Evaluation Of The Effect Of Spinal Orthosis On Tactile Sense And Balance In Individuals With Lumbal Curve And Adolescent Idiopathic Scoliosis

NCT06170112 | Unknown DMC

• 1 other identifier: Orthosis Prosthesis
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In individuals with lumbar curvature, significant regressions in the curvature have been observed with spinal orthosis treatment, especially with use of a minimum of 20 hours a day. Symptoms such as numbness and decreased sense of touch are observed in the areas where the curvature is located, and changes in the skin structure are affected by the changes in the spine. Sensory testing may vary with changes in body posture. At the same time, the use of spinal orthosis, balance, fat mass, and the presence of pain show us sensitivity to touch on the skin. Sensory stimuli on the skin and trunk posture are interconnected. There are a limited number of studies in the literature examining the effects of sensory test results and fat mass on individuals diagnosed with AIS after using a spinal orthosis.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent idiopathic scoliosis; Sense of Touch; Dynamic balance; Spinal orthosis

Outcome Measures

Primary Outcomes (1)

• The effect of spinal orthosis on the sense of touch

  Individuals between the ages of 10-18 included in the study will touch the ends of the monofilament kit, consisting of 6 different tips, to the concave and convex sections of the slope in the T10-L4 and L5 regions. The results are recorded when the individual answers "I felt it/I didn't feel it". Evaluations will be made immediately before orthosis use and 12 weeks after orthosis use.

  5 minute

Secondary Outcomes (3)

• Effect of spinal orthosis on dynamic balance

  10 minute

• Effect of spinal orthosis on fat tissue

  5 minute

• The effect of spinal orthosis on quality of life

  20 minute

Study Arms (1)

Spinal Orthosis

There are pressure forces applied by the design of the spinal orthosis in changing the biomechanics of the scoliotic spine. In the design of the spinal orthosis designed with the 3-point principle, there is a corrective lateral force applied to the main curvature area and two support forces opposing this force. There are breathing spaces in the back area.

Other: Spinal Orthosis Application

Interventions

Spinal Orthosis Application OTHER

Spinal orthosis treatment is to prevent secondary curvature and provide correction. Corrective pressure forces in spinal orthosis are basically; There are pressure points on the material of the spinal orthosis, pressure pads, and velcros used to adjust the tightness and ensure the stability of the orthosis. The duration of use of spinal orthoses varies from patient to patient; It is known that using it for an average of 23 hours a day gives the best results. Orthosis use is required for 12 weeks during the study.

Spinal Orthosis

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals between the ages of 10-18 who have been diagnosed with AIS by a doctor come to our clinic. Following clinical evaluations, a spinal orthosis evaluation will be performed. Individuals must not have used a spinal orthosis before.They should not have any accompanying neurological disease.

You may qualify if:

• Being diagnosed with Adolescent Idiopathic Scoliosis (AIS) between the ages of 10-18,
• Curvature only in the lumbar region,
• degree curvature degree,
• Being deemed suitable for spinal orthosis use by the doctor,
• Not having used a spinal orthosis before

You may not qualify if:

• Having different diagnoses such as congenital scoliosis, spina bfida, traumatic scoliosis, osteoporosis,
• Having had spine surgery
• Having used a scoliosis spinal orthosis,
• Having an accompanying disease that may prevent the use of spinal orthosis and
• Failure to sign the consent form required to participate in the study

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, 34722, Turkey (Türkiye)

RECRUITING

Study Officials

• Basak Iscioglu

  Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basak I Iscioglu

CONTACT

05319238578; iscioglubasak@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthosist Prosthetist

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 14, 2023
• Study Start: November 13, 2023
• Primary Completion: February 20, 2024
• Study Completion: March 6, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)