Stroke Sequelae Clinical Trial
— HEMISEATOfficial 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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | November 2021 |
Est. primary completion date | May 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Service de Médecine Physique et Réadaptation - Hôpital de Pontchaillou | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 day | |
Secondary | 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. | 1 day | |
Secondary | 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. | 1 day | |
Secondary | 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. | 1 day | |
Secondary | 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. | 1 day | |
Secondary | Hemiplegia characteristics | at inclusion | ||
Secondary | Spatial representation test | subjective straight ahead (SSA), Longitudinal Body Axis (LBA) and subjective visual vertical (SVV) | At inclusion | |
Secondary | Clinical evaluation of posture: lateropulsion | Scale for Lateropulsion (SCALA) | At inclusion | |
Secondary | Clinical evaluation of posture: postural assessment | Postural Assessment Scale for Stroke (PASS) | At inclusion |
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