Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients - a Multicentric Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 70
- Locations
- 12
- Primary Endpoint
- Gait speed by 10 meters Walk Test (in meter /second) results
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stroke patients in subacute rehabilitation phase (between 14 days and 3 months post-stroke)
- •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
- •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 phlebitis or risk of thrombosis in the lower limb
- •Patient under tutorship
Arms & Interventions
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.
Intervention: SPM - Statistical Parametric Mapping (Other)
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.
Intervention: Vibration (Device)
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.
Intervention: 10 meters Walk Test (Other)
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.
Intervention: 2 Minute Walk Test (2MWT) (Other)
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.
Intervention: Fugl-Meyer (FMA-LE) (Other)
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.
Intervention: Modified Ashworth scale (Other)
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.
Intervention: ABILOCO questionnaire (Other)
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.
Intervention: Barthel index (Other)
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.
Intervention: isometric ergometer (Other)
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.
Intervention: Electromyograms (EMG) (Other)
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.
Intervention: Traditional quantified gait analysis (Other)
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.
Intervention: FACIT questionnaire (Functional Assessment of Chronic Illness Therapy) (Other)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: Sham vibration (Device)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: 10 meters Walk Test (Other)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: 2 Minute Walk Test (2MWT) (Other)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: Fugl-Meyer (FMA-LE) (Other)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: Modified Ashworth scale (Other)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: ABILOCO questionnaire (Other)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: Barthel index (Other)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: isometric ergometer (Other)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: Electromyograms (EMG) (Other)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: Traditional quantified gait analysis (Other)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: SPM - Statistical Parametric Mapping (Other)
no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Intervention: FACIT questionnaire (Functional Assessment of Chronic Illness Therapy) (Other)
Outcomes
Primary Outcomes
Gait speed by 10 meters Walk Test (in meter /second) results
Time Frame: Month 2
Analysis Gait speed by 10 meters Walk Test (in meter /second) results
Secondary Outcomes
- Walking performance by 2 Minute Walk Test (2MWT) (in meter) results(Month 0, 1, 2, 3, 4)
- Walking performance by 10 meters Walk Test (in meter /second) results(Month 0, 1, 2, 3, 4)
- Walking performance by Quantified Gait Analysis results(Month 2, 4)
- Lower limb spasticity level(Month 4)
- Autonomy in walking activities(Month 4)
- Lower limb strength(Month 4)
- Motor function of the paretic lower limb(Month 4)
- Neuromuscular fatigue (1)(Month 4)
- Neuromuscular fatigue (2)(Month 4)
- Neuromuscular fatigue (4)(Month 4)
- Neuromuscular fatigue (3)(Month 4)