NCT05833425

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. Children with adolescent idiopathic scoliosis have inadequate respiratory function. At the same time, these children show muscle weakness in certain parts of the body. The aim of this study is to compare young adolescents with scoliosis with their healthy peers and examine whether respiratory muscle strength, peripheral muscle strength and postural control are affected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

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

Study Start

First participant enrolled

June 10, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

1.6 years

First QC Date

April 14, 2023

Last Update Submit

August 6, 2024

Conditions

Keywords

ScoliosisAdolescent Idiopathic ScoliosisRespiratory Muscle StrengthPeripheral Muscle StrengthPostural Control

Outcome Measures

Primary Outcomes (3)

  • Respiratory Muscle Strength

    Respiratory muscle strength will be made with a portable, electronic intraoral pressure measuring device.

    Baseline

  • Peripheral Muscle Strength

    Peripheral muscle strength will be performed using an electronic dynamometer.

    Baseline

  • Postural Control

    Postural Stability and Balance will be evaluated with the Biodex Balance System®.

    Baseline

Study Arms (2)

Scoliosis group

In this study, an evaluation form including demographic and clinical characteristics, respiratory muscle strength measurement, quadriceps muscle strength measurement with electronic hand dynamometer, hand grip strength with dynamometer and postural stability assessment with Biodex Balance System® will be applied to all scoliosis adolescent.

Device: Respiratory Pressure Meter (MicroRPM)

Healthy group

In this study, an evaluation form including demographic and clinical characteristics, respiratory muscle strength measurement, quadriceps muscle strength measurement with electronic hand dynamometer, hand grip strength with dynamometer and postural stability assessment with Biodex Balance System® will be applied to all healthy adolescent.

Device: Respiratory Pressure Meter (MicroRPM)

Interventions

Peripheral muscle strength, respiratory muscle strength and postural controls of all adolescents will be evaluated. The values of the scoliotic and healthy groups will be compared.

Also known as: Biodex Balance System®
Healthy groupScoliosis group

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

It was calculated that at least 36 patients in total, 18 patients in the scoliosis and healthy groups, should be included in the study.

You may qualify if:

  • Individuals agreeing to participate in the study
  • In the age range of 10-20
  • Patients with scoliosis with a Cobb angle of 15-40 degrees measured on X-Ray

You may not qualify if:

  • Surgical operation in the last 3 months
  • Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Eyüp, 34050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2023

First Posted

April 27, 2023

Study Start

June 10, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations