NCT07736417

Brief Summary

This randomized controlled trial will evaluate the effectiveness of a 12-week comprehensive core stabilization exercise program on balance, trunk control, and gross motor function in children with spastic diplegic cerebral palsy. Outcome measures will be assessed at baseline and at the end of the intervention to determine changes following treatment.

Trial Health

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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 25, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 25, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

BalanceTrunk controlGross motor function

Outcome Measures

Primary Outcomes (2)

  • Balance

    Pediatric Balance Scale (PBS) is a 14-item performance-based scale used to assess functional balance in children. Total scores range from 0 to 56, with higher scores indicating better balance.

    Baseline and post 12 weeks of intervention

  • Trunk Control

    Trunk Control Measurement Scale (TCMS) is a clinical scale used to evaluate static and dynamic trunk control and trunk coordination in children with cerebral palsy. Total scores range from 0 to 58, with higher scores indicating better trunk control.

    Baseline and post 12 weeks of intervention

Secondary Outcomes (1)

  • Gross Motor Function

    Baseline and post 12 weeks of intervention

Study Arms (2)

Core Stabilization Exercise Program with Conventional Therapy

EXPERIMENTAL

Participants will receive a structured core stabilization exercise program in addition to conventional physiotherapy. The program includes progressive exercises targeting trunk muscle activation, trunk control, and postural control, tailored to each participant's functional ability. Sessions will be conducted 3 times per week for 12 weeks.

Other: ExerciseOther: Conventional

Conventional therapy

ACTIVE COMPARATOR

Participants will receive conventional physiotherapy consisting of stretching, strengthening, balance training, gait training, and functional exercises according to standard rehabilitation practice. Sessions will be conducted 3 times per week for 12 weeks.

Other: Conventional

Interventions

Progressive exercises targeting trunk muscle strength, stability, and postural control alongside conventional therapy

Core Stabilization Exercise Program with Conventional Therapy

Stretching exercises, strengthening exercises, balance training, gait training, functional activities according to standard rehabilitation practice

Conventional therapyCore Stabilization Exercise Program with Conventional Therapy

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed with spastic diplegic cerebral palsy
  • Gross Motor Function Classification System (GMFCS) Levels II-III
  • Stable medical management for at least 3 months prior to enrollment
  • Ability to understand and follow simple verbal instructions

You may not qualify if:

  • Fixed contracture or musculoskeletal deformities limiting exercise
  • Orthopedic surgery or botulinum injection within the previous 3 months
  • Uncontrolled epilepsy
  • Severe visual impairment
  • Participation in another rehabilitation intervention during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa Tameer-e-Millat University

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

ExerciseCongresses as Topic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaOrganizationsHealth Care Economics and Organizations

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

July 25, 2026

First Posted

July 30, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations