NCT06822296

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
Last Updated

February 12, 2025

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

December 15, 2024

Last Update Submit

February 6, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    Baseline and after 12 weeks of training

Study Arms (2)

Core Stability Training

EXPERIMENTAL

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

Other: Designed rehabilitation program

Traditional physical therapy

ACTIVE COMPARATOR

Traditional physical therapy used to treat the same condition

Other: Physical Therapy

Interventions

Exercises to improve function of children with CP

Traditional physical therapy

Program of exercises to enhance function

Core Stability Training

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years
  • to 1+ spasticity according to modified Ashworth scale
  • level II and III according to GMFCs
  • able to follow instructions and understand commands

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, 12613, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 31914039BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 15, 2024

First Posted

February 12, 2025

Study Start

February 1, 2023

Primary Completion

June 30, 2023

Study Completion

September 30, 2023

Last Updated

February 12, 2025

Record last verified: 2023-07

Locations