Efficacy of Spinal Orthoses on Mobility in Older Adults With Hyperkyphosis

NANot yet recruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

September 30, 2026

Conditions
Hyperkyphosis
Interventions
DEVICE

Triple-Adjustable Posture Corrector Manufacturer: Mercur®, Santa Cruz do Sul, Brazil

"The Triple-Adjustable Posture Corrector is a thoracic spinal orthosis designed to provide biomechanical support and postural correction in individuals with excessive thoracic kyphosis. It consists of elastic and adjustable non-rigid bands positioned around the shoulders and thorax, allowing individualized tension regulation. The brace promotes scapular retraction and axial alignment by increasing proprioceptive feedback and limiting thoracic flexion.~Participants randomized to this intervention will be instructed to wear the orthosis for a minimum of four consecutive hours per day, during waking hours, for 16 weeks. The orthosis is to be removed during bathing, aquatic activities, and sleep. Individualized fitting will be provided at baseline by trained personnel, following the manufacturer's guidelines. Adherence will be monitored through self-reported daily logbooks. Participants will be advised to report discomfort, adverse effects, or perceived benefits.~The primary clinical obje"

DEVICE

Generation Dynamic Osteoporosis Brace Manufacturer: Bort®, Weinstadt, Germany

"The Generation Dynamic Osteoporosis Brace is a semi-rigid thoracic orthosis designed to stabilize the spine and counteract the progression of hyperkyphosis, especially in populations at risk for vertebral fragility. The brace is composed of lightweight, breathable material, with anterior and posterior structural support and adjustable tension straps. It is intended to reduce spinal flexion, improve sagittal alignment, and facilitate back extensor activation.~Participants assigned to this group will wear the orthosis for a minimum of four hours daily during waking hours, excluding sleep and aquatic activities, over a 16-week period. The orthosis will be individually fitted at the initial session by a trained physical therapist, following manufacturer protocols to ensure comfort, stability, and effectiveness. Participants will receive a daily logbook to record usage duration, comfort level, and perceived effects. Adherence will be monitored weekly.~The brace is intended to improve trun"

Trial Locations (2)

90619-900

Pontifical Catholic University of Rio Grande do Sul., Porto Alegre

Pontifical Catholic University of Rio Grande do Sul, Porto Alegre

All Listed Sponsors
collaborator

Financiadora de Estudos e Projetos

OTHER

lead

Pontificia Universidade Católica do Rio Grande do Sul

OTHER

NCT06970470 - Efficacy of Spinal Orthoses on Mobility in Older Adults With Hyperkyphosis | Biotech Hunter | Biotech Hunter