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.
Aged 60 years or older
Thoracic hyperkyphosis with Cobb angle of 40 degrees or more (Goniometer-Pro app)
Ability to walk independently without assistive devices
Active participation in a supervised physical activity program (Senior Physical Activity Incentive Program - PIAFI, PUCRS)
Cognitive impairment, defined by Mini-Mental State Examination scores below education-adjusted cutoffs
Inability to complete the required assessments (gait analysis, isokinetic dynamometry, accelerometry)
Non-compliance with orthosis use during the intervention period
Discontinuation of participation in the PIAFI supervised exercise program
Parallel
Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil
DeviceThe 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
DeviceThe 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
DeviceElastic/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).
Change in Functional Mobility Score (FMS, 0-100 scale)
Composite score integrating 12 parameters in four equally weighted domains: gait (velocity, % single support, % double support; P-Walk baropodometer), trunk (isokinetic flexor and extensor peak torque, flexor/extensor ratio; Humac Norm), shoulder (internal and external rotator peak torque, ER/IR ratio; Humac Norm), and physical activity (steps/day, % sedentary time, MVPA time; ActiGraph accelerometer). Each parameter is standardized as a z-score (direction-adjusted so higher = better; ratios scored as -\|z\| to reflect muscle imbalance); domain subscores are the mean of their three z-scores, and FMS\_z is the mean of the four domains. The score is reported on a 0-100 scale (FMS\_100 = 50 + 10 x FMS\_z); higher values indicate better functional mobility. The score was defined using baseline data before any post-intervention data were available.
Gait Velocity (m/s)
Gait velocity in meters per second. Measured with the P-Walk 3000 baropodometer (BTS Engineering, Italy; 400 Hz; G-Studio software) while walking at self-selected speed; mean of at least three valid trials.
Step Length (cm)
Step length in centimeters. Measured with the P-Walk 3000 baropodometer (BTS Engineering, Italy; 400 Hz; G-Studio software) while walking at self-selected speed; mean of at least three valid trials.
Shoulder Internal and External Rotator Isokinetic Peak Torque (Nm/kg)
Concentric and eccentric peak torque of shoulder internal and external rotators, dominant and non-dominant sides, normalized to body mass, measured with the Humac Norm isokinetic dynamometer (seated, 45 deg abduction in the scapular plane, elbow 90 deg) at 60 deg/s (5 repetitions) and 140 deg/s (10 repetitions). The ER/IR ratio, power, and work are also reported.
Daily Physical Activity (ActiGraph accelerometry)
Sedentary time, light, moderate and vigorous physical activity (min/day, Freedson cut-points), steps/day, and energy expenditure (kcal), measured with a waist-worn ActiGraph accelerometer during waking hours (removed for sleep, bathing, and aquatic activities). Valid wear: at least 10 h/day on at least 4 days.
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Pontificia Universidade Católica do Rio Grande do Sul
Lead sponsor
Financiadora de Estudos e Projetos
Collaborator
