Clinical Trials Logo

Clinical Trial Summary

The purposes of this study are to use motion analysis techniques to study the biomechanical interactions between the spine and the lower limbs in scoliosis patients with or without leg length discrepancy (LLD) during activity; to investigate the effects of correction of LLD: using foot orthosis on the functional scoliotic spinal curve and motion during functional activity; and to test whether idiopathic scoliosis without LLD can be improved by artificially creating a leg length discrepancy with a foot orthosis.


Clinical Trial Description

Scoliosis is one of the most common back deformities in children. Idiopathic and functional (secondary) scoliosis are arguably the two most common types. The etiology of idiopathic scoliosis has been studied in many aspects such as genetic factors, skeletal muscle abnormalities, neurological mechanisms, and biomechanical factors, while the common causes of secondary or functional scoliosis are leg length inequality and muscle spasm. It is evident that biomechanical factors that involve the interactions of the musculoskeletal alignment and loading are closely associated with the development of both types of scoliosis.

Leg length discrepancy (LLD) is defined as a condition in which paired limbs are unequal in length. It is now generally accepted that LLD can lead to lumbar scoliosis and it is assumed that scoliosis caused by LLD can be removed if LLD is eliminated. However, no study has documented the effects of the correction of LLD on the functional scoliotic spinal curve and motion during functional activity. Since spinal curve and motion have clear associations with leg length inequality, one would wonder whether idiopathic scoliosis without LLD can be improved by artificially creating a leg length difference with an orthosis when spine surgery is not considered or in a less severe condition. It has been shown that LLD and scoliosis have effects on pain, force transmission and performance of motion. Therefore, the artificially created leg length difference may have negative effects even though the scoliosis is improved. The benefits and disadvantages of using a foot orthosis to create artificial LLD in order to relieve idiopathic scoliosis require careful investigation. Although the biomechanics of the spine or the lower extremities have been studied separately in the literature, the biomechanical interactions between the spine and the lower limbs in scoliosis patients with or without LLD and the biomechanical effects of treatments using foot orthosis on these patients remain to be studied.

Using motion analysis techniques, the present study aims:

1. to study the biomechanical interactions between the spine and the lower limbs in scoliosis patients with or without LLD during activity;

2. to investigate effects of correction of LLD using a foot orthosis on the functional scoliotic spinal curve and motion during functional activity; and

3. to test whether idiopathic scoliosis without LLD can be improved by artificially creating a leg length discrepancy with a foot orthosis. The optimal heights of the foot orthosis for the later two objectives will also be determined. It is hoped that the present study will lead to a better understanding of the mechanical interactions between the spine and the lower extremities in functional and idiopathic scoliosis patients, and a better treatment for these patients. ;


Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT00155545
Study type Interventional
Source National Taiwan University Hospital
Contact
Status Completed
Phase Phase 1
Start date September 2005
Completion date September 2008

See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Recruiting NCT05944393 - Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery N/A
Recruiting NCT05888038 - Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair N/A
Completed NCT02413788 - Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis N/A
Completed NCT02890654 - Scoliosis and Quality of Life of Adolescents
Completed NCT02531945 - Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years N/A
Completed NCT02558985 - Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
Completed NCT02609009 - Back Pain and Spinal Manipulation in Adolescent Scoliosis N/A
Terminated NCT02134704 - MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis N/A
Completed NCT02285621 - Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis N/A
Withdrawn NCT00768313 - Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis. Phase 4
Completed NCT00154505 - Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons Phase 1
Completed NCT00320619 - Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery N/A
Completed NCT00273598 - Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis Phase 2
Completed NCT03135665 - Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure N/A
Completed NCT06428864 - Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
Recruiting NCT04423146 - Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery
Completed NCT03814239 - Blood and Fluid Management During Scoliosis Surgery
Withdrawn NCT02058238 - ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
Completed NCT02904421 - 6 Years Study on Changes in Bone Quality, Bone Turnover and Curve Severity in AIS With and Without Calcium and Vit-D Supplementation