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CompletedNCT03112616VIBR-HEMIUpdated Feb 19, 2018

The Long-lasting Effects of Repetitive Neck Muscle Vibrations on Postural Disturbances in Standing Position in Chronic Stroke Patients

An observational study in Hemiplegia and Stroke, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
39
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hemiplegia
  • Stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 39 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with stroke

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
39 participants (actual)
Patient registry
No

Groups and cohorts

  • Left-brain damaged chronic patients

    Other: Vibration sessions

  • Right-brain damaged chronic patients

    Other: Vibration sessions

Interventions

  • OtherVibration sessions

    The patients will undergo a program of 10 sessions of vibrations of the neck muscle, each of 10 minutes, during a period of 15 days at the rate of one session per day.

06

What researchers measure

Primary outcomes

  1. Changes from baseline Weight Bearing Asymmetry at Day 15

    The primary evaluation criteria is the percentage of the Weight Bearing Asymmetry on the hemiparetic lower limb (WBA) calculated as the mean of 4 trys, each based on a 30 seconds duration with the two eyes open (OP) and then again with the two eyes closed. This evaluation is realized on a force platform.

    Time frame: Before and after the intervention program (Day 15)

Secondary outcomes

  1. Haptic and visual Subjective Straight Ahead (SSA) test

    The effect on spatial reference frame evaluated by haptic and visual Subjective Straight Ahead (SSA) test

    Time frame: 7 days and 15 days after the start of the intervention

  2. Subjective Visual Vertical (SVV) test

    The effect on spatial reference frame is evaluated by Subjective Visual Vertical (SVV) test

    Time frame: 7 days and 15 days after the start of the intervention

  3. Evaluation of Longitudinal Body Axis (LBA)

    The effect on spatial reference frame is evaluated on Longitudinal Body Axis (LBA)

    Time frame: 7 days and 15 days after the start of the intervention

  4. Rod and Frame Test

    The effect on spatial reference frame is evaluated by the Rod and Frame Test

    Time frame: 7 days and 15 days after the start of the intervention

  5. Change from baseline of patients' motor skills

    Assessment of motor skills with simple motor tasks

    Time frame: 1 month after the end of the program

  6. Change from baseline of patients' sensitivity

    Assessment of superficial tact on the hemiplegic lower limb compared to the safe limb

    Time frame: 1 month after the end of the program

  7. Change from baseline of patients' spasticity

    Assessment of spasticity with Ashworth Modified scale

    Time frame: 1 month after the end of the program

  8. Change from baseline of patients' functional capacity

    Functional capacity is a composite index made of sensitivity test, motor scale and spasticity scale

    Time frame: 1 month after the end of the program

07

Study locations

1 site
  • CHU Rennes - Pontchaillou Hospital
    Rennes, Brittany 35000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03112616
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Apr 13, 2017
Start date
Feb 15, 2016
Primary completion
Feb 27, 2017
Completion
Apr 18, 2017
Last update
Feb 19, 2018

Study contacts

Isabelle BONAN, MD, PhD
principal investigator · CHU Rennes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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