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

NCT07683624 | Not Yet Recruiting DMC

• 1 other identifier: P.T.REC/012/006164
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gait Training; Hemiplegic Cerebral Palsy

Keywords

cerebral palsy; hemiplegia; gait parameters; inertial sensors; biofeedback; gait assessment; Steadys gait training

Outcome Measures

Primary Outcomes (11)

• 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.

Study Arms (2)

Study Group

EXPERIMENTAL

* Conventional physical therapy program * Steadys Biofeedback Gait Training system

Device: Steadys Biofeedback Gait Training System; Other: Conventional Physical Therapy

Control Group

ACTIVE COMPARATOR

* Conventional physical therapy program * Traditional gait training

Other: Conventional Physical Therapy; Other: Traditional Gait Training

Interventions

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.

Study Group

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.

Control Group; Study Group

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.

Control Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy Cairo University

Cairo, 11351, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Naglaa Ezzat, MSc

CONTACT

+20 01061074626; naglaaezzat39@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: 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 control group will receive traditional gait training for 30 minutes while children in study group will receive gait training using Steadys system for 30 minutes.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)