Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients.
NCT ID: NCT05945212
Last Updated: 2025-12-04
Study Results
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Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-03-12
2027-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Vibration
Stroke patients in subacute rehabilitation phase will be included. In addition of a subacute post-stroke standard rehabilitation program, they will have a vibration program.
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
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.
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.
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
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
ABILOCO questionnaire
The ABILOCO questionnaire evaluate the autonomy in the walking capacities of the patients (13-items)
Barthel index
The Barthel index measure autonomy in daily life.
isometric ergometer
Evaluate voluntary maximum force in isometric ankle dorsiflexion by Cybex isometric ergometer results.
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.
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.
SPM - Statistical Parametric Mapping
Addition 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)
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.
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
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.
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.
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.
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
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
ABILOCO questionnaire
The ABILOCO questionnaire evaluate the autonomy in the walking capacities of the patients (13-items)
Barthel index
The Barthel index measure autonomy in daily life.
isometric ergometer
Evaluate voluntary maximum force in isometric ankle dorsiflexion by Cybex isometric ergometer results.
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.
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.
SPM - Statistical Parametric Mapping
Addition 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)
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.
Interventions
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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
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.
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.
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.
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
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
ABILOCO questionnaire
The ABILOCO questionnaire evaluate the autonomy in the walking capacities of the patients (13-items)
Barthel index
The Barthel index measure autonomy in daily life.
isometric ergometer
Evaluate voluntary maximum force in isometric ankle dorsiflexion by Cybex isometric ergometer results.
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.
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.
SPM - Statistical Parametric Mapping
Addition 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)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Having received informed information about the study and having signed the written consent
* Affiliated or entitled to a social security scheme.
* Patients under guardianship may be included; they may give their consent with the assistance of their guardian.
If the participant is unable to write, their consent may be given and documented by other appropriate means in the presence of at least one impartial witness. In this case, the witness will sign and date the informed consent document.
Exclusion Criteria
* Other neurological, cognitive or psychiatric conditions
* Orthopedic ankle history compromising measurements
* Botulinum toxin injected in the lower limb prior the study protocol
* Patient with phlebitis or risk of thrombosis in the lower limb
* Patient under tutorship
18 Years
80 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Bruno FERNANDEZ, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Saint Etienne
Locations
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Centre Hospitalier Georges Claudinon
Le Chambon-Feugerolles, , France
Hôpital Marrel
Rive-de-Gier, , France
Centre Hospitalier de Roanne
Roanne, , France
Service de SSR Val-Rosay
Saint-Didier-au-Mont-d'Or, , France
Hôpital Bellevue, CHU de Saint-etienne
Saint-Etienne, , France
Service de SSR du Centre Le Clos Champirol
Saint-Etienne, , France
Hospices Civils de Lyon, site Henry Gabrielle
Saint-Genis-Laval, , France
Countries
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Central Contacts
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Facility Contacts
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Thibault TRAMOY, MD
Role: primary
Bachir SAHI, MD
Role: primary
Julie DI MARCO, MD
Role: primary
Bruno FERNANDEZ, MD
Role: primary
Alexandre BERTHOLON, MD
Role: primary
Sophie JACQUIN COURTOIS, MD PhD
Role: primary
References
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Bessaguet H, Fernandez B, Malejac V, Nerriere E, Velarde M, Coiffet A, Rimaud D, Lapole T. Effect of tibialis anterior focal muscle vibration for gait rehabilitation in hemiplegic individuals during the subacute phase after stroke: the NEUROVIB-AVC study protocol - a multicentric randomised controlled trial. BMJ Open. 2025 May 6;15(5):e102838. doi: 10.1136/bmjopen-2025-102838.
Other Identifiers
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2023-A00489-36
Identifier Type: OTHER
Identifier Source: secondary_id
21PH266
Identifier Type: -
Identifier Source: org_study_id
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