Back to resultsEffects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients. (NEUROVIB-AVC)
Primary Purpose
Stroke Rehabilitation
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vibration
Sham vibration
10 meters Walk Test
2 Minute Walk Test (2MWT)
Fugl-Meyer (FMA-LE)
Modified Ashworth scale
ABILOCO questionnaire
Barthel index
isometric ergometer
Electromyograms (EMG)
Traditional quantified gait analysis
SPM - Statistical Parametric Mapping
FACIT questionnaire (Functional Assessment of Chronic Illness Therapy)
Sponsored by
About this trial
This is an interventional other trial for Stroke Rehabilitation focused on measuring Local vibration, Stroke, Motor recovery, Walking speed, Gait
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Georges Claudinon
- Hôpital Marrel
- Centre Hospitalier de Roanne
- Service de SSR Val-Rosay
- Hospices Civils de Lyon, site Henry Gabrielle
- Hôpital Bellevue, CHU de Saint-etienne
- Service de SSR du Centre Le Clos Champirol
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Vibration
no vibration
Arm Description
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.
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Outcomes
Primary Outcome Measures
Gait speed by 10 meters Walk Test (in meter /second) results
Analysis Gait speed by 10 meters Walk Test (in meter /second) results
Secondary Outcome Measures
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.
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.
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.
Lower limb strength
Lower extremity strength will be measured as maximal voluntary strength in isometric ankle dorsiflexion.
Neuromuscular fatigue (1)
Neuromuscular fatigue will be assessed by the level of voluntary activation (in %).
Neuromuscular fatigue (2)
Neuromuscular fatigue will be assessed by corticospinal and intracortical excitability thanks to electromyographic responses evoked by transcranial magnetic stimulation.
Neuromuscular fatigue (3)
Neuromuscular fatigue will be assessed by spinal excitability thanks to electromyographic responses evoked by electrical nerve stimulation.
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.
Full Information
NCT ID
NCT05945212
First Posted
July 6, 2023
Last Updated
October 9, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT05945212
Brief Title
Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients.
Acronym
NEUROVIB-AVC
Official Title
Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients - a Multicentric Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
January 7, 2027 (Anticipated)
Study Completion Date
May 15, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation
Keywords
Local vibration, Stroke, Motor recovery, Walking speed, Gait
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vibration
Arm Type
Experimental
Arm Description
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.
Arm Title
no vibration
Arm Type
Sham Comparator
Arm Description
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention Type
Device
Intervention Name(s)
Vibration
Other Intervention Name(s)
VIBRAMOOV PHYSIO
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham vibration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
10 meters Walk Test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
2 Minute Walk Test (2MWT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fugl-Meyer (FMA-LE)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Modified Ashworth scale
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
ABILOCO questionnaire
Intervention Description
The ABILOCO questionnaire evaluate the autonomy in the walking capacities of the patients (13-items)
Intervention Type
Other
Intervention Name(s)
Barthel index
Intervention Description
The Barthel index measure autonomy in daily life.
Intervention Type
Other
Intervention Name(s)
isometric ergometer
Other Intervention Name(s)
Cybex isometric ergometer (Henley Healthcare, Sugarland, TX, USA)
Intervention Description
Evaluate voluntary maximum force in isometric ankle dorsiflexion by Cybex isometric ergometer results.
Intervention Type
Other
Intervention Name(s)
Electromyograms (EMG)
Other Intervention Name(s)
Electrodes Meditrace 100, Covidien, Mansfield, MA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional quantified gait analysis
Other Intervention Name(s)
0D
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
SPM - Statistical Parametric Mapping
Other Intervention Name(s)
1D
Intervention Description
Addition of a temporal component to the traditional quantified gait analysis, allowing the focus to be on time series parameters.
