Набор скоро начнётся NCT07683624

Effect of Biofeedback-Based Inertial Sensors Gait Training on Walking Parameters in Children With Hemiplegia

Без фазы С лечением Hemiplegic Cerebral Palsy Gait Training

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Steadys Biofeedback Gait Training System, Conventional Physical Therapy, Traditional Gait Training.
Кому может быть актуально: Состояния в реестре: Hemiplegic Cerebral Palsy, Gait Training. Базовые параметры: 7 лет — 12 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to learn about the effect of biofeedback-based inertial sensors gait training on walking parameters in children with hemiplegia. The main question it aims to answer is: Does biofeedback-based inertial sensors gait training have an effect on walking parameters in children with hemiplegia. * Participants in the study and control groups will receive 30 minutes designed physical therapy program, three times per week for three successive months. * Children in the control group will receive traditional gait training for 30 minutes, three times per week for three successive months. * Children in the study group will receive 30 minutes biofeedback-based inertial sensors gait training session three times per week for three successive months.

Подробное описание

* The current study is randomized controlled trial (RCT). * Thirty children with spastic hemiplegic CP of both sexes (8to 12 years) will be selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University. * Children will be randomly assigned into two groups; group A (control) and group B (study). * Children in both groups will receive traditional physical therapy program for 30 minutes, three times per week for three successive months. In addition, children in group A will receive traditional gait training for 30 minutes while children in group B will receive gait training using Steadys system for 30 minutes. * Instrumentation for patient selection include:

1- Modified Ashworth' Scale: Spasticity of children participating in this study will be ranged from 1 to 1+. 2- The Gross Motor Function Classification System (GMFCS): Children participating in this study will be level I or II on GMFCS. * Instrumentation for Evaluation include:

1. Steadys Software System

The Steadys system primary components and adjustment mechanisms include:

1. The Neurosens inertial measurement units (IMU) sensors 2. Treadmill 3. BFB Monitor 4. Record 5. Patient folder 6. Report For Treatment

Children in each group will receive 30 minutes designed physical therapy program, three times per week for three successive months. Each session will consist from the following:

* Mat activities: standing up from sitting, kneeling and half kneeling. * Activities while standing: weight bearing exercises, single leg balance with bar, and balance exercise with different floor styles. * Training righting, equilibrium a protective reactions from standing. Control group

Children in this group will receive traditional gait training for 30 minutes, three times per week for three successive months. Each gait training session will consist from the following:

* Walking on balance beam - Walking on balance board * walking over stepper - Gait training using separator Study group

Children in this group will receive 30 minutes BFB gait training session three times per week for three successive months. The gait training steps will be as follows:

* Each child with the attached sensors will stand on the treadmill, which will be turned on and set to a speed comfortable for the child then the child's gait data will be acquired by the IMU sensors and transferred to PC via Wi-Fi to be converted to the easy-to-read displays. * The child will be asked to look at the BFB monitor while walking on the treadmill. * Instructions will be given to the child to correct the abnormal walking pattern based on the visual and auditory feedback that will be provided through the BFB monitor. * The abnormal gait parameter will be visualized on the monitor and played back as audio cues to ensure the feedback. * The feedback is shown as interaction with virtual walking environment. * During the session, the selected parameter will be displayed as columns with a marked specified range of change. An out-of-range value shown as an error and causes a slowdown in the movement around the virtual environment and in the completion of the set task. Depending on the virtual environment used, there will be also other details reflecting the test performance. The automatic training algorithm will be configured such that in the case of a successful completion, the range of change will be adjusted towards greater symmetry of the parameters. * Based on the obtained BFB, the patient changes his/her gait pattern to improve it.

Вмешательства

Устройство Steadys Biofeedback Gait Training System
Participants receive gait training using the Steadys biofeedback gait training system for 30 minutes, three times per week for three consecutive months. The system uses wearable inertial measurement unit (IMU) sensors to provide real-time visual and auditory biofeedback while the child walks on a treadmill, enabling correction of abnormal gait patterns and improvement of gait symmetry.
Другое Conventional Physical Therapy
Conventional physical therapy program for 30 minutes, three times per week for three consecutive months, including mat activities, standing exercises, and training of righting, equilibrium, and protective reactions.
Другое Traditional Gait Training
Traditional gait training for 30 minutes, three times per week for three consecutive months, including walking on a balance beam, balance board, stepper, and separator.

Первичные конечные точки

Gait cycle time [Срок оценки: Baseline and immediately after completion of the 3-month intervention.]
Step time [Срок оценки: Baseline and immediately after completion of the 3-month intervention.]
Cadence [Срок оценки: Baseline and immediately after completion of the 3-month intervention.]
Stance phase [Срок оценки: Baseline and immediately after completion of the 3-month intervention.]
Single support [Срок оценки: Baseline and immediately after completion of the 3-month intervention.]
Double support [Срок оценки: Baseline and immediately after completion of the 3-month intervention.]
Swing phase [Срок оценки: Baseline and immediately after completion of the 3-month intervention.]
Stride length [Срок оценки: Baseline and immediately after completion of the 3-month intervention.]
Gait speed [Срок оценки: Baseline and immediately after completion of the 3-month intervention.]
Foot clearance [Срок оценки: Baseline and immediately after completion of the 3-month intervention.]

Критерии участия

Критерии включения

Their age will range from 7 to 12 years.
The degree of their spasticity will range from 1 to 1+ according to Modified Ashworth' Scale (Bohannon et al., 1987) (Appendix IⅠ).
They will be on level Ⅰ or Ⅱ on GMFCS (Palisano et al., 2007) (Appendix IⅡ).
They will be able to walk without the use of an assistive device
Children can follow instructions and understand given orders.