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

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ClinicalTrials.gov Identifier: NCT03112616
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease Intervention/treatment
Hemiplegia Stroke Other: Vibration sessions

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.


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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 15, 2016
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : April 18, 2017

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Group/Cohort Intervention/treatment
Left-brain damaged chronic patients Other: Vibration 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.

Right-brain damaged chronic patients Other: Vibration 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.




Primary Outcome Measures :
  1. Changes from baseline Weight Bearing Asymmetry at Day 15 [ Time Frame: Before and after the intervention program (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.


Secondary Outcome Measures :
  1. Haptic and visual Subjective Straight Ahead (SSA) test [ Time Frame: 7 days and 15 days after the start of the intervention ]
    The effect on spatial reference frame evaluated by haptic and visual Subjective Straight Ahead (SSA) test

  2. Subjective Visual Vertical (SVV) test [ Time Frame: 7 days and 15 days after the start of the intervention ]
    The effect on spatial reference frame is evaluated by Subjective Visual Vertical (SVV) test

  3. Evaluation of Longitudinal Body Axis (LBA) [ Time Frame: 7 days and 15 days after the start of the intervention ]
    The effect on spatial reference frame is evaluated on Longitudinal Body Axis (LBA)

  4. Rod and Frame Test [ Time Frame: 7 days and 15 days after the start of the intervention ]
    The effect on spatial reference frame is evaluated by the Rod and Frame Test

  5. Change from baseline of patients' motor skills [ Time Frame: 1 month after the end of the program ]
    Assessment of motor skills with simple motor tasks

  6. Change from baseline of patients' sensitivity [ Time Frame: 1 month after the end of the program ]
    Assessment of superficial tact on the hemiplegic lower limb compared to the safe limb

  7. Change from baseline of patients' spasticity [ Time Frame: 1 month after the end of the program ]
    Assessment of spasticity with Ashworth Modified scale

  8. Change from baseline of patients' functional capacity [ Time Frame: 1 month after the end of the program ]
    Functional capacity is a composite index made of sensitivity test, motor scale and spasticity scale



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stroke
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112616


Locations
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France
CHU Rennes - Pontchaillou Hospital
Rennes, Brittany, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Isabelle BONAN, MD, PhD CHU Rennes

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03112616     History of Changes
Other Study ID Numbers: 35RC16_3049-VIBR-HEMI
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Brain Diseases
Stroke
Hemiplegia
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms