NCT05127902

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

November 9, 2021

Last Update Submit

March 11, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    1 hour

  • sEMG Muscle Activity

    1 hour

Secondary Outcomes (6)

  • Angle of trunk rotation (ATR)

    10 minutes

  • Anthropometric Measurements

    5 minutes

  • Body composition

    5 minutes

  • Sexual Maturity

    5 minutes

  • Physical Activity Level

    5 minutes

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Diagnostic Test: Proprioceptive-stabilometric assessment machine (ProKin 252, TecnoBody®, Italy)

Interventions

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.

Also known as: Noraxon wireless TELEmyo Direct Transmission System (TELEmyo DTS) with product code of 580 (Noraxon, USA Inc., USA)
Control groupadolescent idiopathic scoliosis group

Eligibility Criteria

Age10 Years - 16 Years
Sexfemale
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Recruited from community

You may qualify if:

  • (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 (vi) currently taking medications that affecting their bone or muscle metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tung Wah College

Hong Kong, 000, Hong Kong

Location

Related Publications (23)

  • 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.

    PMID: 25615844BACKGROUND
  • Nishida 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.

    PMID: 27764749BACKGROUND
  • Smania 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.

    PMID: 18432434BACKGROUND
  • Cheung 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.

    PMID: 16449906BACKGROUND
  • Jung 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.

    PMID: 26406054BACKGROUND
  • Pasha 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.

    PMID: 29277028BACKGROUND
  • Sahlstrand T, Ortengren R, Nachemson A. Postural equilibrium in adolescent idiopathic scoliosis. Acta Orthop Scand. 1978 Aug;49(4):354-65. doi: 10.3109/17453677809050088.

    PMID: 696275BACKGROUND
  • Le 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.

    PMID: 27844226BACKGROUND
  • Byl 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.

    PMID: 8483034BACKGROUND
  • Pollock AS, Durward BR, Rowe PJ, Paul JP. What is balance? Clin Rehabil. 2000 Aug;14(4):402-6. doi: 10.1191/0269215500cr342oa.

    PMID: 10945424BACKGROUND
  • Gatev 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.

    PMID: 9882761BACKGROUND
  • Tsao 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.

    PMID: 17336546BACKGROUND
  • Notarnicola 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

    BACKGROUND
  • 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.

    PMID: 20525239BACKGROUND
  • Chan 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.

    PMID: 18476928BACKGROUND
  • Bago J, Sanchez-Raya J, Perez-Grueso FJ, Climent JM. The Trunk Appearance Perception Scale (TAPS): a new tool to evaluate subjective impression of trunk deformity in patients with idiopathic scoliosis. Scoliosis. 2010 Mar 25;5:6. doi: 10.1186/1748-7161-5-6.

    PMID: 20338048BACKGROUND
  • Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.

    PMID: 11018445BACKGROUND
  • Criswell E. Cram's Introduction to Surface Electromyography. 2nd ed. Sudbury: Jones and Bartlett Publishers; 2011.

    BACKGROUND
  • Cibulka M, Wenthe A, Boyle Z, Callier D, Schwerdt A, Jarman D, Strube MJ. VARIATION IN MEDIAL AND LATERAL GASTROCNEMIUS MUSCLE ACTIVITY WITH FOOT POSITION. Int J Sports Phys Ther. 2017 Apr;12(2):233-241.

    PMID: 28515978BACKGROUND
  • Mochizuki G, Ivanova TD, Garland SJ. Postural muscle activity during bilateral and unilateral arm movements at different speeds. Exp Brain Res. 2004 Apr;155(3):352-61. doi: 10.1007/s00221-003-1732-x. Epub 2003 Dec 6.

    PMID: 14661120BACKGROUND
  • Nairn BC, Drake JD. Impact of lumbar spine posture on thoracic spine motion and muscle activation patterns. Hum Mov Sci. 2014 Oct;37:1-11. doi: 10.1016/j.humov.2014.06.003. Epub 2014 Jul 12.

    PMID: 25026559BACKGROUND
  • Sahli S, Rebai H, Ghroubi S, Yahia A, Guermazi M, Elleuch MH. The effects of backpack load and carrying method on the balance of adolescent idiopathic scoliosis subjects. Spine J. 2013 Dec;13(12):1835-42. doi: 10.1016/j.spinee.2013.06.023. Epub 2013 Oct 2.

    PMID: 24095102BACKGROUND
  • Romano M, Minozzi S, Bettany-Saltikov J, Zaina F, Chockalingam N, Kotwicki T, Maier-Hennes A, Negrini S. Exercises for adolescent idiopathic scoliosis. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007837. doi: 10.1002/14651858.CD007837.pub2.

    PMID: 22895967BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 19, 2021

Study Start

October 15, 2021

Primary Completion

December 31, 2021

Study Completion

May 30, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations