An interventional study of Cover spine orthosis (CSO) and Semi-rigid thoracolumbar orthosis in Postural Kyphosis and Hyperkyphosis, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Supportive care
Among 35 studies in Kyphosis with a site in Turkey — 9 open to participants now, 10 under way, none of them phase 3. Kyphosis · Turkey.
Among the 35 studies in Kyphosis with a site in Turkey, this one is the 17th largest by enrollment of the 21 interventional ones that give a count, is one of 3 that started in 2022, is one of 21 with no phase, and was the 21st registered.
132 studies on the registry are indexed under Kyphosis; 31 are open to participants now.
Browse Kyphosis studies →9 of the 35 studies in Kyphosis with a site in Turkey are open now. Recruiting first, the newest first:
Istinye University · Sites in Turkey
Istinye University · Sites in Turkey
Gaziosmanpasa Research and Education Hospital · Sites in Turkey
Istanbul University - Cerrahpasa · Sites in Turkey
Izmir Democracy University · Sites in Turkey
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 20 Kyphosis studies recruiting now, 7 (35%) set no upper age limit and 12 (60%) stop at 75 or younger; 7 take children under 18; 1 take healthy volunteers.
This study: 20 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
35 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 3 started in 2022.
This study's enrollment of 34 is below the median of 44 across 82 interventional studies indexed under Kyphosis.
Median enrollment 40 across the 21 interventional studies, 57 across the 14 observational. Of the 25 that completed or were terminated, 0 (0%) have results posted.
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None of the 35 has an industry lead sponsor. The 10 most frequent:
Istanbul Medipol University Hospital is the lead sponsor of 366 studies on the registry; 46 are open to participants now.
Istanbul Medipol University Hospital has 2 studies filed under Kyphosis — fewer than ten, so there is no comparison to draw.
4 of the studies in Kyphosis with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07860606Istinye UniversityPosture, Proprioception, Core Stability, and Balance in Weightlifters | 2026-12-01 |
| NCT07888790Istinye UniversityKinesio Taping in Young Adults With Thoracic Hyperkyphosis | 2026-12-15 |
| NCT07905014Istinye UniversitySurface Electromyographic Analysis of Scapular Stabilizer Muscle in Postural Hyperkyphosis | 2027-01-15 |
| NCT07922369Istanbul University - CerrahpasaA Comparison of the Effects of Exercise Methods for Adolescent Hyperkyphosis on the Sensorimotor System | 2027-05-15 |
Among the 35 studies in Kyphosis with a site in Turkey, from their registry updates:
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Thoracic hyperkyphosis is a common postural deformity; however, the optimal treatment strategy has yet to be clearly defined. This randomized controlled trial aimed to assess the effectiveness of an innovative three-dimensional printed Cover Spine Orthosis (CSO) in managing thoracic hyperkyphosis. Specifically, the study compared the effects of the CSO on kyphosis angle, quality of life (QoL), and user satisfaction with those of a semi-rigid thoracolumbar orthosis (SRTLO) that has established efficacy in the literature.
Postural kyphosis is associated with various clinical symptoms, including fatigue, pain, weakness of the back extensor muscles, depressive mood, and a reduction in quality of life (QoL). Previous research has consistently shown that spinal deformities negatively impact overall health, particularly diminishing individuals' QoL. Although conservative approaches are commonly recommended for managing postural kyphosis, a universally accepted treatment protocol has not yet been established. Current evidence suggests that interventions such as exercise, kinesio-taping, and orthotic use may be effective in decreasing the thoracic kyphosis angle (TKA). Among these, orthotic interventions have been widely employed to correct posture and reduce TKA. While various orthosis designs have been studied, and some have demonstrated significant outcomes, there is still no consensus on the most effective orthotic treatment. In light of existing literature and advancements in biomechanics and design technologies, a novel three-dimensional (3D) orthosis was developed to address these gaps. This study aimed primarily to assess the effectiveness of a custom-designed, 3D-printed Cover Spine Orthosis (CSO) in reducing TKA in individuals with postural kyphosis, in comparison to a semi-rigid thoracolumbar orthosis (SRTLO) previously validated in the literature. A secondary objective was to evaluate and compare the effects of both orthoses on quality of life and user satisfaction
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
he Cover Spine Orthosis (CSO) is a novel therapeutic device specifically engineered to address excessive thoracic curvature in individuals diagnosed with hyperkyphosis. Utilizing three-dimensional (3D) printing technology, the orthosis is produced from thermoplastic polyurethane, a material known for its flexibility and durability. The CSO incorporates two primary corrective components positioned anteriorly and posteriorly. The anterior section functions to stabilize the thoracic region from the front, while the posterior section delivers a corrective force from the back, targeting spinal alignment. To ensure a secure and adaptive fit, elastic webbing with Velcro and loop fasteners is integrated on both sides of the shoulder and trunk. These connectors link the anterior and posterior components, maintaining optimal suspension of the orthosis on the user's body. Furthermore, the design features a broad contact area, which enhances postural control by distributing mechanical forces more
Device: Cover spine orthosis (CSO)
The control group was fitted with a semi-rigid thoracolumbar orthosis (SRTLO), a device whose clinical efficacy has been previously validated. This orthosis includes paraspinal support bars, bilateral shoulder straps, and a Velcro-based fastening system. The paraspinal bars function to limit spinal flexion, thereby promoting an extended spinal posture. The shoulder straps are passed anteriorly over the shoulders, routed posteriorly through the axillary regions, crossed to the opposite side, and brought back to the front. Once appropriate tension is applied, the straps are secured using Velcro fasteners. Final stabilization is accomplished by anterior traction on the thoracic section straps to ensure optimal corrective force distribution.
Device: Semi-rigid thoracolumbar orthosis
The participants included in the study were asked to use the orthoses given as a result of randomization for four weeks, excluding the time they were asleep (average 12 h per day).
The participants included in the study were asked to use the orthoses given as a result of randomization for four weeks, excluding the time they were asleep (average 12 h per day).
Thoracic kyphosis angle (TKA)
Thoracic kyphosis angle (TKA) was assessed using a flexicurve, a flexible, plastic-coated metal ruler that conforms to the curvature of the spine. For measurement, the flexicurve was molded along the thoracic spine between the C7 and T12 vertebrae while the participant maintained an upright posture. Once the curve was shaped, its outline was transferred onto paper for further analysis. The kyphosis index was calculated by measuring the height of the apex of the curve (B) and dividing it by the total horizontal length of the thoracic curve (X), then multiplying the result by 100: (B/X) × 100. Additionally, the flexicurve angle (θ) was derived by constructing a triangle from the traced curve and measuring the angle formed by lines drawn perpendicular to its sides.
Time frame: 3 minutes
Quality of life (QoL)
Participant quality of life (QoL) was assessed using the Scoliosis Research Society-22 (SRS-22) questionnaire. This instrument comprises 22 items divided into five distinct domains: pain, self-image, spinal function, mental health, and satisfaction with treatment. Each item is scored on a 5-point likert scale ranging from 1 (least favorable) to 5 (most favorable). Higher total and subscale scores reflect better perceived quality of life, whereas lower scores indicate reduced well-being.
Time frame: 3 minutes
User satisfaction
User satisfaction was measured using the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0), a validated instrument designed to assess satisfaction with assistive technologies. The questionnaire consists of 12 items divided into two subdomains: device-related (8 items) and service-related (4 items). These items evaluate features such as size, weight, usability, comfort, and overall effectiveness. Responses are rated on a 5-point Likert scale, ranging from 1 (not satisfied at all) to 5 (very satisfied), with higher scores reflecting greater satisfaction with the device or service.
Time frame: 2 minutes
Plan to share: No — The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Ran from Jan 2022 to primary completion in Nov 2022, 10 months.
Of 56 non-industry interventional studies with no phase under Kyphosis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's 10 months is above that.
Counting every sponsor, half of 58 studies reached it within 9 months; a quarter within 4 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Istanbul Medipol University Hospital →