Spastic Hemiplegic Cerebral PalsyNCT06473298
Role of Light Tracking Intervention in Children With Spastic Hemiplegia
A study testing Visual Light Tracking in people with Spastic Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to investigate the effect of visual light tracking on gait, selective motor control and sensory processing in children with spastic hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Spastic Hemiplegic Cerebral Palsy
- What is being tested?
- Visual Light Tracking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ranged from (4-7 years).
- They will be able to walk independently.
- They will have intact auditory pathways.
- They will have intact visual pathways.
- They will have a mild degree of spasticity graded from 1 to 1+ according to the modified Ashworth scale
- They will be mentally stable.
Who cannot join
- Any other neuromuscular disorders.
- Convulsion.
- Botox injection
- Fixed deformities of lower limbs and spine.
- Selective dorsal rhizotomy (SDR).
- Children with spasticity more than 1+ according to the modified Ashworth scale.
- Children with visual disorders such as squint myopia.
- children with auditory problems.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Mahmoud Ahmed Abdelmoneim, B.Sc, +201000409225, mahmoudgouda2022@gmail.com
About this study
Official title: EFFICACY OF VISUAL LIGHT TRACKING ON CHILDREN WITH SPASTIC HEMIPLEGIA
The study aims to investigate the effect of visual light tracking on gait, selective motor control and sensory processing in children with spastic hemiplegic cerebral palsy.
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Being tested
- Visual Light Tracking
- Keywords
- Visual Light Tracking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Light TrackingOther
visual light tracking program consists of 10 tasks every task lasts for 6 minutes and may be repeated for the child especially in the first sessions to give him trials to him/her to understand the exercise.
| Study group | Role | What they receive |
|---|---|---|
| Visual light tracking program | Experimental | Visual light tracking program Receives: Other: Visual Light Tracking |
| Selective physical therapy program | Experimental | Selective physical therapy program Receives: Other: Visual Light Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Visual light tracking intervention on quality of walking, selective motor control and sensory processing of the study group compared to control group with different intervention.
The quality of walking as step length will be assessed using Kinovea software. Selective motor control will be assessed using Selective Control Assessment of the Lower Extremity (points).
Sensory processing will be assessed using the Sensory Profile Caregiver Questionnaire(points).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAHMOUD AHMED GOUDA ALI ABDELAZIZ ABDELMONEIM, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473298
- Sponsor's protocol ID
- Light Tracking in Hemiplegia
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 25 Jun 2024
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF VISUAL LIGHT TRACKING ON CHILDREN WITH SPASTIC HEMIPLEGIA
- ClinicalTrials.gov ID
- NCT06473298
- Acronym / sponsor ID
- Light Tracking in Hemiplegia
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Keywords
- Visual Light Tracking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 25 Jun 2024 (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 study aims to investigate the effect of visual light tracking on gait, selective motor control and sensory processing in children with spastic hemiplegic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual light tracking program | Experimental | Other: Visual Light TrackingVisual light tracking program |
| Selective physical therapy program | Experimental | Other: Visual Light TrackingSelective physical therapy program |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age ranged from (4-7 years).
- They will be able to walk independently.
- They will have intact auditory pathways.
- They will have intact visual pathways.
- They will have a mild degree of spasticity graded from 1 to 1+ according to the modified Ashworth scale
Key exclusion criteria (8 listed)
- Any other neuromuscular disorders.
- Convulsion.
- Botox injection
- Fixed deformities of lower limbs and spine.
- Selective dorsal rhizotomy (SDR).
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 |
|---|---|---|
| Visual Light Trackingvisual light tracking program consists of 10 tasks every task lasts for 6 minutes and may be repeated for the child especially in the first sessions to give him trials to him/her to understand the exercise. | Other | Selective physical therapy program, Visual light tracking program |
Primary outcome
Effect of Visual light tracking intervention on quality of walking, selective motor control and sensory processing of the study group compared to control group with different intervention.
Time frame: Baseline
The quality of walking as step length will be assessed using Kinovea software. Selective motor control will be assessed using Selective Control Assessment of the Lower Extremity (points). Sensory processing will be assessed using the Sensory Profile Caregiver Questionnaire(points).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Light Tracking in people with Spastic Hemiplegic Cerebral Palsy, 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Ahmed Abdelmoneim, B.Sc (01000409225, mahmoudgouda2022@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Visual light tracking intervention on quality of walking, selective motor control and sensory processing of the study group compared to control group with different intervention. (time frame: Baseline). 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 25 Jun 2024.