The aim of the vibration intervention proposed in the current study is to allow a better neuromotor recovery in subacute stroke patients when compared with standard rehabilitation alone. These last years, it has been proven that the solicitation of a muscle using vibrations may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition to a standard rehabilitation program of local vibrations sessions of the dorsiflexor muscles of the paretic limb of stroke patients may allow a better recovery of walking speed (primary outcome). One group using vibrations (i.e. experimental group) and one group with sham vibration (i.e. control group) will take part to this study.
Stroke patients in subacute rehabilitation phase (between 14 days and 3 months post-stroke)
Presenting with a stroke, ischemic or hemorrhagic
Lower-limb deficiency with an initial motor testing < 4 according to the MRC scale
No neurological history with functional impact other than stroke
Multiple stroke
Other neurological, cognitive or psychiatric conditions
Orthopedic ankle history compromising measurements
Botulinum toxin injected in the lower limb prior the study protocol
Parallel
Vibration
DeviceThe 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
Sham vibration
DeviceThe 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.
10 meters Walk Test
Other interventionShort-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.
2 Minute Walk Test (2MWT)
Other interventionLong-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.
Fugl-Meyer (FMA-LE)
Other interventionThe 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
Modified Ashworth scale
Other interventionThe 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
ABILOCO questionnaire
Other interventionThe ABILOCO questionnaire evaluate the autonomy in the walking capacities of the patients (13-items)
Barthel index
Other interventionThe Barthel index measure autonomy in daily life.
isometric ergometer
Other interventionEvaluate voluntary maximum force in isometric ankle dorsiflexion by Cybex isometric ergometer results.
Electromyograms (EMG)
Other interventionAssessment 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.
Traditional quantified gait analysis
Other interventionGait 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.
SPM - Statistical Parametric Mapping
Other interventionAddition of a temporal component to the traditional quantified gait analysis, allowing the focus to be on time series parameters.
FACIT questionnaire (Functional Assessment of Chronic Illness Therapy)
Other interventionA 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.
Gait speed by 10 meters Walk Test (in meter /second) results
Analysis Gait speed by 10 meters Walk Test (in meter /second) results
Walking performance by 10 meters Walk Test (in meter /second) results
Analysis Walking performance (comfort speed) by 10 meters Walk Test (in meter /second) results
Walking performance by 2 Minute Walk Test (2MWT) (in meter) results
Analysis Walking performance (distance) by 2 Minute Walk Test (2MWT) (in meter) results
Walking performance by Quantified Gait Analysis results
Walking performance will be assessed using: (in m/s) in the 10-meter test (short distance), distance (in m) covered in a 2-minute walk test (long distance) , and qualitatively by a Quantified Gait Analysis (performed only in M2 and M4).
Motor function of the paretic lower limb
The motor function of the paretic lower limb will be measured by the Fugl Meyer Assessment scale for lower limbs (FMA-LE) which includes five domains: Motor skills; Balance skills; Sensitivity; Range of motion; Joint pain. A three-point ordinal scale (0: cannot perform; 1: partially performed; 2: fully performed) is applied to each item. The maximum score is 226.
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Centre Hospitalier Universitaire de Saint Etienne
Lead sponsor
Ministry of Health, France
Collaborator
