NCT03823053

Brief Summary

The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates. Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. In addition, the quality of life in these individuals is also seen to decrease.Children with adolescent idiopathic scoliosis have inadequate respiratory function and a decrease in functional capacity. At the same time, these children show muscle weakness in certain parts of the body. The aim of this study was to investigate the relationship between home based core stabilization training, respiratory parameters, peripheral muscle strength, balance, functional capacity and quality of life in individuals with young scoliosis. The investigators suggest that the addition of core stabilization training to children with mild and moderate adolescent idiopathic scoliosis will produce good results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

January 28, 2019

Last Update Submit

November 12, 2020

Conditions

Keywords

Adolescent idiopathic scoliosisScoliosisCore Stabilization TrainingExercise TrainingPulmonary Function Test6 - Minute Walk TestPeripheral Muscle StrengthBalance with BiodexQuality of Life

Outcome Measures

Primary Outcomes (5)

  • Change from baseline Forced Vital Capacity (FVC) at 8 weeks

    Eight weeks

  • Change from baseline Forced Expiratory volume in 1 second (FEV1)at 8 weeks

    Eight weeks

  • Change from baseline Peripheral Muscle strength at 8 weeks

    Eight weeks

  • Change from baseline Balance at 8 weeks

    Eight weeks

  • Change from baseline distance covered in Six- Minute Walk Test at 8 weeks

    Eight weeks

Secondary Outcomes (1)

  • Change from baseline axial trunk rotation (ATR)

    Eight weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 30 minutes. The content of the physiotherapy program; posture, interscapular muscle strengthening, stretching and lateral flexion exercises are formed.

Other: Home Based Traditional Scoliosis Exercise

Training Group

EXPERIMENTAL

In addition to home based traditional scoliosis exercise, the training group will also receive core stabilization exercise training for 8 weeks, 5 days a week, for 30 minutes. Core stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the "local system" muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the "global system" includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and latissimus dorsi.

Other: Home Based Traditional Scoliosis ExerciseOther: Home Based Core Stabilization Training

Interventions

Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. Exercises will be applied 1 sets of 10 repetitions and once a day.

Control GroupTraining Group

Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. In addition, the training group received core stabilization exercises for multifidus, transversus abdominis, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and pelvic floor muscles.Exercises will be applied 1 sets of 10 repetitions and once a day.

Training Group

Eligibility Criteria

Age10 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescent Idiopathic Scoliosis diagnosis

You may not qualify if:

  • Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental disorders which may affect the assessments results.
  • Subjects previously undertaken any of spinal surgeries.
  • Subjects involved in exercise training 3 or more days a week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Eyüp, 34050, Turkey (Türkiye)

Location

Related Publications (1)

  • Yildirim S, Ozyilmaz S, Elmadag NM, Yabaci A. Effects of Core Stabilization Exercises on Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength, Functional Capacity, and Perceived Appearance in Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Aug 1;101(8):719-725. doi: 10.1097/PHM.0000000000001984. Epub 2022 Feb 2.

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

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
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 30, 2019

Study Start

February 25, 2019

Primary Completion

June 21, 2019

Study Completion

June 28, 2019

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations