NCT05082194

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

September 30, 2021

Last Update Submit

October 14, 2021

Conditions

Keywords

stroke,CAA,upper limb,trunk exercises,stabilization

Outcome Measures

Primary Outcomes (5)

  • static balance

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

    up to 1 week

  • dynamic balance

    FALL RISK TEST was assessed on the Biodex SD platform.

    up to 1 week

  • Unterberga Test

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

    up to 1 week

  • Sternocleidomastoid muscle tension

    It was assessed on the Luna EMG

    up to 1 week

  • Longus Colli muscle tension

    It was assessed on the Luna EMG

    up to 1 week

Study Arms (2)

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

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 CAABalance in healthy participants

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study involved 8 patients after stroke in the course of Cerebral Amyloid Angiopathy (CAA) and 8 healthy subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Institute of Medicine

Warsaw, Masovian District, 04-141, Poland

Location

MeSH Terms

Conditions

Cerebral Amyloid AngiopathyStroke

Condition Hierarchy (Ancestors)

Cerebral Arterial DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Anna Olczak, PhD

    Military Institute of Medicine, Rehabilitation Clinic Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD; Senior Specjalit of the Rehabilitation Clinc

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 18, 2021

Study Start

February 10, 2020

Primary Completion

June 15, 2020

Study Completion

October 10, 2020

Last Updated

October 18, 2021

Record last verified: 2021-10

Locations