Stroke SequelaeHEMISEATNCT04152616
Mechanisms of Balance Disorders in a Seated Position Following a Stroke
A study testing Instrumental evaluation of posture in people with Stroke Sequelae, run by Rennes University Hospital at 1 site in France.
Trial summary
One of the causes of disability in stroke patients is postural disturbances that result in postural asymmetry in the standing position, characterized during an evaluation on a force platform by a greater displacement of the center of pressure towards the lesion side and thus by a greater percentage of weight on the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Instrumental evaluation of posture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2020to 13 Sep 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1st symptomatic vascular accident
- With a stroke
- With right and left unilateral ischemic or supra-tentory hemorrhagic disease,
- Dated less than 3 months old
- Able to sit for 30 seconds with eyes closed to perform the assessment on the pressure slick
- Postural Assessment Scale for Stroke ≤ 23/36 (patient not standing up)
- Non-opposition to participate in the study
Who cannot join
- Orthopedic, rheumatological or visual history affecting the distribution of the pressure center in the seated position
- Visual history not allowing the evaluation of LBA, SSA, SVV tests
- Major comprehension disorder not allowing to understand the use of vibration or to give its non-opposition
- Pregnant or breastfeeding women
- Persons of full age who are subject to legal protection (protection of justice, guardianship, guardianship), persons deprived of their liberty
- Simultaneous participation in other research related to balance and/or posture
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Physique et Réadaptation - Hôpital de Pontchaillou
Rennes, 35033
About this study
Official title: Characterization and Understanding of the Mechanisms of Balance Disorders in a Seated Position Following a Stroke
One of the causes of disability in stroke patients is postural disturbances that result in postural asymmetry in the standing position, characterized during an evaluation on a force platform by a greater displacement of the center of pressure towards the lesion side and thus by a greater percentage of weight on the lower limb (Weight -Bearing Asymmetry (WBA)). Today, the mechanisms of balance disorders in standing position are better understood. Indeed, in addition to sensory and motor deficits, spatial cognitive disorders also contribute to these postural disturbances, particularly in right brain damage stroke. This would be the reason why patients with right brain damage have a more precarious and time-consuming balance to re-educate than patients with lesions located in the left hemisphere.
Postural disturbances can also result in a disturbance of balance in the sitting position, which is a poor prognosis for the acquisition of transfers, standing and walking. To date, seated postural disturbances are not perfectly described with many differences in the explanatory mechanisms found in the literature. Thus, some people notice a more pronounced asymmetry on the medio-lateral plane while others find a more pronounced imbalance at the antero-posterior plane.
Sitting posture disorders benefit from few instrumental measurement tools outside clinical measurement scales. A very wide variety of evaluation methods by instrumental measurements are proposed and not validated. Sensor pad, which are usually used to adjust the bases of pressure ulcer patients, may be useful in quantifying the postural balance. But since the involvement of the head and trunk in the sitting posture is well documented in the literature, the addition of an evaluation of the position of the trunk and head seems essential. To our knowledge, no author has proposed to quantify sitting balance disorders by combining a measure of support asymmetry by taking into account the posture of the trunk with that of the head.
Read the detailed description
In France, stroke is the third leading cause of death and the first cause of acquired disability in adults. Approximately 130,000 people suffer a stroke each year. On the other hand, since the frequency of stroke is age-related, the aging of the population suggests that the number of people with stroke will increase in the coming years.
One of the causes of disability in stroke patients is postural disturbances. These postural disturbances cause a greater risk of falls and are a source of loss of autonomy for these patients. In standing position, during evaluation on a force platform, these postural disturbances can be characterized by postural asymmetry which results in a greater displacement of the center of pressure on the lesion side and thus a greater percentage of support on the lower limb non-paretic (Weight-Bearing Asymmetry (WBA)). Today, the mechanisms of balance disorders in standing position are better understood. Indeed, in addition to sensory and motor deficits, spatial cognitive disorders also contribute to these postural disturbances, particularly in right brain damage stroke. Many authors agree on a localization of spatial cognition and in particular the mental elaboration of the representation of the body in space according to the different types of spatial frame at the level of the right cerebral hemisphere. This would be the reason why patients with right brain damage have a more precarious and time-consuming balance to rehabilitate than patients with lesions located in the left hemisphere.
Postural disturbances can also result in a disturbance of balance in the sitting position. The persistence of these disorders in a sitting position is a poor prognosis for the acquisition of transfers, standing and walking. To date, the mechanisms of these postural disturbances in the seated position in stroke patients have not been fully described. Indeed, many discrepancies are found in the literature. Although it appears that for a majority of authors, stroke patients have greater sitting asymmetry than healthy subjects, not all of them are unanimous. Moreover, among these authors highlighting this asymmetry in the sitting position, some note a more pronounced lateral plane while others find a more pronounced imbalance in the antero-posterior plane. Apart from the motor and sensory deficit, the postural asymmetry found in the sitting position could also be due to a spatial cognitive disorder. The authors Au-Yeung et al showed a more pronounced deviation in patients with a localized stroke in the right hemisphere. This result in relation to the relationship between posturography data from the sitting position and the postural vertical suggests the involvement of spatial cognition in balance disorders in the sitting position. However, since the authors Van Nes et al did not find this result in their study, this hypothesis remains to be confirmed.
Unlike standing posture disorders, which are commonly assessed by force platforms in rehabilitation, sitting posture disorders benefit from few instrumental measurement tools outside clinical measurement scales. In addition, in the literature, a very wide variety of evaluation methods by instrumental measures are proposed and not validated. In some cases, the patient was placed directly on the force platform, others chose to sit the patient on a chair positioned on the platform. Initially, sensor pad are usually used to adapt the bases of patients with pressure ulcers but they may be useful for quantifying the postural base. However, the involvement of the head and trunk in the sitting posture is well documented in the literature and the addition of an assessment of the trunk and head therefore seems essential. To our knowledge, no author has studied sitting balance disorders in a quantified way by taking into account both the posture of the trunk associated with the head and a measurement of postural asymmetry.
- Conditions
- Stroke Sequelae
- Being tested
- Instrumental evaluation of posture
- Keywords
- Stroke, postural asymmetry, sitting balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumental evaluation of postureOther
After a time of installation of the Optitrack® device's and two accelerometers (one placed on the subject's trunk facing the sternum fixed with a headband and the second at the level of the head also held with a headband), the subject will perform an evaluation of the balance sitting on the sensor pad; the movements of the head and trunk will be analyzed by the Optitrack® device and by the two accelerometers.
The subject will perform 4 30-second tests, two with eyes open and two with eyes closed. A rest period may be taken between each assessment depending on the subject.
During these evaluations, a physiotherapist will be present to avoid the risk of falling.
After a rest period of 30 minutes, a new assessment of the sitting posture will be carried out to assess the reproducibility of the tools (sensor pad, accelerometers, Optitrack®).
| Study group | Role | What they receive |
|---|---|---|
| Optitrack® | Experimental | Instrumental evaluation of posture Receives: Other: Instrumental evaluation of posture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight bearing asymmetry on the paretic side
The main judgement criterion is the percentage of the weight bearing on the hemiplegic side evaluated on a sensor pad (BodiTrak® Seat pressure mapping system), a thin mattress (size 32X32) made up of sensors usually used to adapt the bases of patients with pressure ulcers . The subject will be in a sitting position on the pressure sheet with his legs hanging and his upper limbs relaxed on his knees. The value selected will be the average of 2 tests performed with the eyes open and 2 tests performed with the eyes closed, for 30 seconds. This all test will be repeated twice.
Measured: 1 day
Secondary outcomes (8)
Lateral (mean X, mm) and antero-posterior (mean Y, mm) deviation from the mean position of the pressure centre
The value selected will be the average of 2 tests performed with the eyes open and 2 tests performed with the eyes closed, for 30 seconds. This all test will be repeated twice.
Measured: 1 day
Surface of the displacement of the centre of mass (Surface, mm²),
The value selected will be the average of 2 tests performed with the eyes open and 2 tests performed with the eyes closed, for 30 seconds. This all test will be repeated twice.
Measured: 1 day
Accelerometer posture evaluation
Trunk and head movements will be analyzed by inertial measurement units (IMU) (Xsens®) by estimating the variations in orientation between conditions. The IMUs estimate the orientation of the sensor in a land reference frame. The anatomical orientation of the segments is calculated after correction of the sensor orientation. This correction is quantified by a quick calibration procedure. The value selected will be the average of 2 tests performed with the eyes open and 2 tests performed with the eyes closed, for 30 seconds. This all test will be repeated twice.
