The Effect Insoles on Functional Capacity With Adolescent Idiopathic Scoliosis Using Spinal Orthosis

Not Applicable

Completed

• Conditions: Scoliosis; Adolescence; Scoliosis; Pressure Area; Orthosis
• Interventions: Device: Spinal Orthoses and Insoles; Device: Spinal Orthoses

• Registration Number: NCT05479695
• Lead Sponsor: Istanbul Medipol University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-03-12
• Study Start: 2021-05-22
• Primary Completion: 2021-11-22
• Study Completion: 2022-04-22
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Patient who use spinal orthoses and insoles	Spinal Orthoses and Insoles	Spinal Orthoses: Devices that used in spinal deformities. Insoles: Devices that used in foot deformities.
Patient who use only spinal orthoses	Spinal Orthoses	Spinal Orthoses: Devices that used in spinal deformities.

Primary Outcome Measures

Name	Time	Method
plantar pressure analysis	Change from Baseline of treatment at 3 months	static and dynamic plantar pressure analysis
6-minute walk test	Change from Baseline of treatment at 3 months	assessment of functional capacity
Scoliosis Research Society (SRS-22 test)	Change from Baseline of treatment at 3 months	assessment of quality of life
sway balance test	Change from Baseline of treatment at 3 months	assessment of postural balance

Trial Locations

Locations (1)

Istanbul Medipol University; 🇹🇷 Istanbul, Beykoz, Turkey