NCT06407843

Brief Summary

A spinal malformation called scoliosis typically manifests in the first two decades of life. It is defined as a lateral curvature of the spine larger than 10, which can be identified by an x-ray using the Cobb angle. Clinically, idiopathic scoliosis is defined as a spinal curvature in the coronal plane of more than 10 degrees. It accounts for 85% of nearly all scoliosis cases. It is advised that patients with curves less than 45° get nonoperative care. The Schroth technique is mostly utilized in the treatment of scoliosis. This technique uses a physiotherapeutic approach to stretch and strengthen any weak muscles. The study's objective is to ascertain how the Scroth method affects the size of the curve, the lumbar extensors' endurance, and the mobility of the chest in cases with idiopathic scoliosis. The present research will employ a randomized control trial design, with data sourced from the Children Hospital and Institute of Child Health in Lahore, as well as the Pakistan Society for the Rehabilitation of the Disabled, Lahore (PSRD). Thirty-two patients total will be randomly assigned to two equal groups for the study. The study's inclusion criteria will include any patient with idiopathic scoliosis who is between the ages of 9 and 17 and has a Cobb angle between 10˞ and 26˞, regardless of gender. The study will not include any patients with neurological conditions, other orthopedic conditions, surgery histories involving the spine, severe systemic disorders, psychological conditions, or neuromuscular disorders. The experimental group will engage in both routine physical therapy (RPT) and Schroth exercise therapy (SET), while the control group will only receive normal physical treatment. Chest mobility, lumbar extensor endurance, and curve magnitude (Cobb angle) will all be examined. The Sorensen test for lumbar muscle endurance, the X-ray for Cobb angle, and the measuring tape for chest mobility will be the instruments utilized to collect data. The data analysis tool of choice will be SPSS 23.00.

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 May 2024

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

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

May 6, 2024

Last Update Submit

March 10, 2025

Conditions

Keywords

Cobb angleChest mobilityIdiopathic scoliosisLumbar muscle enduranceSchroth Exercise therapy

Outcome Measures

Primary Outcomes (1)

  • Cobb angle using X-rays to determine curve magnitude

    By measuring the end vertebra tilt angles, one may determine the Cobb angle, which is the curve magnitude that is the sum of the upper and lower end vertebra tilt angles. Just identifying the two end vertebrae and measuring the tilt angles will yield an accurate and quick computation of the Cobb angle. The tilt angle method's measurement steps are as follows: 1. Sketch the connecting line between the upper and lower vertebral endplates on the film. 2. Determine the upper and lower endplate tilt angles. 3. To calculate the Cobb angle, add the two measured findings.

    Baseline and 2 weeks

Secondary Outcomes (2)

  • Sorenson test to measure Lumbar extensor muscle

    Baseline and 2 weeks

  • Measuring tape to measure chest Mobility

    Baseline and 2 weeks

Study Arms (2)

Schroth Method

EXPERIMENTAL

In addition to regular physical therapy, this group will engage in Schroth exercises therapy (SET). These regular workouts will include breathing exercises, posture training, spinal flexibility exercises, and stretching activities (especially for the muscles on the concave side of the curve). Patients were positioned asymmetrically to optimize trunk rectification. These exercises will include spinal elongation, de-flexion, stretching, de-rotation, and strengthening. To provide passive support and correct posture during the SET, long poles, foam blocks, and rice sacks were employed. Ten sessions total (30 minutes each, five days a week) will be conducted.

Other: Schroth MethodOther: Regular Physical Therapy

Regular Physical Therapy

EXPERIMENTAL

This Group will engage in independent routine physical therapy (RPT). Stretching exercises (especially for the muscles on the concave side of the curve) will be part of these regular workouts. The patient will be actively taught standard upper extremity range-of-motion exercises. Without using any creams or lotions, myofascial release (MFR) procedures will be applied straight to the skin. To assist avoid back discomfort, pressure will be administered to the restricted area for 90-120 seconds in order to release the tissue. Twice day, perform 10 repetitions of a 5-second hold while supine pelvic tilt, twice. The same protocol will be followed for the cat and camel, double-leg abdominal presses, and superwoman exercises. There will be breathing exercises including thoracic expansion and diaphragmatic breathing.

Other: Regular Physical Therapy

Interventions

In addition to regular physical therapy, Group A will engage in Schroth exercises therapy (SET). These regular workouts will include breathing exercises, posture training, spinal flexibility exercises, and stretching activities (especially for the muscles on the concave side of the curve). Ten sessions total (30 minutes each, five days a week) will be conducted.

Schroth Method

Stretching exercises (especially for the muscles on the concave side of the curve) will be part of these regular workouts. Twice day, perform 10 repetitions of a 5-second hold while supine pelvic tilt, twice. Ten sessions total (30 minutes each, five days a week) will be conducted.

Regular Physical TherapySchroth Method

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages 9 to 17
  • Both genders will be included.
  • X-rays will show idiopathic scoliosis with Cobb Angle 10-26.

You may not qualify if:

  • Any type of cerebral illness
  • Any other skeletal issue
  • Spine procedure history
  • Severe systemic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

pakistan Society for the Rehabilitaion of Disables

Lahore, Punjab Province, 05308, Pakistan

Location

Related Publications (5)

  • Strukčinskaitė V, Raistenskis J, Šidlauskienė A, Strukčinskienė B, Griškonis S. EFFECTS OF THE SCHROTH METHOD FOR TRUNK MUSCLES'STATIC ENDURANCE AND SPINE MOBILITY IN GIRLS WITH IDIOPATHIC SCOLIOSIS. Health sciences. 2017;27(5):71-5.

    BACKGROUND
  • Athawale V, Phansopkar P, Darda P, Chitale N, Chinewar A. Impact of Physical Therapy on Pain and Function in a Patient With Scoliosis. Cureus. 2021 May 26;13(5):e15261. doi: 10.7759/cureus.15261.

    PMID: 34188999BACKGROUND
  • Blevins K, Battenberg A, Beck A. Management of Scoliosis. Adv Pediatr. 2018 Aug;65(1):249-266. doi: 10.1016/j.yapd.2018.04.013. Epub 2018 Jun 12. No abstract available.

    PMID: 30053928BACKGROUND
  • Kocaman H, Bek N, Kaya MH, Buyukturan B, Yetis M, Buyukturan O. The effectiveness of two different exercise approaches in adolescent idiopathic scoliosis: A single-blind, randomized-controlled trial. PLoS One. 2021 Apr 15;16(4):e0249492. doi: 10.1371/journal.pone.0249492. eCollection 2021.

    PMID: 33857180BACKGROUND
  • Park J, So WY. The Effect of the Schroth Rehabilitation Exercise Program on Spinal and Feet Alignment in Adolescent Patients with Idiopathic Scoliosis: A Pilot Study. Healthcare (Basel). 2022 Feb 20;10(2):398. doi: 10.3390/healthcare10020398.

    PMID: 35207011BACKGROUND

Study Officials

  • Anna Zaheer, MSPT-(NMPT)

    Riphah International University Lahore

    STUDY CHAIR
  • Mowadat Zahra, MSPT-(PPT)

    Riphah International University, Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

May 15, 2024

Primary Completion

August 5, 2024

Study Completion

October 15, 2024

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations