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

Completed

• Conditions: Elderly People
• Interventions: Other: assessment

• Registration Number: NCT05905718
• Lead Sponsor: Gazi University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-15
• Study Start: 2023-06-19
• Primary Completion: 2023-08-19
• Status Verified: 2023-09
• Study Completion: 2023-09-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biofeedback orthosis group	assessment	-
Spinomed orthosis group	assessment	-

Primary Outcome Measures

Name	Time	Method
Gait assessment without the orthosis	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.
Balance assessment with the orthosis	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.
Gait assessment with the orthosis	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.
Balance assessment without the orthosis	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.

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey