Scoliosis; AdolescenceNCT05479695
The Effect Insoles on Functional Capacity With Adolescent Idiopathic Scoliosis Using Spinal Orthosis
A study testing Spinal Orthoses and Insoles and Spinal Orthoses in people with Scoliosis; Adolescence and Pressure Area, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Scoliosis; Adolescence, Pressure Area, Scoliosis
- What is being tested?
- Spinal Orthoses and Insoles and Spinal Orthoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2021to 22 Apr 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Previously used insoles
- Finding a neurological problem
- Those with congenital lower extremity deformities
- Patients with lower extremity length difference more than 2 cm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34810
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Scoliosis; Adolescence, Pressure Area, Scoliosis, Orthosis
- Being tested
- Spinal Orthoses and Insoles, Spinal Orthoses
- Keywords
- Adolescent Idiopathic Scoliosis, Scoliosis Brace, Insoles
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Orthoses and InsolesDevice
Evaluation of scoliosis treatment in people using spinal orthoses and insoles
Spinal OrthosesDevice
Evaluation of scoliosis treatment in people using spinal orthoses
| Study group | Role | What they receive |
|---|---|---|
| Patient who use spinal orthoses and insoles | Experimental | Spinal Orthoses: Devices that used in spinal deformities. Insoles: Devices that used in foot deformities. Receives: Device: Spinal Orthoses and Insoles |
| Patient who use only spinal orthoses | Other | Spinal Orthoses: Devices that used in spinal deformities. Receives: Device: Spinal Orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
assessment of functional capacity
Measured: Change from Baseline of treatment at 3 months
Scoliosis Research Society (SRS-22 test)
assessment of quality of life
Measured: Change from Baseline of treatment at 3 months
sway balance test
assessment of postural balance
Measured: Change from Baseline of treatment at 3 months
plantar pressure analysis
static and dynamic plantar pressure analysis
Measured: Change from Baseline of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start22 May 2021
- Primary completion22 Nov 2021
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The first group uses spinal orthoses. The second group uses spinal orthosis and insoles.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve arslan, Istanbul Medipol University Hospital
- Investigators
- Sena OZDEMİR GORGU, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479695
- Sponsor's protocol ID
- mervearslan
- Status last verified
- Jul 2022
- First submitted
- 12 Mar 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No