Spastic DiplegiaNCT06270550
Role of Dynamic Movement Intervention in Children with Spastic Diplegia
A study testing Dynamic Movement Intervention in people with Spastic Diplegia, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Spastic Diplegia
- What is being tested?
- Dynamic Movement Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Sep 2025
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Spastic Diplegia
- Being tested
- Dynamic Movement Intervention
- Keywords
- Dynamic Movement Intervention
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Movement InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Dynamic movement intervention based group. | Experimental | Not described Receives: Other: Dynamic Movement Intervention |
| Selective physical therapy program based group. | Experimental | Not described Receives: Other: Dynamic Movement Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group, measured using Humac Balance System.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (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.
- 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 Abdel Aziz Abdel Aziz Awara, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270550
- Sponsor's protocol ID
- DMI in Spastic Diplegia
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dynamic Movement Intervention on Children with Spastic Diplegia
- ClinicalTrials.gov ID
- NCT06270550
- Acronym / sponsor ID
- DMI in Spastic Diplegia
- Conditions
- Spastic Diplegia
- Keywords
- Dynamic Movement Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 21 Feb 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic movement intervention based group. | Experimental | Other: Dynamic Movement Intervention |
| Selective physical therapy program based group. | Experimental | Other: Dynamic Movement Intervention |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Visual impairment (visual loss- cataract- myopia- hyperopia).
- Hearing impairment (deafness)
- Cognitive problem.
- Uncontrolled Convulsions.
- Orthopedic surgery for the affected lower limbs within one year.
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 |
|---|---|---|
| Dynamic Movement InterventionDynamic 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 | Other | Dynamic movement intervention based group., Selective physical therapy program based group. |
Primary outcome
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.
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 12 Feb 2025.
- Individual participant dataSharing planned: No
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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 Dynamic Movement Intervention in people with Spastic Diplegia, 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 6 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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 Mahmoud Awara, B.Sc (+201013829575, crawara07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 12 Feb 2025.