Adolescent Idiopathic ScoliosisNCT05127902
Association Between Postural Balance and Muscle Activity of the Lumbar and Lower Limb Muscles in Female With or Without Adolescent Idiopathic Scoliosis (AIS) During Standing Balance Tasks With Upper Limb Movement
An observational study of Adolescent Idiopathic Scoliosis, run by Tung Wah College at 1 site in Hong Kong.
Trial summary
Adolescent idiopathic scoliosis (AIS) is the most common type of three-dimensional deformity of the spine in adolescence with a clear female predominance at a prevalence rate of 3.5% in Hong Kong. AIS increases the risk of spinal degeneration, back pain, and cardiorespiratory dysfunction. Read more about this study
- Who is it for?
- Ages 10 to 16 years, women only
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy)
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Oct 2021to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- Women only
- Child
Study population: Recruited from community
Who may be able to join
- Cobb angle larger or equal to 40° (ii) scoliosis with any known aetiologies such as congenital, neuromuscular, metabolic, and skeletal dysplasia (iii) known endocrine and connective tissue abnormalities (iv) known heart condition or other diseases that could affect the safety of exercise (v) eating disorders or gastrointestinal malabsorption disorders (vi) currently taking medications that affecting their bone or muscle metabolism
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Adolescent idiopathic scoliosis (AIS) is the most common type of three-dimensional deformity of the spine in adolescence with a clear female predominance at a prevalence rate of 3.5% in Hong Kong. AIS increases the risk of spinal degeneration, back pain, and cardiorespiratory dysfunction. These impairments caused by AIS can be related to the abnormal lateral deviation, axial rotation, and reduction of sagittal curves of the spine. AIS has been associated with asymmetrical muscle activity and impaired postural balance performance. AIS who had convex side of the major curves to the right demonstrated an increase in right side thoracic and lumbar erector spinae muscle activity during pelvic anterior, posterior, and left tilting on an unstable sitting board as measured by electromyography (EMG).
Postural balance is defined as the act of maintaining, achieving and restoring a state of balance during any posture or activity. The ability of maintaining postural balance in AIS is influenced by multiple factors including spinal deformities, asymmetrical muscle activities, alteration in sensory input, central integration or motor response. Previous studies have investigated the motor response in young adults. They were found to depend more on ankle strategy than hip strategy during a balance perturbation on a movable platform. Increased lateral gastrocnemius muscle activity was also observed when centre of gravity falls forward during an EMG measurement in quiet stance. In a study of low back pain patients, training regime involving single rapid arm movement in flexion and extension was found to promote the activation of the transversus abdominis muscle and improved the feedforward postural adjustment. There are limited studies to investigate the association between somatosensory input and motor response particularly lower limb muscle activity and upper limb movement on balance control in AIS. Recent evidence also suggested that AIS tend to overestimate the severity of their spinal deformity but their perception of their body schema and spinal curvature can be improved by enhancing motor skills. Therefore, training of postural balance that involved enhancing motor skills and stimulating somatosensory system will have the potential to improve motor response as well as improve self-perceived body schema in AIS.
Read the detailed description
Ten female subjects aged 10 to 16 will be recruited if they are diagnosed with AIS by standard standing long X-ray examinations, with Cobb angle larger or equal to 15°, without prior treatment for their AIS and been cleared for physical activity by their doctors. Subjects were excluded if they had (i) Cobb angle larger or equal to 40°, (ii) scoliosis with any known aetiologies such as congenital, neuromuscular, metabolic, and skeletal dysplasia, (iii) known endocrine and connective tissue abnormalities, (iv) known heart condition or other diseases that could affect the safety of exercise, (v) eating disorders or gastrointestinal malabsorption disorders, and (vi) currently taking medications that affecting their bone or muscle metabolism. Ten healthy female subjects with matched for age, height and weight will be recruited as control. All subjects will be recruited in the community.
All subjects will participate voluntarily in this study. Informed consent will be signed by subject in the presence of their parents after thorough explanation by research personnel before data collection. This study will be carried out with Low/Negligible Risk Human Research Ethics Approval issued by TWC Research Ethics Committee (REC).
Study Procedures This cross-sectional study will be carried out at Physiotherapy laboratory, School of Medical and Health Sciences, Tung Wah College between October 2021 and May 2022.
The experiment environment will be maintained at 25 degrees Celsius. Subjects should not perform any vigorous exercise before testing time.
Subjects will be asked to complete 3 questionnaires: The Chinese University of Hong Kong: Physical Activity Rating for Children and Youth (CUHK-PARCY), Tanner Scale and Trunk Appearance Perception Scale (TAPS) prior to the experiment for determining their physical activity level, sexual maturity and self-perception of spinal deformity respectively. Bioelectric Impedance Analysis (BIA) will be done to collect body composition data. Anthropometric parameters and spinal deformity data will be collected by female student investigators.
Surface EMG (sEMG) electrodes will be used for detection of muscle activity during balance tasks. According to the Surface EMG for Non-Invasive Assessment of Muscles (SENIAM) guidelines, skin preparation with hair removal by single-use razor and alcohol swab will be done before applying electrodes to reduce the skin impedance below 5k Ohm. sEMG electrodes will be positioned on muscle bellies of erector spinae (ES) at lumbar level (largest muscle mass lateral to L3 spinous process). For gluteus medius (GM), electrodes will be placed at proximal 1/3 of the distance between iliac crest and the greater trochanter. For lateral gastrocnemius (LG), electrodes will be placed at most prominent part of muscle belly during resisted plantar flexion.
After placing the sEMG for muscle activity measurement, balance performance of subjects will be tested on a proprioceptive-stabilometric assessment machine. Four tasks will be carried out, including: 1) open eyes fixing at a set point (170 cm height and 200 cm away) on a wall with relaxed arm aside; 2) eyes closed with relaxed arm aside; 3) eyes open with arm movements and 4) eye closed with arm movements. The arm movements are unilateral shoulder flexion and and extension of both arms with two frequencies (40 bpm and 120 bpm). The tempo will be given using a metronome. Each task will be tested twice with at least fifteen seconds rest between trials.
Balance Functions Performance for each balance test will be recorded by proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy). The outcome will be analysed in terms of Ellipse area (mm2), Perimeter (mm), Forward-backward standard deviation (mm), Medial-lateral standard deviation, Average center of pressure in the medial-lateral direction on X-axis projection (mm), Average center of pressure in the anterior-posterior direction on Y-axis projection (mm), Standard deviation of forward-backward displacement (mm), Standard deviation of medial-lateral displacement (mm), Average velocity for forward-backward displacement (mm/s), Average velocity for medial-lateral displacement (mm/s) and Standard deviation of Trunk sway (o).
sEMG Muscle Activity The muscle activity will be measured by surface electromyography and recorded by the Noraxon wireless TELEmyo Direct Transmission System (TELEmyo DTS) with product code of 580 (Noraxon, USA Inc., USA). The sampling frequency will be of 1000Hz and bandwidth of 10-500Hz. Bipolar silver chloride electrodes of 15mm diameter will be used for EMG signals collection, the interelectrode distance will be fixed at 20mm. Electrodes will be attached to surface of 3 groups of muscles bilaterally, namely the lumbar erector spinae (LES), gluteus medius (GM) and lateral gastrocnemius (LG). Placement of electrodes will be based on previous studies to reduce inconsistency and inter-subject variability in normalizing the sEMG signal [21]. Normalization procedure will be done by asking subjects to perform isometric maximum voluntary contractions (MVC). The MVC will be measured by Lafayette hand-held dynamometer connected to flat stirrup. MVC will be tested as listed below. For LES, resisted lumbar extension against belt on lower thoracic area (T12) in prone lying. For GM, resisted hip abduction against belt in side-lying. For LG, resisted ankle plantarflexion in sitting position against belt in 90º dorsiflexion.
The sEMG signals during each experiment will be normalized to the sEMG at isometric MVC and expressed as percentages of the maximum sEMG activity (%EMG_max) for comparison with normalization signal processing program in Noraxon System.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy)Diagnostic test
Also called Noraxon wireless TELEmyo Direct Transmission System (TELEmyo DTS) with product code of 580 (Noraxon, USA Inc., USA)
Proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy) Balance performance of subjects will be tested on the proprioceptive-stabilometric assessment machine.
Noraxon wireless TELEmyo Direct Transmission System (TELEmyo DTS) with product code of 580 (Noraxon, USA Inc., USA)
The sampling frequency will be of 1000Hz and bandwidth of 10-500Hz. Bipolar silver chloride electrodes of 15mm diameter will be used for EMG signals collection, the interelectrode distance will be fixed at 20mm. Normalization procedure will be done by asking subjects to perform isometric maximum voluntary contractions (MVC). The MVC will be measured by Lafayette hand-held dynamometer connected to flat stirrup. MVC will be tested as listed below.
The sEMG signals during each experiment will be normalized to the sEMG at isometric MVC and expressed as percentages of the maximum sEMG activity (%EMG_max) for comparison with normalization signal processing program in Noraxon System.
| Study group | Role | What they receive |
|---|---|---|
| adolescent idiopathic scoliosis group | Female subjects aged 10 to 16 will be recruited if they are diagnosed with AIS by standard standing long X-ray examinations, with Cobb angle larger or equal to 15°, without prior treatment for their AIS and been cleared for physical activity by their doctors. Subjects were excluded if they had (i) Cobb angle larger or equal to 40°, (ii) scoliosis with any known aetiologies such as congenital, neuromuscular, metabolic, and skeletal dysplasia, (iii) known endocrine and connective tissue abnormalities, (iv) known heart condition or other diseases that could affect the safety of exercise, (v) eating disorders or gastrointestinal malabsorption disorders, and (vi) currently taking medications that affecting their bone or muscle metabolism. All subjects will be recruited in the community. Receives: Diagnostic Test: Proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy) | |
| Control group | Ten healthy female subjects with matched for age, height and weight will be recruited as control. Receives: Diagnostic Test: Proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance function
Ellipse area (mm2), Perimeter (mm), Forward-backward standard deviation (mm), Medial-lateral standard deviation, Average center of pressure in the medial-lateral direction on X-axis projection (mm), Average center of pressure in the anterior-posterior direction on Y-axis projection (mm), Standard deviation of forward-backward displacement (mm), Standard deviation of medial-lateral displacement (mm), Average velocity for forward-backward displacement (mm/s), Average velocity for medial-lateral displacement (mm/s) and Standard deviation of Trunk sway (o).
Measured: 1 hour
sEMG Muscle Activity
Measured: 1 hour
Secondary outcomes (6)
Angle of trunk rotation (ATR)
Measured: 10 minutes
Anthropometric Measurements
Standing height, Sitting height and Arm span
Measured: 5 minutes
Body composition
body fat mass (BFM), fat-free mass (FFM), body fat percentage (%BFM) and visceral adipose tissue (VAT), BMI
Measured: 5 minutes
Sexual Maturity
Puberty maturity level including age of menarche correct to nearest month, breast development and pubic hair distribution will be self-assessed by subjects using Tanner Scale
Measured: 5 minutes
Physical Activity Level
self-administered, 1-item questionnaire that measures the physical activity level with the consideration of frequency, duration, and intensity of the physical activity. CUHK-PARCY results in a score that stratifies subjects as low, moderate, and high in physical activity.
Measured: 5 minutes
Self-perceived Spinal Appearance
the Trunk Appearance Perception Scale (TAPS) includes 3 sets of figures from 3 viewpoints: looking toward the back, looking toward the head with the patient bending over (Adam's test), and looking toward the front. Each drawing is scored from 1 (greatest deformity) to 5 (smallest deformity) and a mean score is obtained by adding the scores for the 3 drawings and dividing by 3
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start15 Oct 2021
- Primary completion31 Dec 2021
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tung Wah College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chak Long Hay Forest, Tung Wah College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127902
- Sponsor's protocol ID
- MHS_SRC_2021_010
- Status last verified
- Mar 2023
- First submitted
- 9 Nov 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The possible IPD to be shared include the primary outcome measure and secondary outcome measure.
