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

Stroke Rehabilitation Clinical Trial

— NEUROVIB-AVC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945212
• Other study ID #: 21PH266
• Secondary ID: 2023-A00489-36
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: May 15, 2027

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Bruno FERNANDEZ, MD
• Phone: (0)477120638
• Email: bruno.fernandez[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 15, 2027
• Est. primary completion date: January 7, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Stroke patients in subacute rehabilitation phase (between 14 days and 3 months post-stroke)

• First hemispheric, ischemic or hemorrhagic stroke

• 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.

Exclusion Criteria:

• Multiple stroke

• Other neurological, cognitive or psychiatric conditions

• Orthopedic ankle history compromising measurements

• Botulinum toxin injected in the lower limb prior the study protocol

• Patient with a skin lesion close to the site for the placement of the stimulator

• Patient under tutorship or curatorship

Related Conditions & MeSH terms

• Stroke
• Stroke Rehabilitation

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
France	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-Étienne
France	Service de SSR du Centre Le Clos Champirol	Saint-Étienne
France	Hospices Civils de Lyon, site Henry Gabrielle	Saint-Genis-Laval

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed by 10 meters Walk Test (in meter /second) results	Analysis Gait speed by 10 meters Walk Test (in meter /second) results	Month 2
Secondary	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	Month 0, 1, 2, 3, 4
Secondary	Walking performance by 2 Minute Walk Test (2MWT) (in meter) results	Analysis Walking performance (distance) by 2 Minute Walk Test (2MWT) (in meter) results	Month 0, 1, 2, 3, 4
Secondary	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).	Month 2, 4
Secondary	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.	Month 4
Secondary	Lower limb spasticity level	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.	Month 4
Secondary	Autonomy in walking activities	The patient's autonomy in walking activities will be measured by the ABILOCO questionnaire and in daily living activities by the Barthel index.	Month 4
Secondary	Lower limb strength	Lower extremity strength will be measured as maximal voluntary strength in isometric ankle dorsiflexion.	Month 4
Secondary	Neuromuscular fatigue (1)	Neuromuscular fatigue will be assessed by the level of voluntary activation (in %).	Month 4
Secondary	Neuromuscular fatigue (2)	Neuromuscular fatigue will be assessed by corticospinal and intracortical excitability thanks to electromyographic responses evoked by transcranial magnetic stimulation.	Month 4
Secondary	Neuromuscular fatigue (3)	Neuromuscular fatigue will be assessed by spinal excitability thanks to electromyographic responses evoked by electrical nerve stimulation.	Month 4
Secondary	Neuromuscular fatigue (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.	Month 4