HyperkyphosisNCT06970470
Efficacy of Spinal Orthoses on Mobility in Older Adults With Hyperkyphosis
A study testing Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil and Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, Germany in people with Hyperkyphosis, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hyperkyphosis
- What is being tested?
- Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil and Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, Germany
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Pontifical Catholic University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90619-900
Rafael R Baptista, PHD, +5551999996331, rafael.baptista@pucrs.br
Rodrigo A França, Master, +5551980241006, franca.r@edu.pucrs.br
About this study
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
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.
Read more
How does the study work?
Participants are randomly assigned, in equal numbers, to one of four groups:
- Triple-Adjustable Posture Corrector (Mercur, Brazil), a three-point pressure orthosis;
- Generation Dynamic Osteoporosis Brace (Bort, Germany), a dynamic elastic-resistance orthosis;
- Placebo orthosis, similar in appearance but without corrective function;
- 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.
Read the detailed description
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).
- Conditions
- Hyperkyphosis
- Being tested
- Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil, Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, Germany, Placebo Thoracic Orthosis
- Keywords
- Older Adults, Spinal Orthoses, Biomechanics
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, BrazilDevice
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, GermanyDevice
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 OrthosisDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Triple-Adjustable Posture Corrector - Thoracic Spinal Orthosis (Mercur®, Brazil) | Experimental | 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. Receives: Device: Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil |
| Generation Dynamic Osteoporosis Brace - Thoracic Spinal Orthosis (Bort®, Germany) | Experimental | 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. Receives: Device: Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, Germany |
| No Intervention - Control Group | No intervention | 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. |
| Placebo Orthosis | Placebo comparator | 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. Receives: Device: Placebo Thoracic Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0) and week 16
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (week 0) and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for HyperkyphosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four-arm, parallel-group, randomized, placebo-controlled trial with 1:1:1:1 allocation to: (1) Triple-Adjustable Posture Corrector (Mercur), (2) Generation Dynamic Osteoporosis Brace (Bort), (3) placebo orthosis, or (4) no-intervention control, over 16 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Responsible party
- Sponsor
- Investigators
- Rafael R Baptista, PhD, Principal investigator, Pontifical Catholic University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970470
- Sponsor's protocol ID
- 7.097.128
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 33298028Dauty 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.
PubMed 21828388Valentini 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.
PubMed 22078730Kadaba 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.
PubMed 2795325Sasaki 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.
PubMed 29213658Koele 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.
PubMed 32038498Saghaei 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.
PubMed 15535880Serrao 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.
PubMed 28627859Veiskarami 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.
PubMed 32507057Yao 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.
PubMed 35799432
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06970470
- Acronym / sponsor ID
- 7.097.128
- Conditions
- Hyperkyphosis
- Keywords
- Older Adults, Spinal Orthoses, Biomechanics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Triple-Adjustable Posture Corrector (Mercur, Brazil), a three-point pressure orthosis;
- Generation Dynamic Osteoporosis Brace (Bort, Germany), a dynamic elastic-resistance orthosis;
- Placebo orthosis, similar in appearance but without corrective function;
- 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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Four-arm, parallel-group, randomized, placebo-controlled trial with 1:1:1:1 allocation to: (1) Triple-Adjustable Posture Corrector (Mercur), (2) Generation Dynamic Osteoporosis Brace (Bort), (3) placebo orthosis, or (4) no-intervention control, over 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| Triple-Adjustable Posture Corrector - Thoracic Spinal Orthosis (Mercur®, Brazil) | Experimental | Device: Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, BrazilDaily 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. |
| Generation Dynamic Osteoporosis Brace - Thoracic Spinal Orthosis (Bort®, Germany) | Experimental | Device: Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, GermanyDaily 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. |
| No Intervention - Control Group | No intervention | –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. |
| Placebo Orthosis | Placebo comparator | Device: Placebo Thoracic OrthosisDaily 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, BrazilThe 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. | Device | Triple-Adjustable Posture Corrector - Thoracic Spinal Orthosis (Mercur®, Brazil) |
| Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, GermanyThe 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. | Device | Generation Dynamic Osteoporosis Brace - Thoracic Spinal Orthosis (Bort®, Germany) |
| Placebo Thoracic OrthosisElastic/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). | Device | Placebo Orthosis |
Primary outcome
Change in Functional Mobility Score (FMS, 0-100 scale)
Time frame: Baseline (week 0) and week 16
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.
8 secondary outcomes
Gait Velocity (m/s)
Time frame: Baseline (week 0) and week 16
Step Length (cm)
Time frame: Baseline (week 0) and week 16
Shoulder Internal and External Rotator Isokinetic Peak Torque (Nm/kg)
Time frame: Baseline (week 0) and week 16
Daily Physical Activity (ActiGraph accelerometry)
Time frame: Baseline (week 0) and week 16
Trunk Flexor and Extensor Isokinetic Peak Torque (Nm/kg)
Time frame: Baseline (week 0) and week 16
Single and Double Support Phase Duration (ms)
Time frame: Baseline (week 0) and week 16
Mean and Peak Plantar Pressure (kPa)
Time frame: Baseline (week 0) and week 16
Step Width (cm)
Time frame: Baseline (week 0) and week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- BackgroundStegeman DF, Hermens HJ. Standards for surface electromyography: the European project "Surface EMG for non-invasive assessment of muscles (SENIAM)
- Background: PubMed 33298028Yang 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.
- BackgroundDauty 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
- Background: PubMed 21828388Edouard 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.
- Background: PubMed 22078730Valentini 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.
- Background: PubMed 2795325Kadaba 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.
- BackgroundSasaki 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
- Background: PubMed 29213658Kochhann 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.
- Background: PubMed 32038498Koele 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.
- Background: PubMed 15535880Saghaei 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.
- Background: PubMed 28627859Serrao 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.
- BackgroundVeiskarami 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
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafael R Baptista, PhD principal investigator
Pontifical Catholic University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil and Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, Germany in people with Hyperkyphosis, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael R Baptista, PhD (+5551999996331, rafael.baptista@pucrs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Mobility Score (FMS, 0-100 scale) (time frame: Baseline (week 0) and week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06970470, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.