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

Stroke Clinical Trial

— VIBR-HEMI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112616
• Other study ID #: 35RC16_3049-VIBR-HEMI
• Status: Completed
• Phase: N/A
• First received: August 9, 2016
• Last updated: February 16, 2018
• Start date: February 15, 2016
• Est. completion date: April 18, 2017

Study information

• Verified date: February 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 18, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

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.

Locations

Country	Name	City	State
France	CHU Rennes - Pontchaillou Hospital	Rennes	Brittany

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before and after the intervention program (Day 15)
Secondary	Haptic and visual Subjective Straight Ahead (SSA) test	The effect on spatial reference frame evaluated by haptic and visual Subjective Straight Ahead (SSA) test	7 days and 15 days after the start of the intervention
Secondary	Subjective Visual Vertical (SVV) test	The effect on spatial reference frame is evaluated by Subjective Visual Vertical (SVV) test	7 days and 15 days after the start of the intervention
Secondary	Evaluation of Longitudinal Body Axis (LBA)	The effect on spatial reference frame is evaluated on Longitudinal Body Axis (LBA)	7 days and 15 days after the start of the intervention
Secondary	Rod and Frame Test	The effect on spatial reference frame is evaluated by the Rod and Frame Test	7 days and 15 days after the start of the intervention
Secondary	Change from baseline of patients' motor skills	Assessment of motor skills with simple motor tasks	1 month after the end of the program
Secondary	Change from baseline of patients' sensitivity	Assessment of superficial tact on the hemiplegic lower limb compared to the safe limb	1 month after the end of the program
Secondary	Change from baseline of patients' spasticity	Assessment of spasticity with Ashworth Modified scale	1 month after the end of the program
Secondary	Change from baseline of patients' functional capacity	Functional capacity is a composite index made of sensitivity test, motor scale and spasticity scale	1 month after the end of the program