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

NCT05479695 | Completed

• 1 other identifier: mervearslan
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Adolescence; Pressure Area; Scoliosis; Orthosis

Keywords

Adolescent Idiopathic Scoliosis; Scoliosis Brace; Insoles

Outcome Measures

Primary Outcomes (4)

• 6-minute walk test

  assessment of functional capacity

  Change from Baseline of treatment at 3 months

• Scoliosis Research Society (SRS-22 test)

  assessment of quality of life

  Change from Baseline of treatment at 3 months

• sway balance test

  assessment of postural balance

  Change from Baseline of treatment at 3 months

• plantar pressure analysis

  static and dynamic plantar pressure analysis

  Change from Baseline of treatment at 3 months

Study Arms (2)

Patient who use spinal orthoses and insoles

EXPERIMENTAL

Spinal Orthoses: Devices that used in spinal deformities. Insoles: Devices that used in foot deformities.

Device: Spinal Orthoses and Insoles

Patient who use only spinal orthoses

OTHER

Spinal Orthoses: Devices that used in spinal deformities.

Device: Spinal Orthoses

Interventions

Spinal Orthoses and Insoles DEVICE

Evaluation of scoliosis treatment in people using spinal orthoses and insoles

Patient who use spinal orthoses and insoles

Spinal Orthoses DEVICE

Evaluation of scoliosis treatment in people using spinal orthoses

Patient who use only spinal orthoses

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Previously used insoles
• Finding a neurological problem
• Those with congenital lower extremity deformities
• Patients with lower extremity length difference more than 2 cm

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Sena OZDEMİR GORGU

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: The first group uses spinal orthoses. The second group uses spinal orthosis and insoles.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: July 29, 2022
• Study Start: May 22, 2021
• Primary Completion: November 22, 2021
• Study Completion: April 22, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)