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CompletedNCT05082194Updated Oct 18, 2021

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

An observational study in Cerebral Amyloid Angiopathy, sponsored by Anna Olczak. Completed at 1 site in Poland. Open to participants aged 55 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-18.

Sponsored by Anna Olczak · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
16
Ages
55 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Amyloid Angiopathy

Keywords

  • stroke,
  • CAA,
  • upper limb,
  • trunk exercises,
  • stabilization
03

In context

Cerebral Amyloid Angiopathy

38 studies on the registry are indexed under Cerebral Amyloid Angiopathy; 9 are open to participants now.

This study's enrollment of 16 is below the median of 81 across 20 observational studies indexed under Cerebral Amyloid Angiopathy.

Browse Cerebral Amyloid Angiopathy studies →

Lead sponsor

Anna Olczak is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • Balance in CAA

    Each of the examined post-stroke patients (CAA) performed the given test twice, with the eyes open the first time and the eyes closed the second time. 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. In both tests, the patients performed each of the tests 6 times, 3 with eyes open and 3 with eyes closed, on the same day.

    Procedure: balance with open and closed eyes

  • Balance in healthy participants

    Each of the examined healthy participants performed the given test twice, with the eyes open the first time and the eyes closed the second time. 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. In both tests, the subject performed each of the tests 6 times, 3 with eyes open and 3 with eyes closed, on the same day.

    Procedure: balance with open and closed eyes

Interventions

  • Procedurebalance 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.

06

What researchers measure

Primary outcomes

  1. static balance

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

    Time frame: up to 1 week

  2. dynamic balance

    FALL RISK TEST was assessed on the Biodex SD platform.

    Time frame: up to 1 week

  3. Unterberga Test

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

    Time frame: up to 1 week

  4. Sternocleidomastoid muscle tension

    It was assessed on the Luna EMG

    Time frame: up to 1 week

  5. Longus Colli muscle tension

    It was assessed on the Luna EMG

    Time frame: up to 1 week

07

Study locations

1 site
  • Military Institute of Medicine
    Warsaw, Masovian District 04-141, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05082194
Lead sponsor
Anna Olczak
Responsible party
Anna Olczak (PhD; Senior Specjalit of the Rehabilitation Clinc, Military Institute od Medicine National Research Institute) — Sponsor-investigator
First posted
Oct 18, 2021
Start date
Feb 10, 2020
Primary completion
Jun 15, 2020
Completion
Oct 10, 2020
Last update
Oct 18, 2021

Study contacts

Anna Olczak, PhD
principal investigator · Military Institute of Medicine, Rehabilitation Clinic Poland

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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