Spastic DiplegiaNCT06822296
Effect of Core Stability Training on Segmental Trunk Control and Quality of Life in Children with Cerebral Palsy
A study testing Physical Therapy and Designed rehabilitation program in people with Spastic Diplegia and Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Spastic diplegia is a common shape of cerebral palsy that significantly affects trunk control and quality of life in children. Core stability training (CST) has been utilized as a potential intervention to improve the trunk function. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Spastic Diplegia, Cerebral Palsy
- What is being tested?
- Physical Therapy and Designed rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 30 Sep 2023
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-6 years
- 1 to 1+ spasticity according to modified Ashworth scale
- level II and III according to GMFCs
- able to follow instructions and understand commands
Who cannot join
- significant visual or auditory problems
- fixed deformities
- Botox injection
- orthopedic surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza, Cairo Governorate, 12613
About this study
Official title: Effect of Core Stability Training on Segmental Trunk Control and Quality of Life in Children with Spastic Diplegia: a Randomized Controlled Trial
Spastic diplegia is a common shape of cerebral palsy that significantly affects trunk control and quality of life in children. Core stability training (CST) has been utilized as a potential intervention to improve the trunk function. This study investigated the effects of CST on segmental trunk control and quality of life in children with spastic diplegia.
Forty children with spastic diplegia (age: 3 - 6 years) were randomly assigned to either a control group (n=20) receiving a selected physical therapy program or an experimental group (n=20) receiving the same program plus a 30-minute CST program three times weekly for 12 weeks. Segmental trunk control was assessed using the Segmental Assessment of Trunk Control (SATCO) scale, and quality of life was measured using the Pediatric Quality of Life Inventory (PedsQL). Both outcome measures were evaluated pre- and post-intervention.
- Conditions
- Spastic Diplegia, Cerebral Palsy
- Being tested
- Physical Therapy, Designed rehabilitation program
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Exercises to improve function of children with CP
Designed rehabilitation programOther
Program of exercises to enhance function
| Study group | Role | What they receive |
|---|---|---|
| Core Stability Training | Experimental | receive an experimental intervention in form of functional exercises to improve core Receives: Other: Designed rehabilitation program |
| Traditional physical therapy | Active comparator | Traditional physical therapy used to treat the same condition Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segmental Assessment of Trunk Control scale
Higher scores mean a better outcome. Minimum Score: 0 (No control at any level) Maximum Score: 14 (Full control at all seven levels, each scoring 2)
Measured: Baseline and after 12 weeks of training
Quality of Life Inventory Scale
Higher scores mean a better outcome. Minimum Score: 0 (poorest quality of life) Maximum Score: 100 (best quality of life)
Measured: Baseline and after 12 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Feb 2023
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Mohamed El-Saeed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822296
- Sponsor's protocol ID
- P.T.REC/012/004816
- Status last verified
- Jul 2023
- First submitted
- 15 Dec 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang C, Chen Y, Chen G, Xie Y, Mo J, Li K, Huang R, Pan G, Cai Y, Zhou L. Efficacy and safety of core stability training on gait of children with cerebral palsy: A protocol for a systematic review and meta-analysis. Medicine (Baltimore). 2020 Jan;99(2):e18609. doi: 10.1097/MD.0000000000018609.
PubMed 31914039
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
- Effect of Core Stability Training on Segmental Trunk Control and Quality of Life in Children with Spastic Diplegia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06822296
- Acronym / sponsor ID
- P.T.REC/012/004816
- Conditions
- Spastic Diplegia, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 12 Feb 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.
Spastic diplegia is a common shape of cerebral palsy that significantly affects trunk control and quality of life in children. Core stability training (CST) has been utilized as a potential intervention to improve the trunk function. This study investigated the effects of CST on segmental trunk control and quality of life in children with spastic diplegia.
Forty children with spastic diplegia (age: 3 - 6 years) were randomly assigned to either a control group (n=20) receiving a selected physical therapy program or an experimental group (n=20) receiving the same program plus a 30-minute CST program three times weekly for 12 weeks. Segmental trunk control was assessed using the Segmental Assessment of Trunk Control (SATCO) scale, and quality of life was measured using the Pediatric Quality of Life Inventory (PedsQL). Both outcome measures were evaluated pre- and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Stability Training | Experimental | Other: Designed rehabilitation programreceive an experimental intervention in form of functional exercises to improve core |
| Traditional physical therapy | Active comparator | Other: Physical TherapyTraditional physical therapy used to treat the same condition |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3-6 years
- 1 to 1+ spasticity according to modified Ashworth scale
- level II and III according to GMFCs
- able to follow instructions and understand commands
Key exclusion criteria (4 listed)
- significant visual or auditory problems
- fixed deformities
- Botox injection
- orthopedic surgery
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 |
|---|---|---|
| Physical TherapyExercises to improve function of children with CP | Other | Traditional physical therapy |
| Designed rehabilitation programProgram of exercises to enhance function | Other | Core Stability Training |
Primary outcome
Segmental Assessment of Trunk Control scale
Time frame: Baseline and after 12 weeks of training
Higher scores mean a better outcome. Minimum Score: 0 (No control at any level) Maximum Score: 14 (Full control at all seven levels, each scoring 2)
Quality of Life Inventory Scale
Time frame: Baseline and after 12 weeks of training
Higher scores mean a better outcome. Minimum Score: 0 (poorest quality of life) Maximum Score: 100 (best quality of life)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 31914039Huang C, Chen Y, Chen G, Xie Y, Mo J, Li K, Huang R, Pan G, Cai Y, Zhou L. Efficacy and safety of core stability training on gait of children with cerebral palsy: A protocol for a systematic review and meta-analysis. Medicine (Baltimore). 2020 Jan;99(2):e18609. doi: 10.1097/MD.0000000000018609.
- Individual participant dataSharing planned: Undecided
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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 Physical Therapy and Designed rehabilitation program in people with Spastic Diplegia and 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 4 inclusion and 4 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Segmental Assessment of Trunk Control scale (time frame: Baseline and after 12 weeks of training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06822296, which also lists 1 linked publication.
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.