AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Dmitry V Skvortsov, PhD contact

+79166925419

skvortsov.biom@gmail.com

Sergey N Kaurkin, PhD contact

+79164348631

kaurkins@bk.ru

Russia1 site, 1 recruiting
  • FCCerebroPathStroke

    Moscow, 117997

    Dmitry Skvortsov, PhD, +79166925419, skvortsov.biom@gmail.com

    Recruiting

Other trials in Russia

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.

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 groups in NCT06299943
Study groupRoleWhat they receive
Target Biofeedbak gait trainingExperimentalPatients 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-2ExperimentalPatients 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.

  1. Gait cycle

    gait cycle duration - at seconds;

    Measured: Change from baseline at 3 weeks

  2. Foot clearance

    foot clearance at centimeters;

    Measured: Change from baseline at 3 weeks

  3. Speed of walking

    walking speed - km/h;

    Measured: Change from baseline at 3 weeks

  4. Stance phase

    stance phase at percent of gait cycle duration,

    Measured: Change from baseline at 3 weeks

  5. Single support phase

    single support phase at percent of gait cycle duration

    Measured: Change from baseline at 3 weeks

  6. Hip joint amplitude

    hip joint range of motion at degree

    Measured: Change from baseline at 3 weeks

  7. Knee joint amplitude

    knee joint range of motion at degree

    Measured: Change from baseline at 3 weeks

  8. Ankle joint amplitude

    ankle joint range of motion at degree

    Measured: Change from baseline at 3 weeks

  9. EMG amplitude of tibialis anterior muscle

    envelope EMG amplitude of the tibialis anterior muscle at mkV

    Measured: Change from baseline at 3 weeks

  10. EMG amplitude of gastrocnemus muscle

    envelope EMG amplitude of the gastrocnemus muscle at mkV

    Measured: Change from baseline at 3 weeks

  11. EMG amplitude of quadriceps femoris muscle

    envelope EMG amplitude of the quadriceps femoris muscle at mkV

    Measured: Change from baseline at 3 weeks

  12. EMG amplitude of Hamstring muscle

    envelope EMG amplitude of the hamstring muscle at mkV

    Measured: Change from baseline at 3 weeks

Secondary outcomes (5)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted8 Mar 2024
  2. Study start24 Jan 2022
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in