NCT05945212

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

Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients - a Multicentric Randomized Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stroke Rehabilitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-12
• Primary completion: 2027-01-07
• Completion: 2027-05-15
• First posted: 2023-07-14
• Last updated: 2025-12-04

Locations

7 sites across 1 country: France