HemiplegiaVIBR-AVCNCT02096367
Immediate Effect of Postural Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia
A study testing Gait analysis, Kinematic gait analysis in lower limb and Analysis of static posture in people with Hemiplegia and Stroke, run by Rennes University Hospital at 1 site in France.
Trial summary
Balance disorders are very common after strokes and often last for long periods of time. Their origin is multifactorial and their impact on the daily lives of patients are particularly important, especially on gait. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegia, Stroke
- What is being tested?
- Gait analysis, Kinematic gait analysis in lower limb and Analysis of static posture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Apr 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiplegic subjects after stroke:
- Men or women aged over 18
- Stroke due to ischemic or haemorrhagic cause
- More than 6 months after stroke
- First episode of stroke
- Gait asymmetry before stimulation
- Able to walk more than 100 meters with or without cane
- Written informed consent
Who cannot join
- Orthopaedic or rheumatologic disorders impeding the good realisation of the measurement
- Adults under legal protective regimen or deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect of Cervical Posterior Muscles' and Gluteus Medius Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia
Balance disorders are very common after strokes and often last for long periods of time. Their origin is multifactorial and their impact on the daily lives of patients are particularly important, especially on gait.
The vibration technology for rehabilitation was already studied in static posture with force plats but their impact on gait have yet to be evaluated.
This present study aims at investigating the effects of vibrations applied by an approved medical device to the posterior neck muscles and the gluteus medius - major actors of proprioception and posture mechanisms - on gait disorders in patients with hemiplegia during the chronic phase after stroke.
Read the detailed description
An inclusion medical exam will occur in order to explain the protocol to the patients, to receive their written informed consent and to check the inclusion and absence of non-inclusion criteria.
The study visit will happen in a 2 weeks' time span at most after the inclusion exam.
During the study visit, the patients will undergo:
- A quantitative gait analysis with Gait Rite and Optitrack before any intervention;
- Then, in a randomized order:
- A vibration stimulation on a non-postural muscle (biceps brachii muscle) in order to get a control stimulation (or "sham") with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped,
- A vibration stimulation of the posterior neck muscles on the hemiplegic side, with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped. The precise stimulation location will be located by the pressures centre deviation on a medio-lateral axis on a strength platform (this area can vary for a few centimetres from patient to patient),
- In order to assess the secondary outcome aiming at defining the best stimulation location, a vibration stimulation of the gluteus medius on the hemiplegic side, with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped. In the same way than for the neck muscles, the scouting of the precise location will be assessed facing the greater trochanter by the pressures centre deviation on a medio-lateral axis on a strength platform.
The realisation of the entire protocol will last approximately 90 minutes.
At the end of the test, an optoelectronic recording by Optitrack will be realised on a treadmill in order to highlight potential differences between the gait on the ground and trained gait at comfortable speed for 2 minutes maximum.
- Conditions
- Hemiplegia, Stroke
- Being tested
- Gait analysis, Kinematic gait analysis in lower limb, Analysis of static posture, Gait on treadmill, Muscle vibration stimulation
- Keywords
- vibrations, stroke, posture, gait, readaptation
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisOther
Also called Gait analysis system : Gait Rite®
Kinematic gait analysis in lower limbOther
Also called Optoelectronic system : Optitrack
Analysis of static postureOther
Also called Force platform Feetest® (Technoconcept, France)
Gait on treadmillOther
Treadmill during 2 minutes
Muscle vibration stimulationDevice
Also called Device : VB 115 Vibrasens© (Technoconcept, France)
Vibration stimulation at a 70 Hz frequency of biceps brachii muscle (sham), posterior neck muscles and gluteus medius muscle on the hemiplegic side
| Study group | Role | What they receive |
|---|---|---|
| Hemiplegia after vascular stroke | Experimental | * Muscle vibration stimulation
* Gait analysis with Gait Rite : quantitative and spatio-temporal gait parameters
* Kinematic gait analysis in lower limb measured by optoelectronic system (Optitrack).
* Analysis of static posture on force platform
* Evaluation of the gait on treadmill during 2 minutes Receives: Other: Gait analysis; Other: Kinematic gait analysis in lower limb; Other: Analysis of static posture; Other: Gait on treadmill; Device: Muscle vibration stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of monopodal stance on the hemiplegic side
Improvement of the percentage of monopodal stance on the hemiplegic side during walking after stimulation by vibrations measured by quantitative gait analysis with Gait Rite
Measured: Day 0
Secondary outcomes (4)
Spatio-temporal gait parameters
Spatio-temporal gait parameters : speed, step time, time of double stance, time of swing, length and width of step
Measured: Day 0
Kinematic gait parameters in lower limb
Kinematic gait parameters in lower limb (hip, knee, ankle) measured by optoelectronic system (Optitrack).
