- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06473298
Role of Light Tracking Intervention in Children With Spastic Hemiplegia
June 22, 2024 updated by: MAHMOUD AHMED GOUDA ALI ABDELAZIZ ABDELMONEIM, Cairo University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mahmoud Ahmed Abdelmoneim, B.Sc
- Phone Number: 01000409225
- Email: mahmoudgouda2022@gmail.com
Study Locations
-
-
-
Cairo, Egypt, 12613
- Recruiting
- Cairo University
-
Contact:
- Mahmoud Ahmed Abdelmoneim, B.Sc
- Phone Number: +201000409225
- Email: mahmoudgouda2022@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Visual light tracking program
|
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.
|
Experimental: Selective physical therapy program
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
June 7, 2024
First Submitted That Met QC Criteria
June 22, 2024
First Posted (Actual)
June 25, 2024
Study Record Updates
Last Update Posted (Actual)
June 25, 2024
Last Update Submitted That Met QC Criteria
June 22, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Light Tracking in Hemiplegia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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