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NCT Number: NCT05905718

The Effects of Spinomed Orthosis and Biofeedback Orthosis in Elderly Individuals With Thoracic Hyperkyphosis

Hyperkyphosis, defined as excessive sagittal curvature of the thoracic spine, is the most common spinal deformity in elderly individuals. The prevalence of hyperkyphosis in elderly individuals is reported to be between 20% and 40%. Hyperkyphosis affects the mobility, walking, and balance of the individual negatively and causes changes in the physical performance of elderly individuals. Therefore, it is important to evaluate and treat hyperkyphosis in elderly people. One of the approaches to treating people with hyperkyphosis is the use of spinal orthoses such as the Spinomed orthosis and Biofeedback orthosis. Regular use of spinal orthoses reduces the angle of kyphosis by 11%. In addition, spinal orthoses help increase walking speed and distance, improve balance, and prevent falls. Spinomed and Biofeedback soft posture orthoses are spinal orthoses used in the treatment of kyphotic posture. Studies on Spinomed orthosis have demonstrated that it strengthens postural muscles, and therefore also prevents falls. Soft orthoses, which provide feedback, provide a warning to the individual through sound or vibration when the spinal alignment of the individual is disturbed, and provide the correction of posture with active muscle strength. However, little evidence exists regarding the effect of these two orthoses on improving balance and walking performance in elderly people with thoracic hyperkyphosis. Therefore, this study was developed to enable a comparison of the effect of the Spinomed orthosis and the biofeedback orthosis on balance and walking performance in elderly people with thoracic hyperkyphosis.

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Key information

Conditions

Elderly People

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

Volunteer healthy elderly individuals between the ages of 60-80 will be recruited into our study and the individuals will be randomly divided into two groups Spinomed orthosis and postural orthosis which provides biofeedback. In both groups, balance and gait assessments with or without orthosis will be done twice.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • having an age of 60 years or above
  • the ability to walk at least 10 meters independently
  • thoracic hyperkyphosis angle above 40 degrees
  • Mini-mental test score greater than 24

Exclusion criteria

  • having fractures or surgery on the spine or lower limbs within the last 12 months
  • having degenerative impairment in the spine, such as scoliosis and osteoarthritis
  • having any neurological and cognitive impairment

Treatment and study plan

Assessment

Other

Assessments of thoracic kyphosis angle, balance performance, and gait performance.

Primary outcomes

  1. Balance assessment without the orthosis

    Time frame: at baseline

    The Balance Performance Tests, which are performed using computerized posturography, measure postural sway and limit of stability in response to static and dynamic conditions, are measured using a force platform.

  2. Balance assessment with the orthosis

    Time frame: 1.5 hours after applying orthosis

    The Balance Performance Tests, which are performed using computerized posturography, measure postural sway and limit of stability in response to static and dynamic conditions, are measured using a force platform.

  3. Gait assessment without the orthosis

    Time frame: at baseline

    Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk has with a triaxial accelerometer,, a triaxial magnetometer, and a triaxial gyroscope. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.

  4. Gait assessment with the orthosis

    Time frame: 1.5 hours after applying orthosis

    Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk has with a triaxial accelerometer,, a triaxial magnetometer, and a triaxial gyroscope. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Comparison of the Immediate Effects of Spinomed Orthosis and Biofeedback Orthosis on Balance and Walking Performance in Elderly Individuals With Thoracic Hyperkyphosis

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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