Cerebrovascular DisordersNCT07358338
Application of Device-based Training to Improve Postural Control in Older Adults With CCI
A study testing "Huber" (LPG-Systems, France), "C-mill" (Physiomed Elektromedizin AG, Germany) and Physical therapy in people with Cerebrovascular Disorders and Gait Disorders, Neurologic, run by Litvina Lyubov Dmitrievna at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 98 years
- Conditions the study is for
- Cerebrovascular Disorders, Gait Disorders, Neurologic, Accidental Fall
- What is being tested?
- "Huber" (LPG-Systems, France), "C-mill" (Physiomed Elektromedizin AG, Germany) and Physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jun 2025to 30 Apr 2026
- 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 65 to 98 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Device-based Training to Improve Postural Control in Older Adults With Chronic Cerebral Ischemia
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:
Read more
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.
Read the detailed description
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.
The study hypothesizes that rehabilitation programs incorporating biofeedback-based device training will lead to more pronounced improvements in postural control, gait parameters, cognitive function, and fall risk reduction compared to conventional therapeutic exercise alone. It is expected that treadmill-based training using the C-Mill system will demonstrate a greater effect on dynamic balance and gait-related outcomes, whereas stabilometric training using the Huber system will primarily enhance static and reactive balance components. Improvements in quality of life are anticipated to be more pronounced in the biofeedback intervention groups.
- Conditions
- Cerebrovascular Disorders, Gait Disorders, Neurologic, Accidental Fall, Aged, Postural Balance
- Being tested
- "Huber" (LPG-Systems, France), "C-mill" (Physiomed Elektromedizin AG, Germany), Physical therapy
- Medical subject headings
- Cerebrovascular Disorders, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Huber" (LPG-Systems, France)Device
Procedures on the Huber stabilization trainer (LPG-Systems, France) include a 5-minute warm-up, followed by an individual selection of 3 tasks from the "Balance and Posture" program and 2 tasks from the "Resistance" program from levels 1 to 5.
"C-mill" (Physiomed Elektromedizin AG, Germany)Device
The procedures on the C-mill biofeedback video reconstruction track (Physiomed Elektromedizin AG, Germany) include a warm-up (3 minutes of normal walking), followed by blocks of tasks of 2-4 minutes each: "Slalom", "Tandem", "Obstacles", "Random Marks", "Speed Change", and ending with a cool-down (3 minutes of normal walking).
Physical therapyOther
The therapeutic exercise program consists of complex coordination exercises in various starting positions, including with objects. Each session will include a 5-minute warm-up, including breathing exercises and active joint exercises, followed by a 15-minute main block of exercises, and concludes with a 3-4-minute cool-down with stretching exercises for the back and lower extremities.
| Study group | Role | What they receive |
|---|---|---|
| training on the "Huber" (LPG-Systems, France) | Experimental | 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). Receives: Device: "Huber" (LPG-Systems, France) |
| treadmill training on the "C-mill" (Physiomed Elektromedizin AG, Germany) | Experimental | 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). Receives: Device: "C-mill" (Physiomed Elektromedizin AG, Germany) |
| Control group | Active comparator | 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). Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The risk of falls was reduced more in groups using biofeedback equipment
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)
Measured: 10 days
The risk of falls was reduced more in groups using biofeedback equipment
Fall risk assessment using the Get-Up-and-Go test before and after the rehabilitation course (Taking more than 14 seconds to complete the test indicates a high risk of falls)
Measured: 10 days
The risk of falls was reduced more in groups using biofeedback equipment
Fall risk assessment using the gait speed before and after the rehabilitation course (a walking speed of more than 1 km/h indicates a high risk of falls)
Measured: 10 days
Static balance will improve more in the group training on the "Huber", and dynamic balance in the group training on the treadmill "Cmill"
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)
Measured: 10 days
Secondary outcomes (2)
Improving cognitive functions
Montreal Cognitive Assessment (MoCA) (min 0 max 30 points, a higher score means a better result)
Measured: 10 days
Improving the quality of life
EQ-5D-3L questionnaire (EuroQol five-dimension three-level questionnaire).The first part of the scale has a system of indices that form a code that does not calculate to a single score. The second part of the scale EQ VAS (scale from 0-100), has a range from 0 to 100, where 100 is the best state.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jun 2025
- Primary completion6 Apr 2026
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Litvina Lyubov Dmitrievna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Litvina Lyubov Dmitrievna, MEDSI Clinical Hospital 1, ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358338
- Sponsor's protocol ID
- 32
- Status last verified
- May 2026
- First submitted
- 25 Dec 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Device-based Training to Improve Postural Control in Older Adults With Chronic Cerebral Ischemia
- ClinicalTrials.gov ID
- NCT07358338
- Acronym / sponsor ID
- 32
- Conditions
- Cerebrovascular Disorders, Gait Disorders, Neurologic, Accidental Fall, Aged, Postural Balance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Litvina Lyubov DmitrievnaUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The study hypothesizes that rehabilitation programs incorporating biofeedback-based device training will lead to more pronounced improvements in postural control, gait parameters, cognitive function, and fall risk reduction compared to conventional therapeutic exercise alone. It is expected that treadmill-based training using the C-Mill system will demonstrate a greater effect on dynamic balance and gait-related outcomes, whereas stabilometric training using the Huber system will primarily enhance static and reactive balance components. Improvements in quality of life are anticipated to be more pronounced in the biofeedback intervention groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| training on the "Huber" (LPG-Systems, France) | Experimental | Device: "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). |
| treadmill training on the "C-mill" (Physiomed Elektromedizin AG, Germany) | Experimental | Device: "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). |
| Control group | Active comparator | Other: Physical therapyA 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). |
Who may qualify
- Ages
- 65 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Huber" (LPG-Systems, France)Procedures on the Huber stabilization trainer (LPG-Systems, France) include a 5-minute warm-up, followed by an individual selection of 3 tasks from the "Balance and Posture" program and 2 tasks from the "Resistance" program from levels 1 to 5. | Device | training on the "Huber" (LPG-Systems, France) |
| "C-mill" (Physiomed Elektromedizin AG, Germany)The procedures on the C-mill biofeedback video reconstruction track (Physiomed Elektromedizin AG, Germany) include a warm-up (3 minutes of normal walking), followed by blocks of tasks of 2-4 minutes each: "Slalom", "Tandem", "Obstacles", "Random Marks", "Speed Change", and ending with a cool-down (3 minutes of normal walking). | Device | treadmill training on the "C-mill" (Physiomed Elektromedizin AG, Germany) |
| Physical therapyThe therapeutic exercise program consists of complex coordination exercises in various starting positions, including with objects. Each session will include a 5-minute warm-up, including breathing exercises and active joint exercises, followed by a 15-minute main block of exercises, and concludes with a 3-4-minute cool-down with stretching exercises for the back and lower extremities. | Other | Control group |
Primary outcome
The risk of falls was reduced more in groups using biofeedback equipment
Time frame: 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)
The risk of falls was reduced more in groups using biofeedback equipment
Time frame: 10 days
Fall risk assessment using the Get-Up-and-Go test before and after the rehabilitation course (Taking more than 14 seconds to complete the test indicates a high risk of falls)
The risk of falls was reduced more in groups using biofeedback equipment
Time frame: 10 days
Fall risk assessment using the gait speed before and after the rehabilitation course (a walking speed of more than 1 km/h indicates a high risk of falls)
Static balance will improve more in the group training on the "Huber", and dynamic balance in the group training on the treadmill "Cmill"
Time frame: 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)
2 secondary outcomes
Improving cognitive functions
Time frame: 10 days
Improving the quality of life
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Huber" (LPG-Systems, France), "C-mill" (Physiomed Elektromedizin AG, Germany) and Physical therapy in people with Cerebrovascular Disorders and Gait Disorders, Neurologic, run by Litvina Lyubov Dmitrievna at 1 site in Russia.
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 2 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 5 May 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 Russia. 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?
The risk of falls was reduced more in groups using biofeedback equipment (time frame: 10 days). The study lists 4 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 5 May 2026.