- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289373
Moderate Versus High-intensity Interval Training in Children With Diplegia.
December 4, 2025 updated by: Mai Elsayed Abbass, Cairo University
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.
Study Overview
Status
Completed
Conditions
Intervention / 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 Type
Interventional
Enrollment (Actual)
30
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 Locations
-
-
-
Giza, Egypt
- Faculty of physical therapy, 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:
- 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.
Exclusion criteria:
- 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.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
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.
|
Moderate-intensity endurance training (MIET) by walking or running on a treadmill
|
|
Experimental: Group B
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.
|
Aerobic training exercises in a form of high-intensity interval training (HIIT) by walking or running on a treadmill
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait
Time Frame: 2 months
|
Assessed by 2D gait analysis
|
2 months
|
|
Functional mobility
Time Frame: 2 months
|
Assessed by Time Up and Go test
|
2 months
|
|
Energy Expenditure
Time Frame: 2 months
|
Assessed by Energy Expenditure Index Heart Rate
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mai E. Abbass, Cairo University
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 (Actual)
November 23, 2024
Primary Completion (Actual)
March 10, 2025
Study Completion (Actual)
March 10, 2025
Study Registration Dates
First Submitted
December 4, 2025
First Submitted That Met QC Criteria
December 4, 2025
First Posted (Actual)
December 17, 2025
Study Record Updates
Last Update Posted (Actual)
December 17, 2025
Last Update Submitted That Met QC Criteria
December 4, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/002427
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
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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