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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.
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:
The Steadys system primary components and adjustment mechanisms include:
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:
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental |
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| Control Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naglaa Ezzat, MSc | Contact | +20 01061074626 | naglaaezzat39@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy Cairo University | Cairo | 11351 | Egypt |
Individual participant data (IPD) will not be shared because there is no plan to make de-identified participant-level data publicly available.
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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.
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| 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. |
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| 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. |
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| 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. |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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