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

Sponsor
Gazi University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05905718
Collaborator
(none)
52
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
52 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Comparison of the Immediate Effects of Spinomed Orthosis and Biofeedback Orthosis on Balance and Walking Performance in Elderly Individuals With Thoracic Hyperkyphosis
Anticipated Study Start Date :
Jun 9, 2023
Anticipated Primary Completion Date :
Jul 9, 2023
Anticipated Study Completion Date :
Aug 9, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kader Eldemir, Doctor Physiotherapist, T.C. ORDU ÜNİVERSİTESİ
ClinicalTrials.gov Identifier:
NCT05905718
Other Study ID Numbers:
  • Spinomed-Biofeedback orthosis
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023