Mechanisms of Balance Disorders in a Seated Position Following a Stroke (HEMISEAT)
Primary Purpose
Stroke Sequelae
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Instrumental evaluation of posture
Sponsored by
About this trial
This is an interventional basic science trial for Stroke Sequelae focused on measuring Stroke, postural asymmetry, sitting balance
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Service de Médecine Physique et Réadaptation - Hôpital de PontchaillouRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Optitrack®
Arm Description
Instrumental evaluation of posture
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Hemiplegia characteristics
Spatial representation test
subjective straight ahead (SSA), Longitudinal Body Axis (LBA) and subjective visual vertical (SVV)
Clinical evaluation of posture: lateropulsion
Scale for Lateropulsion (SCALA)
Clinical evaluation of posture: postural assessment
Postural Assessment Scale for Stroke (PASS)
Full Information
NCT ID
NCT04152616
First Posted
October 25, 2019
Last Updated
August 12, 2020
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04152616
Brief Title
Mechanisms of Balance Disorders in a Seated Position Following a Stroke
Acronym
HEMISEAT
Official Title
Characterization and Understanding of the Mechanisms of Balance Disorders in a Seated Position Following a Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Sequelae
Keywords
Stroke, postural asymmetry, sitting balance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Optitrack®
Arm Type
Experimental
Arm Description
Instrumental evaluation of posture
Intervention Type
Other
Intervention Name(s)
Instrumental evaluation of posture
Intervention Description
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®).
Primary Outcome Measure Information:
Title
Weight bearing asymmetry on the paretic side
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Lateral (mean X, mm) and antero-posterior (mean Y, mm) deviation from the mean position of the pressure centre
Description
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.
Time Frame
1 day
Title
Surface of the displacement of the centre of mass (Surface, mm²),
Description
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.
Time Frame
1 day
Title
Accelerometer posture evaluation
Description
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.
Time Frame
1 day
Title
Optitrack® posture evaluation
Description
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.
Time Frame
1 day
Title
Hemiplegia characteristics
Time Frame
at inclusion
Title
Spatial representation test
Description
subjective straight ahead (SSA), Longitudinal Body Axis (LBA) and subjective visual vertical (SVV)
Time Frame
At inclusion
Title
Clinical evaluation of posture: lateropulsion
Description
Scale for Lateropulsion (SCALA)
Time Frame
At inclusion
Title
Clinical evaluation of posture: postural assessment
Description
Postural Assessment Scale for Stroke (PASS)
Time Frame
At inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karim JAMAL
Phone
+33299284218
Email
karim.jamal@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim JAMAL
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Médecine Physique et Réadaptation - Hôpital de Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim JAMAL
Phone
+33299284218
Email
karim.jamal@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Florian BIDET
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mechanisms of Balance Disorders in a Seated Position Following a Stroke
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