NCT03112616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2017

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

August 9, 2016

Last Update Submit

February 16, 2018

Conditions

HemiplegiaStroke

Outcome Measures

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.

    Before and after the intervention program (Day 15)

Secondary Outcomes (8)

  • Haptic and visual Subjective Straight Ahead (SSA) test

    7 days and 15 days after the start of the intervention

  • Subjective Visual Vertical (SVV) test

    7 days and 15 days after the start of the intervention

  • Evaluation of Longitudinal Body Axis (LBA)

    7 days and 15 days after the start of the intervention

  • Rod and Frame Test

    7 days and 15 days after the start of the intervention

  • Change from baseline of patients' motor skills

    1 month after the end of the program

  • +3 more secondary outcomes

Study Arms (2)

Left-brain damaged chronic patients

Other: Vibration sessions

Right-brain damaged chronic patients

Other: Vibration sessions

Interventions

Vibration sessionsOTHER

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.

Left-brain damaged chronic patientsRight-brain damaged chronic patients

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stroke

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes - Pontchaillou Hospital

Rennes, Brittany Region, 35000, France

Location

MeSH Terms

Conditions

HemiplegiaStroke

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Isabelle BONAN, MD, PhD

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

April 13, 2017

Study Start

February 15, 2016

Primary Completion

February 27, 2017

Study Completion

April 18, 2017

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)