Postural KyphosisNCT06988046
Innovative Orthosis in Hyperkyphosis
A study testing Cover spine orthosis (CSO) and Semi-rigid thoracolumbar orthosis in people with Postural Kyphosis and Hyperkyphosis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Kyphosis, Hyperkyphosis
- What is being tested?
- Cover spine orthosis (CSO) and Semi-rigid thoracolumbar orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals of both sexes (male and female)
- Aged between 20 and 60 years
- Presence of thoracic kyphosis angle (TKA) ≥ 40°
Who cannot join
- History of spinal surgery or traumatic injury
- Received physiotherapy treatment within the last six months
- Diagnosed with congenital spinal deformities or scoliosis
- Presence of acute musculoskeletal injury
- Inability to tolerate or adapt to orthotic application
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Prosthetics-Orthotics Research Center (POMER)
Istanbul, Kavacık, 34815
About this study
Official title: Clinical Effects of an Innovative Three-Dimensional Orthosis in Thoracic Hyperkyphosis: A Randomized Controlled Trial
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.
Read the detailed description
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
- Conditions
- Postural Kyphosis, Hyperkyphosis
- Being tested
- Cover spine orthosis (CSO), Semi-rigid thoracolumbar orthosis
- Keywords
- Thoracic hyperkyphosis, postural kyphosis, three-dimensional orthosis, thoracic kyphosis angle
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cover spine orthosis (CSO)Device
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).
Semi-rigid thoracolumbar orthosisDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Cover spine orthosis group (CSO) | Experimental | 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 Receives: Device: Cover spine orthosis (CSO) |
| Semi-rigid thoracolumbar orthosis group (SRTLO) | Active comparator | 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. Receives: Device: Semi-rigid thoracolumbar orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 minutes
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start10 Jan 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural KyphosisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sena ozdemir, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988046
- Sponsor's protocol ID
- E-30 10840098-772.02-6671
- Status last verified
- Dec 2021
- First submitted
- 16 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of an Innovative Three-Dimensional Orthosis in Thoracic Hyperkyphosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06988046
- Acronym / sponsor ID
- E-30 10840098-772.02-6671
- Conditions
- Postural Kyphosis, Hyperkyphosis
- Keywords
- Thoracic hyperkyphosis, postural kyphosis, three-dimensional orthosis, thoracic kyphosis angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cover spine orthosis group (CSO) | Experimental | Device: Cover spine orthosis (CSO)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 |
| Semi-rigid thoracolumbar orthosis group (SRTLO) | Active comparator | Device: Semi-rigid thoracolumbar orthosisThe 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals of both sexes (male and female)
- Aged between 20 and 60 years
- Presence of thoracic kyphosis angle (TKA) ≥ 40°
Key exclusion criteria (5 listed)
- History of spinal surgery or traumatic injury
- Received physiotherapy treatment within the last six months
- Diagnosed with congenital spinal deformities or scoliosis
- Presence of acute musculoskeletal injury
- Inability to tolerate or adapt to orthotic application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cover spine orthosis (CSO)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). | Device | Cover spine orthosis group (CSO) |
| Semi-rigid thoracolumbar orthosisThe 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). | Device | Semi-rigid thoracolumbar orthosis group (SRTLO) |
Primary outcome
Thoracic kyphosis angle (TKA)
Time frame: 3 minutes
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.
2 secondary outcomes
Quality of life (QoL)
Time frame: 3 minutes
User satisfaction
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cover spine orthosis (CSO) and Semi-rigid thoracolumbar orthosis in people with Postural Kyphosis and Hyperkyphosis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic kyphosis angle (TKA) (time frame: 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.