Innovative Orthosis in Hyperkyphosis

NCT06988046 | Completed

• 1 other identifier: E-30 10840098-772.02-6671
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Kyphosis; Hyperkyphosis

Keywords

Thoracic hyperkyphosis; postural kyphosis; three-dimensional orthosis; thoracic kyphosis angle

Outcome Measures

Primary Outcomes (1)

• 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.

  3 minutes

Secondary Outcomes (2)

• Quality of life (QoL)

  3 minutes

• User satisfaction

  2 minutes

Study Arms (2)

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

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.

Device: Semi-rigid thoracolumbar orthosis

Interventions

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).

Cover spine orthosis group (CSO)

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).

Semi-rigid thoracolumbar orthosis group (SRTLO)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Prosthetics-Orthotics Research Center (POMER)

Istanbul, Kavacık, 34815, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, PT

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 23, 2025
• Study Start: January 10, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: May 23, 2025

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)