NCT06141759

Brief Summary

Adolescent idiopathic scoliosis (AIS) patients have been found to exhibit cortical asymmetry. This study aimed to examine the impact of conservative treatments on perceptual and cognitive asymmetry in the auditory system assessed by dichotic listening in AIS patients with thoracic major curves.

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 Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

November 14, 2023

Last Update Submit

November 17, 2023

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

  • Dichotic Listening Paradigm

    The Dichotic Listening Paradigm is a method that provides behavioral information to determine auditory system asymmetry and is reliable for use with adolescents. The DLP was implemented in both groups at baseline and at the end of week 6 in a seated position with eyes open in a quiet room. In this paradigm, syllables ba, da, ga, pa, ta, and ka were utilized; these were standardized by the Dokuz Eylül University Music Sciences Voice Studio for Turkish society

    6 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Schroth Best Practice Exercises and Cheneau braces. There were 18 sessions, each lasting 90 minutes, a total of 6 weeks for the exercise training.

Other: Exercise

Control Group

NO INTERVENTION

For six weeks, no application was made.

Interventions

ExerciseOTHER

Cheneau brace and Schroth Best Practice exercise

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Having been diagnosed with AIS,
  • Being 10-16 years of age,
  • Having a Cobb angle of between 20° and 50°
  • Risser's sign of 0-3,
  • Having right thoracic scoliosis,
  • Being right-handed,
  • Having received no previous treatment that may affect scoliosis,
  • Having no chronic disease requiring the use of medication.
  • Participants aged 10-16 years

You may not qualify if:

  • Having previous spinal operations,
  • Hearing loss, or the presence of other muscular, neurological, or rheumatic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Burçin Akçay

Balıkesir, 10200, Turkey (Türkiye)

Location

Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Balıkesir, Turkey (Türkiye)

Location

Related Publications (1)

  • Akcay B, Inanc G. The effect of Schroth Best Practice exercises and Cheneau brace treatment on perceptual and cognitive asymmetry in adolescent idiopathic scoliosis with thoracic major curve. Ir J Med Sci. 2024 Jun;193(3):1479-1486. doi: 10.1007/s11845-023-03593-2. Epub 2023 Dec 20.

    PMID: 38123885DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 21, 2023

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 10, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

TU(2)