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

NCT ID: NCT05905718

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-19
• Study Completion Date: 2023-09-09

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.

Conditions

Elderly People

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Spinomed orthosis group

assessment

Intervention Type: OTHER

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

Biofeedback orthosis group

assessment

Intervention Type: OTHER

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

Interventions

assessment

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Kader Eldemir

Doctor Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gazi University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Spinomed-Biofeedback orthosis

Identifier Type: -

Identifier Source: org_study_id