Cerebral PalsyNCT07289373
Moderate Versus High-intensity Interval Training in Children With Diplegia.
A study testing Moderate intensity training and High intensity interval training in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
The aim is to compare the effects of moderate-intensity training and high-intensity interval training on gait, energy expenditure, and functional mobility in children with spastic diplegia. Methods: Thirty children with spastic diplegic cerebral palsy were allocated randomly into two groups (n=15 each). Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Moderate intensity training and High intensity interval training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Nov 2024to 10 Mar 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their age ranged from 3 to 5 years old
- The degree of spasticity ranged from 1+ to 2 according to modified Ashworth scale
- They were able to walk with limitations or holding on according to Gross Motor Function Classification System (II, III).
- They were able to follow instructions and understand commands.
- They were medically stable.
Who cannot join
- Children who had bone and tendon lengthening surgeries within the last 6 months.
- Children with lung and heart diseases and disorders.
- Children with fixed deformities in joints and bones of lower limbs.
- Children performing different sorts of physical activities.
- Children receiving any medications affecting muscle and mental function or antiepileptic drugs that affect the mental function.
- Children with perceptual defects.
- Children with any visual or sound-related issues.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Moderate Intensity Training Versus High Intensity Interval Training on Gait and Energy Expenditure in Children With Spastic Diplegia.
The aim is to compare the effects of moderate-intensity training and high-intensity interval training on gait, energy expenditure, and functional mobility in children with spastic diplegia. Methods: Thirty children with spastic diplegic cerebral palsy were allocated randomly into two groups (n=15 each). The group A and the group B. Assessment of functional mobility and energy expenditure and gait analysis for all children of both groups were assessed before and after the suggested period of treatment.
Read the detailed description
Methods: Thirty children with with spastic diplegic cerebral palsy were allocated randomly into two groups ( n= 15 each). The group A (received aerobic training with moderate intensity endurance training "MIET" by walking or running on a treadmill) and the group B (received aerobic training exercises in a form of high intensity interval training "HIT" by walking or running on a treadmill). Treatment was delivered for 20minutes, 3 times per week for two successive months. Assessment of functional mobility and energy expenditure using Timed Up and Go(TUG) test and Energy Expenditure Index Heart Rate(EEIHR) respectively, while gait analysis for both lower limb angles of (hips and Knees) assessment using 2d gait analysis by( Kinovea) software. All children of both groups assessed before and after the suggested period of treatment.
- Conditions
- Cerebral Palsy
- Being tested
- Moderate intensity training, High intensity interval training
- Keywords
- Cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity trainingProcedure or surgery
Moderate-intensity endurance training (MIET) by walking or running on a treadmill
High intensity interval trainingProcedure or surgery
Aerobic training exercises in a form of high-intensity interval training (HIIT) by walking or running on a treadmill
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A (received aerobic training with moderate intensity endurance training "MIET" by walking or running on a treadmill). Treatment was delivered for 20minutes, 3 times per week for two successive months. Receives: Procedure: Moderate intensity training |
| Group B | Experimental | Group B (received aerobic training exercises in the form of high-intensity interval training (HIT) by walking or running on a treadmill). Treatment was delivered for 20minutes, 3 times per week for two successive months. Receives: Procedure: High intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait
Assessed by 2D gait analysis
Measured: 2 months
Functional mobility
Assessed by Time Up and Go test
Measured: 2 months
Energy Expenditure
Assessed by Energy Expenditure Index Heart Rate
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start23 Nov 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elsayed Abbass, Cairo University
- Investigators
- Mai E. Abbass, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289373
- Sponsor's protocol ID
- P.T.REC/012/002427
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Intensity Training Versus High Intensity Interval Training on Gait and Energy Expenditure in Children With Spastic Diplegia.
- ClinicalTrials.gov ID
- NCT07289373
- Acronym / sponsor ID
- P.T.REC/012/002427
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Nov 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 17 Dec 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.
The aim is to compare the effects of moderate-intensity training and high-intensity interval training on gait, energy expenditure, and functional mobility in children with spastic diplegia. Methods: Thirty children with spastic diplegic cerebral palsy were allocated randomly into two groups (n=15 each). The group A and the group B. Assessment of functional mobility and energy expenditure and gait analysis for all children of both groups were assessed before and after the suggested period of treatment.
Detailed description
Methods: Thirty children with with spastic diplegic cerebral palsy were allocated randomly into two groups ( n= 15 each). The group A (received aerobic training with moderate intensity endurance training "MIET" by walking or running on a treadmill) and the group B (received aerobic training exercises in a form of high intensity interval training "HIT" by walking or running on a treadmill). Treatment was delivered for 20minutes, 3 times per week for two successive months. Assessment of functional mobility and energy expenditure using Timed Up and Go(TUG) test and Energy Expenditure Index Heart Rate(EEIHR) respectively, while gait analysis for both lower limb angles of (hips and Knees) assessment using 2d gait analysis by( Kinovea) software. All children of both groups assessed before and after the suggested period of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Moderate intensity trainingGroup A (received aerobic training with moderate intensity endurance training "MIET" by walking or running on a treadmill). Treatment was delivered for 20minutes, 3 times per week for two successive months. |
| Group B | Experimental | Procedure: High intensity interval trainingGroup B (received aerobic training exercises in the form of high-intensity interval training (HIT) by walking or running on a treadmill). Treatment was delivered for 20minutes, 3 times per week for two successive months. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Their age ranged from 3 to 5 years old
- The degree of spasticity ranged from 1+ to 2 according to modified Ashworth scale
- They were able to walk with limitations or holding on according to Gross Motor Function Classification System (II, III).
- They were able to follow instructions and understand commands.
- They were medically stable.
Key exclusion criteria (7 listed)
- Children who had bone and tendon lengthening surgeries within the last 6 months.
- Children with lung and heart diseases and disorders.
- Children with fixed deformities in joints and bones of lower limbs.
- Children performing different sorts of physical activities.
- Children receiving any medications affecting muscle and mental function or antiepileptic drugs that affect the mental function.
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 |
|---|---|---|
| Moderate intensity trainingModerate-intensity endurance training (MIET) by walking or running on a treadmill | Procedure or surgery | Group A |
| High intensity interval trainingAerobic training exercises in a form of high-intensity interval training (HIIT) by walking or running on a treadmill | Procedure or surgery | Group B |
Primary outcome
Gait
Time frame: 2 months
Assessed by 2D gait analysis
Functional mobility
Time frame: 2 months
Assessed by Time Up and Go test
Energy Expenditure
Time frame: 2 months
Assessed by Energy Expenditure Index Heart Rate
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 17 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Mai E. Abbass study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity training and High intensity interval training in people with 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 5 inclusion and 7 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 17 Dec 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?
Gait (time frame: 2 months). The study lists 3 primary outcomes in all. 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 17 Dec 2025.