Biofeedback Gait Training by Target Biomechanical Parameters in the Early Recovery Period of Stroke (TargetGait)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Hemiparesis; Gait, Hemiplegic; Biofeedback; Gait Training
• Intervention / Treatment: Other: Biofeedback gait training by biomechanical target parameter

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dmitry V Skvortsov, PhD; Phone Number: +79166925419; Email: skvortsov.biom@gmail.com
• Study Contact Backup: Name: Sergey N Kaurkin, PhD; Phone Number: +79164348631; Email: kaurkins@bk.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 117997
    • Recruiting
    • FCCerebroPathStroke
    • Contact: Dmitry Skvortsov, PhD; Phone Number: +79166925419; Email: skvortsov.biom@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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,
• 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

Exclusion Criteria:

• Signs of orthostatic hypotension during training,
• patient desire to withdraw from the study,
• neurological deficit worsening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Target Biofeedbak gait training; 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.
Experimental: Target Biofeedbak gait training-2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait cycle	gait cycle duration - at seconds;	Change from baseline at 3 weeks
Foot clearance	foot clearance at centimeters;	Change from baseline at 3 weeks
Speed of walking	walking speed - km/h;	Change from baseline at 3 weeks
Stance phase	stance phase at percent of gait cycle duration,	Change from baseline at 3 weeks
Single support phase	single support phase at percent of gait cycle duration	Change from baseline at 3 weeks
Hip joint amplitude	hip joint range of motion at degree	Change from baseline at 3 weeks
Knee joint amplitude	knee joint range of motion at degree	Change from baseline at 3 weeks
Ankle joint amplitude	ankle joint range of motion at degree	Change from baseline at 3 weeks
EMG amplitude of tibialis anterior muscle	envelope EMG amplitude of the tibialis anterior muscle at mkV	Change from baseline at 3 weeks
EMG amplitude of gastrocnemus muscle	envelope EMG amplitude of the gastrocnemus muscle at mkV	Change from baseline at 3 weeks
EMG amplitude of quadriceps femoris muscle	envelope EMG amplitude of the quadriceps femoris muscle at mkV	Change from baseline at 3 weeks
EMG amplitude of Hamstring muscle	envelope EMG amplitude of the hamstring muscle at mkV	Change from baseline at 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Change from baseline at 3 weeks

Collaborators and Investigators

• Sponsor: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
• Investigators: Study Chair: Galina E Ivanova, PhD, Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: stroke; hemiparesis; gait; rehabilitation; biofeedback
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis; Gait Disorders, Neurologic
• Other Study ID Numbers: BiofeedbackTargetGaitTraining

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No