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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Gait cycle time [Time frame: Baseline and immediately after completion of the 3-month intervention.]
• Step time [Time frame: Baseline and immediately after completion of the 3-month intervention.]
• Cadence [Time frame: Baseline and immediately after completion of the 3-month intervention.]
• Stance phase [Time frame: Baseline and immediately after completion of the 3-month intervention.]
• Single support [Time frame: Baseline and immediately after completion of the 3-month intervention.]
• Double support [Time frame: Baseline and immediately after completion of the 3-month intervention.]
• Swing phase [Time frame: Baseline and immediately after completion of the 3-month intervention.]
• Stride length [Time frame: Baseline and immediately after completion of the 3-month intervention.]
• Gait speed [Time frame: Baseline and immediately after completion of the 3-month intervention.]
• Foot clearance [Time frame: Baseline and immediately after completion of the 3-month intervention.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Physical Therapy Cairo University — Cairo

Identifiers

NCT: NCT07683624 · P.T.REC/012/006164

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