NCT07248514

Brief Summary

This randomized clinical trial focuses on a sample of 139 of children diagnosed with backpack syndrome, assessing both subjective pain levels and objective measures of trunk muscle endurance before and after a structured Pilates intervention. The Pilates regimen is designed to strengthen core muscles, improve flexibility, and promote better posture, all of which are critical for mitigating the adverse effects associated with heavy backpack use.Data will be collected from North Star School Allama Iqbal town,Lahore,Standard Grammar School, Allama iqbal town ,Kips School, Allama iqbal town,Ali School System, Allama Iqbal Town Using standardized pain assessment scales(VAS) and endurance tests(Modified Biering-Sørensen Test), the effect of pilates on pain and trunk endurance will concluded and the data will analysed with spss 23

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

Pilates, Modified Biering-Sørensen Test

Outcome Measures

Primary Outcomes (2)

  • Visual Analouge Scale

    The Visual Analog Scale (VAS) is a tool used to measure subjective characteristics or attitudes that cannot be directly measured, commonly used in pain assessment. The scale is often represented as a horizontal line, typically 10 cm in length, anchored by terms at each end that represent extremes of the sensation being measured

    12 weeks

  • Modified Biering-Sørensen

    The Modified Biering-Sørensen Test is an adaptation of the original Biering-Sørensen test, used to assess endurance in the muscles of the lower back, particularly the lumbar extensor muscles. The test measures how long a person can hold a specific static position, which helps evaluate core strength and endurance.

    12 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

Interventional group

Other: Pilates exercise

Group B

ACTIVE COMPARATOR

Experimental group

Other: General Stretching exercises

Interventions

The exercise program will be performed twice a week for 12 weeks changing the exercises for every four weeks. Pilates exercises will consist of four exercises which are selected from original Pilates plan (month 1: rolling back, one leg stretch, shoulder bridge and the push up; month 2: the hundred, one leg stretch, the leg pull and one leg circle; month 3: roll up, scissors, swimming and one leg stretch) (4)

Group A

Group B will perform routine physical therapy (RPT) alone. These routine exercises will consist of stretching exercises adding some games, stretching and relaxation exercises at the end. i,e stretching exercises, posture training, and spinal flexibility exercises

Group B

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 12-16 years.
  • Being Systemically healthy
  • Being physically active and participating in ordinary assessments(4)
  • Children with musculoskeletal backpain
  • Children with hyper thoracic kyphosis i.e. excessive antero-posterior curvature of the thoracic spine of greater than 40°
  • Children complaining about low back pain

You may not qualify if:

  • Children with a history of severe musculoskeletal conditions (e.g., scoliosis, fractures, or surgery).
  • Any neurological disorders or developmental conditions affecting motor function
  • Children with cardiological, metabolic or rheumatic illness
  • Children with no complaints of low back pain and postural instability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imran Amjad

Lahore, Punjab Province, 5400, Pakistan

RECRUITING

Related Publications (1)

  • Gonzalez-Galvez N, Vaquero-Cristobal R, Marcos-Pardo PJ. Effect of Pilates Method on muscular trunk endurance and hamstring extensibility in adolescents during twelve weeks training and detraining. J Bodyw Mov Ther. 2020 Apr;24(2):11-17. doi: 10.1016/j.jbmt.2020.02.002. Epub 2020 Feb 21.

    PMID: 32507135BACKGROUND

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Muhammad Farooqi, MS-PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS-PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This randomized clinical trial focuses on a sample of 140 of children diagnosed with backpack syndrome, assessing both subjective pain levels and objective measures of trunk muscle endurance before and after a structured Pilates intervention. The Pilates regimen is designed to strengthen core muscles, improve flexibility, and promote better posture, all of which are critical for mitigating the adverse effects associated with heavy backpack use.Data will be collected from North Star School Allama Iqbal town,Lahore,Standard Grammar School, Allama iqbal town ,Kips School, Allama iqbal town,Ali School System, Allama Iqbal Town Using standardized pain assessment scales(VAS) and endurance tests(Modified Biering-Sørensen Test), the effect of pilates on pain and trunk endurance will concluded and the data will analysed with spss 23.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

October 27, 2025

Primary Completion

January 25, 2026

Study Completion

January 30, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations