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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemiplegic Cerebral Palsy; Gait Training
• Intervention / Treatment: Device: Steadys Biofeedback Gait Training System; Other: Conventional Physical Therapy; Other: Traditional Gait Training

Detailed Description

• 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naglaa Ezzat, MSc; Phone Number: +20 01061074626; Email: naglaaezzat39@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11351
    • Faculty of Physical Therapy Cairo University
    • Contact: Naglaa Ezzat, MSc; Phone Number: +20 01061074626; Email: naglaaezzat39@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Conventional physical therapy program; Steadys Biofeedback Gait Training system	Device: 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.; Other: 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.
Active Comparator: Control Group; Conventional physical therapy program; Traditional gait training	Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait cycle time	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	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	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	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	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	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	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	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	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	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	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.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: biofeedback; hemiplegia; cerebral palsy; inertial sensors; gait parameters; gait assessment; Steadys gait training
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebral Palsy; Hemiplegia
• Other Study ID Numbers: P.T.REC/012/006164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because there is no plan to make de-identified participant-level data publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No