Spastic DiplegiaNCT07289347
Effect of a Light Stimulated Footsteps Pathway on Gait in Spastic Children
A study testing therapeutic exercise and gait training on light stimulated footsteps pathway in people with Spastic Diplegia, run by Amira saad mohamed at 1 site in Egypt.
Trial summary
PURPOSE: The purpose of this study will be investigation of the effect oflight stimulated footsteps pathway on kinematics of gait in spastic diplegic children BACKGROUND: The goal of most therapy procedures for children with spastic cerebral palsy is to increase their walking abilities. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Spastic Diplegia
- What is being tested?
- therapeutic exercise and gait training on light stimulated footsteps pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2025to 20 May 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age will range between5 and 8 years old.
- They had Grade 1 and 1+ hypertonia according to Modified Ashworth Scale (Bohannon and Smith, 1987)
- Motor Classification System, they were at level I and II (GMFCS)
- They will capable of following commands and comprehend them.
- They will exhibit defective gait kinematics, which can be determined through gait kinematics evaluation.
- All patients who will be enrolled to the study will have their informed consent.
Who cannot join
- Epilepsy history.
- Taking any anti spastic drugs.
- Both lower limbs had permanent deformity.
- Surgical intervention history.
- Have visual or auditory defects.
- Chest infections or unstable cardiac status.
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- Infective skin conditions.
- Markedly high or low blood pressure.
- Individuals with cardiopulmonary conditions.
- Individuals with any pelvic disease.
- Individuals undergoing radiation therapy or chemotherapy.
- Hepatic or pancreatic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Light Stimulated Footsteps Pathway on Kinematics of Gait in Spastic Diplegic Children
PURPOSE: The purpose of this study will be investigation of the effect oflight stimulated footsteps pathway on kinematics of gait in spastic diplegic children BACKGROUND: The goal of most therapy procedures for children with spastic cerebral palsy is to increase their walking abilities. Locomotor training usinglight stimulated footsteps pathwayhas been recommended for the rehabilitation of children with cerebral palsy in an effort to improve walking independence and gait speed.
HYPOTHESES: Walking on light stimulated footsteps pathway may not affect kinematics of gait in spastic diplegic children RESEARCH QUESTION: Does walking on light stimulated footsteps pathway have any effect onkinematics of gait in spastic diplegic children?
- Conditions
- Spastic Diplegia
- Being tested
- therapeutic exercise, gait training on light stimulated footsteps pathway
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic exerciseOther
Balance training from different positions. Weight shifting exercises by facilitation of single limb support while standing.
Ascending and descending stairs. Gait training between parallel bars applied three times per week for three month
gait training on light stimulated footsteps pathwayOther
same routine program as the control group as well as 30 minutes of gait training on light stimulated footsteps pathway:
- Walk on the light stimulated footsteps (Forward steps)
- Walk on the light stimulated footsteps (backward steps)
- Tandem gait over light yellow line applied three times per week for three month
| Study group | Role | What they receive |
|---|---|---|
| Control Group (A) | Active comparator | This group of fifteen children received a regular traditional therapeutic exercise program three times per week for three month based on the Pragmatic approach . Receives: Other: therapeutic exercise |
| Study Group (B) | Experimental | The fifteen children in this group got the same therapeutic exercise program as the control group, as well as 30 minutes of gait training on light stimulated footsteps pathway three times per week for three month. Receives: Other: therapeutic exercise; Other: gait training on light stimulated footsteps pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
step length
kinovea software used to evaluate step length The unit of measurement for Step Length is centimeter (cm)
Measured: At baseline and re assessed following 3 months
step width
kinovea software used to evaluate step width The unit of measurement for Step width is centimeter (cm)
Measured: At baseline and re assessed following 3 months
spasticity
The Modified Ashworth Scale (MAS) used for evaluation
MAS assigns a grade of spasticity from a 0-4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch.
Measured: At baseline and re assessed following 3 months
gross motor function
The Gross Motor Function Measure (GMFM) is a standardized tool used to assess changes in gross motor function in children, particularly those with cerebral palsy.
The GMFM uses a four-point ordinal scale for scoring each item, where:
0: Does not initiate
- Initiates (but does not complete)
- Partially completes
- Completes the task fully Scores can be summed to calculate raw and percent scores for each dimension and a total GMFM score.
Measured: At baseline and re assessed following 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start20 Sep 2025
- Primary completion27 Apr 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic DiplegiaStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amira saad mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amira saad mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289347
- Sponsor's protocol ID
- 012/006097
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Light Stimulated Footsteps Pathway on Kinematics of Gait in Spastic Diplegic Children
- ClinicalTrials.gov ID
- NCT07289347
- Acronym / sponsor ID
- 012/006097
- Conditions
- Spastic Diplegia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Amira saad mohamedUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 27 Apr 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 17 Dec 2025 (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.
PURPOSE: The purpose of this study will be investigation of the effect oflight stimulated footsteps pathway on kinematics of gait in spastic diplegic children BACKGROUND: The goal of most therapy procedures for children with spastic cerebral palsy is to increase their walking abilities. Locomotor training usinglight stimulated footsteps pathwayhas been recommended for the rehabilitation of children with cerebral palsy in an effort to improve walking independence and gait speed.
HYPOTHESES: Walking on light stimulated footsteps pathway may not affect kinematics of gait in spastic diplegic children RESEARCH QUESTION: Does walking on light stimulated footsteps pathway have any effect onkinematics of gait in spastic diplegic children?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (A) | Active comparator | Other: therapeutic exerciseThis group of fifteen children received a regular traditional therapeutic exercise program three times per week for three month based on the Pragmatic approach . |
| Study Group (B) | Experimental | Other: therapeutic exercise, Other: gait training on light stimulated footsteps pathwayThe fifteen children in this group got the same therapeutic exercise program as the control group, as well as 30 minutes of gait training on light stimulated footsteps pathway three times per week for three month. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age will range between5 and 8 years old.
- They had Grade 1 and 1+ hypertonia according to Modified Ashworth Scale (Bohannon and Smith, 1987)
- Motor Classification System, they were at level I and II (GMFCS)
- They will capable of following commands and comprehend them.
- They will exhibit defective gait kinematics, which can be determined through gait kinematics evaluation.
Key exclusion criteria (12 listed)
- Epilepsy history.
- Taking any anti spastic drugs.
- Both lower limbs had permanent deformity.
- Surgical intervention history.
- Have visual or auditory defects.
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 |
|---|---|---|
| therapeutic exerciseBalance training from different positions. Weight shifting exercises by facilitation of single limb support while standing. Ascending and descending stairs. Gait training between parallel bars applied three times per week for three month | Other | Control Group (A), Study Group (B) |
| gait training on light stimulated footsteps pathwaysame routine program as the control group as well as 30 minutes of gait training on light stimulated footsteps pathway: 1. Walk on the light stimulated footsteps (Forward steps) 2. Walk on the light stimulated footsteps (backward steps) 3. Tandem gait over light yellow line applied three times per week for three month | Other | Study Group (B) |
Primary outcome
step length
Time frame: At baseline and re assessed following 3 months
kinovea software used to evaluate step length The unit of measurement for Step Length is centimeter (cm)
step width
Time frame: At baseline and re assessed following 3 months
kinovea software used to evaluate step width The unit of measurement for Step width is centimeter (cm)
spasticity
Time frame: At baseline and re assessed following 3 months
The Modified Ashworth Scale (MAS) used for evaluation MAS assigns a grade of spasticity from a 0-4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch.
gross motor function
Time frame: At baseline and re assessed following 3 months
The Gross Motor Function Measure (GMFM) is a standardized tool used to assess changes in gross motor function in children, particularly those with cerebral palsy. The GMFM uses a four-point ordinal scale for scoring each item, where: 0: Does not initiate 1. Initiates (but does not complete) 2. Partially completes 3. Completes the task fully Scores can be summed to calculate raw and percent scores for each dimension and a total GMFM score.
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 Apr 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic exercise and gait training on light stimulated footsteps pathway in people with Spastic Diplegia, run by Amira saad mohamed 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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
step length (time frame: At baseline and re assessed following 3 months). The study lists 4 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 Apr 2026.