NCT07764952

Brief Summary

This study aims to evaluate the effects of a Core Stability Program on abdominal endurance and constipation severity in wheelchair-bound children with cerebral palsy. It seeks to determine whether targeted core strengthening exercises can improve muscular endurance of the abdominal region while also alleviating constipation symptoms, thereby enhancing overall functional health and quality of life in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2026

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

April 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

May 5, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

Cerebral PalsyExercise TherapyMuscle StrengthMuscle EnduranceConstipationPosture

Outcome Measures

Primary Outcomes (2)

  • Change in Abdominal Muscle Endurance

    Abdominal muscle endurance will be assessed to evaluate the effect of a core stability program in wheelchair-bound children with cerebral palsy. The Modified Curl-Up Test will be used. Participants perform as many correct curl-ups as possible in 1 minute with standardized form and positioning. Time Frame: Baseline and 3 months Measurement: Number of correctly performed curl-ups in 1 minute. Higher number indicates better outcome.

    3 months

  • Change in Constipation Severity

    Constipation severity will be assessed to evaluate the effect of a core stability program on bowel function in wheelchair-bound children with cerebral palsy. The Modified Bristol Stool Form Scale for Children \[mBSFS-C\] will be used. Parents/caregivers record stool type daily for 7 days. An average weekly score will be calculated. Time Frame: Baseline and 3 months Measurement: mBSFS-C score ranging from 1 to 7. Scores of 1-2 indicate constipation. Scores of 3-4 indicate normal stool form. Improvement toward scores of 3-4 indicates better outcome.

    3 months

Study Arms (2)

Core Stability Program

EXPERIMENTAL

Participants in this arm will receive a structured core stability training program designed to improve abdominal muscle strength and endurance. The program will include supervised therapeutic exercises focusing on trunk control, core activation, and postural stability, administered over a specified period in addition to routine care or standard management.

Other: Core Stability Program

traditional Physiotherapy

EXPERIMENTAL

Participants in this arm will receive conventional physiotherapy focusing on improving abdominal endurance. The intervention will include exercises such as static and dynamic trunk strengthening, pelvic tilts, assisted sit-ups, breathing exercises, and postural control activities. Sessions will be conducted under the supervision of a trained physiotherapist, typically 3-5 times per week for a specified duration. The program aims to enhance core muscle strength, improve trunk stability, and support functional activities in wheelchair-bound children with cerebral palsy.

Other: traditional Physiotherapy

Interventions

The intervention consists of a structured core stability program designed to improve trunk control and abdominal muscle function in wheelchair-bound children with cerebral palsy. The program includes targeted exercises focusing on strengthening deep abdominal and trunk muscles through progressive, age-appropriate, and functional activities performed under physiotherapist supervision over a defined period.

Core Stability Program

Participants in this arm will receive conventional physiotherapy focusing on improving abdominal endurance. The intervention will include exercises such as static and dynamic trunk strengthening, pelvic tilts, assisted sit-ups, breathing exercises, and postural control activities. Sessions will be conducted under the supervision of a trained physiotherapist, typically 3-5 times per week for a specified duration. The program aims to enhance core muscle strength, improve trunk stability, and support functional activities in wheelchair-bound children with cerebral palsy.

traditional Physiotherapy

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of cerebral palsy - particularly spastic or hemiplegic types
  • Regardless the cause of CP
  • Age range typically 6-12 years old
  • A motor function level IV as per the Gross Motor Function Classification System
  • Grade 1 / 1+ (mild spasticity) according to Modified Ashworth Scale (MAS)
  • Non-ambulatory or inability to ambulate
  • CP children with constipation ; Fewer than 3 defecations per week, History of hard stools or painful defecation
  • Defecation frequency measured less than three times a week is considered constipation using Rome IV
  • Parental/guardian permission (informed consent) and child assent of a minor if the patient was able to assent (35).
  • The ability to understand and follow instructions

You may not qualify if:

  • Had visual impairments, extreme spasticity, uncontrolled convulsions, any other neuromuscular diseases, ataxia-telangiectasia, spinocerebellar ataxia, and/or Joubert syndrome
  • Children who received botulinum toxin injection within the last six months, had fixed contractures or deformities of the spine or the extremities, and had previous surgeries of the spine or the lower extremities within one year or visual, auditary or respiratory disorders
  • Children with any other systemic co morbidities, physical deformity in GIT, intellectual disability and recent traumatic brain injury
  • Participation in other intensive physical therapy programs simultaneously
  • Severe musculoskeletal deformities that limit participation in the training
  • Children with congenital anatomic abnormalities of the urogenital area, including Hirschsprung's disease, spina bifida, anorectal malformations, urethral strictures, down syndrome or hypothyroidism, gastrointestinal bleeding, intestinal perforation, ileus obstruction, inflammatory bowel disease, toxic megacolon, metal implants or pacemakers in the abdominal area, open wounds in the abdominal and thoracic region, history of surgery on the stomach, malignancy .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CLC

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • El Shemy SA. Trunk endurance and gait changes after core stability training in children with hemiplegic cerebral palsy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2018;31(6):1159-1167. doi: 10.3233/BMR-181123.

    PMID: 30056415BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyConstipation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Javeria Azeem, MS PPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
In this study, participant masking will be implemented by limiting participants' awareness of group allocation to reduce expectancy bias. Investigator masking will be applied by ensuring that the assessors responsible for measuring abdominal endurance and constipation outcomes are not informed about the participants' group assignments. This approach helps minimize assessment bias and improves the reliability and validity of the study results.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This interventional study will employ a parallel design in which participants are assigned to two groups that receive different interventions or conditions simultaneously. Each group will be followed over the same study period, and outcomes will be assessed at baseline and after the intervention. This design allows comparison of effects between groups receiving the core stability program and the comparison Traditional physiotherapy, ensuring evaluation of the intervention's effectiveness under similar time conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

August 14, 2026

Study Start

April 1, 2026

Primary Completion

May 15, 2026

Study Completion

June 1, 2026

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations