StrokeTargetGaitNCT06299943
Biofeedback Gait Training by Target Biomechanical Parameters in the Early Recovery Period of Stroke
A study testing Biofeedback gait training by biomechanical target parameter in people with Stroke and Biofeedback, run by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Biofeedback, Gait, Hemiplegic
- What is being tested?
- Biofeedback gait training by biomechanical target parameter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 24 Jan 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age - < 75 years;
- type of stroke - ischemic;
- structure of the lesion - cerebral hemisphere;
- disease type - primary;
- functional ability to walk for at least 5 minutes without using external means of support;
- absence of reduced higher mental functions,
Show all 9Show fewer
- sensorimotor aphasia,
- muscle tone in the limbs above 2 points according to Ashworth (Modified Ashworth Scale);
- no history of orthopedic and neurological pathology; absence of pronounced pain syndrome
Who cannot join
- Signs of orthostatic hypotension during training,
- patient desire to withdraw from the study,
- neurological deficit worsening.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
FCCerebroPathStroke
Moscow, 117997
Dmitry Skvortsov, PhD, +79166925419, skvortsov.biom@gmail.com
About this study
Official title: Blind Randomized Controlled Study of Biofeedback Training Based on Target Biomechanical Gait Parameters at Patients in the Early Recovery Period of Stroke Whith Hemiparesis
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.
Read the detailed description
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.
- Conditions
- Stroke, Biofeedback, Gait, Hemiplegic, Gait Training, Hemiparesis
- Being tested
- Biofeedback gait training by biomechanical target parameter
- Keywords
- stroke; hemiparesis; gait; rehabilitation; biofeedback
- Medical subject headings
- Stroke, Gait Disorders, Neurologic, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback gait training by biomechanical target parameterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Target Biofeedbak gait training | Experimental | 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. Receives: Other: Biofeedback gait training by biomechanical target parameter |
| Target Biofeedbak gait training-2 | Experimental | 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. Receives: Other: Biofeedback gait training by biomechanical target parameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait cycle
gait cycle duration - at seconds;
Measured: Change from baseline at 3 weeks
Foot clearance
foot clearance at centimeters;
Measured: Change from baseline at 3 weeks
Speed of walking
walking speed - km/h;
Measured: Change from baseline at 3 weeks
Stance phase
stance phase at percent of gait cycle duration,
Measured: Change from baseline at 3 weeks
Single support phase
single support phase at percent of gait cycle duration
Measured: Change from baseline at 3 weeks
Hip joint amplitude
hip joint range of motion at degree
Measured: Change from baseline at 3 weeks
Knee joint amplitude
knee joint range of motion at degree
Measured: Change from baseline at 3 weeks
Ankle joint amplitude
ankle joint range of motion at degree
Measured: Change from baseline at 3 weeks
EMG amplitude of tibialis anterior muscle
envelope EMG amplitude of the tibialis anterior muscle at mkV
Measured: Change from baseline at 3 weeks
EMG amplitude of gastrocnemus muscle
envelope EMG amplitude of the gastrocnemus muscle at mkV
Measured: Change from baseline at 3 weeks
EMG amplitude of quadriceps femoris muscle
envelope EMG amplitude of the quadriceps femoris muscle at mkV
Measured: Change from baseline at 3 weeks
EMG amplitude of Hamstring muscle
envelope EMG amplitude of the hamstring muscle at mkV
Measured: Change from baseline at 3 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start24 Jan 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Model description
- Parallel-group, single-blinded controlled clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Galina E Ivanova, PhD, Study chair, Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299943
- Sponsor's protocol ID
- BiofeedbackTargetGaitTraining
- Acronym
- TargetGait
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blind Randomized Controlled Study of Biofeedback Training Based on Target Biomechanical Gait Parameters at Patients in the Early Recovery Period of Stroke Whith Hemiparesis
- ClinicalTrials.gov ID
- NCT06299943
- Acronym / sponsor ID
- TargetGait / BiofeedbackTargetGaitTraining
- Conditions
- Stroke, Biofeedback, Gait, Hemiplegic, Gait Training, Hemiparesis
- Keywords
- stroke; hemiparesis; gait; rehabilitation; biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of HealthUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Mar 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group, single-blinded controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Target Biofeedbak gait training | Experimental | Other: Biofeedback gait training by biomechanical target parameterPatients 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. |
| Target Biofeedbak gait training-2 | Experimental | Other: Biofeedback gait training by biomechanical target parameterPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age - < 75 years;
- type of stroke - ischemic;
- structure of the lesion - cerebral hemisphere;
- disease type - primary;
- functional ability to walk for at least 5 minutes without using external means of support;
Key exclusion criteria (3 listed)
- Signs of orthostatic hypotension during training,
- patient desire to withdraw from the study,
- neurological deficit worsening.
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 |
|---|---|---|
| Biofeedback gait training by biomechanical target parameterThe 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. | Other | Target Biofeedbak gait training, Target Biofeedbak gait training-2 |
Primary outcome
Gait cycle
Time frame: Change from baseline at 3 weeks
gait cycle duration - at seconds;
Foot clearance
Time frame: Change from baseline at 3 weeks
foot clearance at centimeters;
Speed of walking
Time frame: Change from baseline at 3 weeks
walking speed - km/h;
Stance phase
Time frame: Change from baseline at 3 weeks
stance phase at percent of gait cycle duration,
Single support phase
Time frame: Change from baseline at 3 weeks
single support phase at percent of gait cycle duration
Hip joint amplitude
Time frame: Change from baseline at 3 weeks
hip joint range of motion at degree
Knee joint amplitude
Time frame: Change from baseline at 3 weeks
knee joint range of motion at degree
Ankle joint amplitude
Time frame: Change from baseline at 3 weeks
ankle joint range of motion at degree
EMG amplitude of tibialis anterior muscle
Time frame: Change from baseline at 3 weeks
envelope EMG amplitude of the tibialis anterior muscle at mkV
EMG amplitude of gastrocnemus muscle
Time frame: Change from baseline at 3 weeks
envelope EMG amplitude of the gastrocnemus muscle at mkV
EMG amplitude of quadriceps femoris muscle
Time frame: Change from baseline at 3 weeks
envelope EMG amplitude of the quadriceps femoris muscle at mkV
EMG amplitude of Hamstring muscle
Time frame: Change from baseline at 3 weeks
envelope EMG amplitude of the hamstring muscle at mkV
5 secondary outcomes
Muscle strength
Time frame: Change from baseline at 3 weeks
Activities of Daily Living
Time frame: Change from baseline at 3 weeks
Modified Rankin Scale for Neurologic Disability
Time frame: Change from baseline at 3 weeks
The Timed Up and Go Test
Time frame: Change from baseline at 3 weeks
The Medical Research Council Weakness Scale
Time frame: Change from baseline at 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- 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.
Galina E Ivanova, PhD study chair
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback gait training by biomechanical target parameter in people with Stroke and Biofeedback, run by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health 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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry V Skvortsov, PhD (+79166925419, skvortsov.biom@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait cycle (time frame: Change from baseline at 3 weeks). The study lists 12 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 12 Mar 2024.