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

July 28, 2022 updated by: merve arslan, Istanbul Medipol University Hospital

The Effect of Insoles on Functional Capacity, Quality of Life, Balance and Plantar Pressure in Patient With Adolescent Idiopathic Scoliosis Using Chêneau Type Spinal Orthosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Beykoz
      • Istanbul, Beykoz, Turkey, 34810
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient who use spinal orthoses and insoles
Spinal Orthoses: Devices that used in spinal deformities. Insoles: Devices that used in foot deformities.
Device: Spinal Orthoses and Insoles
Evaluation of scoliosis treatment in people using spinal orthoses and insoles
Other: Patient who use only spinal orthoses
Spinal Orthoses: Devices that used in spinal deformities.
Device: Spinal Orthoses
Evaluation of scoliosis treatment in people using spinal orthoses

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Study Director: Sena OZDEMİR GORGU, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2021

Primary Completion (Actual)

November 22, 2021

Study Completion (Actual)

April 22, 2022

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mervearslan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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