Clinical trial NCT05905718: The Effects of Spinomed Orthosis and Biofeedback Orthosis in Elderly Individuals With Thoracic Hyperkyphosis
Official title: Comparison of the Immediate Effects of Spinomed Orthosis and Biofeedback Orthosis on Balance and Walking Performance in Elderly Individuals With Thoracic Hyperkyphosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly People
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly people with thoracic hyperkyphosis will be invited to this study.

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.

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

Primary outcomes:
measure: Balance assessment without the orthosis
timeFrame: at baseline
measure: Balance assessment with the orthosis
timeFrame: 1.5 hours after applying orthosis
measure: Gait assessment without the orthosis
timeFrame: at baseline
measure: Gait assessment with the orthosis
timeFrame: 1.5 hours after applying orthosis
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References: