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

1 de julio de 2026 actualizado por: Naglaa Ezzat Abd Allah Mahmoud, Cairo University

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.

Descripción general del estudio

Descripción detallada

  • 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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Cairo, Egipto, 11351
        • faculty of physical therapy Cairo university
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Severe visual or hearing impairment.
  • Fixed deformities or surgical interventions in the lower extremities.
  • Botulinum toxin injections in the last 6 months.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Study Group
  • Conventional physical therapy program
  • 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.
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.
Comparador activo: Control Group
  • Conventional physical therapy program
  • Traditional gait training
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gait cycle time
Periodo de tiempo: Baseline and immediately after completion of the 3-month intervention.
Change in gait cycle time measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Baseline and immediately after completion of the 3-month intervention.
Step time
Periodo de tiempo: Baseline and immediately after completion of the 3-month intervention.
Change in step time measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Baseline and immediately after completion of the 3-month intervention.
Cadence
Periodo de tiempo: Baseline and immediately after completion of the 3-month intervention.
Change in cadence (steps/minute) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Baseline and immediately after completion of the 3-month intervention.
Stance phase
Periodo de tiempo: Baseline and immediately after completion of the 3-month intervention.
Change in stance phase duration (% of the gait cycle) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Baseline and immediately after completion of the 3-month intervention.
Single support
Periodo de tiempo: Baseline and immediately after completion of the 3-month intervention.
Change in single support duration (% of the gait cycle) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Baseline and immediately after completion of the 3-month intervention.
Double support
Periodo de tiempo: Baseline and immediately after completion of the 3-month intervention.
Change in double support duration (% of the gait cycle) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Baseline and immediately after completion of the 3-month intervention.
Swing phase
Periodo de tiempo: Baseline and immediately after completion of the 3-month intervention.
Change in swing phase duration (% of the gait cycle) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Baseline and immediately after completion of the 3-month intervention.
Stride length
Periodo de tiempo: Baseline and immediately after completion of the 3-month intervention.
Change in stride length (cm) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Baseline and immediately after completion of the 3-month intervention.
Gait speed
Periodo de tiempo: Baseline and immediately after completion of the 3-month intervention.
Change in gait speed measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Baseline and immediately after completion of the 3-month intervention.
Foot clearance
Periodo de tiempo: Baseline and immediately after completion of the 3-month intervention.
Change in foot clearance (cm) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Baseline and immediately after completion of the 3-month intervention.
Swing width
Periodo de tiempo: Baseline and immediately after completion of the 3-month intervention.
Change in swing width (cm) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Baseline and immediately after completion of the 3-month intervention.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

30 de junio de 2026

Finalización primaria (Estimado)

30 de septiembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

26 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de julio de 2026

Publicado por primera vez (Actual)

6 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data (IPD) will not be shared because there is no plan to make de-identified participant-level data publicly available.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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