Hemiplegic Cerebral PalsyNCT07683624
Effect of Biofeedback-Based Inertial Sensors Gait Training on Walking Parameters in Children With Hemiplegia
A study testing Steadys Biofeedback Gait Training System, Conventional Physical Therapy and Traditional Gait Training in people with Hemiplegic Cerebral Palsy and Gait Training, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy, Gait Training
- What is being tested?
- Steadys Biofeedback Gait Training System, Conventional Physical Therapy and Traditional Gait Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Severe visual or hearing impairment.
- Fixed deformities or surgical interventions in the lower extremities.
- Botulinum toxin injections in the last 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Physical Therapy Cairo University
Cairo, 11351
Naglaa Ezzat, MSc, +20 01061074626, naglaaezzat39@gmail.com
About this study
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.
Read the 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:
- Steadys Software System
The Steadys system primary components and adjustment mechanisms include:
- The Neurosens inertial measurement units (IMU) sensors
- Treadmill
- BFB Monitor
- Record
- Patient folder
- 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.
- Conditions
- Hemiplegic Cerebral Palsy, Gait Training
- Being tested
- Steadys Biofeedback Gait Training System, Conventional Physical Therapy, Traditional Gait Training
- Keywords
- cerebral palsy, hemiplegia, gait parameters, inertial sensors, biofeedback, gait assessment, Steadys gait training
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steadys Biofeedback Gait Training SystemDevice
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.
Conventional Physical TherapyOther
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.
Traditional Gait TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | * Conventional physical therapy program
* Steadys Biofeedback Gait Training system Receives: Device: Steadys Biofeedback Gait Training System; Other: Conventional Physical Therapy |
| Control Group | Active comparator | * Conventional physical therapy program
* Traditional gait training Receives: Other: Conventional Physical Therapy; Other: Traditional Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately after completion of the 3-month intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Ezzat Abd Allah Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683624
- Sponsor's protocol ID
- P.T.REC/012/006164
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because there is no plan to make de-identified participant-level data publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biofeedback-Based Inertial Sensors Gait Training on Walking Parameters in Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT07683624
- Acronym / sponsor ID
- P.T.REC/012/006164
- Conditions
- Hemiplegic Cerebral Palsy, Gait Training
- Keywords
- cerebral palsy, hemiplegia, gait parameters, inertial sensors, biofeedback, gait assessment, Steadys gait training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Steadys Software System
The Steadys system primary components and adjustment mechanisms include:
- The Neurosens inertial measurement units (IMU) sensors
- Treadmill
- BFB Monitor
- Record
- Patient folder
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Steadys Biofeedback Gait Training System, Other: Conventional Physical Therapy* Conventional physical therapy program * Steadys Biofeedback Gait Training system |
| Control Group | Active comparator | Other: Conventional Physical Therapy, Other: Traditional Gait Training* Conventional physical therapy program * Traditional gait training |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Severe visual or hearing impairment.
- Fixed deformities or surgical interventions in the lower extremities.
- Botulinum toxin injections in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steadys Biofeedback Gait Training SystemParticipants 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. | Device | Study Group |
| Conventional Physical TherapyConventional 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 | Control Group, Study Group |
| Traditional Gait TrainingTraditional gait training for 30 minutes, three times per week for three consecutive months, including walking on a balance beam, balance board, stepper, and separator. | Other | Control Group |
Primary outcome
Gait cycle time
Time frame: Baseline and immediately after completion of the 3-month intervention.
Change in gait cycle time measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Step time
Time frame: Baseline and immediately after completion of the 3-month intervention.
Change in step time measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Cadence
Time frame: Baseline and immediately after completion of the 3-month intervention.
Change in cadence (steps/minute) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Stance phase
Time frame: Baseline and immediately after completion of the 3-month intervention.
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.
Single support
Time frame: Baseline and immediately after completion of the 3-month intervention.
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.
Double support
Time frame: Baseline and immediately after completion of the 3-month intervention.
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.
Swing phase
Time frame: Baseline and immediately after completion of the 3-month intervention.
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.
Stride length
Time frame: Baseline and immediately after completion of the 3-month intervention.
Change in stride length (cm) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Gait speed
Time frame: Baseline and immediately after completion of the 3-month intervention.
Change in gait speed measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Foot clearance
Time frame: Baseline and immediately after completion of the 3-month intervention.
Change in foot clearance (cm) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Swing width
Time frame: Baseline and immediately after completion of the 3-month intervention.
Change in swing width (cm) measured using the Steadys gait analysis system with inertial measurement unit (IMU) sensors during a 10-meter walking test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steadys Biofeedback Gait Training System, Conventional Physical Therapy and Traditional Gait Training in people with Hemiplegic Cerebral Palsy and Gait Training, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naglaa Ezzat, MSc (+20 01061074626, naglaaezzat39@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait cycle time (time frame: Baseline and immediately after completion of the 3-month intervention.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.