Measured: Day 0
Static posture asymmetry
Analysis of static posture on force platform
Measured: Day 0
Gait parameters on treadmill
Evaluation of gait parameters during 2 minutes on treadmill, measured by optoelectronic system (Optitrack).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- École Normale Supérieure de Cachan
- Responsible party
- Sponsor
- Investigators
- Isabelle Bonan, MD, PhD, Principal investigator, CHU Rennes - Service de Médecine Physique et de Réadaptation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096367
- Sponsor's protocol ID
- VIBR-AVC
- Acronym
- VIBR-AVC
- Status last verified
- Jun 2015
- First submitted
- 12 Mar 2014
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Cervical Posterior Muscles' and Gluteus Medius Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia
- ClinicalTrials.gov ID
- NCT02096367
- Acronym / sponsor ID
- VIBR-AVC / VIBR-AVC
- Conditions
- Hemiplegia, Stroke
- Keywords
- vibrations, stroke, posture, gait, readaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- École Normale Supérieure de Cachan
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Mar 2014 (estimated)
- 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.
Balance disorders are very common after strokes and often last for long periods of time. Their origin is multifactorial and their impact on the daily lives of patients are particularly important, especially on gait.
The vibration technology for rehabilitation was already studied in static posture with force plats but their impact on gait have yet to be evaluated.
This present study aims at investigating the effects of vibrations applied by an approved medical device to the posterior neck muscles and the gluteus medius - major actors of proprioception and posture mechanisms - on gait disorders in patients with hemiplegia during the chronic phase after stroke.
Detailed description
An inclusion medical exam will occur in order to explain the protocol to the patients, to receive their written informed consent and to check the inclusion and absence of non-inclusion criteria.
The study visit will happen in a 2 weeks' time span at most after the inclusion exam.
During the study visit, the patients will undergo:
- A quantitative gait analysis with Gait Rite and Optitrack before any intervention;
- Then, in a randomized order:
- A vibration stimulation on a non-postural muscle (biceps brachii muscle) in order to get a control stimulation (or "sham") with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped,
- A vibration stimulation of the posterior neck muscles on the hemiplegic side, with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped. The precise stimulation location will be located by the pressures centre deviation on a medio-lateral axis on a strength platform (this area can vary for a few centimetres from patient to patient),
- In order to assess the secondary outcome aiming at defining the best stimulation location, a vibration stimulation of the gluteus medius on the hemiplegic side, with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped. In the same way than for the neck muscles, the scouting of the precise location will be assessed facing the greater trochanter by the pressures centre deviation on a medio-lateral axis on a strength platform.
The realisation of the entire protocol will last approximately 90 minutes.
At the end of the test, an optoelectronic recording by Optitrack will be realised on a treadmill in order to highlight potential differences between the gait on the ground and trained gait at comfortable speed for 2 minutes maximum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemiplegia after vascular stroke | Experimental | Other: Gait analysis, Other: Kinematic gait analysis in lower limb, Other: Analysis of static posture, Other: Gait on treadmill, Device: Muscle vibration stimulation* Muscle vibration stimulation * Gait analysis with Gait Rite : quantitative and spatio-temporal gait parameters * Kinematic gait analysis in lower limb measured by optoelectronic system (Optitrack). * Analysis of static posture on force platform * Evaluation of the gait on treadmill during 2 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women aged over 18
- Stroke due to ischemic or haemorrhagic cause
- More than 6 months after stroke
- First episode of stroke
- Gait asymmetry before stimulation
Key exclusion criteria (2 listed)
- Orthopaedic or rheumatologic disorders impeding the good realisation of the measurement
- Adults under legal protective regimen or deprived of liberty
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 |
|---|---|---|
| Gait analysisAlso: Gait analysis system : Gait Rite® | Other | Hemiplegia after vascular stroke |
| Kinematic gait analysis in lower limbAlso: Optoelectronic system : Optitrack | Other | Hemiplegia after vascular stroke |
| Analysis of static postureAlso: Force platform Feetest® (Technoconcept, France) | Other | Hemiplegia after vascular stroke |
| Gait on treadmillTreadmill during 2 minutes | Other | Hemiplegia after vascular stroke |
| Muscle vibration stimulationAlso: Device : VB 115 Vibrasens© (Technoconcept, France)Vibration stimulation at a 70 Hz frequency of biceps brachii muscle (sham), posterior neck muscles and gluteus medius muscle on the hemiplegic side | Device | Hemiplegia after vascular stroke |
Primary outcome
Percentage of monopodal stance on the hemiplegic side
Time frame: Day 0
Improvement of the percentage of monopodal stance on the hemiplegic side during walking after stimulation by vibrations measured by quantitative gait analysis with Gait Rite
4 secondary outcomes
Spatio-temporal gait parameters
Time frame: Day 0
Kinematic gait parameters in lower limb
Time frame: Day 0
Static posture asymmetry
Time frame: Day 0
Gait parameters on treadmill
Time frame: Day 0
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 9 Jun 2015.
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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
CHU Rennes - Service de Médecine Physique et de Réadaptation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis, Kinematic gait analysis in lower limb and Analysis of static posture in people with 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 8 inclusion and 2 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 9 Jun 2015. 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?
Percentage of monopodal stance on the hemiplegic side (time frame: Day 0). 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 9 Jun 2015.