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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05082194
Other study ID # 8/KRN/2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 10, 2020
Est. completion date October 10, 2020

Study information

Verified date October 2021
Source Military Institute of Medicine, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date October 10, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
balance with open and closed eyes
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.

Locations

Country Name City State
Poland Military Institute of Medicine Warsaw Masovian District

Sponsors (1)

Lead Sponsor Collaborator
Anna Olczak

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary static balance TESTING STABILITY OF ATTITUDE with the use of the Biodex SD balance platform. up to 1 week
Primary dynamic balance FALL RISK TEST was assessed on the Biodex SD platform. up to 1 week
Primary Unterberga Test The subjects performed 50 steps, once with their eyes open and then with their eyes closed. up to 1 week
Primary Sternocleidomastoid muscle tension It was assessed on the Luna EMG up to 1 week
Primary Longus Colli muscle tension It was assessed on the Luna EMG up to 1 week
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