Application of Device-based Training to Improve Postural Control in Older Adults With CCI
1 other identifier
interventional
120
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2025
1 active site
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 Start
First participant enrolled
June 1, 2025
CompletedFirst Submitted
Initial submission to the registry
December 25, 2025
CompletedFirst Posted
Study publicly available on registry
January 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedMay 5, 2026
May 1, 2026
10 months
December 25, 2025
May 3, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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)
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)
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)
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)
10 days
Secondary Outcomes (2)
Improving cognitive functions
10 days
Improving the quality of life
10 days
Study Arms (3)
training on the "Huber" (LPG-Systems, France)
EXPERIMENTALA 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)
EXPERIMENTALA 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 COMPARATORA 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).
Interventions
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.
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).
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MEDSI Clinic
Moscow, 143442, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- physiotherapist
Study Record Dates
First Submitted
December 25, 2025
First Posted
January 22, 2026
Study Start
June 1, 2025
Primary Completion
April 6, 2026
Study Completion
April 30, 2026
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share