NCT06187623

Brief Summary

In individuals diagnosed with AIS, significant regressions in curvature were observed with the use of schroth exercises and brace. It is known that neurological changes affect the vestibular system and create changes in the individual's balance and proprioception. At the same time, when static and balance are examined, it is seen that they have difficulty in maintaining their dynamic balance and their body center of gravity oscillations increase. There are a limited number of studies in the literature evaluating individuals diagnosed with AIS in the combined treatment of brace use and Schroth exercises.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2024

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

December 15, 2023

Last Update Submit

December 15, 2023

Conditions

Keywords

scoliosisbraceexerciseproprioceptionneck

Outcome Measures

Primary Outcomes (2)

  • The effect of clinical based Schroth exercises on the cervical proprioception

    Individuals will be seated with their eyes closed, with the laser pointer on their heads, and will be asked to target the 0 point on the target board in front of them. After performing 5 repetitions of flexion and 5 repetitions of extension movements, deviations from the 0 point will be recorded.

    15 minutes

  • The effect of home based Schroth exercises on the cervical proprioception

    Individuals will be seated with their eyes closed, with the laser pointer on their heads, and will be asked to target the 0 point on the target board in front of them. After performing 5 repetitions of flexion and 5 repetitions of extension movements, deviations from the 0 point will be recorded.

    15 minutes

Secondary Outcomes (2)

  • The effect of home based Schroth exercises on the dynamic balance

    10 minutes

  • The effect of clinic based Schroth exercises on the dynamic balance

    10 minutes

Study Arms (2)

Home based Group

15 patients in the home-based group and their parents will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy. Individuals in this group will be included in an exercise program 1 day a week (8 sessions) accompanied by a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 6 days of the week.

Other: Home based exercise

Clinic based Group

15 patients and their parents in the clinic-based group will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy. Individuals in this group will be included in an exercise program 3 days a week (24 sessions) with a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 4 days of the week.

Other: Clinic based exercise

Interventions

15 patients and their parents in the clinic-based group will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy. Individuals in this group will be included in an exercise program 3 days a week (24 sessions) with a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 4 days of the week.

Clinic based Group

15 patients in the home-based group and their parents will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy. Individuals in this group will be included in an exercise program 1 day a week (8 sessions) accompanied by a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 6 days of the week.

Home based Group

Eligibility Criteria

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

ınviduals between the ages of 10-18 who have been diagnosed with AIS and having brace treatment given by the doctor come to our clinic.

You may qualify if:

  • Being between the ages of 10-18,
  • Being diagnosed with Adolescent Idiopathic Scoliosis (AIS),
  • COBB angles should be between 20 and 45 degrees,
  • Risser sign being between 0-5,
  • Having brace treatment given by the doctor.

You may not qualify if:

  • Having a different diagnosis such as congenital scoliosis, spina bifida, traumatic scoliosis, osteoporosis,
  • Having had spine surgery,
  • Stating that you will not comply with the corset period prescribed by the doctor,
  • Having serious cardiopulmonary problems that will prevent them from exercising,
  • Individuals and parents did not agree to sign the consent form required to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University

Istanbul, 34674, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

ScoliosisMotor Activity

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesBehavior

Study Officials

  • ipek yurttaş

    Üsküdar University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
8 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

December 15, 2023

First Posted

January 2, 2024

Study Start

December 15, 2023

Primary Completion

February 25, 2024

Study Completion

March 4, 2024

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations