NCT07568808

Brief Summary

This randomized controlled trial aimed to compare the effects of core stabilization exercises (CSE) and kinesthetic training (KT) on postural control in children with spastic diplegic cerebral palsy (GMFCS Level III), aged 4-8 years. Cerebral palsy was recognized as a non-progressive neurological disorder that affects movement, posture, and motor function, often leading to impaired balance, reduced trunk control, and decreased functional independence. Postural instability was identified as a key concern in diplegic CP, and effective rehabilitation strategies were considered essential to improve mobility and daily functioning. Core stabilization exercises focused on strengthening deep trunk muscles to enhance stability and alignment, whereas kinesthetic training emphasized proprioceptive awareness and neuromuscular coordination to improve movement accuracy and balance. Although both interventions had shown benefits individually, their comparative effectiveness remained unclear. A total of 32 participants were recruited using purposive sampling and were randomly assigned into two groups: CSE (n=16) and KT (n=16). Both groups received conventional physiotherapy for 15 minutes followed by 30 minutes of their respective interventions, three times per week for 12 weeks. Outcome assessment was conducted at baseline, mid-intervention (6 weeks), and post-intervention (12 weeks) using the Pediatric Berg Balance Scale (PBBS) to evaluate static and dynamic balance. Data were analyzed using SPSS, applying paired t-tests for within-group comparisons and independent t-tests for between-group analysis, with significance set at p \< 0.05. This study aimed to determine the more effective intervention for improving balance and functional outcomes, thereby supporting evidence-based clinical practice in pediatric rehabilitation. A total of 32 participants will be recruited using purposive sampling and randomly assigned into two groups: CSE (n=16) and KT (n=16). Both groups will receive conventional physiotherapy for 15 minutes followed by 30 minutes of their respective interventions, three times per week for 12 weeks. Outcome assessment will be conducted at baseline, mid-intervention (6 weeks), and post-intervention (12 weeks) using the Pediatric Berg Balance Scale (PBBS) to evaluate static and dynamic balance. Data will be analyzed using SPSS, applying paired t-tests for within-group comparisons and independent t-tests for between-group analysis, with significance set at p \< 0.05. This study aims to determine the more effective intervention for improving balance and functional outcomes, thereby supporting evidence-based clinical practice in pediatric rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

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

August 8, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

core stabilitykinestheticpeadetriccerebral palsydiaplegia

Outcome Measures

Primary Outcomes (1)

  • Balance Control is measured using the PBBS to evaluate both static and dynamic postural stability.

    The Pediatric Berg Balance Scale (PBBS) is a standardized clinical assessment used to measure functional balance and postural control in children with motor challenges. It consists of 14 distinct tasks that mimic activities of daily living, including the ability to sit and stand without support, transfer between chairs, reach forward, and pick up objects from the floor. Each task is evaluated on a 5-point scale ranging from 0 to 4, where a higher score reflects a greater level of independence and stability. With a maximum total score of 56, the PBBS serves as a reliable tool for tracking a child's progress over time and determining the effectiveness of therapeutic interventions. In this clinical trial, the scale is utilized at baseline, week 6, and week 12 to provide a clear quantitative record of the participant's balance improvements.

    6 months

Study Arms (2)

Core Stabilization Group

EXPERIMENTAL

Participants in this group received a core stabilization exercise program focusing on deep abdominal and back muscles. The protocol included the plank, bird-dog, and dead bug exercises, which were performed three times per week for four weeks.

Other: Core Stabilization Exercises

Kinesthetic Training Group

EXPERIMENTAL

Participants in this group underwent kinesthetic training aimed at improving proprioception and joint position sense. This included weight-shifting and balance activities on stable and unstable surfaces, which were performed three times per week for four weeks.

Other: Kinesthetic Training

Interventions

A 4-week exercise program focusing on deep abdominal and back muscles. Sessions are 45 minutes each, 3 times per week. Exercises include The Plank (front and side), Bird-Dog, and Dead Bug. Progression will be managed by increasing hold times and repetitions as the patient's stability improves.

Core Stabilization Group

A 4-week sensory-motor training program designed to improve proprioception and balance. Sessions are 45 minutes each, 3 times per week. Activities include single-limb standing, weight shifting on stable and unstable surfaces (like foam pads), and coordinated limb movements to enhance joint position sense and postural control.

Kinesthetic Training Group

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Spastic diplegic CP
  • GMFCS Level III
  • Age range: 4 to 8 years
  • Must have verbal communication
  • Ability to follow verbal commands

You may not qualify if:

  • Severe cognitive impairment
  • History of epilepsy or seizures in the past 3 months.
  • Children with progressive neurological or genetic disorders (e.g., muscular dystrophy).
  • Any acute respiratory infection or chronic pulmonary disease
  • Any visual or auditory impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex, Pediatric Rehabilitation Department, ULTH.

Lahore, Punjab Province, 42000, Pakistan

Location

Related Publications (2)

  • Eliasson, A. C., Krumlinde-Sundholm, L., Rösblad, B., Beckung, E., Arner, M., Ohrvall, A. M., & Rosenbaum, P. (2006). The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol, 48(7), 549-554.

    BACKGROUND
  • Akay, T., & Murray, A. J. (2021). Relative contribution of proprioceptive and vestibular sensory systems to locomotion: opportunities for discovery in the age of molecular science. International Journal of Molecular Sciences, 22(3), 1467.

    BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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
Student

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 6, 2026

Study Start

August 8, 2025

Primary Completion

March 9, 2026

Study Completion

April 10, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations