Innovative Orthosis in Hyperkyphosis

Not Applicable

Completed

• Conditions: Postural Kyphosis; Hyperkyphosis

• Registration Number: NCT06988046
• Lead Sponsor: Istanbul Medipol University Hospital

Brief 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. 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 Timeline

• Status Verified: 2021-12
• Study Start: 2022-01-10
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Thoracic kyphosis angle (TKA)	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 Outcome Measures

Name	Time	Method
Quality of life (QoL)	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.
User satisfaction	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.

Trial Locations

Locations (1)

Istanbul Medipol University Prosthetics-Orthotics Research Center (POMER); 🇹🇷 Istanbul, Kavacık, Turkey