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
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis
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.
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
NCT ID
NCT04921813
First Posted
February 7, 2021
Last Updated
June 4, 2021
Sponsor
Bandırma Onyedi Eylül University
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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