Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients. (NEUROVIB-AVC)

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Stroke Rehabilitation

Treatments: Other: FACIT questionnaire (Functional Assessment of Chronic Illness Therapy); Other: Electromyograms (EMG); Device: Sham vibration; Other: 10 meters Walk Test; Other: 2 Minute Walk Test (2MWT); Other: isometric ergometer; Other: Traditional quantified gait analysis; Other: SPM - Statistical Parametric Mapping; Other: ABILOCO questionnaire; Other: Fugl-Meyer (FMA-LE); Other: Modified Ashworth scale; Other: Barthel index; Device: Vibration

Study type: Interventional

Funder types: Other

Identifiers

NCT05945212

21PH266

2023-A00489-36 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Vibration

Experimental group

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.

Treatment:

Device: Vibration

Other: Barthel index

Other: Modified Ashworth scale

Other: Fugl-Meyer (FMA-LE)

Other: ABILOCO questionnaire

Other: SPM - Statistical Parametric Mapping

Other: Traditional quantified gait analysis

Other: isometric ergometer

Other: 2 Minute Walk Test (2MWT)

Other: 10 meters Walk Test

Other: Electromyograms (EMG)

Other: FACIT questionnaire (Functional Assessment of Chronic Illness Therapy)

no vibration

Sham Comparator group

Description:

In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.

Treatment:

Other: Barthel index

Other: Modified Ashworth scale

Other: Fugl-Meyer (FMA-LE)

Other: ABILOCO questionnaire

Other: SPM - Statistical Parametric Mapping

Other: Traditional quantified gait analysis

Other: isometric ergometer

Other: 2 Minute Walk Test (2MWT)

Other: 10 meters Walk Test

Device: Sham vibration

Other: Electromyograms (EMG)

Other: FACIT questionnaire (Functional Assessment of Chronic Illness Therapy)