NCT07289373

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 4, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

Cerebral palsy

Outcome Measures

Primary Outcomes (3)

  • Gait

    Assessed by 2D gait analysis

    2 months

  • Functional mobility

    Assessed by Time Up and Go test

    2 months

  • Energy Expenditure

    Assessed by Energy Expenditure Index Heart Rate

    2 months

Study Arms (2)

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.

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.

Procedure: High intensity interval training

Interventions

Moderate-intensity endurance training (MIET) by walking or running on a treadmill

Group A

Aerobic training exercises in a form of high-intensity interval training (HIIT) by walking or running on a treadmill

Group B

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mai E. Abbass

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Proffessor, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

November 23, 2024

Primary Completion

March 10, 2025

Study Completion

March 10, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations