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StrokeNCT07395180

Differentiation of Human Body Balance Disorders

A study testing Patients after stroke, Patients with posterior columns of the spinal cord and Patients with labyrinth diseases in people with Stroke and Visual Defects, run by Military Institute od Medicine National Research Institute at 1 site in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Our research aims to analyze the possibilities of functional assessment of imbalances in the human body. Using the available, commonly known and used tests and devices for objective examination of static and dynamic body balance, as well as changes in the tension of selected muscles of the cervical spine in static and… Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, Visual Defects, Labyrinth Diseases
What is being tested?
Patients after stroke, Patients with posterior columns of the spinal cord and Patients with labyrinth diseases
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
1 sitePoland
Study dates
19 Jan 2026to 30 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1) stroke patients (7 to 9 weeks after cerebellar stroke), with degenerative changes of the spine, including the cervical section, with labyrinth disorders, with visual defects, with changes in the posterior cords of the spinal cord;
  • 2) functional status of patients that allows them to stand and walk in place and over a distance (Rankin ≤ 3);
  • 3) Modified Ashworth Muscle Tone Scale (MAS ≤1/1+);
  • 4) positive Tandem test;
  • 5) no major deficits in communication, memory or comprehension which may impede correct measurement;
  • 6) over 20 years of age; maximum 80 years.
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  • The main criteria for inclusion in the control group:
  • 1) healthy people with a stable trunk (100 TCT points);
  • 2) having normal muscle tone (MAS=0), walking independently;
  • 3) at least 20 years old; maximum 80 years.

Who cannot join

  • 1) coexisting diseases considered in the study;
  • 2) stroke up to seven weeks after the episode;
  • 3) epilepsy;
  • 4) lack of trunk stability;
  • 5) lack of independent standing and walking;
  • 6) high or very low blood pressure, dizziness, malaise.
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  • Criteria for exclusion from the control group:
  • 1) history of neurological or musculoskeletal disorders, such as stroke or brain injury, or other neurological conditions that may affect their ability to move the trunk and legs actively;
  • 2) degenerative changes, labyrinth disorders, vision defects;
  • 3) pain, dizziness;
  • 4) constant use of orthopedic supplies;
  • 5) severe deficits in communication, memory, or comprehension, which may make it difficult to perform the measurement correctly;
  • 6) high or very low blood pressure, feeling unwell.

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Military Institute od Medicine National Research Institute

    Warsaw, 04-141

Other trials in Poland

About this study

Official title: Differentiation of Human Body Balance Disorders - Analysis of the Potential of Functional Tests in Determining the Cause of Disorders

Our research aims to analyze the possibilities of functional assessment of imbalances in the human body. Using the available, commonly known and used tests and devices for objective examination of static and dynamic body balance, as well as changes in the tension of selected muscles of the cervical spine in static and dynamic conditions, depending on visual control or its absence, we hope to identify important research tools that help to differentiate the causes of imbalances. Studies conducted on a group of healthy people and groups of patients: after a stroke, with changes in the posterior cords of the spinal cord, with labyrinth disorders, with degenerative changes in the spine, with visual impairments, and in healthy people, seem to be important in the analysis of the discussed topic. The investigators will answer the following detailed research questions: 1. Does the type of disease/disease or its absence affect the human balance in the Romberg test? 2. Do visual defects affect the tension of the muscles of the cervical spine? 3. Do changes in the muscle tension of the cervical spine affect the ability to maintain balance in the Unterberger test? 4. Do the mobility deficits in the cervical spine coincide with cervical or labyrinthine balance disorders in the differential test for vertigo and in the Fukuda test? 5. How does the tension of the muscles of the cervical spine change in the tested groups on the stable and unstable, depending on the vision control? 6. Does the type of disease/illness or its absence affect changes in the tension of the muscles of the cervical spine, and does it correlate with the balance of the body on a stable and unstable surface? The results of the research may facilitate the functional differentiation of imbalances in the human body. The investigators hypothesize that functional tests will help determine the cause of imbalance in the human body. This will allow us to determine with high probability the dominant cause of balance disorders (eye disorders, changes in the cervical spine / musculoskeletal system, labyrinth, proprioceptors, cerebellum, posterior cords of the spinal cord), already at the initial stage of diagnosis. The research will improve the process of implementing effective treatment and therapeutic procedures.

Being tested
Patients after stroke, Patients with posterior columns of the spinal cord, Patients with labyrinth diseases, Patients with visual defects, Patients with cervical spine degenerative disease
Keywords
stroke, posterior columns of the spinal cord, cervical spine degenerative disease, labyrinth diseases, visual defects, healthy, balance
Medical subject headings
Stroke, Vision Disorders, Labyrinth Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients after strokeDiagnostic test

    Body posture assessment (APECS), the Tandem test, the Trunk Stability test, the modified Rankin Scale to assess the general physical impairment of patients, and the National Institute for Health Stroke Scale (NIHSS) to determine the neurological deficit. , and the Modified Ashworth Scale, Romberg test, Fukuda test, differential test for vertigo, Unterberg test, body balance test using Biodex SD balance platform, Cervical spine muscle tone test using Luna EMG.

  • Patients with posterior columns of the spinal cordDiagnostic test

    Body posture assessment (APECS), the Tandem test, the Trunk Stability test, the modified Rankin Scale to assess the general physical impairment of patients, and the National Institute for Health Stroke Scale (NIHSS) to determine the neurological deficit. , and the Modified Ashworth Scale, Romberg test, Fukuda test, differential test for vertigo, Unterberg test, body balance test using Biodex SD balance platform, Cervical spine muscle tone test using Luna EMG.

  • Patients with labyrinth diseasesDiagnostic test

    Body posture assessment (APECS), the Tandem test, the Trunk Stability test, the modified Rankin Scale to assess the general physical impairment of patients, and the National Institute for Health Stroke Scale (NIHSS) to determine the neurological deficit. , and the Modified Ashworth Scale, Romberg test, Fukuda test, differential test for vertigo, Unterberg test, body balance test using Biodex SD balance platform, Cervical spine muscle tone test using Luna EMG.

  • Patients with visual defectsDiagnostic test

    Body posture assessment (APECS), the Tandem test, the Trunk Stability test, the modified Rankin Scale to assess the general physical impairment of patients, and the National Institute for Health Stroke Scale (NIHSS) to determine the neurological deficit. , and the Modified Ashworth Scale, Romberg test, Fukuda test, differential test for vertigo, Unterberg test, body balance test using Biodex SD balance platform, Cervical spine muscle tone test using Luna EMG.

  • Patients with cervical spine degenerative diseaseDiagnostic test

    Body posture assessment (APECS), the Tandem test, the Trunk Stability test, the modified Rankin Scale to assess the general physical impairment of patients, and the National Institute for Health Stroke Scale (NIHSS) to determine the neurological deficit. , and the Modified Ashworth Scale, Romberg test, Fukuda test, differential test for vertigo, Unterberg test, body balance test using Biodex SD balance platform, Cervical spine muscle tone test using Luna EMG.

  • Healthy participantsDiagnostic test

    Body posture assessment (APECS), the Tandem test, the Trunk Stability test, the modified Rankin Scale to assess the general physical impairment of patients, and the National Institute for Health Stroke Scale (NIHSS) to determine the neurological deficit. , and the Modified Ashworth Scale, Romberg test, Fukuda test, differential test for vertigo, Unterberg test, body balance test using Biodex SD balance platform, Cervical spine muscle tone test using Luna EMG.

Study groups in NCT07395180
Study groupRoleWhat they receive
Patients after strokeExperimentalNot described
Receives: Diagnostic Test: Patients after stroke; Diagnostic Test: Patients with posterior columns of the spinal cord; Diagnostic Test: Patients with labyrinth diseases; Diagnostic Test: Patients with visual defects; Diagnostic Test: Patients with cervical spine degenerative disease; Diagnostic Test: Healthy participants
Patients with posterior columns of the spinal cordExperimentalNot described
Receives: Diagnostic Test: Patients after stroke; Diagnostic Test: Patients with posterior columns of the spinal cord; Diagnostic Test: Patients with labyrinth diseases; Diagnostic Test: Patients with visual defects; Diagnostic Test: Patients with cervical spine degenerative disease; Diagnostic Test: Healthy participants
Patients with labyrinth diseasesExperimentalNot described
Receives: Diagnostic Test: Patients after stroke; Diagnostic Test: Patients with posterior columns of the spinal cord; Diagnostic Test: Patients with labyrinth diseases; Diagnostic Test: Patients with visual defects; Diagnostic Test: Patients with cervical spine degenerative disease; Diagnostic Test: Healthy participants
Patients with visual defectsExperimentalNot described
Receives: Diagnostic Test: Patients after stroke; Diagnostic Test: Patients with posterior columns of the spinal cord; Diagnostic Test: Patients with labyrinth diseases; Diagnostic Test: Patients with visual defects; Diagnostic Test: Patients with cervical spine degenerative disease; Diagnostic Test: Healthy participants
Patients with cervical spine degenerative diseaseExperimentalNot described
Receives: Diagnostic Test: Patients after stroke; Diagnostic Test: Patients with posterior columns of the spinal cord; Diagnostic Test: Patients with labyrinth diseases; Diagnostic Test: Patients with visual defects; Diagnostic Test: Patients with cervical spine degenerative disease; Diagnostic Test: Healthy participants
Healthy participantsOtherNot described
Receives: Diagnostic Test: Patients after stroke; Diagnostic Test: Patients with posterior columns of the spinal cord; Diagnostic Test: Patients with labyrinth diseases; Diagnostic Test: Patients with visual defects; Diagnostic Test: Patients with cervical spine degenerative disease; Diagnostic Test: Healthy participants

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Advanced Packaging and Heterogeneous Integration for Electronic Components and Systems (APECS)

    Evaluation of body posture in the frontal and sagittal planes - Advanced Packaging and Heterogeneous Integration for Electronic Components and Systems (APECS)

    Measured: Day 1

  2. The Tandem Test

    Measured: Day 1

  3. Modified Ashworth Scale (MAS)

    Measured: Day 1

  4. Trunk Stability Test

    Measured: Day 1

  5. Rankin Scale

    Measured: Day 1

  6. NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS)

    Measured: Day 1

Secondary outcomes (6)
  1. Romberg test

    Measured: Day 1

  2. Fukuda test

    Measured: Day 1

  3. Differential test for vertigo

    Measured: Day 1

  4. Body balance test on the Biodex SD platform

    Measured: Day 1

  5. Cervical spine muscle tone test using Luna EMG

    Measured: Day 1

  6. Unterberger test

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start19 Jan 2026
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion30 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
. Type of research - study with a control group; Study Group - patients after a stroke/cerebellum, with changes in the posterior cords of the spinal cord, with degenerative changes of the spine, including the cervical section, with labyrinth disorders, with uncorrected vision defects. Control group - healthy volunteers. Age of the respondents - range from 20 to 80 years; women and men, in the acute and subacute period of the disease, as well as healthy volunteers. The group size with a moderate effect (f = 0.25), alpha = 0.05, and test power = 0.95 will be \> 324 people (54 people in each group).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07395180
Sponsor's protocol ID
12/KRN/24
Status last verified
Jan 2026
First submitted
18 Jan 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Patients after stroke, Patients with posterior columns of the spinal cord and Patients with labyrinth diseases in people with Stroke and Visual Defects, run by Military Institute od Medicine National Research Institute at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Advanced Packaging and Heterogeneous Integration for Electronic Components and Systems (APECS) (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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