Efficacy of Spinal Orthoses on Mobility in Older Adults With Hyperkyphosis
NCT ID: NCT06970470
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
75 participants
INTERVENTIONAL
2025-06-30
2026-09-30
Brief Summary
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Study Purpose
The purpose is to evaluate the impact of two types of thoracic spinal orthoses on functional mobility, which includes walking, muscle function, and overall physical activity. This information will help healthcare providers better understand how braces can be used to manage hyperkyphosis and improve daily functioning for older adults.
Who Can Participate?
The study will include adults aged 60 or older who have been diagnosed with hyperkyphosis. Eligible participants will be randomly assigned to one of three groups:
1. Group 1: Participants will use the Triple-Adjustable Posture Corrector (TAPC), a brace designed to improve posture and reduce kyphosis.
2. Group 2: Participants will use the Generation Dynamic Osteoporosis Brace (G-DOB), another type of spinal brace targeting posture and mobility.
3. Control Group: Participants will not wear any brace.
How the Study Works
The study will run for 16 weeks. Participants in the brace groups will wear their assigned braces throughout the day, except during specific activities like bathing, sleeping, and swimming. No other changes to their daily routines will be required.
At the start and end of the study, participants will undergo assessments to measure their physical function and mobility. These assessments will include:
* Gait analysis: Evaluates walking patterns using advanced 3D motion technology.
* Muscle strength and joint function testing: Measures how well muscles and joints are working using isokinetic dynamometry.
* Muscle activity recording: Tracks how muscles respond during movement using surface electromyography (EMG).
* Physical activity monitoring: Captures activity levels using accelerometers, which are small devices that track movement.
Why Is This Study Important?
Hyperkyphosis can lead to challenges in daily life, such as difficulty walking, decreased balance, pain, and a higher risk of falls. While physical therapy and exercise are common treatments, many older adults need additional support to manage the condition. Spinal orthoses may offer a practical, non-invasive option to improve posture, reduce symptoms, and increase physical activity.
By comparing the effects of these two braces, the study aims to:
1. Determine whether these orthoses improve functional mobility, such as walking and muscle performance.
2. Provide evidence to guide healthcare professionals in using braces to treat hyperkyphosis.
3. Develop a standardized approach for incorporating orthoses into the care of older adults with this condition.
Benefits for Participants
While the study focuses on research, participants may also experience direct benefits, such as:
* Improved posture and comfort while moving.
* Increased awareness of their physical health and function.
* Access to state-of-the-art assessments and expert support throughout the study.
How Will Results Be Used?
The findings will inform healthcare providers about the potential benefits of using spinal braces for older adults with hyperkyphosis. If successful, this research could lead to:
* Better treatment plans for patients.
* Increased availability of braces tailored for older adults.
* Improved quality of life for people living with hyperkyphosis.
Key Takeaways for Patients and Families
* Hyperkyphosis is a manageable condition, and this study explores a promising new way to support mobility and independence.
* Participation involves wearing a brace during regular daily activities and attending two comprehensive evaluations.
* The study is safe, non-invasive, and designed to minimize disruptions to daily life.
This research offers an exciting opportunity to improve care for older adults with hyperkyphosis. By understanding how braces affect movement and strength, healthcare providers can develop better tools and strategies to support aging populations. Families and caregivers can also benefit from knowing there are new, evidence-based options to help their loved ones stay active and independent.
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Detailed Description
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Design: This protocol outlines a randomized clinical trial with two intervention groups and one control group, to be conducted over 16 weeks. Participants will be older adults aged 60 years or older with a diagnosis of hyperkyphosis. They will be randomized to use one of two thoracic spinal orthoses (the Triple-Adjustable Posture Corrector or the Generation Dynamic Osteoporosis Brace). The intervention will involve continuous orthosis use, excluding aquatic activities, bathing, and sleep. Assessments will occur before and after the intervention period. Functional mobility will be measured through biomechanical parameters such as gait, joint torque, muscle activation, and physical activity levels, using 3D motion analysis, isokinetic dynamometry, surface electromyography, and accelerometry.
Conclusion: This study will evaluate the impact of spinal orthoses on the functional mobility of older adults with hyperkyphosis, enabling the development of a clinical application methodology for this population.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Triple-Adjustable Posture Corrector - Thoracic Spinal Orthosis (Mercur®, Brazil)
This intervention involves the daily use of the Triple-Adjustable Posture Corrector, a thoracic spinal orthosis manufactured by Mercur® (Santa Cruz do Sul, Brazil). The orthosis is used for postural support in older adults with hyperkyphosis. Participants will wear the orthosis for at least four hours per day during waking hours, excluding aquatic activities, bathing, and sleeping.
Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil
The Triple-Adjustable Posture Corrector is a thoracic spinal orthosis designed to provide biomechanical support and postural correction in individuals with excessive thoracic kyphosis. It consists of elastic and adjustable non-rigid bands positioned around the shoulders and thorax, allowing individualized tension regulation. The brace promotes scapular retraction and axial alignment by increasing proprioceptive feedback and limiting thoracic flexion.
Participants randomized to this intervention will be instructed to wear the orthosis for a minimum of four consecutive hours per day, during waking hours, for 16 weeks. The orthosis is to be removed during bathing, aquatic activities, and sleep. Individualized fitting will be provided at baseline by trained personnel, following the manufacturer's guidelines. Adherence will be monitored through self-reported daily logbooks. Participants will be advised to report discomfort, adverse effects, or perceived benefits.
The primary clinical obje
Generation Dynamic Osteoporosis Brace.
This intervention involves the daily use of the Generation Dynamic Osteoporosis Brace, a thoracic spinal orthosis manufactured by Bort® (Weinstadt, Germany). Participants will wear the orthosis for at least four hours per day during waking hours, excluding aquatic activities, bathing, and sleeping.
Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, Germany
The Generation Dynamic Osteoporosis Brace is a semi-rigid thoracic orthosis designed to stabilize the spine and counteract the progression of hyperkyphosis, especially in populations at risk for vertebral fragility. The brace is composed of lightweight, breathable material, with anterior and posterior structural support and adjustable tension straps. It is intended to reduce spinal flexion, improve sagittal alignment, and facilitate back extensor activation.
Participants assigned to this group will wear the orthosis for a minimum of four hours daily during waking hours, excluding sleep and aquatic activities, over a 16-week period. The orthosis will be individually fitted at the initial session by a trained physical therapist, following manufacturer protocols to ensure comfort, stability, and effectiveness. Participants will receive a daily logbook to record usage duration, comfort level, and perceived effects. Adherence will be monitored weekly.
The brace is intended to improve trun
No Intervention - Control Group
Participants in this group will not use any spinal orthosis during the study period but will undergo the same biomechanical and functional assessments as the intervention groups.
No interventions assigned to this group
Interventions
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Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil
The Triple-Adjustable Posture Corrector is a thoracic spinal orthosis designed to provide biomechanical support and postural correction in individuals with excessive thoracic kyphosis. It consists of elastic and adjustable non-rigid bands positioned around the shoulders and thorax, allowing individualized tension regulation. The brace promotes scapular retraction and axial alignment by increasing proprioceptive feedback and limiting thoracic flexion.
Participants randomized to this intervention will be instructed to wear the orthosis for a minimum of four consecutive hours per day, during waking hours, for 16 weeks. The orthosis is to be removed during bathing, aquatic activities, and sleep. Individualized fitting will be provided at baseline by trained personnel, following the manufacturer's guidelines. Adherence will be monitored through self-reported daily logbooks. Participants will be advised to report discomfort, adverse effects, or perceived benefits.
The primary clinical obje
Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, Germany
The Generation Dynamic Osteoporosis Brace is a semi-rigid thoracic orthosis designed to stabilize the spine and counteract the progression of hyperkyphosis, especially in populations at risk for vertebral fragility. The brace is composed of lightweight, breathable material, with anterior and posterior structural support and adjustable tension straps. It is intended to reduce spinal flexion, improve sagittal alignment, and facilitate back extensor activation.
Participants assigned to this group will wear the orthosis for a minimum of four hours daily during waking hours, excluding sleep and aquatic activities, over a 16-week period. The orthosis will be individually fitted at the initial session by a trained physical therapist, following manufacturer protocols to ensure comfort, stability, and effectiveness. Participants will receive a daily logbook to record usage duration, comfort level, and perceived effects. Adherence will be monitored weekly.
The brace is intended to improve trun
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of hyperkyphosis
* Ability to walk without assistive devices
Exclusion Criteria
* Inability to complete the proposed assessments
* Non-compliance with orthosis use during the intervention period
60 Years
ALL
No
Sponsors
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Financiadora de Estudos e Projetos
OTHER
Pontificia Universidade Católica do Rio Grande do Sul
OTHER
Responsible Party
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Principal Investigators
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Rafael R Baptista, PhD
Role: PRINCIPAL_INVESTIGATOR
Pontifical Catholic University of Rio Grande do Sul
Locations
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Pontifical Catholic University of Rio Grande do Sul.