Intervention Type
Other
Intervention Name(s)
FACIT questionnaire (Functional Assessment of Chronic Illness Therapy)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gait speed by 10 meters Walk Test (in meter /second) results
Description
Analysis Gait speed by 10 meters Walk Test (in meter /second) results
Time Frame
Month 2
Secondary Outcome Measure Information:
Title
Walking performance by 10 meters Walk Test (in meter /second) results
Description
Analysis Walking performance (comfort speed) by 10 meters Walk Test (in meter /second) results
Time Frame
Month 0, 1, 2, 3, 4
Title
Walking performance by 2 Minute Walk Test (2MWT) (in meter) results
Description
Analysis Walking performance (distance) by 2 Minute Walk Test (2MWT) (in meter) results
Time Frame
Month 0, 1, 2, 3, 4
Title
Walking performance by Quantified Gait Analysis results
Description
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 2, 4
Title
Motor function of the paretic lower limb
Description
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
Title
Lower limb spasticity level
Description
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
Title
Autonomy in walking activities
Description
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
Title
Lower limb strength
Description
Lower extremity strength will be measured as maximal voluntary strength in isometric ankle dorsiflexion.
Time Frame
Month 4
Title
Neuromuscular fatigue (1)
Description
Neuromuscular fatigue will be assessed by the level of voluntary activation (in %).
Time Frame
Month 4
Title
Neuromuscular fatigue (2)
Description
Neuromuscular fatigue will be assessed by corticospinal and intracortical excitability thanks to electromyographic responses evoked by transcranial magnetic stimulation.
Time Frame
Month 4
Title
Neuromuscular fatigue (3)
Description
Neuromuscular fatigue will be assessed by spinal excitability thanks to electromyographic responses evoked by electrical nerve stimulation.
Time Frame
Month 4
Title
Neuromuscular fatigue (4)
Description
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.
Time Frame
Month 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno FERNANDEZ, MD
Phone
(0)477120638
Ext
+33
Email
bruno.fernandez@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno FERNANDEZ, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Georges Claudinon
City
Le Chambon-Feugerolles
ZIP/Postal Code
42500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibault TRAMOY, MD
First Name & Middle Initial & Last Name & Degree
Thibault TRAMOY, MD
Facility Name
Hôpital Marrel
City
Rive-de-Gier
ZIP/Postal Code
42800
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bachir SAHI, MD
First Name & Middle Initial & Last Name & Degree
Bachir SAHI, MD
First Name & Middle Initial & Last Name & Degree
Kevin STAMPONE, MD
Facility Name
Centre Hospitalier de Roanne
City
Roanne
ZIP/Postal Code
42300
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel CORDIER, MD
First Name & Middle Initial & Last Name & Degree
Lionel CORDIER, MD
Facility Name
Service de SSR Val-Rosay
City
Saint-Didier-au-Mont-d'Or
ZIP/Postal Code
69370
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie DI MARCO, MD
First Name & Middle Initial & Last Name & Degree
Julie DI MARCO, MD
Facility Name
Hospices Civils de Lyon, site Henry Gabrielle
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie JACQUIN COURTOIS, MD PhD
First Name & Middle Initial & Last Name & Degree
Sophie JACQUIN COURTOIS, MD PhD
First Name & Middle Initial & Last Name & Degree
Laure HUCHON, MD
Facility Name
Hôpital Bellevue, CHU de Saint-etienne
City
Saint-Étienne
ZIP/Postal Code
42100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno FERNANDEZ, MD
First Name & Middle Initial & Last Name & Degree
Bruno FERNANDEZ, MD
First Name & Middle Initial & Last Name & Degree
Pascal GIRAUX, MD PhP
First Name & Middle Initial & Last Name & Degree
Julia TOULY, MD
First Name & Middle Initial & Last Name & Degree
Etienne OJARDIAS, MD
First Name & Middle Initial & Last Name & Degree
Hugo BESSAGUET, MD
Facility Name
Service de SSR du Centre Le Clos Champirol
City
Saint-Étienne
ZIP/Postal Code
42270
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre BERTHOLON, MD
First Name & Middle Initial & Last Name & Degree
Alexandre BERTHOLON, MD
12. IPD Sharing Statement
Learn more about this trial
Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients.
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