Scoliosis Clinical Trial
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
NCT number | NCT05479695 |
Other study ID # | mervearslan |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 22, 2021 |
Est. completion date | April 22, 2022 |
Verified date | July 2022 |
Source | Istanbul Medipol University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | April 22, 2022 |
Est. primary completion date | November 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 19 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol University | Istanbul | Beykoz |
Lead Sponsor | Collaborator |
---|---|
Istanbul Medipol University Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6-minute walk test | assessment of functional capacity | Change from Baseline of treatment at 3 months | |
Primary | Scoliosis Research Society (SRS-22 test) | assessment of quality of life | Change from Baseline of treatment at 3 months | |
Primary | sway balance test | assessment of postural balance | Change from Baseline of treatment at 3 months | |
Primary | plantar pressure analysis | static and dynamic plantar pressure analysis | Change from Baseline of treatment at 3 months |
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