An interventional study of Biofeedback gait training by biomechanical target parameter in Stroke, Biofeedback and Gait, Hemiplegic, sponsored by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health · Not applicable, Interventional, and Treatment
Single-blinded controlled clinical trial. Biofeedback training courses based on target biomechanical gait parameters are being studied. For targeted biofeedback training, various biomechanical parameters are used: parameters of the gait cycle, EMG or kinematics of joint movements. The number of sessions is 8-11 for each patient. Clinical gain analysis is carried out before and after a course of training. Changes in biomechanical parameters that occurred at the end of the training course are assessed in comparison with those before training, and both statuses (before and after training) are compared with similar gait parameters in a group of healthy adults.
Walking function disorders are typical for patients after cerebral stroke. A cerebral stroke normally affects one hemisphere and causes a hemiplegic syndrome. The gait of hemiplegic patients has very specific features: reduced walking speed, increased double stance phase, and reduced amplitude of movement in the leg joints. Biofeedback technology (BFB) is currently considered effective and promising for training walking function, including in patients after cerebral stroke. The technology is based on capturing a physiological parameter and presenting it to the patient in a perceivable form, so that the subject can understand its changes and respond appropriately. BFB can be used independently or as part of rehabilitation therapy. Nevertheless, efficiency, as noted by most authors, remains the subject of discussion. This is due to the fact, that at the previous stage of development of these systems, there was no technical capability to use the specific biomechanical gait parameters as targets for training. Therefore, more general parameters-such as walking speed, step frequency, etc.-were and are still used. This circumstance is attributable to the very nature of the main biomechanical gait parameters, which require special means of recording. One of the significant technical difficulties in BFB implementation is the need for accurate and fast registration of the gait parameters in real-time to use them for biofeedback. At the same time, the use of portable sensors for BFB training goals can represent a certain solution to technical problems. In recent years, owing to its important advantages, wearable IMU technology (systems using inertial measurement units) has been widely applied for capturing biomechanical gait parameters. Investigators used a system that was originally developed with our participation for targeted training based on biofeedback according to the biomechanical parameters of gait. The use of inertial technology and artificial intelligence technology has made it possible to use biomechanical parameters of gait (time and general gait parameters, EMG and kinematics of leg's joints) for biofeedback in a very low-cost and practically convenient way. Biofeedback training courses based on target biomechanical gait parameters are being studied. For targeted biofeedback training, various biomechanical parameters are used: parameters of the gait cycle, EMG or kinematics of joint movements. The number of sessions is 8-11 for each patient. Clinical gait analysis is carried out before and after a course of training. Changes in biomechanical parameters that occurred at the end of the training course are assessed in comparison with those before training, and both statuses (before and after training) are compared with similar gait parameters in a group of healthy adults.
Stroke patients participated in the study in Federal Center of Cerebrovascular Pathology and Stroke FMBA in Moscow, Russia. The study was approved by a local ethic committee and followed principles of the Declaration of Helsinki.
Single-blinded controlled clinical trial. The study involved stroke patients with hemiparesis (no more than 3 points on a scale Rankin). Experimental groups are determined by the target training parameter (time and general gait parameters, EMG and kinematics of leg's joints). One target parameter is using for one group. The number of sessions is 8-11 for each patient during three weeks of hospital stay. The duration of each session for each patient on each training day varies according to his well-being and current exercise tolerance, but does not exceed 30 minutes of training in one session. . Changes in biomechanical parameters that occurred at the end of the training course are assessed in comparison with those before training, and both statuses (before and after training) are compared with similar gait parameters in a group of healthy adults.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 120 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Patients in this group receive, in addition to conventional therapy, biofeedback gait training by selected biomechanical (Staince or single support phase, range of motion at joint or EMG amplitude) gait parameter. Training takes place 8-12 times over three weeks. The duration of each workout varies from 10 to 30 minutes.
Other: Biofeedback gait training by biomechanical target parameter
Patients in this group receive, in addition to conventional therapy, biofeedback gait training by selected biomechanical (Staince or single support phase, range of motion at joint or EMG amplitude) gait parameter. Training takes place 8-12 times over three weeks. The duration of each workout varies from 10 to 30 minutes.
Other: Biofeedback gait training by biomechanical target parameter
The patient walks using a treadmill at a comfortable speed until he gets tired. The patient is instructed that when performing a virtual task (in a virtual environment on the screen), his walking will be harmonized (without informing him on what parameter). If it fails to cope, then the zones of permissible changes (on the information columns) will expand, and the virtual task will signal its incomplete completion.
Gait cycle
gait cycle duration - at seconds;
Time frame: Change from baseline at 3 weeks
Foot clearance
foot clearance at centimeters;
Time frame: Change from baseline at 3 weeks
Speed of walking
walking speed - km/h;
Time frame: Change from baseline at 3 weeks
Stance phase
stance phase at percent of gait cycle duration,
Time frame: Change from baseline at 3 weeks
Single support phase
single support phase at percent of gait cycle duration
Time frame: Change from baseline at 3 weeks
Hip joint amplitude
hip joint range of motion at degree
Time frame: Change from baseline at 3 weeks
Knee joint amplitude
knee joint range of motion at degree
Time frame: Change from baseline at 3 weeks
Ankle joint amplitude
ankle joint range of motion at degree
Time frame: Change from baseline at 3 weeks
EMG amplitude of tibialis anterior muscle
envelope EMG amplitude of the tibialis anterior muscle at mkV
Time frame: Change from baseline at 3 weeks
EMG amplitude of gastrocnemus muscle
envelope EMG amplitude of the gastrocnemus muscle at mkV
Time frame: Change from baseline at 3 weeks
EMG amplitude of quadriceps femoris muscle
envelope EMG amplitude of the quadriceps femoris muscle at mkV
Time frame: Change from baseline at 3 weeks
EMG amplitude of Hamstring muscle
envelope EMG amplitude of the hamstring muscle at mkV
Time frame: Change from baseline at 3 weeks
Muscle strength
Muscle strength was assessed using the MRC (Medical Research Council Weakness Scale). MRC is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). Paresis is defined as light at compliance with strength 4 points, moderate - 3 points, pronounced - 2 points, rough - 1 point and with - 0 points.
Time frame: Change from baseline at 3 weeks
Activities of Daily Living
The Barthel Index for Activities of Daily Living where 0 is no activity and score 100 is normal activity.
Time frame: Change from baseline at 3 weeks
Modified Rankin Scale for Neurologic Disability
Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability and ranged from 0 (no symptoms) to +6 - dead.
Time frame: Change from baseline at 3 weeks
The Timed Up and Go Test
Mobility is assessed based on time to complete the test: where \< 10 seconds = normal, \< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.
Time frame: Change from baseline at 3 weeks
The Medical Research Council Weakness Scale
The Medical Research Council Weakness Scale where grades: 0 is paralysis;5 - is normal.
Time frame: Change from baseline at 3 weeks
Plan to share: No
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Started Jan 2022 (actual). Primary completion is estimated for Dec 2025, 47 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 47 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health