HemiplegiaOPTIVIBENCT04449328
Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects
A study testing Computerized Mirror Therapy (CMT) and Tendon vibration in people with Hemiplegia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Two movement illusion techniques can currently be used in clinical practice for motor rehabilitation after stroke hemiplegia: visual illusion (mirror therapy) and proprioceptive illusion (tendon vibration). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Computerized Mirror Therapy (CMT) and Tendon vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2021to 28 Apr 2023
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hemiplegic subjects :
- Male or female
- Aged 18 to 70 years,
- First ischemic or hemorrhagic stroke causing hemiplegic
- Having signed the written consent
- Affiliated or entitled to a social security scheme
Show all 11Show fewer
- Healthy subjects :
- Male or female, aged 18 to 70 years,
- Matched in sex, age and laterally with hemiplegic subjects
- Having signed the written consent
- Affiliated or entitled to a social security scheme
Who cannot join
- Hemiplegic subjects :
- With complete lesion of the primary motor cortex
- With an addiction to alcohol or drugs
- With psychiatric illness, cognitive impairment, uncontrolled disease/epilepsy, malignant illness severe kidney or lung disease
- With history of associated general disabling disease
- With cerebellar syndrome
Show all 15Show fewer
- With clinical brain stem involvement
- Under legal protection
- Pregnant or breastfeeding women
- Healthy subjects :
- Neurological, cardiovascular, musculoskeletal diseases
- Taking medication that can affect attention
- Unable to understand instructions of the study
- Under legal protection
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Two movement illusion techniques can currently be used in clinical practice for motor rehabilitation after stroke hemiplegia: visual illusion (mirror therapy) and proprioceptive illusion (tendon vibration). Mirror therapy, in its computerized version (IVS3, Dessintey, Saint-Etienne, France), is based on the substitution of the deficient visual feedback by a visual feedback of a correctly realized movement. The proprioceptive illusion is based on the external application of a vibrator on muscle tendons at a frequency between 50 and 120 Hz. These two techniques are currently used independently. They are, in theory, complementary and additive. No study has described the combinatorial properties of the illusions generated by these 2 techniques in hemiplegic subjects and healthy subjects.
Read the detailed description
The study hypothesis is that the administration of mirror therapy together with vibration will increase the perception of movement in a subjective scale.
- Conditions
- Hemiplegia
- Being tested
- Computerized Mirror Therapy (CMT), Tendon vibration
- Keywords
- Computerized Mirror Therapy (CMT), Intensive Visual Simulation3 (IVS3), Vibration, Vibrasens, Upper limb rehabilitation, Stroke, Hemiplegic
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Mirror Therapy (CMT)Device
Also called Intensive Visual Simulation3 (IVS3), Dessintey, Saint Etienne, France
Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3).
The patient looks on a screen in front of him, mirroring the movements made by his hand, while attempting to perform the same movement with his other hand.
Tendon vibrationDevice
Also called Vibrasens, VB115, Techno Concept, France
Transcutaneous vibrations are used. This device allows vibrations from 50 to 120 Hz with amplitude of 1 mm. This study the frequency used is 70 and 80 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Patient with first stroke causing hemiplegic | Experimental | Patient with first stroke causing hemiplegic will be included.
They will have Computerized Mirror Therapy (CMT) associated at tendon vibration:
* Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence))
* Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes. Receives: Device: Computerized Mirror Therapy (CMT); Device: Tendon vibration |
| healthy subjects | Sham comparator | Healthy subjects will be included.
They will have Computerized Mirror Therapy (CMT) associated at tendon vibration:
* Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence))
* Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes. Receives: Device: Computerized Mirror Therapy (CMT); Device: Tendon vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective measure of the intensity of the perception of movements: change from baseline impression of movement at day 7
Measured impression of movement on conditions (visual and/or proprioceptive; yes/no/don't know)
Measured: Day: 0, 7
subjective measure of the intensity of the perception of movements: change from baseline nature of this impression at day 7
Measured nature of this impression of movement (flexion/extension)
Measured: Day: 0, 7
subjective measure of the intensity of the perception of movements: change from baseline intensity of the movement felt at day 7
Measured intensity of the movement felt by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement.)
Measured: Day: 0, 7
Secondary outcomes (6)
Objective measurement of the perceived movement angle reproduced without motor intention by the hemiplegic subjects with the healthy limb
Measured by Kinovea software.
Measured: Day: 0, 7
Measurement of motor intention in hemiplegic subjects by experimental conditions
Measured by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement).
Measured: Day: 0, 7
To compare the Visual Analogue Scale (VAS) score according to the level of motor impairment
Level of motor impairment is measured by Medical Research Council (MRC) score. Medical Research Council (MRC) score evaluate motricity (0= paralyzed).
Measured: Day: 0
To compare the Visual Analogue Scale (VAS) score with the Erasmus modified Nottingham Sensory Assessment (EmNSA) score
Erasmus modified Nottingham Sensory Assessment (EmNSA) score evaluated the level of sensory impairment.
The Erasmus modified Nottingham Sensory Assessment (EmNSA) includes 2 subscales: somatosensory score (min 0 and max 44) and stereognosis (min 0 and max 20) for left and right members.
Measured: Day: 0
Intensity of the perception of movements using a visual analogue scale and the objective measurement of perceived movement angle reproduced by the healthy subjects with the vibrated arm
Measured by Kinovea software.
Measured: Day: 0, 7
Brain activity according to different experimental conditions (with and without vibration or with and without visual illusion) in hemiplegic subjects.
