- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05082194
Balance Eyesight and Muscle Tension in the Cervical Spine in Cerebral Amyloid Angiopathy
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Masovian District
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Warsaw, Masovian District, Poland, 04-141
- Military Institute of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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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. |
|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
static balance
Time Frame: up to 1 week
|
TESTING STABILITY OF ATTITUDE with the use of the Biodex SD balance platform.
|
up to 1 week
|
|
dynamic balance
Time Frame: up to 1 week
|
FALL RISK TEST was assessed on the Biodex SD platform.
|
up to 1 week
|
|
Unterberga Test
Time Frame: up to 1 week
|
The subjects performed 50 steps, once with their eyes open and then with their eyes closed.
|
up to 1 week
|
|
Sternocleidomastoid muscle tension
Time Frame: up to 1 week
|
It was assessed on the Luna EMG
|
up to 1 week
|
|
Longus Colli muscle tension
Time Frame: up to 1 week
|
It was assessed on the Luna EMG
|
up to 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Olczak, PhD, Military Institute of Medicine, Rehabilitation Clinic Poland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genetic Diseases, Inborn
- Proteostasis Deficiencies
- Metabolism, Inborn Errors
- Brain Diseases, Metabolic
- Brain Diseases, Metabolic, Inborn
- Cerebral Arterial Diseases
- Intracranial Arterial Diseases
- Cerebral Small Vessel Diseases
- Amyloidosis, Familial
- Amyloidosis
- Cerebral Amyloid Angiopathy
- Cerebral Amyloid Angiopathy, Familial
Other Study ID Numbers
- 8/KRN/2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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