NCT Number: NCT05945212
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Centre Hospitalier Georges Claudinon, Le Chambon-Feugerolles, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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
Other names: VIBRAMOOV PHYSIO
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.
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.
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.
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
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
The ABILOCO questionnaire evaluate the autonomy in the walking capacities of the patients (13-items)
The Barthel index measure autonomy in daily life.
Evaluate voluntary maximum force in isometric ankle dorsiflexion by Cybex isometric ergometer results.
Other names: Cybex isometric ergometer (Henley Healthcare, Sugarland, TX, USA)
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 names: Electrodes Meditrace 100, Covidien, Mansfield, MA
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 names: 0D
Addition of a temporal component to the traditional quantified gait analysis, allowing the focus to be on time series parameters.
Other names: 1D
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.
Time frame: Month 2
Analysis Gait speed by 10 meters Walk Test (in meter /second) results
Time frame: Month 0, 1, 2, 3, 4
Analysis Walking performance (comfort speed) by 10 meters Walk Test (in meter /second) results
Time frame: Month 0, 1, 2, 3, 4
Analysis Walking performance (distance) by 2 Minute Walk Test (2MWT) (in meter) results
Time frame: Month 2, 4
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).
Time frame: Month 4
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.
Time frame: Month 4
The level of spasticity of the lower limb will be measured by the modified Ashworth scale : a 6-point scale with scores ranging from 0 to 4, where the lowest scores represent normal muscle tone and the highest scores represent spasticity or increased resistance to passive movement.
Time frame: Month 4
The patient's autonomy in walking activities will be measured by the ABILOCO questionnaire and in daily living activities by the Barthel index.
Time frame: Month 4
Lower extremity strength will be measured as maximal voluntary strength in isometric ankle dorsiflexion.
Time frame: Month 4
Neuromuscular fatigue will be assessed by the level of voluntary activation (in %).
Time frame: Month 4
Neuromuscular fatigue will be assessed by corticospinal and intracortical excitability thanks to electromyographic responses evoked by transcranial magnetic stimulation.
Time frame: Month 4
Neuromuscular fatigue will be assessed by spinal excitability thanks to electromyographic responses evoked by electrical nerve stimulation.
Time frame: Month 4
Neuromuscular fatigue will be assessed by perceived subjective fatigue measured by the FACIT questionnaire : the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness, including over 400 questions. Higher scores for the scales and subscales indicate better quality of life.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Saint Etienne
Other
Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients - a Multicentric Randomized Controlled Study
Acronym: NEUROVIB-AVC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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