Multi Channel EEG Acquisition System
Measured: Day: 0, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start30 Apr 2021
- Primary completion25 Apr 2023
- Study completion28 Apr 2023
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal GIRAUX, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449328
- Sponsor's protocol ID
- 19CH113
- Other IDs
- 2019-A01673-54
- Acronym
- OPTIVIBE
- Status last verified
- May 2023
- First submitted
- 22 Jun 2020
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adham A, Bessaguet H, Struber L, Rimaud D, Ojardias E, Giraux P. Distinct and additive effects of visual and vibratory feedback for motor rehabilitation: an EEG study in healthy subjects. J Neuroeng Rehabil. 2024 Sep 12;21(1):158. doi: 10.1186/s12984-024-01453-3.
PubMed 39267092
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects
- ClinicalTrials.gov ID
- NCT04449328
- Acronym / sponsor ID
- OPTIVIBE / 19CH113
- Conditions
- Hemiplegia
- Keywords
- Computerized Mirror Therapy (CMT), Intensive Visual Simulation3 (IVS3), Vibration, Vibrasens, Upper limb rehabilitation, Stroke, Hemiplegic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 26 Jun 2020 (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.
Two movement illusion techniques can currently be used in clinical practice for motor rehabilitation after stroke hemiplegia: visual illusion (mirror therapy) and proprioceptive illusion (tendon vibration). Mirror therapy, in its computerized version (IVS3, Dessintey, Saint-Etienne, France), is based on the substitution of the deficient visual feedback by a visual feedback of a correctly realized movement. The proprioceptive illusion is based on the external application of a vibrator on muscle tendons at a frequency between 50 and 120 Hz. These two techniques are currently used independently. They are, in theory, complementary and additive. No study has described the combinatorial properties of the illusions generated by these 2 techniques in hemiplegic subjects and healthy subjects.
Detailed description
The study hypothesis is that the administration of mirror therapy together with vibration will increase the perception of movement in a subjective scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with first stroke causing hemiplegic | Experimental | Device: Computerized Mirror Therapy (CMT), Device: Tendon vibrationPatient with first stroke causing hemiplegic will be included. They will have Computerized Mirror Therapy (CMT) associated at tendon vibration: * Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence)) * Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes. |
| healthy subjects | Sham comparator | Device: Computerized Mirror Therapy (CMT), Device: Tendon vibrationHealthy subjects will be included. They will have Computerized Mirror Therapy (CMT) associated at tendon vibration: * Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence)) * Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female
- Aged 18 to 70 years,
- First ischemic or hemorrhagic stroke causing hemiplegic
- Having signed the written consent
- Affiliated or entitled to a social security scheme
Key exclusion criteria (15 listed)
- With complete lesion of the primary motor cortex
- With an addiction to alcohol or drugs
- With psychiatric illness, cognitive impairment, uncontrolled disease/epilepsy, malignant illness severe kidney or lung disease
- With history of associated general disabling disease
- With cerebellar syndrome
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 |
|---|---|---|
| Computerized Mirror Therapy (CMT)Also: Intensive Visual Simulation3 (IVS3), Dessintey, Saint Etienne, FranceComputerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3). The patient looks on a screen in front of him, mirroring the movements made by his hand, while attempting to perform the same movement with his other hand. | Device | Patient with first stroke causing hemiplegic, healthy subjects |
| Tendon vibrationAlso: Vibrasens, VB115, Techno Concept, FranceTranscutaneous vibrations are used. This device allows vibrations from 50 to 120 Hz with amplitude of 1 mm. This study the frequency used is 70 and 80 Hz. | Device | Patient with first stroke causing hemiplegic, healthy subjects |
Primary outcome
subjective measure of the intensity of the perception of movements: change from baseline impression of movement at day 7
Time frame: Day: 0, 7
Measured impression of movement on conditions (visual and/or proprioceptive; yes/no/don't know)
subjective measure of the intensity of the perception of movements: change from baseline nature of this impression at day 7
Time frame: Day: 0, 7
Measured nature of this impression of movement (flexion/extension)
subjective measure of the intensity of the perception of movements: change from baseline intensity of the movement felt at day 7
Time frame: Day: 0, 7
Measured intensity of the movement felt by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement.)
6 secondary outcomes
Objective measurement of the perceived movement angle reproduced without motor intention by the hemiplegic subjects with the healthy limb
Time frame: Day: 0, 7
Measurement of motor intention in hemiplegic subjects by experimental conditions
Time frame: Day: 0, 7
To compare the Visual Analogue Scale (VAS) score according to the level of motor impairment
Time frame: Day: 0
To compare the Visual Analogue Scale (VAS) score with the Erasmus modified Nottingham Sensory Assessment (EmNSA) score
Time frame: Day: 0
Intensity of the perception of movements using a visual analogue scale and the objective measurement of perceived movement angle reproduced by the healthy subjects with the vibrated arm
Time frame: Day: 0, 7
Brain activity according to different experimental conditions (with and without vibration or with and without visual illusion) in hemiplegic subjects.
Time frame: Day: 0, 7
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Derived from this study: PubMed 39267092Adham A, Bessaguet H, Struber L, Rimaud D, Ojardias E, Giraux P. Distinct and additive effects of visual and vibratory feedback for motor rehabilitation: an EEG study in healthy subjects. J Neuroeng Rehabil. 2024 Sep 12;21(1):158. doi: 10.1186/s12984-024-01453-3.
- 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.
Pascal GIRAUX, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Mirror Therapy (CMT) and Tendon vibration in people with Hemiplegia, run by Centre Hospitalier Universitaire de Saint Etienne 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 11 inclusion and 15 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: stopped early, as of the sponsor's last update on 30 May 2023. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: lack of inclusion). Results are not available in the source record.
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?
subjective measure of the intensity of the perception of movements: change from baseline impression of movement at day 7 (time frame: Day: 0, 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04449328, which also lists 1 linked publication.
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 30 May 2023.