NCT05765019

Brief Summary

In this study, it was aimed to evaluate the effect of spinal mobilization techniques applied in addition to core stabilization exercises in Adolescent Idiopathic Scoliosis (AIS) patients. Consecutive adolescents with idiopathic scoliosis, aged 10 to 16 years, without a brace, and with a Cobb curvature of 10 to 25 degrees were randomly divided into two groups using the closed envelope method: Spinal mobilization and core stabilization exercise were applied to the experimental group; Only core stabilization exercises were applied to the control group. Both groups received interventions twice a week for 10 weeks. Outcome measurements were made before treatment and after 10 weeks of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 19, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

February 25, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

February 19, 2023

Last Update Submit

March 3, 2024

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent idiopathic scoliosisCore stabilization exercisesSpinal mobilizationManual therapyPulmonary function

Outcome Measures

Primary Outcomes (1)

  • Cobb angle

    The most accepted way of scoliosis evaluation is Cobb angle measurement performed on frontal plane x-ray. The Cobb angle is the curvature of the spine, and measuring it is essential for determining the severity of scoliosis, selecting the best course of action, and monitoring the progression or regression of cases following treatment. The Cobb angle measure as the vertically intersecting angle after determining the vertebrae above the apex and below the apex, which are the most tilted from the concave side of the curvature of the spine.

    Change from pretreatment and 10 weeks after treatment.

Secondary Outcomes (7)

  • Angle of Trunk Rotation

    Change from pretreatment and 10 weeks after treatment.

  • Pulmonary Functions Test- PEF (Peak expiratory flow)

    Change from pretreatment and 10 weeks after treatment.

  • Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)

    Change from pretreatment and 10 weeks after treatment.

  • Pulmonary Functions Test-FVC (Forced vital capacity)

    Change from pretreatment and 10 weeks after treatment.

  • Pulmonary Functions Test- FEV1/FVC

    Change from pretreatment and 10 weeks after treatment.

  • +2 more secondary outcomes

Study Arms (2)

Spinal mobilization group

EXPERIMENTAL
Other: Spinal mobilizationOther: Core stabilization exercise

Core stabilization exercise group

ACTIVE COMPARATOR
Other: Core stabilization exercise

Interventions

Spinal mobilizationOTHER

Spinal mobilization and core stabilization exercise

Spinal mobilization group
Core stabilization exerciseOTHER

Stabilization exercises for the spine

Core stabilization exercise groupSpinal mobilization group

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients diagnosed with AIS
  • Age 10-16 years
  • Cobb angle was between 10° and 25
  • Risser sing did not exceed 4
  • Informed consent forms were signed by the parents and children

You may not qualify if:

  • Used brace,
  • Had previous spinal surgery, inferior limb length difference,
  • Could not exercise due to another injury/diagnosis,
  • Had neuromuscular, psychiatric, cardiovascular, respiratory insufficiency and mental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 13, 2023

Study Start

February 25, 2023

Primary Completion

October 15, 2023

Study Completion

November 5, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations

TU(1)