protocolSection identificationModule nctId: NCT06299943, orgStudyIdInfo id: BiofeedbackTargetGaitTraining, briefTitle: Biofeedback Gait Training by Target Biomechanical Parameters in the Early Recovery Period of Stroke, acronym: TargetGait, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-24, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Stroke, conditions: Biofeedback, conditions: Gait, Hemiplegic, conditions: Gait Training, conditions: Hemiparesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel-group, single-blinded controlled clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Clinicians involved in the measurements and researchers that worked with data results did not know which group each patient was in., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Biofeedback gait training by biomechanical target parameter, outcomesModule primaryOutcomes measure: Gait cycle, primaryOutcomes measure: Foot clearance, primaryOutcomes measure: Speed of walking, primaryOutcomes measure: Stance phase, primaryOutcomes measure: Single support phase, primaryOutcomes measure: Hip joint amplitude, primaryOutcomes measure: Knee joint amplitude, primaryOutcomes measure: Ankle joint amplitude, primaryOutcomes measure: EMG amplitude of tibialis anterior muscle, primaryOutcomes measure: EMG amplitude of gastrocnemus muscle, primaryOutcomes measure: EMG amplitude of quadriceps femoris muscle, primaryOutcomes measure: EMG amplitude of Hamstring muscle, secondaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Activities of Daily Living, secondaryOutcomes measure: Modified Rankin Scale for Neurologic Disability, secondaryOutcomes measure: The Timed Up and Go Test, secondaryOutcomes measure: The Medical Research Council Weakness Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: FCCerebroPathStroke, status: RECRUITING, city: Moscow, zip: 117997, country: Russian Federation, contacts name: Dmitry Skvortsov, PhD, role: CONTACT, phone: +79166925419, email: skvortsov.biom@gmail.com, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False