Clinical trial NCT03112616: The Long-lasting Effects of Repetitive Neck Muscle Vibrations on Postural Disturbances in Standing Position in Chronic Stroke Patients
Official title: The Long-lasting Effects of Repetitive Neck Muscle Vibrations on Postural Disturbances in Standing Position and on Spatial Frame Reference in Chronic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemiplegia
Stroke
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stroke

Brief summary: One of the causes of disability in patients suffering from a stroke is postural imbalance. Sensory stimulation improves the postural symmetry of the subject transitorily and they are thought to have an effect on the spatial frame of reference through a sensory recalibration. Studies have shown that sensory stimulation by vibration of neck muscles have an immediate effect on static balance and when walking. The objective of this preliminary study is to test the long-lasting effects of repetitive neck muscle vibrations on postural disturbances in standing position and on spatial frame reference in chronic patients.

Detailed description: The hypothesis of this study is that the proprioceptive repeated stimulation by vibration of neck muscles in the long term improved postural asymmetry in connection with the egocentric representation of body disorders.

The effect of vibration simultaneously on improving postural asymmetry and on improving markers of the perception of the body in space (LBA, SSA, Subjective Visual Vertical (SVV), Rod and frame) will be assessed.

Eligibility criteria: Inclusion Criteria:

* Adult (age ≥ 18 years) under 80 years,
* Right or left unilateral supratentorial ischemic or hemorrhagic lesion
* The first symptomatic episode
* Stroke

  * older than 12 months
  * with or without hemianopsia
  * with or without visuospatial hemineglect
* Standing balance ≥ 30 sec unaided
* Percentage of weight bearing asymmetry on the hemiplegic lower limb (on a force platform)
* Written informed consent of the patient or a member of his entourage (in the case of patients with motor difficulties)

Exclusion Criteria:

* Orthopaedic, rheumatologic, neurologic, vestibular or visual disorders affecting the distribution of the centre of pressure while standing on the force platform
* Visual disorder that does not allow assessment of the spatial frame of reference test
* Difficulty with understanding protocol procedures

Primary outcomes:
measure: Changes from baseline Weight Bearing Asymmetry at Day 15
timeFrame: Before and after the intervention program (Day 15)
Secondary outcomes:
measure: Haptic and visual Subjective Straight Ahead (SSA) test
timeFrame: 7 days and 15 days after the start of the intervention
measure: Subjective Visual Vertical (SVV) test
timeFrame: 7 days and 15 days after the start of the intervention
measure: Evaluation of Longitudinal Body Axis (LBA)
timeFrame: 7 days and 15 days after the start of the intervention
measure: Rod and Frame Test
timeFrame: 7 days and 15 days after the start of the intervention
measure: Change from baseline of patients' motor skills
timeFrame: 1 month after the end of the program
measure: Change from baseline of patients' sensitivity
timeFrame: 1 month after the end of the program
measure: Change from baseline of patients' spasticity
timeFrame: 1 month after the end of the program
measure: Change from baseline of patients' functional capacity
timeFrame: 1 month after the end of the program
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes - Pontchaillou Hospital
state: Brittany
Study officials:
affiliation: CHU Rennes
name: Isabelle BONAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: