An interventional study of Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil and Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, Germany in Hyperkyphosis, sponsored by Pontificia Universidade Católica do Rio Grande do Sul. Recruiting at 1 site in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Pontificia Universidade Católica do Rio Grande do Sul · Not applicable, Interventional, and Treatment
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:
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.
Design: Single-center, four-arm, parallel-group, randomized, placebo-controlled trial (allocation ratio 1:1:1:1) with a 16-week intervention period. Assessments are performed at baseline (week 0) and post-intervention (week 16) at the Biomechanics Laboratory of the Pontifical Catholic University of Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.
Participants: Community-dwelling, physically active older adults (aged 60 years or older) with thoracic hyperkyphosis (Cobb angle of 40 degrees or more, measured with the Goniometer-Pro app), recruited from the Senior Physical Activity Incentive Program (PIAFI) at PUCRS. Cognitive status is screened with the Mini-Mental State Examination using education-adjusted cutoffs.
Interventions: (1) Triple-Adjustable Posture Corrector (Mercur, Santa Cruz do Sul, Brazil), a static three-point pressure orthosis; (2) Generation Dynamic Osteoporosis Brace (Bort, Weinstadt, Germany), a dynamic elastic-resistance orthosis; (3) placebo orthosis of similar appearance, without three-point system or corrective tension; (4) no-intervention control. Orthoses are worn according to a progressive 16-week 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). Adherence and adverse events (discomfort, pain, skin lesions, falls) are recorded in a weekly logbook; a usability questionnaire is completed at weeks 5, 11, and 16.
Randomization and blinding: Simple randomization generated with Random Allocation Software. Participants in the orthosis and placebo groups, outcome assessors, and the statistician are blinded to group allocation. Placebo credibility is verified by interface pressure measurement (Picopress).
Outcomes: The primary outcome is the change from baseline to week 16 in the composite Functional Mobility Score (FMS), integrating 12 parameters from four equally weighted domains (gait, trunk, shoulder, and physical activity). Secondary outcomes are the individual parameters: spatiotemporal and plantar pressure gait variables (P-Walk baropodometer, BTS Engineering), shoulder rotator and trunk flexor/extensor isokinetic peak torque (Humac Norm), and accelerometer-derived physical activity (ActiGraph).
Sample size: 14 participants per group were required (alpha = 0.05, power = 80%, based on gait variability data from Serrao et al., 2017); 25 per group (N = 100) are enrolled to account for an estimated attrition of 44%.
Statistical analysis: Analyses are performed in R. Between-group differences are estimated with ANCOVA adjusted for baseline values and with Generalized Estimating Equations (exchangeable correlation; group, time, and group x time interaction; covariates age, sex, and baseline mobility). Intention-to-treat is the primary analysis and per-protocol the secondary analysis. Missing data are assumed missing at random. Effect sizes (Cohen's d) are reported, with alpha = 0.05.
Protocol updates: The original registration was updated to reflect the four-arm design (addition of the placebo arm), blinding of participants, outcome assessors, and statistician, the progressive wearing protocol, replacement of 3D motion capture and surface electromyography by baropodometry, and the definition of the composite Functional Mobility Score as the primary outcome (defined from baseline data before any post-intervention data were available).
132 studies on the registry are indexed under Kyphosis; 31 are open to participants now.
This study's planned enrollment of 100 is above the median of 44 across 82 interventional studies indexed under Kyphosis.
Browse Kyphosis studies →Pontificia Universidade Católica do Rio Grande do Sul is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 8, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily use of the Triple-Adjustable Posture Corrector (Mercur, Santa Cruz do Sul, Brazil), a thoracic orthosis that applies static three-point pressure targeting the thoracic apex to promote sagittal realignment and proprioceptive feedback. The orthosis is worn for 16 weeks following a progressive protocol: weeks 1-2, 1-2 h/day; weeks 3-4, 2-3 h/day; weeks 5-8, 3-4 h/day; weeks 9-12, 4 h/day; weeks 13-16, 3-4 h/day (flexible, according to comfort), during waking hours and removed for bathing, aquatic activities, and sleep. Daily use and adverse events are recorded in a weekly logbook. Participants continue the supervised PIAFI exercise program.
Device: Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil
Daily use of the Generation Dynamic Osteoporosis Brace (Bort, Weinstadt, Germany), a thoracic orthosis with elastic tension elements that generate dynamic resistance to trunk flexion and facilitate back extensor activation. The orthosis is worn for 16 weeks following a progressive protocol: weeks 1-2, 1-2 h/day; weeks 3-4, 2-3 h/day; weeks 5-8, 3-4 h/day; weeks 9-12, 4 h/day; weeks 13-16, 3-4 h/day (flexible, according to comfort), during waking hours and removed for bathing, aquatic activities, and sleep. Daily use and adverse events are recorded in a weekly logbook. Participants continue the supervised PIAFI exercise program.
Device: Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, Germany
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.
Daily use of a placebo orthosis: an elastic/fabric thoracic band of similar appearance to the active orthoses, without a three-point pressure system or corrective tension, and therefore without therapeutic function. It is worn following the same progressive 16-week protocol as the active orthoses (weeks 1-2, 1-2 h/day; weeks 3-4, 2-3 h/day; weeks 5-8, 3-4 h/day; weeks 9-12, 4 h/day; weeks 13-16, 3-4 h/day), with the same logbook and follow-up. Participants continue the supervised PIAFI exercise program.
Device: Placebo Thoracic Orthosis
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.
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.
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).
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.
Time frame: Baseline (week 0) and week 16
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.
Time frame: Baseline (week 0) and week 16
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.
Time frame: Baseline (week 0) and week 16
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.
Time frame: Baseline (week 0) and week 16
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.
Time frame: Baseline (week 0) and week 16
Trunk Flexor and Extensor Isokinetic Peak Torque (Nm/kg)
Concentric and eccentric peak torque of trunk flexors and extensors, normalized to body mass, measured with the Humac Norm isokinetic dynamometer (Stoughton, USA) at 60 deg/s (5 maximal repetitions) and 120 deg/s (10 maximal repetitions), range of motion 0-90 deg of flexion. Power and work are also recorded.
Time frame: Baseline (week 0) and week 16
Single and Double Support Phase Duration (ms)
Duration of single and double support phases in milliseconds (also expressed as percentage of the gait cycle). 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.
Time frame: Baseline (week 0) and week 16
Mean and Peak Plantar Pressure (kPa)
Mean and peak plantar pressure in kilopascals during the stance phase. 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.
Time frame: Baseline (week 0) and week 16
Step Width (cm)
Step width (mediolateral distance between feet) 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.
Time frame: Baseline (week 0) and week 16
Plan to share: Yes — De-identified individual participant data underlying the published results, together with the data dictionary and the R analysis code, will be made available upon reasonable request to the corresponding author.
Supporting information: Study protocol, Analytic code
Time frame: After publication of the main trial results, for at least 5 years.
Access criteria: Requests from qualified researchers with a methodologically sound proposal, sent to the corresponding author (rafael.baptista@pucrs.br); a data use agreement may be required, in accordance with the approval of the PUCRS Research Ethics Committee.
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Pontificia Universidade Católica do Rio Grande do Sul