The Effect Spinal Bracing System on Gait in Adult Scoliosis Patients
NCT ID: NCT03572855
Last Updated: 2018-08-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-06-15
Study Completion Date
2019-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Degenerative adult scoliosis (ADS) results from age related changes leading to segmental instability, deformity and stenosis. Patients with scoliosis demonstrate an altered gait pattern.Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. Bracing has been found to reduce pain within a short time in ADS patients. A new brace has recently become available, the Peak™ Scoliosis Brace (Aspen Medical Products), designed to alleviate pain in adult patients with chronic pain secondary to scoliosis. The purpose of this study is to investigate the impact of spinal bracing using Peak™ Scoliosis Brace on pain and lower extremities kinematics of gait.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Peak Scoliosis Brace in Pain Management For Adult Scoliosis Patients
NCT02643290
Back Pain
COMPLETED
NA
Spinal Bracing in Adults with Painful Degenerative Scoliosis: a Randomized Controlled Open Trial
NCT06774898
Degenerative Scoliosis
Scoliosis Idiopathic
Thoracolumbar Scoliosis
NOT_YET_RECRUITING
PHASE3
Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility
NCT06785207
Scoliosis Idiopathic Adolescent Treatment
RECRUITING
NA
Sagittal Plane Correction With Pass-LP Device in Adult Deformity Patients
NCT01635322
Lumbar or Thoraco-lumbar Adult Deformity
COMPLETED
Active Bodysuits for Adult Degenerative Scoliosis
NCT04509310
Scoliosis
UNKNOWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Degenerative adult scoliosis (ADS) results from age related changes leading to segmental instability, deformity and stenosis. Although the etiology is unclear, degenerative adult scoliosis is associated with progressive and asymmetric degeneration of the disc and facet joints, which typically leads to stenosis. By virtue of the narrowed spinal canal associated with the degeneration these patients frequently develop back pain, as well as leg pain, weakness, and numbness. With an aging population in the USA and an increased attention to quality of life versus cost issues in the current healthcare environment, degenerative adult scoliosis has become a considerable healthcare concern.
Patients with scoliosis demonstrate an altered gait pattern.Such differences include decreased step length and reduced range of motion in the upper and lower extremities asymmetry of trunk rotation and ground reaction force in three-dimensions. Previous research found a decrease in the muscular mechanical work associated with an increase of energy cost and a decrease in the muscular efficiency in a scoliosis population compared to healthy controls. Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. This altered gait pattern demonstrated by subjects with scoliosis may be due to changes in global postural control strategies caused by pain and the spinal deformity.
Previous research showed that scoliosis patients do not have impaired postural balance when compared to healthy controls, while several others did find an effect of scoliosis on postural balance. This discrepancy in findings may be due to differences in curve characteristics included and their effects on postural balance, curve types (single or double), number of different curve types, location of curves (thoracic and lumbar), and/or Cobb angles.
Bracing has been found to reduce pain within a short time in ADS patients. Custom-made rigid torso braces, similar to those commonly used for children, are sometimes used in ADS patients; however, only anecdotal evidence of their efficacy is available and problems with comfort and compliance are quite frequent. A new brace has recently become available, the Peak™ Scoliosis Brace (Aspen Medical Products), designed to alleviate pain in adult patients with chronic pain secondary to scoliosis. The Peak Scoliosis Brace led to some improvement of pain at 1 month in a group of adult women with scoliosis and chronic low back pain, but the quality of life did not change significantly. This is may be due to the very short follow-up time. The effect of these braces on functional tasks and activities of daily living including walking have not been studied either.
The purpose of this study is to investigate the impact of spinal bracing using Peak™ Scoliosis Brace on pain and lower extremities kinematics of gait.
METHODS Design This study will be a repeated measurement design. This study will be a non-randomized, prospective, concurrent control cohort study of patients with adult degenerative scoliosis who are clinically indicated for brace intervention and will serve as their own controls via their own pre-treatment evaluation. The proposal design is based on highly recommended Bayesian Design along with the Bayesian and Gaussian analysis for such population and sample size.
Sample Thirty candidates with symptomatic ADS will be enrolled. The sample size needed to approach 80% statistical power for differences between conditions was estimated from the literature.17,23,24 An effect size index of f = 0.50 was estimated. For a desired power of 80% (1 - β = 0.80) and desired α = 0.05, the effect size index requires a minimum sample size of 26.
Inclusion/Exclusion Criteria Thirty spinal deformity patients will be enrolled.
Patients will be classified using the adult deformity SRS-Schwab system. Radiographs made prior to brace treatment and at the two pre-defined follow-up points will be measured and recorded for each patient.
Patients will report to the Spine Biomechanics Laboratory in the Texas Back Institute, be educated on the study and will be asked to provide written informed consent after their questions, if any, are answered. They will then be scheduled for a test session in the lab. Each patient will be evaluated on 2 different occasions: first day of bracing, and 2±0.5 months post-bracing. Subjects will be fitted with 22 external reflective markers. These markers will be placed based on those validated and published in the literature. A static trial will be recorded with subjects positioned in a neutral, standing posture to create a reference for defining neutral joint angles. Each subject will perform a series of over-ground gait trials with self-selected speed. On all visits, subjects will walk 10 meters, stepping on three sequenced force platforms. Subjects will perform a series of gait trials until five acceptable trials are obtained. In addition, each subject will perform 2 additional tests: 1. Timed up and go, and 6 minutes' walk test. After completion of functional testing, the brace will be fitted to each subject by a spine orthopedic surgeon before the testing. The subject will wear the fitted brace for at least 45 minutes prior to retesting. The subject will then repeat the functional testing as mentioned above. Total time required for each subject to participate in one session will be approximately 90 minutes.Three-dimensional (3D) kinematic data will be recorded at 120 Hz via a Vicon-Peak system (Vicon Nexus 2.0 Inc.). Ground reaction force (GRF) (AMTI Corp.) data will be recorded simultaneously at 1200 Hz. Spine, pelvis, hip, knee, and ankle kinematics and GRF will be analyzed using a custom MATLAB program.
Clinical Data Collection Prior to each gait evaluation, patients will be asked to complete a visual analog scale (VAS) to assess back and leg pain intensity, the Oswestry Disability Index (ODI, version 2.1.a), a pain drawing to record symptom location. Patients will also complete an SRS-22r, Fear Avoidance Beliefs Questionnaire (FABQ), and Tampa Scale for Kinesiophobia (TSK) to record how their spinal deformity affects them across several physical and psycho-social domains. Long cassette sagittal and coronal radiographs will be collected at first visit before brace fitting to assess the extent of spinal deformity. As previously stated, the deformity will be measured via the SRS/Schwab deformity classification system.The bracing system to be used is the Peak Scoliosis Bracing System (Aspen Medical Product Inc., Irvine, CA).
The data will be analyzed with a repeated measurement two-way ANOVA to determine differences between pre- and post-bracing measurements. A conservative alpha correction will be made within each statistical family using Bonferroni correction for the multiple dependent variables in order to avoid type I error. Data will also be analyzed to determine whether any outcomes from the gait and balance analysis correlate with patient completed assessments (pain scores) based on Pearson's R correlation.
Patients with scoliosis demonstrate an altered gait pattern.Such differences include decreased step length and reduced range of motion in the upper and lower extremities asymmetry of trunk rotation and ground reaction force in three-dimensions. Previous research found a decrease in the muscular mechanical work associated with an increase of energy cost and a decrease in the muscular efficiency in a scoliosis population compared to healthy controls. Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. This altered gait pattern demonstrated by subjects with scoliosis may be due to changes in global postural control strategies caused by pain and the spinal deformity.
Previous research showed that scoliosis patients do not have impaired postural balance when compared to healthy controls, while several others did find an effect of scoliosis on postural balance. This discrepancy in findings may be due to differences in curve characteristics included and their effects on postural balance, curve types (single or double), number of different curve types, location of curves (thoracic and lumbar), and/or Cobb angles.
