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

NCT06299943 | Recruiting

• 1 other identifier: BiofeedbackTargetGaitTraining
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Biofeedback; Gait, Hemiplegic; Gait Training; Hemiparesis

Keywords

stroke; hemiparesis; gait; rehabilitation; biofeedback

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (5)

• Muscle strength

  Change from baseline at 3 weeks

• Activities of Daily Living

  Change from baseline at 3 weeks

• Modified Rankin Scale for Neurologic Disability

  Change from baseline at 3 weeks

• The Timed Up and Go Test

  Change from baseline at 3 weeks

• The Medical Research Council Weakness Scale

  Change from baseline at 3 weeks

Study Arms (2)

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.

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.

Other: Biofeedback gait training by biomechanical target parameter

Interventions

Biofeedback gait training by biomechanical target parameter OTHER

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.

Target Biofeedbak gait training; Target Biofeedbak gait training-2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health: lead

Study Sites (1)

FCCerebroPathStroke

Moscow, 117997, Russia

RECRUITING

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Galina E Ivanova, PhD

  Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency

  STUDY CHAIR

Central Study Contacts

Dmitry V Skvortsov, PhD

CONTACT

+79166925419; skvortsov.biom@gmail.com

Sergey N Kaurkin, PhD

CONTACT

+79164348631; kaurkins@bk.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinicians involved in the measurements and researchers that worked with data results did not know which group each patient was in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-group, single-blinded controlled clinical trial.

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 8, 2024
• Study Start: January 24, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)