NCT05381896

Brief Summary

Trunk rotation and distortion of the rib cage, which are common in patients with adolescent idiopathic scoliosis, result in abnormal configuration of the diaphragm and intercostal muscles. This reduces the capacity of the respiratory muscles to produce force, and results in respiratory muscle weakness. The diaphragm, which is the major respiratory muscle, is also a component of the core muscles responsible for postural stability. Therefore, diaphragm muscle weakness results in deterioration of postural stability. Our aim in this study is to investigate the effect of inspiratory muscle training added to the routine scoliosis exercise program on postural stability and posture perception.

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 May 2022

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

May 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 23, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

May 16, 2022

Last Update Submit

February 21, 2023

Conditions

Keywords

postural stabilityposture perceptioninspiratory muscle trainingadolescent idiopathic scoliosis

Outcome Measures

Primary Outcomes (2)

  • Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks

    8 weeks

  • Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks

    8 weeks

Secondary Outcomes (4)

  • Change from baseline "Walter Reed Visual Assessment Scale" at 8 weeks

    8 weeks

  • Change from baseline maximum inspiratory pressure (MIP) at 8 weeks

    8 weeks

  • Change from baseline maximum expiratory pressure (MEP) at 8 weeks

    8 weeks

  • Change from baseline angle of trunk rotation at 8 weeks.

    8 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients in this group will receive conventional scoliosis exercise program for 1 hour, 6 days a week for 8 weeks. One exercise session will be supervised in a clinic per week, other sessions will be performed at home.

Other: Conventional Scoliosis Exercise Program

Training Group

EXPERIMENTAL

In addition to the conventional scoliosis exercise program, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 6 days a week for 8 weeks. One exercise session will be supervised in a clinic per week, other sessions will be performed at home.

Other: Conventional Scoliosis Exercise ProgramOther: Inspiratory Muscle Training

Interventions

Program will include breathing exercises, spinal stabilization and strengthening exercises, posture exercises and stretching execises.

Control GroupTraining Group

Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.

Training Group

Eligibility Criteria

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

You may qualify if:

  • Having adolescent idiopathic scoliosis with a Cobb angle of 20-50° diagnosed by an orthopedic surgeon

You may not qualify if:

  • Having a documented diagnosis of neurological disorders
  • Having a documented diagnosis of mental disorders which may affect cooperation
  • Having a documented diagnosis of chronic airway diseases
  • Having a documented diagnosis of orthopedic disorders which may affect mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asst. prof.

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 19, 2022

Study Start

May 23, 2022

Primary Completion

December 23, 2022

Study Completion

December 23, 2022

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations