Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05479695
Other study ID # mervearslan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 22, 2021
Est. completion date April 22, 2022

Study information

Verified date July 2022
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adolescent Idiopathic Scoliosis; by problem of stabilty causes postural changes, because of this reason patient with scoliosis needs to assesment by risk of balance. Postural adjustments are required, both in a static stance and during walking. Insoles from foot orthoses support better postural balance and control. It has been reported that approximately 87% of scoliosis patients have pelvic asymmetry, and patients with scoliosis with a Cobb angle of 15⁰ or more have balance problems in their feet. Foot orthoses (FO) correct pelvic asymmetry and reduce lower extremity joint angles during walking. In the literature, although there are studies such as balance assessment and plantar pressure analysis in Adolescent Idiopathic Scoliosis (AIS) patients, there are not enough studies on the effect of insoles used in scoliosis patients, and it has been observed that there is no study on the effect of insoles on treatment in patients using spinal orthosis. The aim of this study is to investigate the effect of insoles on the treatment of scoliosis patients using Chêneau type spinal orthosis. In the study; The effect of insoles on patients with 20-45⁰ curvature, adolescent idiopathic scoliosis and using Chêneau type spinal orthosis; It was planned to investigate the groups using and not using insoles at the beginning of the treatment and after 3 months of follow-up by comparing the results of Cobb angle measurement, functional capacity assessment test, quality of life assessment test, balance test and plantar pressure analysis.


Description:

Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine that is commonly seen in individuals aged 10-19 years, and spinal orthosis application, one of the conservative treatment methods, is widely preferred today. Spinal orthosis application in individuals with scoliosis may adversely affect functional capacity, quality of life, balance and plantar pressure. The aim of this study is to determine the use of insoles for 3 months in AIS individuals using Chêneau type spinal orthosis functional capacity, quality of life, balance and the effect of plantar pressure is to investigate. Study group included 42 individuals aged between 10-19 with a Cobb angle of 20-45⁰. Participants were randomly separated into 2 groups; Control-KG (n=21) and using insoles-TG (n=21). While only Chêneau type spinal orthosis was applied to KG group for 3 months, Chêneau type spinal orthosis and insoles were applied to TG group. Measurements were repeated after one week of spinal orthosis application and at the end of the 3rd month. The 6 Minute Walk Test (6 MWT) was used to evaluate the functional capacity of the participants, the Scoliosis Research Society-22 (SRS-22) for quality of life, and the Sensor Medica Maxi pedobarographic device for balance and plantar pressure measurements.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date April 22, 2022
Est. primary completion date November 22, 2021
Accepts healthy volunteers No
Gender All
Age group 10 Years to 19 Years
Eligibility Inclusion criteria; - Adolescent idiopathic scoliosis patients between the ages of 10-19 - Cobb angle to be in the range of 20-45 ° - Adolescent idiopathic scoliosis patients who will use Chêneau type spinal orthosis for the first time or who will be renewed with a Chêneau type spinal orthosis - Absence of neurological problems - Differences in plantar pressure analysis of the two lower extremities Exclusion criteria; - Previously used insoles - Finding a neurological problem - Those with congenital lower extremity deformities - Patients with lower extremity length difference more than 2 cm

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Spinal Orthoses and Insoles
Evaluation of scoliosis treatment in people using spinal orthoses and insoles
Spinal Orthoses
Evaluation of scoliosis treatment in people using spinal orthoses

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6-minute walk test assessment of functional capacity Change from Baseline of treatment at 3 months
Primary Scoliosis Research Society (SRS-22 test) assessment of quality of life Change from Baseline of treatment at 3 months
Primary sway balance test assessment of postural balance Change from Baseline of treatment at 3 months
Primary plantar pressure analysis static and dynamic plantar pressure analysis Change from Baseline of treatment at 3 months
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 NCT02531945 - Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years N/A
Completed NCT02413788 - Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis N/A
Completed NCT02558985 - Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
Completed NCT02890654 - Scoliosis and Quality of Life of Adolescents
Terminated NCT02134704 - MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis N/A
Completed NCT02609009 - Back Pain and Spinal Manipulation in Adolescent 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 NCT00155545 - Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients Phase 1
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