Skip to main content
OpenTrials
Completed

NCT Number: NCT06988046

Innovative Orthosis in Hyperkyphosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postural Kyphosis Bone Diseases Hyperkyphosis Kyphosis Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Prosthetics-Orthotics Research Center (POMER)

Istanbul, Kavacık, 34815, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals of both sexes (male and female)
  • Aged between 20 and 60 years
  • Presence of thoracic kyphosis angle (TKA) ≥ 40°

Exclusion criteria

  • 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

Treatment and study plan

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 orthosis

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Quality of life (QoL)

    Time frame: 3 minutes

    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.

  2. User satisfaction

    Time frame: 2 minutes

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Clinical Effects of an Innovative Three-Dimensional Orthosis in Thoracic Hyperkyphosis: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.