Clinical trial NCT06988046: Innovative Orthosis in Hyperkyphosis
Official title: Clinical Effects of an Innovative Three-Dimensional Orthosis in Thoracic Hyperkyphosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Kyphosis
Hyperkyphosis
Keywords: Thoracic hyperkyphosis
postural kyphosis
three-dimensional orthosis
thoracic kyphosis angle
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Thoracic kyphosis angle (TKA)
timeFrame: 3 minutes
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: 3 minutes
measure: User satisfaction
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Prosthetics-Orthotics Research Center (POMER)
state: Kavacık
Study officials:
References: