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NCT06970470
Efficacy of Spinal Orthoses on Mobility in Older Adults With Hyperkyphosis
Conditions: Hyperkyphosis
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Location: Pontifical Catholic University of Rio Grande do Sul Porto Alegre 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.
Eligibility Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT06970470). StuddyBuddy aggregates publicly available trial information.