Measured: 1 day
Optitrack® posture evaluation
The evaluation of posture (orientation of pelvis, trunk and head) will be measured using an optoelectronic system. The value selected will be the average of 2 tests performed with the eyes open and 2 tests performed with the eyes closed, for 30 seconds. This all test will be repeated twice.
Measured: 1 day
Hemiplegia characteristics
Measured: at inclusion
Spatial representation test
subjective straight ahead (SSA), Longitudinal Body Axis (LBA) and subjective visual vertical (SVV)
Measured: At inclusion
Clinical evaluation of posture: lateropulsion
Scale for Lateropulsion (SCALA)
Measured: At inclusion
Clinical evaluation of posture: postural assessment
Postural Assessment Scale for Stroke (PASS)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start10 Jul 2020
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim JAMAL, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152616
- Sponsor's protocol ID
- 35RC19_8913
- Other IDs
- 2019-A02131-56
- Acronym
- HEMISEAT
- Status last verified
- Jun 2026
- First submitted
- 25 Oct 2019
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Understanding of the Mechanisms of Balance Disorders in a Seated Position Following a Stroke
- ClinicalTrials.gov ID
- NCT04152616
- Acronym / sponsor ID
- HEMISEAT / 35RC19_8913
- Conditions
- Stroke Sequelae
- Keywords
- Stroke, postural asymmetry, sitting balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 5 Nov 2019 (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 stroke patients is postural disturbances that result in postural asymmetry in the standing position, characterized during an evaluation on a force platform by a greater displacement of the center of pressure towards the lesion side and thus by a greater percentage of weight on the lower limb (Weight -Bearing Asymmetry (WBA)). Today, the mechanisms of balance disorders in standing position are better understood. Indeed, in addition to sensory and motor deficits, spatial cognitive disorders also contribute to these postural disturbances, particularly in right brain damage stroke. This would be the reason why patients with right brain damage have a more precarious and time-consuming balance to re-educate than patients with lesions located in the left hemisphere.
Postural disturbances can also result in a disturbance of balance in the sitting position, which is a poor prognosis for the acquisition of transfers, standing and walking. To date, seated postural disturbances are not perfectly described with many differences in the explanatory mechanisms found in the literature. Thus, some people notice a more pronounced asymmetry on the medio-lateral plane while others find a more pronounced imbalance at the antero-posterior plane.
Sitting posture disorders benefit from few instrumental measurement tools outside clinical measurement scales. A very wide variety of evaluation methods by instrumental measurements are proposed and not validated. Sensor pad, which are usually used to adjust the bases of pressure ulcer patients, may be useful in quantifying the postural balance. But since the involvement of the head and trunk in the sitting posture is well documented in the literature, the addition of an evaluation of the position of the trunk and head seems essential. To our knowledge, no author has proposed to quantify sitting balance disorders by combining a measure of support asymmetry by taking into account the posture of the trunk with that of the head.
Detailed description
In France, stroke is the third leading cause of death and the first cause of acquired disability in adults. Approximately 130,000 people suffer a stroke each year. On the other hand, since the frequency of stroke is age-related, the aging of the population suggests that the number of people with stroke will increase in the coming years.
One of the causes of disability in stroke patients is postural disturbances. These postural disturbances cause a greater risk of falls and are a source of loss of autonomy for these patients. In standing position, during evaluation on a force platform, these postural disturbances can be characterized by postural asymmetry which results in a greater displacement of the center of pressure on the lesion side and thus a greater percentage of support on the lower limb non-paretic (Weight-Bearing Asymmetry (WBA)). Today, the mechanisms of balance disorders in standing position are better understood. Indeed, in addition to sensory and motor deficits, spatial cognitive disorders also contribute to these postural disturbances, particularly in right brain damage stroke. Many authors agree on a localization of spatial cognition and in particular the mental elaboration of the representation of the body in space according to the different types of spatial frame at the level of the right cerebral hemisphere. This would be the reason why patients with right brain damage have a more precarious and time-consuming balance to rehabilitate than patients with lesions located in the left hemisphere.
Postural disturbances can also result in a disturbance of balance in the sitting position. The persistence of these disorders in a sitting position is a poor prognosis for the acquisition of transfers, standing and walking. To date, the mechanisms of these postural disturbances in the seated position in stroke patients have not been fully described. Indeed, many discrepancies are found in the literature. Although it appears that for a majority of authors, stroke patients have greater sitting asymmetry than healthy subjects, not all of them are unanimous. Moreover, among these authors highlighting this asymmetry in the sitting position, some note a more pronounced lateral plane while others find a more pronounced imbalance in the antero-posterior plane. Apart from the motor and sensory deficit, the postural asymmetry found in the sitting position could also be due to a spatial cognitive disorder. The authors Au-Yeung et al showed a more pronounced deviation in patients with a localized stroke in the right hemisphere. This result in relation to the relationship between posturography data from the sitting position and the postural vertical suggests the involvement of spatial cognition in balance disorders in the sitting position. However, since the authors Van Nes et al did not find this result in their study, this hypothesis remains to be confirmed.
Unlike standing posture disorders, which are commonly assessed by force platforms in rehabilitation, sitting posture disorders benefit from few instrumental measurement tools outside clinical measurement scales. In addition, in the literature, a very wide variety of evaluation methods by instrumental measures are proposed and not validated. In some cases, the patient was placed directly on the force platform, others chose to sit the patient on a chair positioned on the platform. Initially, sensor pad are usually used to adapt the bases of patients with pressure ulcers but they may be useful for quantifying the postural base. However, the involvement of the head and trunk in the sitting posture is well documented in the literature and the addition of an assessment of the trunk and head therefore seems essential. To our knowledge, no author has studied sitting balance disorders in a quantified way by taking into account both the posture of the trunk associated with the head and a measurement of postural asymmetry.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optitrack® | Experimental | Other: Instrumental evaluation of postureInstrumental evaluation of posture |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1st symptomatic vascular accident
- With a stroke
- Able to sit for 30 seconds with eyes closed to perform the assessment on the pressure slick
- Postural Assessment Scale for Stroke ≤ 23/36 (patient not standing up)
- Non-opposition to participate in the study
Key exclusion criteria (6 listed)
- Orthopedic, rheumatological or visual history affecting the distribution of the pressure center in the seated position
- Visual history not allowing the evaluation of LBA, SSA, SVV tests
- Major comprehension disorder not allowing to understand the use of vibration or to give its non-opposition
- Pregnant or breastfeeding women
- Persons of full age who are subject to legal protection (protection of justice, guardianship, guardianship), persons deprived of their 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 |
|---|---|---|
| Instrumental evaluation of postureAfter a time of installation of the Optitrack® device's and two accelerometers (one placed on the subject's trunk facing the sternum fixed with a headband and the second at the level of the head also held with a headband), the subject will perform an evaluation of the balance sitting on the sensor pad; the movements of the head and trunk will be analyzed by the Optitrack® device and by the two accelerometers. The subject will perform 4 30-second tests, two with eyes open and two with eyes closed. A rest period may be taken between each assessment depending on the subject. During these evaluations, a physiotherapist will be present to avoid the risk of falling. After a rest period of 30 minutes, a new assessment of the sitting posture will be carried out to assess the reproducibility of the tools (sensor pad, accelerometers, Optitrack®). | Other | Optitrack® |
Primary outcome
Weight bearing asymmetry on the paretic side
Time frame: 1 day
The main judgement criterion is the percentage of the weight bearing on the hemiplegic side evaluated on a sensor pad (BodiTrak® Seat pressure mapping system), a thin mattress (size 32X32) made up of sensors usually used to adapt the bases of patients with pressure ulcers . The subject will be in a sitting position on the pressure sheet with his legs hanging and his upper limbs relaxed on his knees. The value selected will be the average of 2 tests performed with the eyes open and 2 tests performed with the eyes closed, for 30 seconds. This all test will be repeated twice.
8 secondary outcomes
Lateral (mean X, mm) and antero-posterior (mean Y, mm) deviation from the mean position of the pressure centre
Time frame: 1 day
Surface of the displacement of the centre of mass (Surface, mm²),
Time frame: 1 day
Accelerometer posture evaluation
Time frame: 1 day
Optitrack® posture evaluation
Time frame: 1 day
Hemiplegia characteristics
Time frame: at inclusion
Spatial representation test
Time frame: At inclusion
Clinical evaluation of posture: lateropulsion
Time frame: At inclusion
Clinical evaluation of posture: postural assessment
Time frame: At inclusion
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 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Karim JAMAL 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?
A study testing Instrumental evaluation of posture in people with Stroke Sequelae, 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 7 inclusion and 6 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 24 Jun 2026. 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?
Weight bearing asymmetry on the paretic side (time frame: 1 day). 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 24 Jun 2026.