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CompletedNCT06822296Updated Feb 12, 2025

Effect of Core Stability Training on Segmental Trunk Control and Quality of Life in Children with Cerebral Palsy

An interventional study of Physical Therapy and Designed rehabilitation program in Spastic Diplegia and Cerebral Palsy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Feb 2023, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Spastic Diplegia
  • Cerebral Palsy
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 40 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • significant visual or auditory problems
  • fixed deformities
  • Botox injection
  • orthopedic surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Core Stability Training

    receive an experimental intervention in form of functional exercises to improve core

    Other: Designed rehabilitation program

  • Active comparator
    Traditional physical therapy

    Traditional physical therapy used to treat the same condition

    Other: Physical Therapy

Interventions

  • OtherPhysical Therapy

    Exercises to improve function of children with CP

  • OtherDesigned rehabilitation program

    Program of exercises to enhance function

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline and after 12 weeks of training

  2. 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)

    Time frame: Baseline and after 12 weeks of training

07

Study locations

1 site
  • Faculty of Physical Therapy, Cairo University
    Giza, Cairo 12613, Egypt
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06822296
Lead sponsor
Cairo University
Responsible party
Tamer Mohamed El-Saeed (Associate Professor, Cairo University) — Principal investigator
First posted
Feb 12, 2025
Start date
Feb 1, 2023
Primary completion
Jun 30, 2023
Completion
Sep 30, 2023
Last update
Feb 12, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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