Bracing has been found to reduce pain within a short time in ADS patients. Custom-made rigid torso braces, similar to those commonly used for children, are sometimes used in ADS patients; however, only anecdotal evidence of their efficacy is available and problems with comfort and compliance are quite frequent. A new brace has recently become available, the Peak™ Scoliosis Brace (Aspen Medical Products), designed to alleviate pain in adult patients with chronic pain secondary to scoliosis. The Peak Scoliosis Brace led to some improvement of pain at 1 month in a group of adult women with scoliosis and chronic low back pain, but the quality of life did not change significantly. This is may be due to the very short follow-up time. The effect of these braces on functional tasks and activities of daily living including walking have not been studied either.
The purpose of this study is to investigate the impact of spinal bracing using Peak™ Scoliosis Brace on pain and lower extremities kinematics of gait.
METHODS Design This study will be a repeated measurement design. This study will be a non-randomized, prospective, concurrent control cohort study of patients with adult degenerative scoliosis who are clinically indicated for brace intervention and will serve as their own controls via their own pre-treatment evaluation. The proposal design is based on highly recommended Bayesian Design along with the Bayesian and Gaussian analysis for such population and sample size.
Sample Thirty candidates with symptomatic ADS will be enrolled. The sample size needed to approach 80% statistical power for differences between conditions was estimated from the literature.17,23,24 An effect size index of f = 0.50 was estimated. For a desired power of 80% (1 - β = 0.80) and desired α = 0.05, the effect size index requires a minimum sample size of 26.
Inclusion/Exclusion Criteria Thirty spinal deformity patients will be enrolled.
Patients will be classified using the adult deformity SRS-Schwab system. Radiographs made prior to brace treatment and at the two pre-defined follow-up points will be measured and recorded for each patient.
Patients will report to the Spine Biomechanics Laboratory in the Texas Back Institute, be educated on the study and will be asked to provide written informed consent after their questions, if any, are answered. They will then be scheduled for a test session in the lab. Each patient will be evaluated on 2 different occasions: first day of bracing, and 2±0.5 months post-bracing. Subjects will be fitted with 22 external reflective markers. These markers will be placed based on those validated and published in the literature. A static trial will be recorded with subjects positioned in a neutral, standing posture to create a reference for defining neutral joint angles. Each subject will perform a series of over-ground gait trials with self-selected speed. On all visits, subjects will walk 10 meters, stepping on three sequenced force platforms. Subjects will perform a series of gait trials until five acceptable trials are obtained. In addition, each subject will perform 2 additional tests: 1. Timed up and go, and 6 minutes' walk test. After completion of functional testing, the brace will be fitted to each subject by a spine orthopedic surgeon before the testing. The subject will wear the fitted brace for at least 45 minutes prior to retesting. The subject will then repeat the functional testing as mentioned above. Total time required for each subject to participate in one session will be approximately 90 minutes.Three-dimensional (3D) kinematic data will be recorded at 120 Hz via a Vicon-Peak system (Vicon Nexus 2.0 Inc.). Ground reaction force (GRF) (AMTI Corp.) data will be recorded simultaneously at 1200 Hz. Spine, pelvis, hip, knee, and ankle kinematics and GRF will be analyzed using a custom MATLAB program.
Clinical Data Collection Prior to each gait evaluation, patients will be asked to complete a visual analog scale (VAS) to assess back and leg pain intensity, the Oswestry Disability Index (ODI, version 2.1.a), a pain drawing to record symptom location. Patients will also complete an SRS-22r, Fear Avoidance Beliefs Questionnaire (FABQ), and Tampa Scale for Kinesiophobia (TSK) to record how their spinal deformity affects them across several physical and psycho-social domains. Long cassette sagittal and coronal radiographs will be collected at first visit before brace fitting to assess the extent of spinal deformity. As previously stated, the deformity will be measured via the SRS/Schwab deformity classification system.The bracing system to be used is the Peak Scoliosis Bracing System (Aspen Medical Product Inc., Irvine, CA).
The data will be analyzed with a repeated measurement two-way ANOVA to determine differences between pre- and post-bracing measurements. A conservative alpha correction will be made within each statistical family using Bonferroni correction for the multiple dependent variables in order to avoid type I error. Data will also be analyzed to determine whether any outcomes from the gait and balance analysis correlate with patient completed assessments (pain scores) based on Pearson's R correlation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Scoliosis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Scoliosis Brace
The Peak Scoliosis Brace designed to alleviate pain in adult patients with chronic pain secondary to scoliosis.
Group Type
EXPERIMENTAL
Scoliosis Brace
Intervention Type
COMBINATION_PRODUCT
Brace will be fitted to each subject by a spine orthopedic surgeon before the testing. The subject will wear the fitted brace for 2 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Scoliosis Brace
Brace will be fitted to each subject by a spine orthopedic surgeon before the testing. The subject will wear the fitted brace for 2 months.
Intervention Type
COMBINATION_PRODUCT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Age 30- 75 years and older
2. Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater
3. Able to ambulate without assistance and stand without assistance with their eyes open for a minimum of 10 seconds
4. Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-treatment follow-up
2. Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater
3. Able to ambulate without assistance and stand without assistance with their eyes open for a minimum of 10 seconds
4. Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-treatment follow-up
Exclusion Criteria
1. History of prior attempt at fusion (successful or not) at the indicated levels, (history of one level fusion is not an exclusion)
2. Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
3. BMI higher than 35
4. Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
5. Major trauma to the pelvis
6. Pregnant or wishing to become pregnant during the study
2. Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
3. BMI higher than 35
4. Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
5. Major trauma to the pelvis
6. Pregnant or wishing to become pregnant during the study
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aspen Medical Products
OTHER
Sponsor Role
collaborator
Texas Back Institute
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ram Haddas, PhD
Role: PRINCIPAL_INVESTIGATOR
Texas Back Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Texas Back Institute
Plano, Texas, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Kotwal S, Pumberger M, Hughes A, Girardi F. Degenerative scoliosis: a review. HSS J. 2011 Oct;7(3):257-64. doi: 10.1007/s11420-011-9204-5. Epub 2011 Jun 11.
Reference Type
BACKGROUND
Kotwicki T, Chowanska J, Kinel E, Czaprowski D, Tomaszewski M, Janusz P. Optimal management of idiopathic scoliosis in adolescence. Adolesc Health Med Ther. 2013 Jul 23;4:59-73. doi: 10.2147/AHMT.S32088. eCollection 2013.
Reference Type
BACKGROUND
Ploumis A, Transfledt EE, Denis F. Degenerative lumbar scoliosis associated with spinal stenosis. Spine J. 2007 Jul-Aug;7(4):428-36. doi: 10.1016/j.spinee.2006.07.015. Epub 2007 Feb 28.
Reference Type
BACKGROUND
Engsberg JR, Bridwell KH, Reitenbach AK, Uhrich ML, Baldus C, Blanke K, Lenke LG. Preoperative gait comparisons between adults undergoing long spinal deformity fusion surgery (thoracic to L4, L5, or sacrum) and controls. Spine (Phila Pa 1976). 2001 Sep 15;26(18):2020-8. doi: 10.1097/00007632-200109150-00016.
Reference Type
BACKGROUND
Yang JH, Suh SW, Sung PS, Park WH. Asymmetrical gait in adolescents with idiopathic scoliosis. Eur Spine J. 2013 Nov;22(11):2407-13. doi: 10.1007/s00586-013-2845-y. Epub 2013 Jun 4.
Reference Type
BACKGROUND
Mahaudens P, Banse X, Mousny M, Detrembleur C. Gait in adolescent idiopathic scoliosis: kinematics and electromyographic analysis. Eur Spine J. 2009 Apr;18(4):512-21. doi: 10.1007/s00586-009-0899-7. Epub 2009 Feb 18.
Reference Type
BACKGROUND
Arima H, Yamato Y, Hasegawa T, et al. Gait analysis after corrective surgery for adult spinal deformity - good sagittal balance with improved lumber lordosis is important. Scoliosis 2015;10:O76
Reference Type
BACKGROUND
Kramers-de Quervain IA, Muller R, Stacoff A, Grob D, Stussi E. Gait analysis in patients with idiopathic scoliosis. Eur Spine J. 2004 Aug;13(5):449-56. doi: 10.1007/s00586-003-0588-x. Epub 2004 Apr 3.
Reference Type
BACKGROUND
Schizas CG, Kramers-de Quervain IA, Stussi E, Grob D. Gait asymmetries in patients with idiopathic scoliosis using vertical forces measurement only. Eur Spine J. 1998;7(2):95-8. doi: 10.1007/s005860050037.
Reference Type
BACKGROUND
Chockalingam N, Dangerfield PH, Rahmatalla A, Ahmed el-N, Cochrane T. Assessment of ground reaction force during scoliotic gait. Eur Spine J. 2004 Dec;13(8):750-4. doi: 10.1007/s00586-004-0762-9. Epub 2004 Jun 22.
Reference Type
BACKGROUND
Giakas G, Baltzopoulos V, Dangerfield PH, Dorgan JC, Dalmira S. Comparison of gait patterns between healthy and scoliotic patients using time and frequency domain analysis of ground reaction forces. Spine (Phila Pa 1976). 1996 Oct 1;21(19):2235-42. doi: 10.1097/00007632-199610010-00011.
Reference Type
BACKGROUND
Mahaudens P, Detrembleur C, Mousny M, Banse X. Gait in adolescent idiopathic scoliosis: energy cost analysis. Eur Spine J. 2009 Aug;18(8):1160-8. doi: 10.1007/s00586-009-1002-0. Epub 2009 Apr 24.
Reference Type
BACKGROUND
O'Beirne J, Goldberg C, Dowling FE, Fogarty EE. Equilibrial dysfunction in scoliosis--cause or effect? J Spinal Disord. 1989 Sep;2(3):184-9.
Reference Type
BACKGROUND
Kuo FC, Wang NH, Hong CZ. Impact of visual and somatosensory deprivation on dynamic balance in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2010 Nov 1;35(23):2084-90. doi: 10.1097/BRS.0b013e3181cc8108.
Reference Type
BACKGROUND
Karimi MT, Kavyani M, Kamali M. Balance and gait performance of scoliotic subjects: A review of the literature. J Back Musculoskelet Rehabil. 2016 Aug 10;29(3):403-15. doi: 10.3233/BMR-150641.
Reference Type
BACKGROUND
Beaulieu M, Toulotte C, Gatto L, Rivard CH, Teasdale N, Simoneau M, Allard P. Postural imbalance in non-treated adolescent idiopathic scoliosis at different periods of progression. Eur Spine J. 2009 Jan;18(1):38-44. doi: 10.1007/s00586-008-0831-6. Epub 2008 Dec 6.
Reference Type
BACKGROUND
Schimmel JJ, Groen BE, Weerdesteyn V, de Kleuver M. Adolescent idiopathic scoliosis and spinal fusion do not substantially impact on postural balance. Scoliosis. 2015 Jun 9;10:18. doi: 10.1186/s13013-015-0042-y. eCollection 2015.
Reference Type
BACKGROUND
Guo X, Chau WW, Hui-Chan CW, Cheung CS, Tsang WW, Cheng JC. Balance control in adolescents with idiopathic scoliosis and disturbed somatosensory function. Spine (Phila Pa 1976). 2006 Jun 15;31(14):E437-40. doi: 10.1097/01.brs.0000222048.47010.bf.
Reference Type
BACKGROUND
Simoneau M, Mercier P, Blouin J, Allard P, Teasdale N. Altered sensory-weighting mechanisms is observed in adolescents with idiopathic scoliosis. BMC Neurosci. 2006 Oct 19;7:68. doi: 10.1186/1471-2202-7-68.
Reference Type
BACKGROUND
Marcotte L. SpineCor in the treatment of adult. Scoliosis 2010;5:47.
Reference Type
BACKGROUND
Zaina F, Poggio M, Donzelli S, Negrini S. Can bracing help adults with chronic back pain and scoliosis? Short-term results from a pilot study. Prosthet Orthot Int. 2018 Aug;42(4):410-414. doi: 10.1177/0309364618757769. Epub 2018 Feb 15.
Reference Type
BACKGROUND
Gallo D. Case reports: orthotic treatment of adult scoliosis patients with chronic back pain. Scoliosis. 2014 Nov 18;9:18. doi: 10.1186/1748-7161-9-18. eCollection 2014.
Reference Type
BACKGROUND
Sachs D, Capobianco R, Cher D, Holt T, Gundanna M, Graven T, Shamie AN, Cummings J Jr. One-year outcomes after minimally invasive sacroiliac joint fusion with a series of triangular implants: a multicenter, patient-level analysis. Med Devices (Auckl). 2014 Aug 28;7:299-304. doi: 10.2147/MDER.S56491. eCollection 2014.
Reference Type
BACKGROUND
Toosizadeh N, Yen TC, Howe C, Dohm M, Mohler J, Najafi B. Gait behaviors as an objective surgical outcome in low back disorders: A systematic review. Clin Biomech (Bristol). 2015 Jul;30(6):528-36. doi: 10.1016/j.clinbiomech.2015.04.005. Epub 2015 Apr 17.
Reference Type
BACKGROUND
Portney LG, Watkins MP. Foundation of clinical research: applications to practice. 3rd ed. Upper Saddle River, New Jersy: Julie Levin Alexander, 2009.
Reference Type
BACKGROUND
Sengupta DK. Re: Schwab F, Ungar B, Blondel B, et al. Scoliosis research society-Schwab adult spinal deformity classification--a validation study. Spine 2012; 37:1077-82. Spine (Phila Pa 1976). 2012 Sep 15;37(20):1790. doi: 10.1097/BRS.0b013e318260d8e4. No abstract available.
Reference Type
BACKGROUND
El Fegoun AB, Schwab F, Gamez L, Champain N, Skalli W, Farcy JP. Center of gravity and radiographic posture analysis: a preliminary review of adult volunteers and adult patients affected by scoliosis. Spine (Phila Pa 1976). 2005 Jul 1;30(13):1535-40. doi: 10.1097/01.brs.0000167534.49069.e9.
Reference Type
BACKGROUND
Vaughan CL, Davis BL, O'Conner JC. Dynamics of Human Gait. 2nd ed. Cape Town, South Africa: Kiboho Publishers, 1999.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TBIRF-Aspen
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Gait and Balance in Thoracolumbar Spinal Deformity
NCT02761265
UNKNOWN
NA
Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease
NCT03484403
COMPLETED
NA
The Rehabilitation Outcome of Patients With Lumbar Spondylolisthesis. A Prospective Randomized Study
NCT02435485
UNKNOWN
NA
Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression
NCT04805437
RECRUITING
NA
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
NCT00154505
COMPLETED
PHASE1
Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
NCT02227537
UNKNOWN
The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial
NCT03676712
TERMINATED
NA
Enhancing the Therapeutic Effect of Bracing for Adolescent Idiopathic Scoliosis With a Hybrid Bracing Protocol
NCT07045337
ACTIVE_NOT_RECRUITING
NA
Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1)
NCT06217510
NOT_YET_RECRUITING
NA
Efficacy of Scoliosis Specific Exercise in Patients With Adolescent Idiopathic Scoliosis During Bracing
NCT03305185
UNKNOWN
NA
Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
NCT02285621
COMPLETED
NA
The Adult Degenerative Scoliosis Exercise Trial (Pilot Study)
NCT03862417
RECRUITING
NA
Scoliosis Surgery Using the PASS® LP System
NCT01019109
COMPLETED
Scoliosis-Specific Exercises for At-Risk AIS Curves
NCT02807545
COMPLETED
NA
A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace
NCT01336114
COMPLETED
Balance Amongst Patients With Lumbar Spinal Stenosis
NCT06075862
RECRUITING
Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis
NCT05001568
ACTIVE_NOT_RECRUITING
NA
Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
NCT04282408
COMPLETED
NA
Treatment With a Spinal Orthosis Compared to Equipment Group Training and a Control Group
NCT03263585
COMPLETED
NA
Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis
NCT04116723
RECRUITING
NA
Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
NCT05790031
RECRUITING
NA
A Pivotal Study of the Premia Spine TOPS™ System
NCT03012776
COMPLETED
NA
The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)
NCT01370057
TERMINATED
NA