Investigation of Conservative Treatment on Adolescent Idiopathic Scoliosis Patients.

NCT04921813 | Completed DMC

• 1 other identifier: BandırmaOnyediEylulU
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (9)

• 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.

  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

• Cobb Angle

  Cobb Angle (degree): The degree of curvature in the coronal plane is measured radiographically according to the Cobb method

  Change from baseline Cobb angle at 1 year

• 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.

  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

• 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.

  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

• 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.

  Change from baseline EEG at 6 weeks

• 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).

  Change from baseline The Dicotic Listening Paradigm parameters at 6 weeks

• 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.

  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

• 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.

  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

• 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 (%).

  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

Study Arms (4)

Schroth method + brace

EXPERIMENTAL

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

Other: 3 dimensional scoliosis exercise; Other: Brace treatment

Schroth + balance-coordination exercises + brace.

EXPERIMENTAL

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

Other: 3 dimensional scoliosis exercise; Other: Balance Exercise; Other: Brace treatment

Brace

EXPERIMENTAL

Only brace treatment.

Other: Brace treatment

healthy individuals

NO INTERVENTION

Age-matched control group

Interventions

3 dimensional scoliosis exercise OTHER

Schroth exercises

Schroth + balance-coordination exercises + brace.; Schroth method + brace

Balance Exercise OTHER

Balance-coordination exercises

Schroth + balance-coordination exercises + brace.

Brace treatment OTHER

Brace usage

Brace; Schroth + balance-coordination exercises + brace.; Schroth method + brace

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bandırma Onyedi Eylül University: lead

Study Design

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

Model Details: rondomized controlled trail

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: June 10, 2021
• Study Start: August 15, 2014
• Primary Completion: April 15, 2017
• Study Completion: December 15, 2017
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share