Application of Device-based Training to Improve Postural Control in Older Adults With Chronic Cerebral Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The risk of falls was reduced more in groups using biofeedback equipment
研究概览
简要总结
The goal of this clinical trial is to improve comprehensive rehabilitation programs for elderly patients with chronic cerebral ischemia by incorporating training methods with biofeedback for postural control training.
The main objectives of the study are as follows:
To evaluate the effectiveness of incorporating stabilometric training with biofeedback using the Huber system (LPG Systems, France) and treadmill-based biofeedback training using the C-Mill system (Physiomed Elektromedizin AG, Germany) into comprehensive rehabilitation programs, with respect to postural and cognitive functions in elderly patients with chronic cerebral ischemia.
To conduct a comparative analysis of the effectiveness of training programs performed using the Huber (LPG Systems, France) and C-Mill (Physiomed Elektromedizin AG, Germany) biofeedback systems, based on outcomes related to gait pattern recovery, postural parameters, and cognitive performance.
The investigators will compare training sessions using the Huber and C-Mill biofeedback systems with a control group (patients receiving conventional therapeutic exercise) in order to determine whether these devices are effective in improving postural control and reducing the risk of falls in patients with chronic cerebral ischemia.
Participants are required to:
Complete a course consisting of 8 procedures, performed once daily. Report any adverse events occurring during or after the procedures, should they arise.
详细描述
This randomized controlled clinical study is designed to evaluate the effectiveness of biofeedback-based training methods incorporated into comprehensive rehabilitation programs for elderly patients with chronic cerebral ischemia.
The study population consists of patients aged 65 years and older with a confirmed diagnosis of chronic cerebral ischemia (ICD-10: I67.8) of atherosclerotic, hypertensive, or mixed etiology, presenting with clinical stage I or II disease and neuroimaging-confirmed structural brain changes. Participants will be randomized into three parallel groups with stratification to ensure comparability by age and severity of cognitive impairment.
Two intervention groups will receive standard inpatient rehabilitation combined with device-based training using biofeedback technologies. The first intervention group will undergo stabilometric training using the Huber system (LPG Systems, France), aimed at improving static and reactive components of postural control. The second intervention group will receive treadmill-based gait and balance training using the C-Mill system with visual biofeedback (Physiomed Elektromedizin AG, Germany), targeting dynamic balance, gait pattern restoration, and fall risk reduction. The control group will receive standard rehabilitation without device-based biofeedback training.
All participants will complete a comprehensive inpatient rehabilitation program lasting 10 days. Each program includes therapeutic exercise focused on general strengthening, balance, and coordination, as well as classical relaxing massage of the cervical-collar region and magnetotherapy when clinically indicated. Participants in the intervention groups will additionally complete 8 device-based training sessions. To ensure comparability across groups, the duration of active training time per session will be standardized and will range from 23 to 24 minutes.
Clinical and instrumental assessments will be conducted before and after the rehabilitation course to evaluate changes in postural stability, gait, mobility, cognitive function, fall risk, and quality of life. Fall risk will be assessed using the Morse Fall Scale, mobility using the Timed Up and Go Test, and cognitive function using the Montreal Cognitive Assessment. Instrumental evaluation of gait and balance will be performed using the C-Mill diagnostic C-Gait program, while postural and pedometric parameters will be assessed using the diagnostic module of the Huber system. Quality of life and psychological well-being will be evaluated using the EQ-5D-3L questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 98 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly people aged 65 years and older, with a diagnosis of "Chronic cerebral ischemia" (according to the ICD-10 classification - I67.8 Other specified cerebral vascular lesions), atherosclerotic/hypertensive/mixed genesis (E.I. Gusev et al. 2022), clinical stage 1 or 2 according to the guidelines of the Research Institute of Neurology of the Russian Academy of Medical Sciences (2001) with neuroimaging-confirmed structural damage to the brain (stage 1 according to O.S. Levin (2006)
- •Signed voluntary consent to participate in the study.
排除标准
- •Age under 65, age over 98
- •Chronic diseases in the decompensation stage
- •Severe cognitive impairment
- •History of acute cerebrovascular accident
- •Presence of hemodynamically significant stenosis of the main cerebral arteries
- •Uncontrolled arterial hypertension
- •Neurodegenerative diseases
- •Dysmetabolic encephalopathy
- •History of traumatic brain injury
- •Condition after endoprosthetics of large joints
- •Severe sarcopenia
- •Oncological diseases in the progression stage
- •Lack of informed consent of the patient for the conduct of the study and access to information.
研究组 & 干预措施
treadmill training on the "C-mill" (Physiomed Elektromedizin AG, Germany)
A course of treatments using a C-mill biofeedback video reconstruction treadmill (Physiomed Elektromedizin AG, Germany); a course of therapeutic exercises consisting of general strengthening exercises, as well as exercises aimed at improving balance and coordination; a course of massage of the cervical and shoulder area using a relaxing technique; a course of magnetic therapy (as indicated).
干预措施: "C-mill" (Physiomed Elektromedizin AG, Germany) (Device)
training on the "Huber" (LPG-Systems, France)
A course of treatments on the Huber stabilization trainer (LPG-Systems, France); a course of therapeutic exercises consisting of general strengthening exercises, as well as exercises aimed at improving balance and coordination; a course of massage of the cervical and shoulder area using a relaxing technique; a course of magnetic therapy (as indicated).
干预措施: "Huber" (LPG-Systems, France) (Device)
Control group
A course of therapeutic exercises consisting of general strengthening exercises, as well as exercises aimed at improving balance and coordination; a course of massage of the cervical and shoulder area using a relaxing technique; a course of magnetic therapy (as indicated).
干预措施: Physical therapy (Other)
结局指标
主要结局
The risk of falls was reduced more in groups using biofeedback equipment
时间窗: 10 days
Fall risk assessment using the Morse fall scale before and after the rehabilitation course (min 0, max 125, higher values on the scale indicate a worse outcome)
Static balance will improve more in the group training on the "Huber", and dynamic balance in the group training on the treadmill "Cmill"
时间窗: 10 days
Evaluation based on the following stabilometric indicators: length and area of the statokinesiogram, average speed of oscillations of the body's center of pressure, indicators of the static and dynamic balance tests TUG, Romberg test with open and closed eyes, indicators of the dynamic walking stereotype (walking speed, step length, step variability)
次要结局
- Improving cognitive functions(10 days)
- Improving the quality of life(10 days)
研究者
Litvina Lyubov Dmitrievna
physiotherapist
MEDSI Clinical Hospital 1, ICU