Porto Alegre, Rio Grande do Sul, Brazil
Pontifical Catholic University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Stegeman DF, Hermens HJ. Standards for surface electromyography: the European project "Surface EMG for non-invasive assessment of muscles (SENIAM)
Yang S, Chen C, Du S, Tang Y, Li K, Yu X, Tan J, Zhang C, Rong Z, Xu J, Wu W, Luo F. Assessment of isokinetic trunk muscle strength and its association with health-related quality of life in patients with degenerative spinal deformity. BMC Musculoskelet Disord. 2020 Dec 9;21(1):827. doi: 10.1186/s12891-020-03844-8.
Dauty M, Delbrouck C, Huguet D, Rousseau B, Potiron-Josse M, Dubois C. Reproducibility of concentric and eccentric isokinetic strength of the shoulder rotators in normal subjects 40 to 55 years old. IES. 2003;11(2):95-100. doi:10.3233/IES-2003-0134
Edouard P, Samozino P, Julia M, Gleizes Cervera S, Vanbiervliet W, Calmels P, Gremeaux V. Reliability of isokinetic assessment of shoulder-rotator strength: a systematic review of the effect of position. J Sport Rehabil. 2011 Aug;20(3):367-83. doi: 10.1123/jsr.20.3.367.
Valentini FA, Granger B, Hennebelle DS, Eythrib N, Robain G. Repeatability and variability of baropodometric and spatio-temporal gait parameters--results in healthy subjects and in stroke patients. Neurophysiol Clin. 2011 Oct;41(4):181-9. doi: 10.1016/j.neucli.2011.08.004. Epub 2011 Sep 13.
Kadaba MP, Ramakrishnan HK, Wootten ME, Gainey J, Gorton G, Cochran GV. Repeatability of kinematic, kinetic, and electromyographic data in normal adult gait. J Orthop Res. 1989;7(6):849-60. doi: 10.1002/jor.1100070611.
Sasaki J, Coutinho A, Santos C, et al. Orientações para utilização de acelerômetros no Brasil. Rev Bras Ativ Fís Saúde. 2017;22(2):110-126. doi:10.12820/rbafs.v.22n2p110-126
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Koele MC, Lems WF, Willems HC. The Clinical Relevance of Hyperkyphosis: A Narrative Review. Front Endocrinol (Lausanne). 2020 Jan 24;11:5. doi: 10.3389/fendo.2020.00005. eCollection 2020.
Saghaei M. Random allocation software for parallel group randomized trials. BMC Med Res Methodol. 2004 Nov 9;4:26. doi: 10.1186/1471-2288-4-26.
Serrao M, Casali C, Ranavolo A, Mari S, Conte C, Chini G, Leonardi L, Coppola G, DI Lorenzo C, Harfoush M, Padua L, Pierelli F. Use of dynamic movement orthoses to improve gait stability and trunk control in ataxic patients. Eur J Phys Rehabil Med. 2017 Oct;53(5):735-743. doi: 10.23736/S1973-9087.17.04480-X. Epub 2017 Jun 19.
Veiskarami M, Gholami M, Aboutorabi A, Ahmadi Bani M, Khamesi E. Motor Control Changes in Trunk Muscles after Using Anatomical Posture Control Orthosis in the Elderly Hyperkyphotic Subjects. JMR. Published online September 26, 2022. doi:10.18502/jmr.v16i4.10762
Caetano GM, Santos Neto APD, Santos LSC, Fhon JRS. Risco de quedas e seus fatores associados na pessoa idosa hospitalizada. Rev bras geriatr gerontol. 2023;26:e230155. doi:10.1590/1981-22562023026.230155.pt
Hosseinabadi M, Kamyab M, Azadinia F, Sarrafzadeh J. Effect of a Spinomed orthosis on balance performance, spinal alignment, joint position sense and back muscle endurance in elderly people with hyperkyphotic posture: A randomized controlled trial. Prosthet Orthot Int. 2020 Aug;44(4):234-244. doi: 10.1177/0309364620923816. Epub 2020 Jun 7.
Yao XM, Liu BB, Deng WY, Wang XH. The Awareness and Knowledge Regarding Sarcopenia among Healthcare Professionals: A Scoping Review. J Frailty Aging. 2022;11(3):274-280. doi: 10.14283/jfa.2022.7.
Seals DR, Justice JN, LaRocca TJ. Physiological geroscience: targeting function to increase healthspan and achieve optimal longevity. J Physiol. 2016 Apr 15;594(8):2001-24. doi: 10.1113/jphysiol.2014.282665. Epub 2015 Mar 11.
Other Identifiers
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7.097.128
Identifier Type: -
Identifier Source: org_study_id
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