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Investigation of Conservative Treatment on Adolescent Idiopathic Scoliosis Patients.

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3 dimensional scoliosis exercise
Balance Exercise
Brace treatment
Sponsored by
Bandırma Onyedi Eylül University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being diagnosed with adolescent idiopathic scoliosis between the ages of 10-16 and being deemed appropriate for brace use,
  • 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, Hearing test results are within normal values,
  • Parents allow the child to participate in the study

Exclusion Criteria:

  • The patient has any contraindications to exercise,
  • Previous spine surgery,
  • Having a curvature of thoracic apex 6 or more,
  • Having any mental problems,
  • Scoliosis is not idiopathic but has occurred for different reasons (neurological, congenital, etc.),
  • Presence of neurological, psychiatric, muscular, rheumatic or orthopedic diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Schroth method + brace

    Schroth + balance-coordination exercises + brace.

    Brace

    healthy individuals

    Arm Description

    3-dimensional scoliosis exercise program according to Schroth method + brace.

    3-dimensional scoliosis exercise program according to Schroth + balance-coordination exercises + brace.

    Only brace treatment.

    Age-matched control group

    Outcomes

    Primary Outcome Measures

    Balance and postural control parameters -Weight Bearing/Squat
    Weight Bearing/Squat (percentage, %): Weight bearing percentages of the right and left feet were measured at 0°, 30°, 60°, 90° knee flexion.
    Cobb Angle
    Cobb Angle (degree): The degree of curvature in the coronal plane is measured radiographically according to the Cobb method
    Angle of Trunk Rotation
    ATR - Angle of Trunk Rotation (degree): Measurement of trunk rotation angle/degree is the most appropriate method used in the clinical evaluation of scoliosis.
    Evaluation of subjective visual vertical perception
    Evaluation of subjective visual vertical perception (degree): Subjects were asked to manually verticalize the deviated laser line projected on a wall 1 m away in a room that is dark enough to prevent them from taking visual references while standing. Photographs were recorded during this process.
    Electroencephalography (EEG)
    In EEG recordings, epochs of 1000 ms before and 1000 ms after the stimulus were created. In these sweeps, those with amplitudes greater than ±50 μV in the EOG electrode channels and those with noise were removed. The files obtained for each individual were baseline corrected and filtered with a digital bandpass filter with 0.5 - 48 Hz limit values (12 dB/oct and zero phase shift, Neuroscan 4.5 ). After the filtering process, the mean (average) file was created for each individual. In measuring the amplitudes of the electrophysiological responses, the responses with the largest amplitudes between 0-1000 ms were measured and evaluated in µV. EEG recordings were taken from 64 channels. However, PO3, POZ and PO4 electrodes in the parieto-occipital region were investigated as these are the primary areas for visual stimuli.
    The Dicotic Listening Paradigm:
    There are 30 different (heteronymous) and 6 identical (homonymous) combinations for syllables. It was applied at 78.9 dB SPL (sound pressure level) in dichotic application. . Three rounds, with an average session duration of 7.5 minutes, and a total of approximately 25-30 minutes of test with intervals. In the dichotic application, the participants were first asked to respond without paying attention to any of their ears (non-forced/NF). In the following session, the participants were told to direct their attention to their right ear (forced right ear attention/FR) and to direct their attention to their left ear (forced left ear attention/FL).
    Assessment of health-related quality of life
    The Scoliosis Research Society - 22 questionnaire (SRS-22) is a health-related quality of life questionnaire designed specifically for patients with spinal deformities. SRS-22 consists of the sub-headings of function, pain, body image, mental health and satisfaction with treatment and includes 22 questions in total.
    Balance and postural control parameters-Modified Clinical test of Sensory Interaction on Balance
    Modified Clinical test of Sensory Interaction on Balance (degrees per second,°/sn): Body center of gravity is expressed as the ratio of swing speed and distance to time. Body center of gravity is the ratio between distance traveled (expressed in degrees) and trial time (10 sn). Average body center of gravity swing rate (degrees per second) i) Eyes open on hard ground, ii) Eyes closed on hard ground, iii) On soft ground, eyes open and iv) It was measured in four different situations with eyes closed on soft ground.
    Balance and postural control parameters-Limit of stability
    Limit of stability (% and °/sn): It is used to determine the limits of body stability. Reaction time (sec), movement speed (degrees / sec), end point reached (%), maximum end point (%) in 8 directions: front, right front, right, right back, rear, left back, left, left front and measurements were taken in terms of directional control (%).

    Secondary Outcome Measures

    Full Information

    First Posted
    February 7, 2021
    Last Updated
    June 4, 2021
    Sponsor
    Bandırma Onyedi Eylül University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04921813
    Brief Title
    Investigation of Conservative Treatment on Adolescent Idiopathic Scoliosis Patients.
    Official Title
    Investigation of the Efficiency of Three Dimensional Scoliosis Exercises and Balance-Coordination Exercises in the Conservative Treatment of Adolescent Idiopathic Scoliosis Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 15, 2014 (Actual)
    Primary Completion Date
    April 15, 2017 (Actual)
    Study Completion Date
    December 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bandırma Onyedi Eylül University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Aim: It was aimed to investigate the effectiveness of three-dimensional scoliosis exercises and balance-coordination exercises in patients with adolescent idiopathic scoliosis.
    Detailed Description
    Method: Thirty patients who were diagnosed with adolescent idiopathic scoliosis were randomly divided into three groups. The first group was treated with 3-dimensional scoliosis exercise program according to Schroth method, second group was treated with Schroth exercises and balance-coordination exercises in addition to brace. Exercises were performed for a total of 6 weeks (18 sessions). The third group was treated only with brace and the control group consisted of healthy individuals. Patients were assessed for their curve angle (Cobb method), rotation angle (scoliometer), spinal flexibility (anterior and lateral bending tests), quality of life (Scoliosis Research Society-22), cosmetic effects (Walter Reed Visual Rating Scale), balance parameters (Balance Master System NeuroCom International Inc. Clackamas, OR, USA ver 8.1), vertical perception (Subjective Vertical Detection test) and brain responses (electroencephalography) were assessed before and after treatment. SPSS 20.0 statistical program was used for data analysis of the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Idiopathic Scoliosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    rondomized controlled trail
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Schroth method + brace
    Arm Type
    Experimental
    Arm Description
    3-dimensional scoliosis exercise program according to Schroth method + brace.
    Arm Title
    Schroth + balance-coordination exercises + brace.
    Arm Type
    Experimental
    Arm Description
    3-dimensional scoliosis exercise program according to Schroth + balance-coordination exercises + brace.
    Arm Title
    Brace
    Arm Type
    Experimental
    Arm Description
    Only brace treatment.
    Arm Title
    healthy individuals
    Arm Type
    No Intervention
    Arm Description
    Age-matched control group
    Intervention Type
    Other
    Intervention Name(s)
    3 dimensional scoliosis exercise
    Intervention Description
    Schroth exercises
    Intervention Type
    Other
    Intervention Name(s)
    Balance Exercise
    Intervention Description
    Balance-coordination exercises
    Intervention Type
    Other
    Intervention Name(s)
    Brace treatment
    Intervention Description
    Brace usage
    Primary Outcome Measure Information:
    Title
    Balance and postural control parameters -Weight Bearing/Squat
    Description
    Weight Bearing/Squat (percentage, %): Weight bearing percentages of the right and left feet were measured at 0°, 30°, 60°, 90° knee flexion.
    Time Frame
    Change from baseline balance and postural control parameters at 6 weeks, Change from baseline balance and postural control parameters at 1 year, Change from 6th weeks balance and postural control parameters at 1 year
    Title
    Cobb Angle
    Description
    Cobb Angle (degree): The degree of curvature in the coronal plane is measured radiographically according to the Cobb method
    Time Frame
    Change from baseline Cobb angle at 1 year
    Title
    Angle of Trunk Rotation
    Description
    ATR - Angle of Trunk Rotation (degree): Measurement of trunk rotation angle/degree is the most appropriate method used in the clinical evaluation of scoliosis.
    Time Frame
    Change from baseline Angle of Trunk Rotation at 6 weeks, Change from baseline Angle of Trunk Rotation at 1 year, Change from 6th weeks Angle of Trunk Rotation at 1 year
    Title
    Evaluation of subjective visual vertical perception
    Description
    Evaluation of subjective visual vertical perception (degree): Subjects were asked to manually verticalize the deviated laser line projected on a wall 1 m away in a room that is dark enough to prevent them from taking visual references while standing. Photographs were recorded during this process.
    Time Frame
    Change from baseline subjective visual vertical perception at 6 weeks, Change from baseline subjective visual vertical perception at 1 year, Change from 6th weeks subjective visual vertical perception at 1 year
    Title
    Electroencephalography (EEG)
    Description
    In EEG recordings, epochs of 1000 ms before and 1000 ms after the stimulus were created. In these sweeps, those with amplitudes greater than ±50 μV in the EOG electrode channels and those with noise were removed. The files obtained for each individual were baseline corrected and filtered with a digital bandpass filter with 0.5 - 48 Hz limit values (12 dB/oct and zero phase shift, Neuroscan 4.5 ). After the filtering process, the mean (average) file was created for each individual. In measuring the amplitudes of the electrophysiological responses, the responses with the largest amplitudes between 0-1000 ms were measured and evaluated in µV. EEG recordings were taken from 64 channels. However, PO3, POZ and PO4 electrodes in the parieto-occipital region were investigated as these are the primary areas for visual stimuli.
    Time Frame
    Change from baseline EEG at 6 weeks
    Title
    The Dicotic Listening Paradigm:
    Description
    There are 30 different (heteronymous) and 6 identical (homonymous) combinations for syllables. It was applied at 78.9 dB SPL (sound pressure level) in dichotic application. . Three rounds, with an average session duration of 7.5 minutes, and a total of approximately 25-30 minutes of test with intervals. In the dichotic application, the participants were first asked to respond without paying attention to any of their ears (non-forced/NF). In the following session, the participants were told to direct their attention to their right ear (forced right ear attention/FR) and to direct their attention to their left ear (forced left ear attention/FL).
    Time Frame
    Change from baseline The Dicotic Listening Paradigm parameters at 6 weeks
    Title
    Assessment of health-related quality of life
    Description
    The Scoliosis Research Society - 22 questionnaire (SRS-22) is a health-related quality of life questionnaire designed specifically for patients with spinal deformities. SRS-22 consists of the sub-headings of function, pain, body image, mental health and satisfaction with treatment and includes 22 questions in total.
    Time Frame
    Change from baseline The Scoliosis Research Society - 22 questionnaire at 6 weeks, Change from baseline The Scoliosis Research Society - 22 questionnaire at 1 year, Change from 6th weeks The Scoliosis Research Society - 22 questionnaire at 1 year
    Title
    Balance and postural control parameters-Modified Clinical test of Sensory Interaction on Balance
    Description
    Modified Clinical test of Sensory Interaction on Balance (degrees per second,°/sn): Body center of gravity is expressed as the ratio of swing speed and distance to time. Body center of gravity is the ratio between distance traveled (expressed in degrees) and trial time (10 sn). Average body center of gravity swing rate (degrees per second) i) Eyes open on hard ground, ii) Eyes closed on hard ground, iii) On soft ground, eyes open and iv) It was measured in four different situations with eyes closed on soft ground.
    Time Frame
    Change from baseline balance and postural control parameters at 6 weeks, Change from baseline balance and postural control parameters at 1 year, Change from 6th weeks balance and postural control parameters at 1 year
    Title
    Balance and postural control parameters-Limit of stability
    Description
    Limit of stability (% and °/sn): It is used to determine the limits of body stability. Reaction time (sec), movement speed (degrees / sec), end point reached (%), maximum end point (%) in 8 directions: front, right front, right, right back, rear, left back, left, left front and measurements were taken in terms of directional control (%).
    Time Frame
    Change from baseline balance and postural control parameters at 6 weeks, Change from baseline balance and postural control parameters at 1 year, Change from 6th weeks balance and postural control parameters at 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Being diagnosed with adolescent idiopathic scoliosis between the ages of 10-16 and being deemed appropriate for brace use, 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, Hearing test results are within normal values, Parents allow the child to participate in the study Exclusion Criteria: The patient has any contraindications to exercise, Previous spine surgery, Having a curvature of thoracic apex 6 or more, Having any mental problems, Scoliosis is not idiopathic but has occurred for different reasons (neurological, congenital, etc.), Presence of neurological, psychiatric, muscular, rheumatic or orthopedic diseases.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Investigation of Conservative Treatment on Adolescent Idiopathic Scoliosis Patients.

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