BalancePREFSENSORNCT01146249
Evaluation of the Sensorial Preference
An observational study of Balance, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Among the components of postural control, sensorial integration is of crucial importance. The most important sensorial inputs for postural maintenance are the vestibular system which provides information regarding accelerations of the head in space (HORAK 1994), the somatosensory system which provides proprioceptive… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Balance assessment under sensory stimulation
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2007to 18 Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects Vestibular patients Post stroke patients Patient with proprioception disorder Old subjects with a history of falls
Who may be able to join
- Healthy subjects without history of balance disorder
- Vestibular patients with a unique history of peripheric vestibular disorder
- Post stroke patients after a unique hemispheric stroke, being able to stand without any help
- Patient with proprioception disorder related to peripheral neuropathy.
- Old subjects with a history of falls (one or more during the last year).
Who cannot join
- For each category, other disorder than the one studied leading to balance trouble.
- Neuropsychological troubles preventing comprehension of the tests.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de MPR - Hôpital Lariboisière - Fernand Widal
Paris, 75010
About this study
Official title: Evaluation of the Sensorial Preference for Balance Control
Among the components of postural control, sensorial integration is of crucial importance. The most important sensorial inputs for postural maintenance are the vestibular system which provides information regarding accelerations of the head in space (HORAK 1994), the somatosensory system which provides proprioceptive information that are used to determine changes in body position (INGLIS 1994) and the visual system which provides information for self motion in the environment. The receptors and the integration channel of each sensorial system have inner characteristics which lead to different performance of the different input in regards to the task and the environmental context (FITZGERALD 1994). Most of time, sensorial information are congruent but sometimes they are conflicted. This is the case when being in a stationary train, the train beside going on, giving the illusory sensation of movement even if the vestibular system is not activated. A sensory weighting process is then necessary for subjects to control balance. The Central Nervous System (CNS) is thought to adjust the relative contribution of sensory input to control stance depending on environmental conditions (CENCIANNI 2006) and the reliability of the sensory input (OIE 2002, KESHNER 2004) in order to maintain or achieve the desired orientation in space and to provide postural stability. Nevertheless the interconnection of the multiple sensorial feedback involved in the postural control is not yet completely understood (CHIARI 2000).
Today, there is no tool available to evaluate the individual use of the sensorial information to postural control. It seems interesting to have such a tool to better understand the sensorial preference of subjects. It would be of particular importance for patients with various pathologies in the aim to design individualized balance rehabilitation programs.
The aim of the study was to test a tool built to evaluate the sensorial preference of subjects by studying their postural reaction related to the 3 main sensorial perturbations. Normal subjects will be first tested to assess the repeatability of the protocol and to collect normal values. Then, patients with post stroke hemiplegia, vestibular disease, neuropathy and fallers will be studied in order to test the feasibility of the protocol and to have preliminary data of sensorial preference among these populations.
Read the detailed description
Subjects Subjects with balance disorder related to a first hemispheric stroke, or vestibular trouble, or neuropathy and or aging
Apparatus Balance evaluation Subjects stand barefoot on a force platform (FeeTest Technoconcept®) consisting of two separate aluminium plates, distant of 12 cm, each placed on 2 force transducers that recorded the vertical ground reaction forces. The position of the center of pression (COP) was calculated from the ground reaction force. The data are collected with a sampling frequency of 40 Hz.
Sensory disturbance Sensory information (vision, proprioception and vestibular information) are successively disturbed. For each sensory information, different perturbations are tested in order to induce a sway in a determined direction (anterior, posterior, right and left).
Vision is disturbed by an optokinetic stimulation in a dark room, an optokinetic bowl (OPTOTEST, Technconcept®) placed behind the subject projecting moving luminous dots on the wall in front of the subject at the speed of 60/°s. The subjects are instructed to stare straight ahead at the stimulus pattern without attempting to follow the moving dots. Four trials are conducted for the visual stimulation in which the direction of the stimulus pattern differs: the direction of the displacement of the luminous dots is first top to bottom up, then bottom to top down, right to left and finally left to right.
Proprioceptive information is disturbed by a vibratory stimulation: vibration is delivered by two mechanical vibrators (VB 115, TECHNOCONCEPT ®). The vibration is of 1mm amplitude and the frequency is 50 Hz. Vibratory stimulation is first applied on the muscle tendon of the triceps sural, afterwards on the tendon of the tibialis anterior.
Then lateral stimulation is applied with a frequency of 90 Hz on the gluteus medius.
Vestibular information Is disturbed by a galvanic stimulation: a binaural galvanic stimulation of 2 mA is applied using a constant current stimulator (World Precision Instruments®). Surface electrodes are placed over the mastoid processes. Four conditions are tested: cathode placed on the right mastoid process then on the left mastoid process with the head looking straight ahead ; cathode placed on the side of the cerebral lesion (or on the right side for the healthy subjects), and head turned to the right then the left.
Procedure Each trial begins with a 15 second baseline period without stimulation, followed by a 35 second period of stimulation and a final 20 second period of observation without stimulation.
Subjects are asked to stand as steel as possible with their arms along the body looking straight ahead (except for the last two trials of the galvanic stimulation where the head is tilted). A trial without stimulation is registered in order to use the subject to the procedure and for each condition sensory perturbation is tested by the subject before starting the recording.
The subjects are tested as soon as possible after the onset of their disease and are retested 4 to 6 weeks later as they completed rehabilitation program.
Healthy subjects are also tested. Data analyzed For each sensory perturbation, we analyze two characteristics of the behavior of the subjects during the stimulation: the displacement induced by the stimulation and the intensity of sway during the stimulation ·Because the position of all the subjects can not be rigorously identical among all the subjects, the displacement induced by the stimulation is calculated by the mean of the displacement (in millimeters)(MD) of the COP (15 to 50 seconds) in the plane of the attended effect (for example anterior-posterior for a triceps sural trial and lateral for an optokinetic trial from the right to the left) minus the mean position of the CoP during the prestimulation period (2 to 13 seconds). A sensorial score is obtained in each direction for the successive sensory stimulation. From these values, and for each sensory perturbation (visual, proprioceptive and vestibular) a composite score is calculated as the mean of all the trials done for one sensorial stimulation. Thus, we obtain three scores: a visual composite score, a proprioceptive composite score and a vestibular composite score.
The number of falls induced by the stimulations is also registered.
·The intensity of sway during the stimulation is evaluated by a fast fourier transform Statistical analysis The reproducibility of our test is assessed by the intra-class correlation coefficient (ICC). Reproducibility is considered as correct if the ICC is superior at 0.6 and excellent if superior at 0.8.
Descriptive data are reported as means with the (standard deviation) SDs. Correlation between the force platform values and the subjects characteristics are evaluated by non parametric statistics: Wilcoxon signed-rank test, Mann-Whitney test and Kruskal-Wallis test. P values are chosen at 0.05.
- Conditions
- Balance
- Being tested
- Balance assessment under sensory stimulation
- Keywords
- Multisensorial integration, Postural control, Visual reliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance assessment under sensory stimulationOther
Balance assessment under sensory stimulation
| Study group | Role | What they receive |
|---|---|---|
| 1: healthy subject | Not described Receives: Other: Balance assessment under sensory stimulation | |
| 3: post stroke patients | Not described Receives: Other: Balance assessment under sensory stimulation | |
| 2: vestibular patients | Vestibular patients with a unique history of peripheric vestibular disorder Receives: Other: Balance assessment under sensory stimulation | |
| 4: ataxic patients | Patient with proprioception disorder related to peripheral neuropathy Receives: Other: Balance assessment under sensory stimulation | |
| 5: Old fallers | Old subjects with a history of falls (one or more during the last year) Receives: Other: Balance assessment under sensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory profile before and after rehabilitation
Sensory profile is defined by change in postural control on force plate under, visual, vestibular, and proprioceptive stimulation.
Measured: at month 1
Secondary outcomes (15)
DISEANESS Handicap Inventory scale
Measured: at month 1
Activities-specific Balance Confidence scale
Measured: at month 1
Berg Balance scale
Balance assessment
Measured: at month 1
Sensory profile before and after rehabilitation
Sensory profile is defined by change in postural control on force plate under, visual, vestibular, and proprioceptive stimulation.
Measured: at month 6
Berg Balance scale
Balance assessment
Measured: at month 6
Timed up and go
Balance assessment
Measured: at month 1
Timed up and go
Balance assessment
Measured: at month 6
Walking distance
Balance assessment
Measured: at month 1
Walking distance
Balance assessment
Measured: at month 6
Speed of walk
Balance assessment
Measured: at month 1
Speed of walk
Balance assessment
Measured: at month 6
Area and length of the center of pression displacement during 10sec. open eyes
Balance assessment
Measured: at month 1
Area and length of the center of pression displacement during 10sec. open eyes
Balance assessment
Measured: at month 6
Area and length of the center of pression displacement during 10sec, closed eyes (assessed during the sensorial tests)
Balance assessment
Measured: at month 1
Area and length of the center of pression displacement during 10sec, closed eyes (assessed during the sensorial tests)
Balance assessment
Measured: at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study start26 Nov 2007
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle BONAN, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146249
- Sponsor's protocol ID
- P070401
- Other IDs
- 2007-A00410-53
- Acronym
- PREFSENSOR
- Status last verified
- Nov 2023
- First submitted
- 28 Apr 2010
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sensorial Preference for Balance Control
- ClinicalTrials.gov ID
- NCT01146249
- Acronym / sponsor ID
- PREFSENSOR / P070401
- Conditions
- Balance
- Keywords
- Multisensorial integration, Postural control, Visual reliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Nov 2007 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 17 Jun 2010 (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.
Among the components of postural control, sensorial integration is of crucial importance. The most important sensorial inputs for postural maintenance are the vestibular system which provides information regarding accelerations of the head in space (HORAK 1994), the somatosensory system which provides proprioceptive information that are used to determine changes in body position (INGLIS 1994) and the visual system which provides information for self motion in the environment. The receptors and the integration channel of each sensorial system have inner characteristics which lead to different performance of the different input in regards to the task and the environmental context (FITZGERALD 1994). Most of time, sensorial information are congruent but sometimes they are conflicted. This is the case when being in a stationary train, the train beside going on, giving the illusory sensation of movement even if the vestibular system is not activated. A sensory weighting process is then necessary for subjects to control balance. The Central Nervous System (CNS) is thought to adjust the relative contribution of sensory input to control stance depending on environmental conditions (CENCIANNI 2006) and the reliability of the sensory input (OIE 2002, KESHNER 2004) in order to maintain or achieve the desired orientation in space and to provide postural stability. Nevertheless the interconnection of the multiple sensorial feedback involved in the postural control is not yet completely understood (CHIARI 2000).
Today, there is no tool available to evaluate the individual use of the sensorial information to postural control. It seems interesting to have such a tool to better understand the sensorial preference of subjects. It would be of particular importance for patients with various pathologies in the aim to design individualized balance rehabilitation programs.
The aim of the study was to test a tool built to evaluate the sensorial preference of subjects by studying their postural reaction related to the 3 main sensorial perturbations. Normal subjects will be first tested to assess the repeatability of the protocol and to collect normal values. Then, patients with post stroke hemiplegia, vestibular disease, neuropathy and fallers will be studied in order to test the feasibility of the protocol and to have preliminary data of sensorial preference among these populations.
Detailed description
Subjects Subjects with balance disorder related to a first hemispheric stroke, or vestibular trouble, or neuropathy and or aging
Apparatus Balance evaluation Subjects stand barefoot on a force platform (FeeTest Technoconcept®) consisting of two separate aluminium plates, distant of 12 cm, each placed on 2 force transducers that recorded the vertical ground reaction forces. The position of the center of pression (COP) was calculated from the ground reaction force. The data are collected with a sampling frequency of 40 Hz.
Sensory disturbance Sensory information (vision, proprioception and vestibular information) are successively disturbed. For each sensory information, different perturbations are tested in order to induce a sway in a determined direction (anterior, posterior, right and left).
Vision is disturbed by an optokinetic stimulation in a dark room, an optokinetic bowl (OPTOTEST, Technconcept®) placed behind the subject projecting moving luminous dots on the wall in front of the subject at the speed of 60/°s. The subjects are instructed to stare straight ahead at the stimulus pattern without attempting to follow the moving dots. Four trials are conducted for the visual stimulation in which the direction of the stimulus pattern differs: the direction of the displacement of the luminous dots is first top to bottom up, then bottom to top down, right to left and finally left to right.
Proprioceptive information is disturbed by a vibratory stimulation: vibration is delivered by two mechanical vibrators (VB 115, TECHNOCONCEPT ®). The vibration is of 1mm amplitude and the frequency is 50 Hz. Vibratory stimulation is first applied on the muscle tendon of the triceps sural, afterwards on the tendon of the tibialis anterior.
Then lateral stimulation is applied with a frequency of 90 Hz on the gluteus medius.
Vestibular information Is disturbed by a galvanic stimulation: a binaural galvanic stimulation of 2 mA is applied using a constant current stimulator (World Precision Instruments®). Surface electrodes are placed over the mastoid processes. Four conditions are tested: cathode placed on the right mastoid process then on the left mastoid process with the head looking straight ahead ; cathode placed on the side of the cerebral lesion (or on the right side for the healthy subjects), and head turned to the right then the left.
Procedure Each trial begins with a 15 second baseline period without stimulation, followed by a 35 second period of stimulation and a final 20 second period of observation without stimulation.
Subjects are asked to stand as steel as possible with their arms along the body looking straight ahead (except for the last two trials of the galvanic stimulation where the head is tilted). A trial without stimulation is registered in order to use the subject to the procedure and for each condition sensory perturbation is tested by the subject before starting the recording.
The subjects are tested as soon as possible after the onset of their disease and are retested 4 to 6 weeks later as they completed rehabilitation program.
Healthy subjects are also tested. Data analyzed For each sensory perturbation, we analyze two characteristics of the behavior of the subjects during the stimulation: the displacement induced by the stimulation and the intensity of sway during the stimulation ·Because the position of all the subjects can not be rigorously identical among all the subjects, the displacement induced by the stimulation is calculated by the mean of the displacement (in millimeters)(MD) of the COP (15 to 50 seconds) in the plane of the attended effect (for example anterior-posterior for a triceps sural trial and lateral for an optokinetic trial from the right to the left) minus the mean position of the CoP during the prestimulation period (2 to 13 seconds). A sensorial score is obtained in each direction for the successive sensory stimulation. From these values, and for each sensory perturbation (visual, proprioceptive and vestibular) a composite score is calculated as the mean of all the trials done for one sensorial stimulation. Thus, we obtain three scores: a visual composite score, a proprioceptive composite score and a vestibular composite score.
The number of falls induced by the stimulations is also registered.
·The intensity of sway during the stimulation is evaluated by a fast fourier transform Statistical analysis The reproducibility of our test is assessed by the intra-class correlation coefficient (ICC). Reproducibility is considered as correct if the ICC is superior at 0.6 and excellent if superior at 0.8.
Descriptive data are reported as means with the (standard deviation) SDs. Correlation between the force platform values and the subjects characteristics are evaluated by non parametric statistics: Wilcoxon signed-rank test, Mann-Whitney test and Kruskal-Wallis test. P values are chosen at 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1: healthy subject | – | Other: Balance assessment under sensory stimulation |
| 3: post stroke patients | – | Other: Balance assessment under sensory stimulation |
| 2: vestibular patients | – | Other: Balance assessment under sensory stimulationVestibular patients with a unique history of peripheric vestibular disorder |
| 4: ataxic patients | – | Other: Balance assessment under sensory stimulationPatient with proprioception disorder related to peripheral neuropathy |
| 5: Old fallers | – | Other: Balance assessment under sensory stimulationOld subjects with a history of falls (one or more during the last year) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects Vestibular patients Post stroke patients Patient with proprioception disorder Old subjects with a history of falls
Key inclusion criteria (5 listed)
- Healthy subjects without history of balance disorder
- Vestibular patients with a unique history of peripheric vestibular disorder
- Post stroke patients after a unique hemispheric stroke, being able to stand without any help
- Patient with proprioception disorder related to peripheral neuropathy.
- Old subjects with a history of falls (one or more during the last year).
Key exclusion criteria (2 listed)
- For each category, other disorder than the one studied leading to balance trouble.
- Neuropsychological troubles preventing comprehension of the tests.
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 |
|---|---|---|
| Balance assessment under sensory stimulationBalance assessment under sensory stimulation | Other | 1: healthy subject, 2: vestibular patients, 3: post stroke patients, 4: ataxic patients, 5: Old fallers |
Primary outcome
Sensory profile before and after rehabilitation
Time frame: at month 1
Sensory profile is defined by change in postural control on force plate under, visual, vestibular, and proprioceptive stimulation.
15 secondary outcomes
DISEANESS Handicap Inventory scale
Time frame: at month 1
Activities-specific Balance Confidence scale
Time frame: at month 1
Berg Balance scale
Time frame: at month 1
Sensory profile before and after rehabilitation
Time frame: at month 6
Berg Balance scale
Time frame: at month 6
Timed up and go
Time frame: at month 1
Timed up and go
Time frame: at month 6
Walking distance
Time frame: at month 1
Walking distance
Time frame: at month 6
Speed of walk
Time frame: at month 1
Speed of walk
Time frame: at month 6
Area and length of the center of pression displacement during 10sec. open eyes
Time frame: at month 1
Area and length of the center of pression displacement during 10sec. open eyes
Time frame: at month 6
Area and length of the center of pression displacement during 10sec, closed eyes (assessed during the sensorial tests)
Time frame: at month 1
Area and length of the center of pression displacement during 10sec, closed eyes (assessed during the sensorial tests)
Time frame: at month 6
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 5 Dec 2023.
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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
Assistance Publique - Hôpitaux de Paris
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 Balance, run by Assistance Publique - Hôpitaux de Paris 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 5 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 5 Dec 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. 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?
Sensory profile before and after rehabilitation (time frame: at month 1). 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 5 Dec 2023.