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

Condition(s) studied

Investigational drug(s) / intervention(s)

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: 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: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Gait cycle time — 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.
• Step time — 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.
• Cadence — 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.
• Stance phase — 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.
• Single support — 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.
• Double support — 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.
• Swing phase — 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.
• Stride length — 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.
• Gait speed — 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.
• Foot clearance — 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.
• Swing width — 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.

Trial sites (1)

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