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

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05479695
Collaborator
(none)
42
1
2
11
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Spinal Orthoses and Insoles
  • Device: Spinal Orthoses
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
The first group uses spinal orthoses. The second group uses spinal orthosis and insoles.The first group uses spinal orthoses. The second group uses spinal orthosis and insoles.
Masking:
Single (Participant)
Masking Description:
54 pre-filled sealed envelopes were prepared for the randomization process of the participants who met the inclusion and exclusion criteria determined in the study. 27 envelope series consists of 1 number and 27 envelope series consists of 2 number. The control group (KG) using Chêneau type spinal orthosis was given number 1, and the group using Chêneau type spinal orthosis and insoles (TG) was given number 2. Each of the participants chose one of the sealed envelopes in turn. Participants included in the study were randomly assigned to the KG group or the TG group according to the number on the selected envelope.
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
May 22, 2021
Actual Primary Completion Date :
Nov 22, 2021
Actual Study Completion Date :
Apr 22, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 6-minute walk test [Change from Baseline of treatment at 3 months]

    assessment of functional capacity

  2. Scoliosis Research Society (SRS-22 test) [Change from Baseline of treatment at 3 months]

    assessment of quality of life

  3. sway balance test [Change from Baseline of treatment at 3 months]

    assessment of postural balance

  4. plantar pressure analysis [Change from Baseline of treatment at 3 months]

    static and dynamic plantar pressure analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Istanbul Beykoz Turkey 34810

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

  • Study Director: Sena OZDEMİR GORGU, Medipol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
merve arslan, Research Assistant, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT05479695
Other Study ID Numbers:
  • mervearslan
First Posted:
Jul 29, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by merve arslan, Research Assistant, Istanbul Medipol University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022