NCT06803121

Brief Summary

To evaluate the efficacy of core stability (CS) exercises on curve magnitude, posture, trunk deformity and quality of life in adolescent females with idiopathic scoliosis.

Trial Health

87
On Track

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
Completed

Started Feb 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

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

January 27, 2025

Last Update Submit

May 11, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Measurement of Cobb angles

    Cobb angles on anterior and posterior spine radiographs taken in standing position. The Cobb angle is the angle between two lines, drawn perpendicular to the upper endplate of the uppermost vertebra involved and the lower endplate of the lowest vertebra involved. Once a patient's Cobb angle is determined, the condition can be further classified on its severity scale of mild, moderate, or severe. Cobb angles will be assessed for all adolescent females in both groups A \& B before and after treatment.

    3 months

  • Measurement of trunk asymmetry in scoliosis

    A scoliometer is an instrument that measures trunk asymmetry in scoliosis, or angle of trunk rotation (ATR). It is a small, non-invasive device (essentially a mini-level) that is placed over the spine while a person is in a forward bending position. The scoliometer reading indicates degree of trunk asymmetry (rotation). Generally, an angle of trunk rotation that is less than 5 degrees is insignificant and may not require follow-up. A measurement of 5 to 9 degrees at least warrants reexamination in six months. A measurement of 10 degrees or greater requires radiologic evaluation for Cobb angle measurement.

    3 months

Secondary Outcomes (2)

  • Trunk appearance perception scale (TAPS)

    3 months

  • The Scoliosis research society-22 questionnaire (SRS-22)

    3 months

Study Arms (2)

Traditional treatment

ACTIVE COMPARATOR

It will be consisted of thirty adolescent females with idiopathic scoliosis and will be treated by traditional treatment (traditional exercises and bracing), two sessions per week for three months (24 sessions).

Other: Traditional treatment

Traditional treatment + Core stability exercises

EXPERIMENTAL

It will be consisted of thirty adolescent females with idiopathic scoliosis and will be treated by traditional treatment (traditional exercises and bracing) in addition to core stability exercises, two sessions per week for three months (24 sessions).

Other: Traditional treatmentOther: Core stability exercises

Interventions

Traditional exercises for scoliosis include breathing exercises, posture training, spinal flexibility exercises, stretching exercises for the involved muscles (especially for the concave side of the curve), and general strengthening exercises for the main muscle groups of trunk, pelvis, and shoulder girdle muscles (especially for the convex side of the curve).

Traditional treatmentTraditional treatment + Core stability exercises

The CS training program includes local muscle stability training (transverses abdominis, multifidus, and diaphragm), global muscle stability training (oblique abdominal muscles, psoas major, quadratus lumborum, and pelvic floor muscles), global muscle mobility training (rectus abdominis, back extensors, and hamstring muscles), and strength training of the core muscles through the thoracolumbar fascia by maintaining the neutral spine position. Diaphragmatic breathing technique will be used during exercises.

Traditional treatment + Core stability exercises

Eligibility Criteria

Age10 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Their ages will be ranged from 10-19 years.
  • All adolescent Females will be diagnosed as idiopathic scoliosis with S shape.
  • Cobb angle on anterior-posterior radiograph will be used in the assessment of thoracic and lumbar cure of each patient in this study.
  • All adolescent females are not under any other treatment method for idiopathic scoliosis.
  • Willingness and ability to comply with the study requirements and give informed consent.

You may not qualify if:

  • Patients with a history of rheumatologic, neuromuscular, cardiovascular, pulmonary, or renal diseases.
  • Patients with congenital scoliosis or spinal deformity.
  • Patients who had undergone surgical correction of the spine.
  • Patients with a tumor.
  • Enrollment in any other clinical trial during the time of this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar University

Cairo, Egypt

Location

Study Officials

  • Mohamed Ahmed Mohamed Awad, PhD

    Professor, Cairo university

    STUDY CHAIR
  • Afaf Mohamed Mahmoud Botla, PhD

    Assistant Professor, Cairo university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

February 1, 2025

Primary Completion

May 1, 2025

Study Completion

May 10, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations