- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06270550
Role of Dynamic Movement Intervention in Children with Spastic Diplegia
February 10, 2025 updated by: Mahmoud Abdel Aziz Abdel Aziz Awara, Cairo University
Efficacy of Dynamic Movement Intervention on Children with Spastic Diplegia
The study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic 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 Awara, B.Sc
- Phone Number: +201013829575
- Email: crawara07@gmail.com
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Cairo University
-
-
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 can walk alone short distance and climb stairs holding on rail (Grade I & II according to GMFCS).
- They can understand and execute instructions.
- They will be medically stable.
- Degree of spasticity will be ranged from 1 to 1+ degree according to the Modified Ashworth Scale.
Exclusion criteria:
- Visual impairment (visual loss- cataract- myopia- hyperopia).
- Hearing impairment (deafness)
- Cognitive problem.
- Uncontrolled Convulsions.
- Orthopedic surgery for the affected lower limbs within one year.
- Botulinum toxin injection within the last 6 months or within the study period.
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: Dynamic movement intervention based group.
|
Dynamic movement intervention is a physical therapy approach for infants suffering abnormal developmental motor evolution caused by a known or unknown non-degenerative syndrome affecting the central nervous system
|
|
Experimental: Selective physical therapy program based group.
|
Dynamic movement intervention is a physical therapy approach for infants suffering abnormal developmental motor evolution caused by a known or unknown non-degenerative syndrome affecting the central nervous system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group, measured using Humac Balance System.
Time Frame: Baseline
|
Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group with different intervention. As balance will be assessed using Humac Balance System. |
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)
March 1, 2025
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
February 12, 2024
First Submitted That Met QC Criteria
February 19, 2024
First Posted (Actual)
February 21, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 10, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMI in Spastic Diplegia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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