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NCT Number: NCT07683624

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

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.

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Key information

Conditions

Hemiplegic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Gait Training Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • 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:
  • Steadys Software System

The Steadys system primary components and adjustment mechanisms include:

  • The Neurosens inertial measurement units (IMU) sensors
  • Treadmill
  • BFB Monitor
  • Record
  • Patient folder
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Steadys Biofeedback Gait Training System

Device

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

Other

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

Other

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.

Primary outcomes

  1. Gait cycle time

    Time frame: 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.

  2. Step time

    Time frame: 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.

  3. Cadence

    Time frame: 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.

  4. Stance phase

    Time frame: 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.

  5. Single support

    Time frame: 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.

  6. Double support

    Time frame: 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.

  7. Swing phase

    Time frame: 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.

  8. Stride length

    Time frame: 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.

  9. Gait speed

    Time frame: 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.

  10. Foot clearance

    Time frame: 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.

  11. Swing width

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Naglaa Ezzat, MSc

CONTACT

[email protected]

+20 01061074626

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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