The Effect Insoles on Functional Capacity With Adolescent Idiopathic Scoliosis Using Spinal Orthosis
Primary Purpose
Scoliosis; Adolescence, Pressure Area, Scoliosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spinal Orthoses and Insoles
Spinal Orthoses
Sponsored by
About this trial
This is an interventional other trial for Scoliosis; Adolescence focused on measuring Adolescent Idiopathic Scoliosis, Scoliosis Brace, Insoles
Eligibility Criteria
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
Sites / Locations
- Istanbul Medipol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Patient who use spinal orthoses and insoles
Patient who use only spinal orthoses
Arm Description
Spinal Orthoses: Devices that used in spinal deformities. Insoles: Devices that used in foot deformities.
Spinal Orthoses: Devices that used in spinal deformities.
Outcomes
Primary Outcome Measures
6-minute walk test
assessment of functional capacity
Scoliosis Research Society (SRS-22 test)
assessment of quality of life
sway balance test
assessment of postural balance
plantar pressure analysis
static and dynamic plantar pressure analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT05479695
First Posted
March 12, 2021
Last Updated
July 28, 2022
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05479695
Brief Title
The Effect Insoles on Functional Capacity With Adolescent Idiopathic Scoliosis Using Spinal Orthosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2021 (Actual)
Primary Completion Date
November 22, 2021 (Actual)
Study Completion Date
April 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis; Adolescence, Pressure Area, Scoliosis, Orthosis
Keywords
Adolescent Idiopathic Scoliosis, Scoliosis Brace, Insoles
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The first group uses spinal orthoses. The second group uses spinal orthosis and insoles.
Masking
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.
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient who use spinal orthoses and insoles
Arm Type
Experimental
Arm Description
Spinal Orthoses: Devices that used in spinal deformities. Insoles: Devices that used in foot deformities.
Arm Title
Patient who use only spinal orthoses
Arm Type
Other
Arm Description
Spinal Orthoses: Devices that used in spinal deformities.
Intervention Type
Device
Intervention Name(s)
Spinal Orthoses and Insoles
Intervention Description
Evaluation of scoliosis treatment in people using spinal orthoses and insoles
Intervention Type
Device
Intervention Name(s)
Spinal Orthoses
Intervention Description
Evaluation of scoliosis treatment in people using spinal orthoses
Primary Outcome Measure Information:
Title
6-minute walk test
Description
assessment of functional capacity
Time Frame
Change from Baseline of treatment at 3 months
Title
Scoliosis Research Society (SRS-22 test)
Description
assessment of quality of life
Time Frame
Change from Baseline of treatment at 3 months
Title
sway balance test
Description
assessment of postural balance
Time Frame
Change from Baseline of treatment at 3 months
Title
plantar pressure analysis
Description
static and dynamic plantar pressure analysis
Time Frame
Change from Baseline of treatment at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sena OZDEMİR GORGU
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34810
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect Insoles on Functional Capacity With Adolescent Idiopathic Scoliosis Using Spinal Orthosis
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