NCT07395180

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for not_applicable stroke

Timeline
11mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress29%
Jan 2026Mar 2027

First Submitted

Initial submission to the registry

January 18, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Expected
Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

January 18, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

strokeposterior columns of the spinal cordcervical spine degenerative diseaselabyrinth diseasesvisual defectshealthybalance

Outcome Measures

Primary Outcomes (6)

  • 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)

    Day 1

  • The Tandem Test

    Day 1

  • Modified Ashworth Scale (MAS)

    Day 1

  • Trunk Stability Test

    Day 1

  • Rankin Scale

    Day 1

  • NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS)

    Day 1

Secondary Outcomes (6)

  • Romberg test

    Day 1

  • Fukuda test

    Day 1

  • Differential test for vertigo

    Day 1

  • Body balance test on the Biodex SD platform

    Day 1

  • Cervical spine muscle tone test using Luna EMG

    Day 1

  • +1 more secondary outcomes

Study Arms (6)

Patients after stroke

EXPERIMENTAL
Diagnostic Test: Patients after strokeDiagnostic Test: Patients with posterior columns of the spinal cordDiagnostic Test: Patients with labyrinth diseasesDiagnostic Test: Patients with visual defectsDiagnostic Test: Patients with cervical spine degenerative diseaseDiagnostic Test: Healthy participants

Patients with posterior columns of the spinal cord

EXPERIMENTAL
Diagnostic Test: Patients after strokeDiagnostic Test: Patients with posterior columns of the spinal cordDiagnostic Test: Patients with labyrinth diseasesDiagnostic Test: Patients with visual defectsDiagnostic Test: Patients with cervical spine degenerative diseaseDiagnostic Test: Healthy participants

Patients with labyrinth diseases

EXPERIMENTAL
Diagnostic Test: Patients after strokeDiagnostic Test: Patients with posterior columns of the spinal cordDiagnostic Test: Patients with labyrinth diseasesDiagnostic Test: Patients with visual defectsDiagnostic Test: Patients with cervical spine degenerative diseaseDiagnostic Test: Healthy participants

Patients with visual defects

EXPERIMENTAL
Diagnostic Test: Patients after strokeDiagnostic Test: Patients with posterior columns of the spinal cordDiagnostic Test: Patients with labyrinth diseasesDiagnostic Test: Patients with visual defectsDiagnostic Test: Patients with cervical spine degenerative diseaseDiagnostic Test: Healthy participants

Patients with cervical spine degenerative disease

EXPERIMENTAL
Diagnostic Test: Patients after strokeDiagnostic Test: Patients with posterior columns of the spinal cordDiagnostic Test: Patients with labyrinth diseasesDiagnostic Test: Patients with visual defectsDiagnostic Test: Patients with cervical spine degenerative diseaseDiagnostic Test: Healthy participants

Healthy participants

OTHER
Diagnostic Test: Patients after strokeDiagnostic Test: Patients with posterior columns of the spinal cordDiagnostic Test: Patients with labyrinth diseasesDiagnostic Test: Patients with visual defectsDiagnostic Test: Patients with cervical spine degenerative diseaseDiagnostic Test: Healthy participants

Interventions

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 participantsPatients after strokePatients with cervical spine degenerative diseasePatients with labyrinth diseasesPatients with posterior columns of the spinal cordPatients 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.

Healthy participantsPatients after strokePatients with cervical spine degenerative diseasePatients with labyrinth diseasesPatients with posterior columns of the spinal cordPatients 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.

Healthy participantsPatients after strokePatients with cervical spine degenerative diseasePatients with labyrinth diseasesPatients with posterior columns of the spinal cordPatients with visual defects
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.

Healthy participantsPatients after strokePatients with cervical spine degenerative diseasePatients with labyrinth diseasesPatients with posterior columns of the spinal cordPatients with visual defects
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.

Healthy participantsPatients after strokePatients with cervical spine degenerative diseasePatients with labyrinth diseasesPatients with posterior columns of the spinal cordPatients 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.

Healthy participantsPatients after strokePatients with cervical spine degenerative diseasePatients with labyrinth diseasesPatients with posterior columns of the spinal cordPatients with visual defects

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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;
  • \) functional status of patients that allows them to stand and walk in place and over a distance (Rankin ≤ 3);
  • \) Modified Ashworth Muscle Tone Scale (MAS ≤1/1+);
  • \) positive Tandem test;
  • \) no major deficits in communication, memory or comprehension which may impede correct measurement;
  • \) over 20 years of age; maximum 80 years.
  • \) healthy people with a stable trunk (100 TCT points);
  • \) having normal muscle tone (MAS=0), walking independently;
  • \) at least 20 years old; maximum 80 years.

You may not qualify if:

  • \) coexisting diseases considered in the study;
  • \) stroke up to seven weeks after the episode;
  • \) epilepsy;
  • \) lack of trunk stability;
  • \) lack of independent standing and walking;
  • \) high or very low blood pressure, dizziness, malaise.
  • \) 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;
  • \) degenerative changes, labyrinth disorders, vision defects;
  • \) pain, dizziness;
  • \) constant use of orthopedic supplies;
  • \) severe deficits in communication, memory, or comprehension, which may make it difficult to perform the measurement correctly;
  • \) high or very low blood pressure, feeling unwell.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Institute od Medicine National Research Institute

Warsaw, 04-141, Poland

Location

MeSH Terms

Conditions

StrokeVision DisordersLabyrinth Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: . 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Senior Specialist of the Rehabilitation Clinic

Study Record Dates

First Submitted

January 18, 2026

First Posted

February 9, 2026

Study Start

January 19, 2026

Primary Completion

February 28, 2026

Study Completion (Estimated)

March 30, 2027

Last Updated

February 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations