- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07395180
Differentiation of Human Body Balance Disorders
February 3, 2026 updated by: Anna Olczak, Military Institute od Medicine National Research Institute
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
- 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
Study Type
Interventional
Enrollment (Estimated)
330
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Warsaw, Poland, 04-141
- Military Institute od Medicine National Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
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.
Exclusion Criteria:
- 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.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthy participants
|
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.
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.
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.
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.
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.
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.
|
|
Experimental: Patients after stroke
|
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.
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.
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.
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.
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.
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.
|
|
Experimental: Patients with posterior columns of the spinal cord
|
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.
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.
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.
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.
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.
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.
|
|
Experimental: Patients with labyrinth diseases
|
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.
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.
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.
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.
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.
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.
|
|
Experimental: Patients with visual defects
|
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.
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.
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.
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.
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.
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.
|
|
Experimental: Patients with cervical spine degenerative disease
|
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.
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.
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.
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Advanced Packaging and Heterogeneous Integration for Electronic Components and Systems (APECS)
Time Frame: Day 1
|
Evaluation of body posture in the frontal and sagittal planes - Advanced Packaging and Heterogeneous Integration for Electronic Components and Systems (APECS)
|
Day 1
|
|
The Tandem Test
Time Frame: Day 1
|
Day 1
|
|
|
Modified Ashworth Scale (MAS)
Time Frame: Day 1
|
Day 1
|
|
|
Trunk Stability Test
Time Frame: Day 1
|
Day 1
|
|
|
Rankin Scale
Time Frame: Day 1
|
Day 1
|
|
|
NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS)
Time Frame: Day 1
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Romberg test
Time Frame: Day 1
|
Day 1
|
|
Fukuda test
Time Frame: Day 1
|
Day 1
|
|
Differential test for vertigo
Time Frame: Day 1
|
Day 1
|
|
Body balance test on the Biodex SD platform
Time Frame: Day 1
|
Day 1
|
|
Cervical spine muscle tone test using Luna EMG
Time Frame: Day 1
|
Day 1
|
|
Unterberger test
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2026
Primary Completion (Estimated)
February 28, 2026
Study Completion (Estimated)
March 30, 2027
Study Registration Dates
First Submitted
January 18, 2026
First Submitted That Met QC Criteria
February 3, 2026
First Posted (Actual)
February 9, 2026
Study Record Updates
Last Update Posted (Actual)
February 9, 2026
Last Update Submitted That Met QC Criteria
February 3, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Eye Diseases
- Otorhinolaryngologic Diseases
- Sensation Disorders
- Ear Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Stroke
- Labyrinth Diseases
- Vision Disorders
Other Study ID Numbers
- 12/KRN/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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