HemiplegiaVIBR-HEMINCT03112616
The Long-lasting Effects of Repetitive Neck Muscle Vibrations on Postural Disturbances in Standing Position in Chronic Stroke Patients
An observational study of Hemiplegia and Stroke, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hemiplegia, Stroke
- What is being tested?
- Vibration sessions
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2016to 18 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stroke
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hemiplegia, Stroke
- Being tested
- Vibration sessions
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Left-brain damaged chronic patients | Not described Receives: Other: Vibration sessions | |
| Right-brain damaged chronic patients | Not described Receives: Other: Vibration sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after the intervention program (Day 15)
Secondary outcomes (8)
Haptic and visual Subjective Straight Ahead (SSA) test
The effect on spatial reference frame evaluated by haptic and visual Subjective Straight Ahead (SSA) test
Measured: 7 days and 15 days after the start of the intervention
Subjective Visual Vertical (SVV) test
The effect on spatial reference frame is evaluated by Subjective Visual Vertical (SVV) test
Measured: 7 days and 15 days after the start of the intervention
Evaluation of Longitudinal Body Axis (LBA)
The effect on spatial reference frame is evaluated on Longitudinal Body Axis (LBA)
Measured: 7 days and 15 days after the start of the intervention
Rod and Frame Test
The effect on spatial reference frame is evaluated by the Rod and Frame Test
Measured: 7 days and 15 days after the start of the intervention
Change from baseline of patients' motor skills
Assessment of motor skills with simple motor tasks
Measured: 1 month after the end of the program
Change from baseline of patients' sensitivity
Assessment of superficial tact on the hemiplegic lower limb compared to the safe limb
Measured: 1 month after the end of the program
Change from baseline of patients' spasticity
Assessment of spasticity with Ashworth Modified scale
Measured: 1 month after the end of the program
Change from baseline of patients' functional capacity
Functional capacity is a composite index made of sensitivity test, motor scale and spasticity scale
Measured: 1 month after the end of the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start15 Feb 2016
- Primary completion27 Feb 2017
- Study completion18 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle BONAN, MD, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112616
- Sponsor's protocol ID
- 35RC16_3049-VIBR-HEMI
- Acronym
- VIBR-HEMI
- Status last verified
- Feb 2018
- First submitted
- 9 Aug 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03112616
- Acronym / sponsor ID
- VIBR-HEMI / 35RC16_3049-VIBR-HEMI
- Conditions
- Hemiplegia, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 18 Apr 2017 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left-brain damaged chronic patients | – | Other: Vibration sessions |
| Right-brain damaged chronic patients | – | Other: Vibration sessions |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke
Key inclusion criteria (10 listed)
- Adult (age ≥ 18 years) under 80 years,
- Right or left unilateral supratentorial ischemic or hemorrhagic lesion
- The first symptomatic episode
- Stroke
- Standing balance ≥ 30 sec unaided
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration sessionsThe 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. | Other | Left-brain damaged chronic patients, Right-brain damaged chronic patients |
Primary outcome
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.
8 secondary outcomes
Haptic and visual Subjective Straight Ahead (SSA) test
Time frame: 7 days and 15 days after the start of the intervention
Subjective Visual Vertical (SVV) test
Time frame: 7 days and 15 days after the start of the intervention
Evaluation of Longitudinal Body Axis (LBA)
Time frame: 7 days and 15 days after the start of the intervention
Rod and Frame Test
Time frame: 7 days and 15 days after the start of the intervention
Change from baseline of patients' motor skills
Time frame: 1 month after the end of the program
Change from baseline of patients' sensitivity
Time frame: 1 month after the end of the program
Change from baseline of patients' spasticity
Time frame: 1 month after the end of the program
Change from baseline of patients' functional capacity
Time frame: 1 month after the end of the program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle BONAN, MD, PhD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegia and Stroke, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline Weight Bearing Asymmetry at Day 15 (time frame: Before and after the intervention program (Day 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.