Efficacy of Spinal Orthoses on Mobility in Older Adults With Hyperkyphosis

NCT06970470 | Not Yet Recruiting

• 1 other identifier: 7.097.128
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

This study investigates whether wearing specific back braces (spinal orthoses) can improve movement and physical function in older adults (60 years and older) with hyperkyphosis, a forward curvature of the upper spine. By testing two types of braces, the study seeks to find effective ways to manage hyperkyphosis and enhance mobility, independence, and quality of life in this population. Study Purpose The purpose is to evaluate the impact of two types of thoracic spinal orthoses on functional mobility, which includes walking, muscle function, and overall physical activity. This information will help healthcare providers better understand how braces can be used to manage hyperkyphosis and improve daily functioning for older adults. Who Can Participate? The study will include adults aged 60 or older who have been diagnosed with hyperkyphosis. Eligible participants will be randomly assigned to one of three groups:

• Gait analysis: Evaluates walking patterns using advanced 3D motion technology.
• Muscle strength and joint function testing: Measures how well muscles and joints are working using isokinetic dynamometry.
• Muscle activity recording: Tracks how muscles respond during movement using surface electromyography (EMG).
• Physical activity monitoring: Captures activity levels using accelerometers, which are small devices that track movement. Why Is This Study Important? Hyperkyphosis can lead to challenges in daily life, such as difficulty walking, decreased balance, pain, and a higher risk of falls. While physical therapy and exercise are common treatments, many older adults need additional support to manage the condition. Spinal orthoses may offer a practical, non-invasive option to improve posture, reduce symptoms, and increase physical activity. By comparing the effects of these two braces, the study aims to:
• Determine whether these orthoses improve functional mobility, such as walking and muscle performance.
• Provide evidence to guide healthcare professionals in using braces to treat hyperkyphosis.
• Develop a standardized approach for incorporating orthoses into the care of older adults with this condition.
• Improved posture and comfort while moving.
• Increased awareness of their physical health and function.
• Access to state-of-the-art assessments and expert support throughout the study. How Will Results Be Used? The findings will inform healthcare providers about the potential benefits of using spinal braces for older adults with hyperkyphosis. If successful, this research could lead to:
• Better treatment plans for patients.
• Increased availability of braces tailored for older adults.
• Improved quality of life for people living with hyperkyphosis. Key Takeaways for Patients and Families
• Hyperkyphosis is a manageable condition, and this study explores a promising new way to support mobility and independence.
• Participation involves wearing a brace during regular daily activities and attending two comprehensive evaluations.
• The study is safe, non-invasive, and designed to minimize disruptions to daily life. This research offers an exciting opportunity to improve care for older adults with hyperkyphosis. By understanding how braces affect movement and strength, healthcare providers can develop better tools and strategies to support aging populations. Families and caregivers can also benefit from knowing there are new, evidence-based options to help their loved ones stay active and independent.

Conditions

Hyperkyphosis

Keywords

Older Adults; Spinal Orthoses; Biomechanics

Outcome Measures

Primary Outcomes (10)

• Thoracic Kyphosis Angle (degrees)

  Thoracic spinal curvature will be assessed using the Goniometer-Pro® mobile application (Digiflex, USA), which provides a validated digital estimation of the Cobb angle in degrees. The measurement will be performed in the standing position with anatomical reference points on the thoracic spine. Two consistent measures will be averaged. This outcome evaluates structural postural changes over time.

  Baseline (Week 0) and post-intervention (Week 16)

• Gait Speed (meters/second)

  Walking speed will be measured in meters per second using the BTS SMART-D™ 3D motion capture system and a synchronized resistive pressure platform (PWalk 3000, BTS Engineering, Italy). Participants will walk at self-selected speed over a flat walkway, and the average of three valid trials will be reported.

  Baseline (Week 0) and post-intervention (Week 16)

• Stride Length (centimeters)

  Stride length will be assessed using the BTS SMART-D™ 3D motion capture system with markers placed according to the modified Helen Hayes protocol. The mean stride length from three valid gait trials will be calculated.

  Baseline (Week 0) and post-intervention (Week 16)

• Step Width (centimeters)

  Step width will be measured in centimeters using synchronized 3D motion capture and baropodometric analysis. The mediolateral distance between foot placements will be averaged from three valid walking trials.

  Baseline (Week 0) and post-intervention (Week 16)

• Peak Plantar Pressure (kilopascals)

  Peak plantar pressure will be recorded using the PWalk 3000 resistive pressure platform (BTS Engineering). Maximum pressure (kPa) detected during the stance phase of gait will be extracted and averaged across trials.

  Baseline (Week 0) and post-intervention (Week 16)

• Support Phase Duration (milliseconds)

  The duration of the support phase (ms) for each foot during gait will be measured using pressure platform data synchronized with 3D motion capture. The mean of three valid gait cycles will be used.

  Baseline (Week 0) and post-intervention (Week 16)

• Trunk Muscle Torque (Newton-meters)

  Concentric and eccentric peak torque of trunk flexor and extensor muscles will be measured in Newton-meters using the HUMAC NORM™ isokinetic dynamometer. Participants will perform five maximal effort repetitions per contraction mode, and peak torque values will be reported.

  Baseline (Week 0) and post-intervention (Week 16)

• Shoulder Muscle Torque (Newton-meters)

  Peak concentric and eccentric torque (Nm) of internal and external shoulder rotator muscles will be measured bilaterally using the HUMAC NORM™ dynamometer. The test will follow a standardized shoulder positioning protocol. The highest value among five trials will be recorded for each contraction type.

  Baseline (Week 0) and post-intervention (Week 16)

• Electromyographic Activity (microvolts RMS)

  Surface electromyography (sEMG) will be collected using the BTS FREEEMG™ system. RMS values (µV) of selected trunk (erector spinae, rectus abdominis, obliques) and shoulder muscles (infraspinatus, subscapularis, teres minor, etc.) will be recorded during isokinetic tests. Data acquisition follows SENIAM recommendations.

  Baseline (Week 0) and post-intervention (Week 16)

• Physical Activity Level (milli-gravity units)

  Daily physical activity will be measured using ActiGraph™ GT3X accelerometers worn on the hip. The mean vector magnitude (mg) will be calculated from at least 4 valid days, excluding periods of sleep and aquatic activities.

  7 consecutive days before baseline (Week -1 to 0) and after final intervention week (Week 15 to 16).

Study Arms (3)

Triple-Adjustable Posture Corrector - Thoracic Spinal Orthosis (Mercur®, Brazil)

EXPERIMENTAL

This intervention involves the daily use of the Triple-Adjustable Posture Corrector, a thoracic spinal orthosis manufactured by Mercur® (Santa Cruz do Sul, Brazil). The orthosis is used for postural support in older adults with hyperkyphosis. Participants will wear the orthosis for at least four hours per day during waking hours, excluding aquatic activities, bathing, and sleeping.

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

Generation Dynamic Osteoporosis Brace.

EXPERIMENTAL

This intervention involves the daily use of the Generation Dynamic Osteoporosis Brace, a thoracic spinal orthosis manufactured by Bort® (Weinstadt, Germany). Participants will wear the orthosis for at least four hours per day during waking hours, excluding aquatic activities, bathing, and sleeping.

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.

Interventions

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

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

Triple-Adjustable Posture Corrector - Thoracic Spinal Orthosis (Mercur®, Brazil)

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

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

Generation Dynamic Osteoporosis Brace.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 60 years or older
• Clinical diagnosis of hyperkyphosis
• Ability to walk without assistive devices

You may not qualify if:

• Cognitive impairment
• Inability to complete the proposed assessments
• Non-compliance with orthosis use during the intervention period

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead
• Financiadora de Estudos e Projetos: collaborator

Study Sites (2)

Pontifical Catholic University of Rio Grande do Sul.

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Location

Pontifical Catholic University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Location

Related Publications (16)

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MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Rafael R Baptista, PhD

  Pontifical Catholic University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael R Baptista, PhD

CONTACT

+5551999996331; rafael.baptista@pucrs.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: May 14, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)