NCT05298371

Brief Summary

The aim of this study is to investigate the acute effect of activities of daily living on trunk rotation in patients with adolescent idiopathic scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

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

March 3, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

March 6, 2022

Last Update Submit

October 12, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Angle of trunk rotation (ATR)

    ATR can be used to monitor the effects of treatment without radiographic evaluation. ATR measurement is done using a special inclinometer called a scoliometer. The patient is asked to lean forward with the arms relaxed. The scoliometer is placed posteriorly and the degree observed at the point of greatest gimbosity is recorded.

    Change from Baseline angle of trunk rotation at 5 minutes

  • Demographic Characteristics

    Within the scope of the demographic information form, participants' age, gender, weight, height, presence of chronic diseases, age at which they were first diagnosed, exercise habits, treatments received, brace use will be questioned.

    Baseline

Study Arms (1)

Patients with adolescent idiopathic scoliosis

Patients with AIS applying to Bandırma Onyedi Eylül University Physiotherapy and Rehabilitation Department will be included in this study. Individuals diagnosed with AIS, whose Cobb angle is between 20º -50º, who do not have any chronic disease requiring neurological or psychiatric medication, and who volunteered to participate in the study will be included. Individuals with any contraindications for exercise, previous spinal surgery, 6 or more curvature of the thoracic apex, mental problems, non-idiopathic scoliosis but with different causes will be excluded from the study.

Behavioral: Corrected Sitting posturesBehavioral: Natural / relaxed sitting posturesBehavioral: Corrected Standing postureBehavioral: Natural / relaxed standing postures

Interventions

Change after being in Corrected Sitting postures

Patients with adolescent idiopathic scoliosis

Change after being in relaxed sitting postures

Patients with adolescent idiopathic scoliosis

Change after being in Corrected Standing posture

Patients with adolescent idiopathic scoliosis

Change after being in relaxed standing postures

Patients with adolescent idiopathic scoliosis

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with adolescent idiopathic scoliosis.

You may qualify if:

  • Being diagnosed with AIS between the ages of 10-35
  • Cobb angle between 20º -50º,
  • To be able to continue the program to be applied,
  • Not having a chronic disease that requires the use of any neurological or psychiatric medication,
  • The willingness of parents and/or patients to participate in the study.

You may not qualify if:

  • The patient has any contraindications for exercise,
  • Having had previous spine surgery,
  • Having a curvature of 6 or more thoracic apex,
  • Having any mental problems,
  • The fact that scoliosis is not idiopathic but has arisen for different reasons (neurological, congenital, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burçin Akçay

Balıkesir, 10200, Turkey (Türkiye)

Location

Study Officials

  • Burçin Akçay

    Bandırma Onyedi Eylül University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 6, 2022

First Posted

March 28, 2022

Study Start

March 3, 2022

Primary Completion

May 15, 2022

Study Completion

June 15, 2022

Last Updated

October 13, 2023

Record last verified: 2023-10

Locations