Clinical trial NCT06970470: Efficacy of Spinal Orthoses on Mobility in Older Adults With Hyperkyphosis
Official title: Efficacy of Spinal Orthoses in Functional Mobility of Older Adults With Hyperkyphosis: Study Protocol for a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hyperkyphosis
Keywords: Older Adults
Spinal Orthoses
Biomechanics
Lead sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Financiadora de Estudos e Projetos
First posted: 2025-05-14
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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:

1. Group 1: Participants will use the Triple-Adjustable Posture Corrector (TAPC), a brace designed to improve posture and reduce kyphosis.
2. Group 2: Participants will use the Generation Dynamic Osteoporosis Brace (G-DOB), another type of spinal brace targeting posture and mobility.
3. Control Group: Participants will not wear any brace.

How the Study Works

The study will run for 16 weeks. Participants in the brace groups will wear their assigned braces throughout the day, except during specific activities like bathing, sleeping, and swimming. No other changes to their daily routines will be required.

At the start and end of the study, participants will undergo assessments to measure their physical function and mobility. These assessments will include:

* 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:

1. Determine whether these orthoses improve functional mobility, such as walking and muscle performance.
2. Provide evidence to guide healthcare professionals in using braces to treat hyperkyphosis.
3. Develop a standardized approach for incorporating orthoses into the care of older adults with this condition.

Benefits for Participants

While the study focuses on research, participants may also experience direct benefits, such as:

* 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.

Detailed description: Objective: This study aims to present the protocol for evaluating the effects of spinal orthoses on the functional mobility of older adults with hyperkyphosis.

Design: This protocol outlines a randomized clinical trial with two intervention groups and one control group, to be conducted over 16 weeks. Participants will be older adults aged 60 years or older with a diagnosis of hyperkyphosis. They will be randomized to use one of two thoracic spinal orthoses (the Triple-Adjustable Posture Corrector or the Generation Dynamic Osteoporosis Brace). The intervention will involve continuous orthosis use, excluding aquatic activities, bathing, and sleep. Assessments will occur before and after the intervention period. Functional mobility will be measured through biomechanical parameters such as gait, joint torque, muscle activation, and physical activity levels, using 3D motion analysis, isokinetic dynamometry, surface electromyography, and accelerometry.

Conclusion: This study will evaluate the impact of spinal orthoses on the functional mobility of older adults with hyperkyphosis, enabling the development of a clinical application methodology for this population.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Thoracic Kyphosis Angle (degrees)
timeFrame: Baseline (Week 0) and post-intervention (Week 16)
measure: Gait Speed (meters/second)
timeFrame: Baseline (Week 0) and post-intervention (Week 16)
measure: Stride Length (centimeters)
timeFrame: Baseline (Week 0) and post-intervention (Week 16)
measure: Step Width (centimeters)
timeFrame: Baseline (Week 0) and post-intervention (Week 16)
measure: Peak Plantar Pressure (kilopascals)
timeFrame: Baseline (Week 0) and post-intervention (Week 16)
measure: Support Phase Duration (milliseconds)
timeFrame: Baseline (Week 0) and post-intervention (Week 16)
measure: Trunk Muscle Torque (Newton-meters)
timeFrame: Baseline (Week 0) and post-intervention (Week 16)
measure: Shoulder Muscle Torque (Newton-meters)
timeFrame: Baseline (Week 0) and post-intervention (Week 16)
measure: Electromyographic Activity (microvolts RMS)
timeFrame: Baseline (Week 0) and post-intervention (Week 16)
measure: Physical Activity Level (milli-gravity units)
timeFrame: 7 consecutive days before baseline (Week -1 to 0) and after final intervention week (Week 15 to 16).
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Pontifical Catholic University of Rio Grande do Sul.
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Pontifical Catholic University of Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Pontifical Catholic University of Rio Grande do Sul
name: Rafael R Baptista, PhD
role: PRINCIPAL_INVESTIGATOR
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