Score from 0 to 4

OTHER

ABILOCO questionnaire

The ABILOCO questionnaire evaluate the autonomy in the walking capacities of the patients (13-items)

OTHER

Barthel index

The Barthel index measure autonomy in daily life.

OTHER

isometric ergometer

Evaluate voluntary maximum force in isometric ankle dorsiflexion by Cybex isometric ergometer results.

OTHER

Electromyograms (EMG)

Assessment of neuromuscular fatigue by electromyograms (EMG). Surface electrodes is place on the tibial muscle anterior to non-invasively collect electromyograms (EMG). The intensity of stimulation will be gradually increased until a plateau in mechanical (strength) and electromyograms (EMG) responses is obtained.

OTHER

Traditional quantified gait analysis

Gait kinematics will be recorded on a force platform (90 x 90 cm, Model 9287C, Kistler, Winterthur, Switzerland) to determine: joint angles, net joint moments and powers at the ankle, knee and hip.

OTHER

SPM - Statistical Parametric Mapping

Addition of a temporal component to the traditional quantified gait analysis, allowing the focus to be on time series parameters.

OTHER

FACIT questionnaire (Functional Assessment of Chronic Illness Therapy)

A short questionnaire consisting of 13 questions to which the patient answers on a scale from 0 to 4. The scores are simply added up, inverting the scale for negative sentences, to give a result out of 52 points. The lower the score, the greater the fatigue.

Trial Locations (7)

42100

RECRUITING

Hôpital Bellevue, CHU de Saint-etienne, Saint-Etienne

42270

NOT_YET_RECRUITING

Service de SSR du Centre Le Clos Champirol, Saint-Etienne

42300

NOT_YET_RECRUITING

Centre Hospitalier de Roanne, Roanne

42500

NOT_YET_RECRUITING

Centre Hospitalier Georges Claudinon, Le Chambon-Feugerolles

42800

RECRUITING

Hôpital Marrel, Rive-de-Gier

69230

NOT_YET_RECRUITING

Hospices Civils de Lyon, site Henry Gabrielle, Saint-Genis-Laval

69370

NOT_YET_RECRUITING

Service de SSR Val-Rosay, Saint-Didier-au-Mont-d'Or

All Listed Sponsors
collaborator

Ministry of Health, France

OTHER_GOV

lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER