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临床试验/NCT07395180
NCT07395180
进行中(未招募)
不适用

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

Military Institute od Medicine National Research Institute1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2026年1月19日最近更新:

概览

阶段
不适用
状态
进行中(未招募)
发起方
Military Institute od Medicine National Research Institute
入组人数
330
试验地点
1
主要终点
Advanced Packaging and Heterogeneous Integration for Electronic Components and Systems (APECS)

概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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;

研究组 & 干预措施

Patients after stroke

Experimental

干预措施: Patients after stroke (Diagnostic Test)

Patients after stroke

Experimental

干预措施: Patients with posterior columns of the spinal cord (Diagnostic Test)

Patients after stroke

Experimental

干预措施: Patients with labyrinth diseases (Diagnostic Test)

Patients after stroke

Experimental

干预措施: Patients with visual defects (Diagnostic Test)

Patients after stroke

Experimental

干预措施: Patients with cervical spine degenerative disease (Diagnostic Test)

Patients after stroke

Experimental

干预措施: Healthy participants (Diagnostic Test)

Patients with posterior columns of the spinal cord

Experimental

干预措施: Patients after stroke (Diagnostic Test)

Patients with posterior columns of the spinal cord

Experimental

干预措施: Patients with posterior columns of the spinal cord (Diagnostic Test)

Patients with posterior columns of the spinal cord

Experimental

干预措施: Patients with labyrinth diseases (Diagnostic Test)

Patients with posterior columns of the spinal cord

Experimental

干预措施: Patients with visual defects (Diagnostic Test)

Patients with posterior columns of the spinal cord

Experimental

干预措施: Patients with cervical spine degenerative disease (Diagnostic Test)

Patients with posterior columns of the spinal cord

Experimental

干预措施: Healthy participants (Diagnostic Test)

Patients with labyrinth diseases

Experimental

干预措施: Patients after stroke (Diagnostic Test)

Patients with labyrinth diseases

Experimental

干预措施: Patients with posterior columns of the spinal cord (Diagnostic Test)

Patients with labyrinth diseases

Experimental

干预措施: Patients with labyrinth diseases (Diagnostic Test)

Patients with labyrinth diseases

Experimental

干预措施: Patients with visual defects (Diagnostic Test)

Patients with labyrinth diseases

Experimental

干预措施: Patients with cervical spine degenerative disease (Diagnostic Test)

Patients with labyrinth diseases

Experimental

干预措施: Healthy participants (Diagnostic Test)

Patients with visual defects

Experimental

干预措施: Patients after stroke (Diagnostic Test)

Patients with visual defects

Experimental

干预措施: Patients with posterior columns of the spinal cord (Diagnostic Test)

Patients with visual defects

Experimental

干预措施: Patients with labyrinth diseases (Diagnostic Test)

Patients with visual defects

Experimental

干预措施: Patients with visual defects (Diagnostic Test)

Patients with visual defects

Experimental

干预措施: Patients with cervical spine degenerative disease (Diagnostic Test)

Patients with visual defects

Experimental

干预措施: Healthy participants (Diagnostic Test)

Patients with cervical spine degenerative disease

Experimental

干预措施: Patients after stroke (Diagnostic Test)

Patients with cervical spine degenerative disease

Experimental

干预措施: Patients with posterior columns of the spinal cord (Diagnostic Test)

Patients with cervical spine degenerative disease

Experimental

干预措施: Patients with labyrinth diseases (Diagnostic Test)

Patients with cervical spine degenerative disease

Experimental

干预措施: Patients with visual defects (Diagnostic Test)

Patients with cervical spine degenerative disease

Experimental

干预措施: Patients with cervical spine degenerative disease (Diagnostic Test)

Patients with cervical spine degenerative disease

Experimental

干预措施: Healthy participants (Diagnostic Test)

Healthy participants

Other

干预措施: Patients after stroke (Diagnostic Test)

Healthy participants

Other

干预措施: Patients with posterior columns of the spinal cord (Diagnostic Test)

Healthy participants

Other

干预措施: Patients with labyrinth diseases (Diagnostic Test)

Healthy participants

Other

干预措施: Patients with visual defects (Diagnostic Test)

Healthy participants

Other

干预措施: Patients with cervical spine degenerative disease (Diagnostic Test)

Healthy participants

Other

干预措施: Healthy participants (Diagnostic Test)

结局指标

主要结局

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

时间窗: Day 1

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

The Tandem Test

时间窗: Day 1

Modified Ashworth Scale (MAS)

时间窗: Day 1

Trunk Stability Test

时间窗: Day 1

Rankin Scale

时间窗: Day 1

NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS)

时间窗: Day 1

次要结局

  • 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)
  • Unterberger test(Day 1)

研究者

发起方
Military Institute od Medicine National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Olczak

PhD; Senior Specialist of the Rehabilitation Clinic

Military Institute od Medicine National Research Institute

研究点 (1)

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