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Clinical Trials/NCT04737018
NCT04737018
Completed
Not Applicable

Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.

Centre Hospitalier Universitaire de Saint Etienne2 sites in 1 country38 target enrollmentMay 14, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
38
Locations
2
Primary Endpoint
score of Fugl Meyer Assessment (lower limbs)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

In about 40 percent of cases, after a stroke, neuromotor impairment leads to activity limitations and the development of chronic functional disorders, which have a significant impact on patient autonomy.

In the early subacute phase, motor deficit in foot lifters is one of the factors limiting standing posture and ambulation, which is ultimately difficult to rehabilitate due to the lack of available techniques for obtaining early onset of useful active voluntary contraction.

The use of muscular focal vibration therapy, applied to relaxed muscle, may be of interest due to the portability and availability of the system and the neuromotor benefits demonstrated in healthy subjects and in acute and chronic post-stroke patients.

Registry
clinicaltrials.gov
Start Date
May 14, 2021
End Date
December 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Having had a stroke (with or without previous stroke) and being in the early subacute phase (between 14 days and 3 months of stroke).
  • Responsible for a motor deficit in the right or left lower limb.
  • No neurological history other than stroke.

Exclusion Criteria

  • Multifocal stroke
  • Patient having received a botulinum toxin injection to the lower limb to be vibrated

Outcomes

Primary Outcomes

score of Fugl Meyer Assessment (lower limbs)

Time Frame: day 30

score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.

Secondary Outcomes

  • assess functional walking ability(day 0, day 15, day 30 and month 2)
  • score of Fugl Meyer Assessment (lower limbs)(day 0, day 15, day 30 and month 2)
  • score of Medical Research Concil(day 0, day 15, day 30 and month 2)
  • score of postural assessment scale for stroke(day 0, day 15, day 30 and month 2)
  • analysis of static equilibrium(day 0, day 15, day 30 and month 2)
  • positional measurement of the center of gravity(day 0, day 15, day 30 and month 2)

Study Sites (2)

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