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

Not Applicable

Recruiting

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

• Registration Number: NCT05945212
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-14
• Study Start: 2024-03-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-01-07
• Study Completion: 2027-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibration	Fugl-Meyer (FMA-LE)	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.
Vibration	ABILOCO questionnaire	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.
no vibration	Sham vibration	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Vibration	10 meters Walk Test	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.
Vibration	Barthel index	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.
no vibration	10 meters Walk Test	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Vibration	Modified Ashworth scale	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.
Vibration	Electromyograms (EMG)	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.
Vibration	Traditional quantified gait analysis	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.
Vibration	SPM - Statistical Parametric Mapping	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.
Vibration	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.
Vibration	2 Minute Walk Test (2MWT)	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.
Vibration	isometric ergometer	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.
no vibration	ABILOCO questionnaire	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
no vibration	Barthel index	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Vibration	FACIT questionnaire (Functional Assessment of Chronic Illness Therapy)	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.
no vibration	2 Minute Walk Test (2MWT)	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
no vibration	Modified Ashworth scale	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
no vibration	FACIT questionnaire (Functional Assessment of Chronic Illness Therapy)	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
no vibration	Fugl-Meyer (FMA-LE)	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
no vibration	SPM - Statistical Parametric Mapping	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
no vibration	isometric ergometer	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
no vibration	Electromyograms (EMG)	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
no vibration	Traditional quantified gait analysis	In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.

Primary Outcome Measures

Name	Time	Method
Gait speed by 10 meters Walk Test (in meter /second) results	Month 2	Analysis Gait speed by 10 meters Walk Test (in meter /second) results

Secondary Outcome Measures

Name	Time	Method
Walking performance by 10 meters Walk Test (in meter /second) results	Month 0, 1, 2, 3, 4	Analysis Walking performance (comfort speed) by 10 meters Walk Test (in meter /second) results
Walking performance by Quantified Gait Analysis results	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).
Lower limb spasticity level	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.
Autonomy in walking activities	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.
Lower limb strength	Month 4	Lower extremity strength will be measured as maximal voluntary strength in isometric ankle dorsiflexion.
Motor function of the paretic lower limb	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.
Neuromuscular fatigue (1)	Month 4	Neuromuscular fatigue will be assessed by the level of voluntary activation (in %).
Neuromuscular fatigue (2)	Month 4	Neuromuscular fatigue will be assessed by corticospinal and intracortical excitability thanks to electromyographic responses evoked by transcranial magnetic stimulation.
Neuromuscular fatigue (4)	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.
Neuromuscular fatigue (3)	Month 4	Neuromuscular fatigue will be assessed by spinal excitability thanks to electromyographic responses evoked by electrical nerve stimulation.
Walking performance by 2 Minute Walk Test (2MWT) (in meter) results	Month 0, 1, 2, 3, 4	Analysis Walking performance (distance) by 2 Minute Walk Test (2MWT) (in meter) results

Trial Locations

Locations (7)

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

Hospices Civils de Lyon, site Henry Gabrielle; 🇫🇷 Saint-Genis-Laval, France

Hôpital Bellevue, CHU de Saint-etienne; 🇫🇷 Saint-Étienne, France

Service de SSR du Centre Le Clos Champirol; 🇫🇷 Saint-Étienne, France