Efficacy of Spinal Orthoses on Mobility in Older Adults With Hyperkyphosis

Официальное название

Efficacy of Spinal Orthoses in Functional Mobility of Older Adults With Hyperkyphosis: Study Protocol for a Randomized Clinical Trial

Обзор

This study investigates whether wearing specific back braces (spinal orthoses) can improve movement and physical function in older adults (60 years and older) with hyperkyphosis, a forward curvature of the upper spine. By testing two types of braces, the study seeks to find effective ways to manage hyperkyphosis and enhance mobility, independence, and quality of life in this population. 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.

Подробное описание

Objective: This study aims to present the protocol for evaluating the effects of spinal orthoses on the functional mobility of older adults with hyperkyphosis.

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.

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• Thoracic Kyphosis Angle (degrees) [Срок оценки: Baseline (Week 0) and post-intervention (Week 16)]
• Gait Speed (meters/second) [Срок оценки: Baseline (Week 0) and post-intervention (Week 16)]
• Stride Length (centimeters) [Срок оценки: Baseline (Week 0) and post-intervention (Week 16)]
• Step Width (centimeters) [Срок оценки: Baseline (Week 0) and post-intervention (Week 16)]
• Peak Plantar Pressure (kilopascals) [Срок оценки: Baseline (Week 0) and post-intervention (Week 16)]
• Support Phase Duration (milliseconds) [Срок оценки: Baseline (Week 0) and post-intervention (Week 16)]
• Trunk Muscle Torque (Newton-meters) [Срок оценки: Baseline (Week 0) and post-intervention (Week 16)]
• Shoulder Muscle Torque (Newton-meters) [Срок оценки: Baseline (Week 0) and post-intervention (Week 16)]
• Electromyographic Activity (microvolts RMS) [Срок оценки: Baseline (Week 0) and post-intervention (Week 16)]
• Physical Activity Level (milli-gravity units) [Срок оценки: 7 consecutive days before baseline (Week -1 to 0) and after final intervention week (Week 15 to 16).]

Критерии участия

Критерии включения

• Aged 60 years or older
• Clinical diagnosis of hyperkyphosis
• Ability to walk without assistive devices

Критерии исключения

• Cognitive impairment
• Inability to complete the proposed assessments
• Non-compliance with orthosis use during the intervention period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 2 центра

• Pontifical Catholic University of Rio Grande do Sul. — Porto Alegre
• Pontifical Catholic University of Rio Grande do Sul — Porto Alegre

Публикации

• 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. PMID 33298028
• 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. PMID 21828388
• 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. PMID 22078730
• 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. PMID 2795325
• 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
• Kochhann R, Varela JS, Lisboa CSM, Chaves MLF. The Mini Mental State Examination: Review of cutoff points adjusted for schooling in a large Southern Brazilian sample. Dement Neuropsychol. 2010 Jan-Mar;4(1):35-41. doi: 10.1590/S1980-57642010DN40100006. PMID 29213658

Идентификаторы

NCT: NCT06970470 · 7.097.128

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