Effect of Biofeedback-Based Inertial Sensors Gait Training on Walking Parameters in Children With Hemiplegia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorCairo University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Severe visual or hearing impairment.
Fixed deformities or surgical interventions in the lower extremities.
Botulinum toxin injections in the last 6 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Steadys Biofeedback Gait Training System
DeviceParticipants 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 interventionConventional 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 interventionTraditional gait training for 30 minutes, three times per week for three consecutive months, including walking on a balance beam, balance board, stepper, and separator.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Study GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and immediately after completion of the 3-month intervention.2
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.
Time frame
Baseline and immediately after completion of the 3-month intervention.3
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.
Time frame
Baseline and immediately after completion of the 3-month intervention.4
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.
Time frame
Baseline and immediately after completion of the 3-month intervention.Sponsors and contacts
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Source ClinicalTrials.gov
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