Clinical trial NCT05082194: Balance Eyesight and Muscle Tension in the Cervical Spine in Cerebral Amyloid Angiopathy
Official title: The Relationship Between the Static and Dynamic Balance of the Body the Influence of Eyesight and Muscle Tension in the Cervical Spine in Cerebral Amyloid Angiopathy Patients - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Amyloid Angiopathy
Keywords: stroke,
CAA,
upper limb,
trunk exercises,
stabilization
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 16
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study involved 8 patients after stroke in the course of Cerebral Amyloid Angiopathy (CAA) and 8 healthy subjects.

Brief summary: Cerebral Amyloid Angiopathy (CAA) is one form of disease of the small vessels of the brain and can cause frequent cerebral hemorrhages as well as other types of stroke. The aim of the research was to examine the balance of the body in patients after a stroke and to determine how the tension of selected muscles of the cervical spine changes under the conditions of statics and dynamics, depending on the visual control or its absence.

Detailed description: This is an observational study. The tests were performed with the use of tools and devices such as the Unterberger test, Biodex SD balance platform, and Luna EMG. The static equilibrium was assessed on a balance platform (stability test). The dynamic equilibrium was tested in the Unterberger test and on the balance platform (the fall risk test). All examinations were performed twice with eyes open and then closed. Additionally, during the tests, the tension of selected muscles of the cervical spine was recorded (the sternocleidomastoid muscle and the long neck muscle) (independent variables). It was examined how the intervention, static position, and dynamic displacement of the center of body mass, as well as the control and lack of eye control, influence the tension of selected muscles, and how the eyesight influences the body's balance in statics and dynamics (dependent variables). A group of healthy people was examined to assess whether neurological deficits in people after stroke could affect the results of static and dynamic balance and changes in muscle tone and whether the organ of vision plays a large role in controlling the center of body mass.

Eligibility criteria: Patients Inclusion Criteria:1) stroke in the course of CAA; 2) the functional state of the patients, which allows independent walking in a place and at a distance; 3) no severe deficits in communication, memory, or understanding what can impede proper measurement performance;

Patients Exclusion Criteria: 1) cause of stroke other than CAA; 2) stroke up to seven weeks after the episode; 3) epilepsy; 4) lack of trunk stability; 5) lack of independent walking; 6) high or very low blood pressure, dizziness, malaise.

Healthy Inclusion Criteria: 1) the control group consisted of healthy subjects with a stable trunk; 2) with independent walking.

Healthy Exclusion Criteria: 1) a history of neurologic or musculoskeletal disorders such as stroke or brain injury or other conditions that could affect their ability to active movement the trunk and the legs; 2) pain, dizziness; 3) permanent use of orthopedic supplies; 4) severe deficits in communication, memory, or understanding what can impede proper measurement performance; 5) high or very low blood pressure, dizziness, malaise.

Primary outcomes:
measure: static balance
timeFrame: up to 1 week
measure: dynamic balance
timeFrame: up to 1 week
measure: Unterberga Test
timeFrame: up to 1 week
measure: Sternocleidomastoid muscle tension
timeFrame: up to 1 week
measure: Longus Colli muscle tension
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine
state: Masovian District
Study officials:
affiliation: Military Institute of Medicine, Rehabilitation Clinic Poland
name: Anna Olczak, PhD
role: PRINCIPAL_INVESTIGATOR
References: