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

Comparison of the Immediate Effects of Spinomed Orthosis and Biofeedback Orthosis on Balance and Walking Performance 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.

Study Overview

• Status: Completed
• Conditions: Elderly People
• Intervention / Treatment: Other: assessment

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 Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

• Study Contact: Name: Kader Eldemir; Phone Number: +0904522265200; Email: fztkader2015@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Elderly people with thoracic hyperkyphosis will be invited to this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spinomed orthosis group	Other: assessment; Assessments of thoracic kyphosis angle, balance performance, and gait performance.
Biofeedback orthosis group	Other: assessment; Assessments of thoracic kyphosis angle, balance performance, and gait performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance assessment without the 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.	at baseline
Balance assessment with the 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.	1.5 hours after applying orthosis
Gait assessment without the 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.	at baseline
Gait assessment with the 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.	1.5 hours after applying orthosis

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): August 19, 2023
• Study Completion (Actual): September 9, 2023

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Kyphosis
• Other Study ID Numbers: Spinomed-Biofeedback orthosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No