Effect of different back braces on mobility in older adults with hyperkyphosis
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
Run by Pontificia Universidade Católica do Rio Grande do Sul · NCT06970470 · Data updated 2026-11-12
This study tests whether wearing a thoracic back brace helps physically active adults aged 60+ with hyperkyphosis walk more easily.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Pontificia Universidade Católica do Rio Grande do Sul Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | December 2026 |
| Study ends | March 2027 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT06970470 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Aged 60 years or older with Cobb angle 40 degrees or more, who walk independently and actively participate in the PUCRS PIAFI program.
✕Probably not a fit
Individuals who cannot tolerate the orthoses, have cognitive impairment affecting participation, or do not adhere to the wear protocol may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, four-arm randomized trial that compares three orthosis strategies and a placebo/no-brace control over 16 weeks in community-dwelling older adults with thoracic hyperkyphosis. Participants are randomly assigned to one of four groups andFollow a progressive wear protocol, with baseline and 16-week assessments of mobility, gait, strength, and biomechanics. Outcomes are collected to see if different braces can improve functional mobility and whether adherence or adverse events affect usability. The study uses gait analysis, isokinetic testing, and accelerometry to quantify changes, with safety monitoring throughout.
Why it matters
Potential benefit: If successful, the braces could improve mobility and reduce fall risk in older adults with hyperkyphosis.
How similar studies have gone: Previous studies in similar populations have shown mixed results; this trial tests multiple brace types and a placebo to clarify effectiveness.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Pontifical Catholic University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil Recruiting
Study contacts
- Principal investigator: Rafael R Baptista, PhD — Pontifical Catholic University of Rio Grande do Sul
- Study coordinator: Rafael R Baptista, PhD
- Email: rafael.baptista@pucrs.br
- Phone: +5551999996331
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Effects of Hatha Yoga and Reformer Pilates on Postural Hyperkyphosis
This study is testing whether Hatha yoga or reformer Pilates can help people with poor posture feel better and improve their overall quality of life.
-
Monitoring the safety and performance of Ennovate® Complex for scoliosis patients
This study looks at how safe and effective the Ennovate® Complex system is for treating scoliosis and other spinal issues in patients after their surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.