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Completed

NCT Number: NCT05082194

Balance Eyesight and Muscle Tension in the Cervical Spine in Cerebral Amyloid Angiopathy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

balance with open and closed eyes

Procedure

The UNTERBERGER TEST. The subjects performed the test once with their eyes open and then with their eyes closed. The participant's task was to assume a standing position with legs apart at hip-width and then walk in place (50 steps).

Static and dynamic balance testing on the Biodex SD balance platform. Moreover, both during the Unterberger functional test and the tests on the Biodex SD balance platform, the muscle tone was assessed in the subjects using the Luna EMG device. Before starting the tests, surface electrodes were glued to the patient's body (according to the SENIAM procedure). Five surface electrodes were used, consisting of three channels. They were placed on the abdomen of the right sternocleidomastoid muscle, two more were placed on the left longus colli muscle, and one reference electrode on the right shoulder process of the scapula. After each completed test, an ongoing test report was generated.

Primary outcomes

  1. static balance

    Time frame: up to 1 week

    TESTING STABILITY OF ATTITUDE with the use of the Biodex SD balance platform.

  2. dynamic balance

    Time frame: up to 1 week

    FALL RISK TEST was assessed on the Biodex SD platform.

  3. Unterberga Test

    Time frame: up to 1 week

    The subjects performed 50 steps, once with their eyes open and then with their eyes closed.

  4. Sternocleidomastoid muscle tension

    Time frame: up to 1 week

    It was assessed on the Luna EMG

  5. Longus Colli muscle tension

    Time frame: up to 1 week

    It was assessed on the Luna EMG

Sponsors and collaborators

Lead sponsor

Anna Olczak

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 18, 2021
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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