Mechanisms of Balance Disorders in a Seated Position Following a Stroke

NCT04152616 | Unknown

• 2 other identifiers: 35RC19_89132019-A02131-56
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae

Keywords

Stroke; postural asymmetry; sitting balance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Lateral (mean X, mm) and antero-posterior (mean Y, mm) deviation from the mean position of the pressure centre

  1 day

• Surface of the displacement of the centre of mass (Surface, mm²),

  1 day

• Accelerometer posture evaluation

  1 day

• Optitrack® posture evaluation

  1 day

• Hemiplegia characteristics

  at inclusion

Study Arms (1)

Optitrack®

EXPERIMENTAL

Instrumental evaluation of posture

Other: Instrumental evaluation of posture

Interventions

Instrumental evaluation of posture OTHER

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®).

Optitrack®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• st 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Service de Médecine Physique et Réadaptation - Hôpital de Pontchaillou

Rennes, 35033, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Karim JAMAL

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karim JAMAL

CONTACT

+33299284218; karim.jamal@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 5, 2019
• Study Start: September 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

FR (1)