Publications
Fong DY, Cheung KM, Wong YW, Wan YY, Lee CF, Lam TP, Cheng JC, Ng BK, Luk KD. A population-based cohort study of 394,401 children followed for 10 years exhibits sustained effectiveness of scoliosis screening. Spine J. 2015 May 1;15(5):825-33. doi: 10.1016/j.spinee.2015.01.019. Epub 2015 Jan 20.
PubMed 25615844Nishida M, Nagura T, Fujita N, Hosogane N, Tsuji T, Nakamura M, Matsumoto M, Watanabe K. Position of the major curve influences asymmetrical trunk kinematics during gait in adolescent idiopathic scoliosis. Gait Posture. 2017 Jan;51:142-148. doi: 10.1016/j.gaitpost.2016.10.004. Epub 2016 Oct 11.
PubMed 27764749Smania N, Picelli A, Romano M, Negrini S. Neurophysiological basis of rehabilitation of adolescent idiopathic scoliosis. Disabil Rehabil. 2008;30(10):763-71. doi: 10.1080/17483100801921311.
PubMed 18432434Cheung J, Veldhuizen AG, Halberts JP, Sluiter WJ, Van Horn JR. Geometric and electromyographic assessments in the evaluation of curve progression in idiopathic scoliosis. Spine (Phila Pa 1976). 2006 Feb 1;31(3):322-9. doi: 10.1097/01.brs.0000197155.68983.d8.
PubMed 16449906Jung JY, Cha EJ, Kim KA, Won Y, Bok SK, Kim BO, Kim JJ. Influence of pelvic asymmetry and idiopathic scoliosis in adolescents on postural balance during sitting. Biomed Mater Eng. 2015;26 Suppl 1:S601-10. doi: 10.3233/BME-151351.
PubMed 26406054Pasha S, Baldwin K. Are we simplifying balance evaluation in adolescent idiopathic scoliosis? Clin Biomech (Bristol). 2018 Jan;51:91-98. doi: 10.1016/j.clinbiomech.2017.11.011. Epub 2017 Nov 29.
PubMed 29277028Sahlstrand T, Ortengren R, Nachemson A. Postural equilibrium in adolescent idiopathic scoliosis. Acta Orthop Scand. 1978 Aug;49(4):354-65. doi: 10.3109/17453677809050088.
PubMed 696275Le Berre M, Guyot MA, Agnani O, Bourdeauducq I, Versyp MC, Donze C, Thevenon A, Catanzariti JF. Clinical balance tests, proprioceptive system and adolescent idiopathic scoliosis. Eur Spine J. 2017 Jun;26(6):1638-1644. doi: 10.1007/s00586-016-4802-z. Epub 2016 Nov 14.
PubMed 27844226Byl NN, Gray JM. Complex balance reactions in different sensory conditions: adolescents with and without idiopathic scoliosis. J Orthop Res. 1993 Mar;11(2):215-27. doi: 10.1002/jor.1100110209.
PubMed 8483034Pollock AS, Durward BR, Rowe PJ, Paul JP. What is balance? Clin Rehabil. 2000 Aug;14(4):402-6. doi: 10.1191/0269215500cr342oa.
PubMed 10945424Gatev P, Thomas S, Kepple T, Hallett M. Feedforward ankle strategy of balance during quiet stance in adults. J Physiol. 1999 Feb 1;514 ( Pt 3)(Pt 3):915-28. doi: 10.1111/j.1469-7793.1999.915ad.x.
PubMed 9882761Tsao H, Hodges PW. Persistence of improvements in postural strategies following motor control training in people with recurrent low back pain. J Electromyogr Kinesiol. 2008 Aug;18(4):559-67. doi: 10.1016/j.jelekin.2006.10.012. Epub 2007 Mar 2.
PubMed 17336546Notarnicola A, Farì G, Maccagnano G, Riondino A, Covelli I, Bianchi FP, et al. Teenagers' perceptions of their scoliotic curves. An observational study of comparison between sports people and non-sports people. Muscle Ligaments Tendons J 2019;09:225-35. https://doi.org/10.32098/mltj.02.2019.11
Kong AP, Choi KC, Li AM, Hui SS, Chan MH, Wing YK, Ma RC, Lam CW, Lau JT, So WY, Ko GT, Chan JC. Association between physical activity and cardiovascular risk in Chinese youth independent of age and pubertal stage. BMC Public Health. 2010 Jun 3;10:303. doi: 10.1186/1471-2458-10-303.
PubMed 20525239Chan NP, Sung RY, Kong AP, Goggins WB, So HK, Nelson EA. Reliability of pubertal self-assessment in Hong Kong Chinese children. J Paediatr Child Health. 2008 Jun;44(6):353-8. doi: 10.1111/j.1440-1754.2008.01311.x.
PubMed 18476928
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Postural Balance and Muscle Activity of the Lumbar and Lower Limb Muscles in Female With or Without Adolescent Idiopathic Scoliosis (AIS) During Standing Balance Tasks With Upper Limb Movement
- ClinicalTrials.gov ID
- NCT05127902
- Acronym / sponsor ID
- MHS_SRC_2021_010
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tung Wah CollegeUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescent idiopathic scoliosis (AIS) is the most common type of three-dimensional deformity of the spine in adolescence with a clear female predominance at a prevalence rate of 3.5% in Hong Kong. AIS increases the risk of spinal degeneration, back pain, and cardiorespiratory dysfunction. These impairments caused by AIS can be related to the abnormal lateral deviation, axial rotation, and reduction of sagittal curves of the spine. AIS has been associated with asymmetrical muscle activity and impaired postural balance performance. AIS who had convex side of the major curves to the right demonstrated an increase in right side thoracic and lumbar erector spinae muscle activity during pelvic anterior, posterior, and left tilting on an unstable sitting board as measured by electromyography (EMG).
Postural balance is defined as the act of maintaining, achieving and restoring a state of balance during any posture or activity. The ability of maintaining postural balance in AIS is influenced by multiple factors including spinal deformities, asymmetrical muscle activities, alteration in sensory input, central integration or motor response. Previous studies have investigated the motor response in young adults. They were found to depend more on ankle strategy than hip strategy during a balance perturbation on a movable platform. Increased lateral gastrocnemius muscle activity was also observed when centre of gravity falls forward during an EMG measurement in quiet stance. In a study of low back pain patients, training regime involving single rapid arm movement in flexion and extension was found to promote the activation of the transversus abdominis muscle and improved the feedforward postural adjustment. There are limited studies to investigate the association between somatosensory input and motor response particularly lower limb muscle activity and upper limb movement on balance control in AIS. Recent evidence also suggested that AIS tend to overestimate the severity of their spinal deformity but their perception of their body schema and spinal curvature can be improved by enhancing motor skills. Therefore, training of postural balance that involved enhancing motor skills and stimulating somatosensory system will have the potential to improve motor response as well as improve self-perceived body schema in AIS.
Detailed description
Ten female subjects aged 10 to 16 will be recruited if they are diagnosed with AIS by standard standing long X-ray examinations, with Cobb angle larger or equal to 15°, without prior treatment for their AIS and been cleared for physical activity by their doctors. Subjects were excluded if they had (i) Cobb angle larger or equal to 40°, (ii) scoliosis with any known aetiologies such as congenital, neuromuscular, metabolic, and skeletal dysplasia, (iii) known endocrine and connective tissue abnormalities, (iv) known heart condition or other diseases that could affect the safety of exercise, (v) eating disorders or gastrointestinal malabsorption disorders, and (vi) currently taking medications that affecting their bone or muscle metabolism. Ten healthy female subjects with matched for age, height and weight will be recruited as control. All subjects will be recruited in the community.
All subjects will participate voluntarily in this study. Informed consent will be signed by subject in the presence of their parents after thorough explanation by research personnel before data collection. This study will be carried out with Low/Negligible Risk Human Research Ethics Approval issued by TWC Research Ethics Committee (REC).
Study Procedures This cross-sectional study will be carried out at Physiotherapy laboratory, School of Medical and Health Sciences, Tung Wah College between October 2021 and May 2022.
The experiment environment will be maintained at 25 degrees Celsius. Subjects should not perform any vigorous exercise before testing time.
Subjects will be asked to complete 3 questionnaires: The Chinese University of Hong Kong: Physical Activity Rating for Children and Youth (CUHK-PARCY), Tanner Scale and Trunk Appearance Perception Scale (TAPS) prior to the experiment for determining their physical activity level, sexual maturity and self-perception of spinal deformity respectively. Bioelectric Impedance Analysis (BIA) will be done to collect body composition data. Anthropometric parameters and spinal deformity data will be collected by female student investigators.
Surface EMG (sEMG) electrodes will be used for detection of muscle activity during balance tasks. According to the Surface EMG for Non-Invasive Assessment of Muscles (SENIAM) guidelines, skin preparation with hair removal by single-use razor and alcohol swab will be done before applying electrodes to reduce the skin impedance below 5k Ohm. sEMG electrodes will be positioned on muscle bellies of erector spinae (ES) at lumbar level (largest muscle mass lateral to L3 spinous process). For gluteus medius (GM), electrodes will be placed at proximal 1/3 of the distance between iliac crest and the greater trochanter. For lateral gastrocnemius (LG), electrodes will be placed at most prominent part of muscle belly during resisted plantar flexion.
After placing the sEMG for muscle activity measurement, balance performance of subjects will be tested on a proprioceptive-stabilometric assessment machine. Four tasks will be carried out, including: 1) open eyes fixing at a set point (170 cm height and 200 cm away) on a wall with relaxed arm aside; 2) eyes closed with relaxed arm aside; 3) eyes open with arm movements and 4) eye closed with arm movements. The arm movements are unilateral shoulder flexion and and extension of both arms with two frequencies (40 bpm and 120 bpm). The tempo will be given using a metronome. Each task will be tested twice with at least fifteen seconds rest between trials.
Balance Functions Performance for each balance test will be recorded by proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy). The outcome will be analysed in terms of Ellipse area (mm2), Perimeter (mm), Forward-backward standard deviation (mm), Medial-lateral standard deviation, Average center of pressure in the medial-lateral direction on X-axis projection (mm), Average center of pressure in the anterior-posterior direction on Y-axis projection (mm), Standard deviation of forward-backward displacement (mm), Standard deviation of medial-lateral displacement (mm), Average velocity for forward-backward displacement (mm/s), Average velocity for medial-lateral displacement (mm/s) and Standard deviation of Trunk sway (o).
sEMG Muscle Activity The muscle activity will be measured by surface electromyography and recorded by the Noraxon wireless TELEmyo Direct Transmission System (TELEmyo DTS) with product code of 580 (Noraxon, USA Inc., USA). The sampling frequency will be of 1000Hz and bandwidth of 10-500Hz. Bipolar silver chloride electrodes of 15mm diameter will be used for EMG signals collection, the interelectrode distance will be fixed at 20mm. Electrodes will be attached to surface of 3 groups of muscles bilaterally, namely the lumbar erector spinae (LES), gluteus medius (GM) and lateral gastrocnemius (LG). Placement of electrodes will be based on previous studies to reduce inconsistency and inter-subject variability in normalizing the sEMG signal [21]. Normalization procedure will be done by asking subjects to perform isometric maximum voluntary contractions (MVC). The MVC will be measured by Lafayette hand-held dynamometer connected to flat stirrup. MVC will be tested as listed below. For LES, resisted lumbar extension against belt on lower thoracic area (T12) in prone lying. For GM, resisted hip abduction against belt in side-lying. For LG, resisted ankle plantarflexion in sitting position against belt in 90º dorsiflexion.
The sEMG signals during each experiment will be normalized to the sEMG at isometric MVC and expressed as percentages of the maximum sEMG activity (%EMG_max) for comparison with normalization signal processing program in Noraxon System.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adolescent idiopathic scoliosis group | – | Diagnostic Test: Proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy)Female subjects aged 10 to 16 will be recruited if they are diagnosed with AIS by standard standing long X-ray examinations, with Cobb angle larger or equal to 15°, without prior treatment for their AIS and been cleared for physical activity by their doctors. Subjects were excluded if they had (i) Cobb angle larger or equal to 40°, (ii) scoliosis with any known aetiologies such as congenital, neuromuscular, metabolic, and skeletal dysplasia, (iii) known endocrine and connective tissue abnormalities, (iv) known heart condition or other diseases that could affect the safety of exercise, (v) eating disorders or gastrointestinal malabsorption disorders, and (vi) currently taking medications that affecting their bone or muscle metabolism. All subjects will be recruited in the community. |
| Control group | – | Diagnostic Test: Proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy)Ten healthy female subjects with matched for age, height and weight will be recruited as control. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- Female only
- Age groups
- Child
- Study population
- Recruited from community
Key inclusion criteria (1 listed)
- Cobb angle larger or equal to 40° (ii) scoliosis with any known aetiologies such as congenital, neuromuscular, metabolic, and skeletal dysplasia (iii) known endocrine and connective tissue abnormalities (iv) known heart condition or other diseases that could affect the safety of exercise (v) eating disorders or gastrointestinal malabsorption disorders (vi) currently taking medications that affecting their bone or muscle metabolism
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy)Also: Noraxon wireless TELEmyo Direct Transmission System (TELEmyo DTS) with product code of 580 (Noraxon, USA Inc., USA)Proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy) Balance performance of subjects will be tested on the proprioceptive-stabilometric assessment machine. Noraxon wireless TELEmyo Direct Transmission System (TELEmyo DTS) with product code of 580 (Noraxon, USA Inc., USA) The sampling frequency will be of 1000Hz and bandwidth of 10-500Hz. Bipolar silver chloride electrodes of 15mm diameter will be used for EMG signals collection, the interelectrode distance will be fixed at 20mm. Normalization procedure will be done by asking subjects to perform isometric maximum voluntary contractions (MVC). The MVC will be measured by Lafayette hand-held dynamometer connected to flat stirrup. MVC will be tested as listed below. The sEMG signals during each experiment will be normalized to the sEMG at isometric MVC and expressed as percentages of the maximum sEMG activity (%EMG_max) for comparison with normalization signal processing program in Noraxon System. | Diagnostic test | Control group, adolescent idiopathic scoliosis group |
Primary outcome
Balance function
Time frame: 1 hour
Ellipse area (mm2), Perimeter (mm), Forward-backward standard deviation (mm), Medial-lateral standard deviation, Average center of pressure in the medial-lateral direction on X-axis projection (mm), Average center of pressure in the anterior-posterior direction on Y-axis projection (mm), Standard deviation of forward-backward displacement (mm), Standard deviation of medial-lateral displacement (mm), Average velocity for forward-backward displacement (mm/s), Average velocity for medial-lateral displacement (mm/s) and Standard deviation of Trunk sway (o).
sEMG Muscle Activity
Time frame: 1 hour
6 secondary outcomes
Angle of trunk rotation (ATR)
Time frame: 10 minutes
Anthropometric Measurements
Time frame: 5 minutes
Body composition
Time frame: 5 minutes
Sexual Maturity
Time frame: 5 minutes
Physical Activity Level
Time frame: 5 minutes
Self-perceived Spinal Appearance
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Background: PubMed 25615844Fong DY, Cheung KM, Wong YW, Wan YY, Lee CF, Lam TP, Cheng JC, Ng BK, Luk KD. A population-based cohort study of 394,401 children followed for 10 years exhibits sustained effectiveness of scoliosis screening. Spine J. 2015 May 1;15(5):825-33. doi: 10.1016/j.spinee.2015.01.019. Epub 2015 Jan 20.
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- Individual participant dataSharing planned: Undecided. The possible IPD to be shared include the primary outcome measure and secondary outcome measure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by Tung Wah College at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance function (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05127902, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.