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Efficacy of Spinal Orthoses on Mobility in Older Adults With Hyperkyphosis
Sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Summary
This study investigates whether wearing a thoracic spinal orthosis (back brace) improves functional mobility in physically active older adults (60 years and older) with thoracic hyperkyphosis, an excessive forward curvature of the upper spine that is associated with slower walking, reduced muscle strength, and a higher risk of falls. Who can participate? Community-dwelling adults aged 60 years or older with thoracic hyperkyphosis (Cobb angle of 40 degrees or more), who walk independently without assistive devices and actively participate in the supervised exercise program for older adults (PIAFI) at the Pontifical Catholic University of Rio Grande do Sul (PUCRS), Porto Alegre, Brazil. How does the study work? Participants are randomly assigned, in equal numbers, to one of four groups: 1. Triple-Adjustable Posture Corrector (Mercur, Brazil), a three-point pressure orthosis; 2. Generation Dynamic Osteoporosis Brace (Bort, Germany), a dynamic elastic-resistance orthosis; 3. Placebo orthosis, similar in appearance but without corrective function; 4. Control group, which does not wear any orthosis. Participants in the orthosis groups wear their device for 16 weeks following a progressive schedule (from 1-2 hours per day in the first weeks up to 4 hours per day), recording daily use in a weekly logbook. All participants continue their usual supervised exercise program. What is measured? At the start (baseline) and after 16 weeks, participants undergo: gait analysis on a pressure platform (baropodometry), isokinetic dynamometry of the shoulder rotator and trunk muscles, and physical activity monitoring with a waist-worn accelerometer. These measures are combined into a Functional Mobility Score (primary outcome). Participants, outcome assessors, and the statistician are blinded to group allocation. Why is this study important? Evidence on the effects of thoracic orthoses on gait, muscle torque, and physical activity in older adults with hyperkyphosis is limited. The results may help clinicians decide whether, and which type of, thoracic orthosis can support mobility in this population.
Official title: Effects of Two Thoracic Spinal Orthoses on Gait Biomechanics, Muscle Torque, and Physical Activity in Older Adults With Hyperkyphosis: A Four-Arm Randomized Placebo-Controlled Trial
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-08-01
Completion Date
2027-03
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil
The Triple-Adjustable Posture Corrector (Mercur, Santa Cruz do Sul, Brazil) is a thoracic orthosis of elastic, adjustable non-rigid bands around the shoulders and thorax. It applies static three-point pressure at the thoracic apex, promoting passive sagittal realignment, scapular retraction, and proprioceptive feedback. Participants wear it for 16 weeks following a progressive protocol: adaptation (weeks 1-2, 1-2 h/day), progression (weeks 3-4, 2-3 h/day), stabilization (weeks 5-8, 3-4 h/day), consolidation (weeks 9-12, 4 h/day), and maintenance (weeks 13-16, 3-4 h/day, flexible), during waking hours; it is removed for bathing, aquatic activities, and sleep. Individual fitting is provided at baseline by the lead investigator. Adherence and adverse events are recorded in a weekly logbook, with a usability questionnaire at weeks 5, 11, and 16 and weekly WhatsApp contact.
Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, Germany
The Generation Dynamic Osteoporosis Brace (Bort, Weinstadt, Germany) is a thoracic orthosis with lightweight, breathable material and elastic tension elements that generate dynamic resistance to trunk flexion, facilitating neuromuscular co-activation of the back extensors rather than passive correction. Participants wear it for 16 weeks following a progressive protocol: adaptation (weeks 1-2, 1-2 h/day), progression (weeks 3-4, 2-3 h/day), stabilization (weeks 5-8, 3-4 h/day), consolidation (weeks 9-12, 4 h/day), and maintenance (weeks 13-16, 3-4 h/day, flexible), during waking hours; it is removed for bathing, aquatic activities, and sleep. Individual fitting is provided at baseline by the lead investigator. Adherence and adverse events are recorded in a weekly logbook, with a usability questionnaire at weeks 5, 11, and 16 and weekly WhatsApp contact.
Placebo Thoracic Orthosis
Elastic/fabric thoracic band with an appearance similar to the active orthoses, but without a three-point pressure system or corrective tension, and therefore without therapeutic function. It is worn for 16 weeks following the same progressive protocol as the active orthoses (1-2 h/day in weeks 1-2, increasing up to 4 h/day), during waking hours, removed for bathing, aquatic activities, and sleep. Use and adverse events are recorded in a weekly logbook. Placebo credibility is verified by interface pressure measurement (Picopress).
Locations (1)
Pontifical Catholic University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil