KyphosisNCT04834141
Correlation Between Thoracic Kyphosis Posture and Static Balance
An observational study of Kyphosis and Balance; Distorted, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The effects of balanced posture and postural changes have been evaluated in specific populations with different factors that can affect body postures and balance, such as age, musculoskeletal system, and other metabolic diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kyphosis, Balance; Distorted, Postural Kyphosis
- What is being tested?
- FlexiCurve ruler method to assess thoracic kyphosis angle
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Oct 2020to 10 Feb 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Fourty-six subjects who joined the study were healthy without any disease might affect balance, body posture, and denied a past history of vestibular disorders, syncope, seizures, or neurological disorders such as stroke or Parkinson's disease. The study take place in Marmara university, Başıbüyük campus, between the period September 2020 to December 2020. Participants were recruited through online poster announcement, they directly contacted the primary investigator for booking an appointment. An appointment were made for the participants in the Faculty of Health Sciences, Physiotherapy and Rehabilitation Department, Biomechanics and Performance Analysis Laboratory, Marmara University.
Who may be able to join
- Adults aged 18 and over willing to attend the study.
- For those who join the thoracic kyphosis group, individuals with a kyphosis angle ≥ 40 degrees.
- Individuals with a kyphosis angle < 40 degrees for the control group.
Who cannot join
- Spine trauma, surgery, bone pathology, arthritis etc. have a history of illness Kyphotic deformity types are rounded back, Scheuermann's disease, hunched back, flat back and Dowager hump.
- Any spinal deformity, bone abnormality, postural deformity and disc herniation with / without peripheral symptoms.
- Body mass index (BMI), which is an indicator of obesity, is more than > 30.
- Complaining of balance problems, coordination problems, other neurological or vestibular diseases that affect body balance and posture.
- Having any orthopedic or neurological disease that affects the body joints or the integrity of the musculoskeletal system.
- Use of any medication that can cause dizziness or drowsiness in the last months.
Trial locations and contacts
1 site in 1 country.
About this study
The effects of balanced posture and postural changes have been evaluated in specific populations with different factors that can affect body postures and balance, such as age, musculoskeletal system, and other metabolic diseases. Studies on postural kyphosis and balance involvement are very few in the literature especially in the health population. Of the few studies that have evaluated kyphosis and balance, most are limited by small sample size and the exclusion of men. Many have focused primarily on the geriatric population. The determination that the effect of thoracic kyphosis posture on trunk biomechanical alignment may be related to balance may contribute to new treatment recommendations in this area. The aim of this study is to investigate whether the thoracic kyphosis posture has an effect on static balance.
Read the detailed description
Background:
Kyphosis is roughly a slight forward curvature of the spine. A slight kyphosis or posterior curvature is normal throughout the human body and is present in every individual. Hyperkyphotic is a kyphotic angle greater than 40° commonly measured on a lateral X-ray measured by the Cobb method between C7 and T12. Postural stability or balance is the ability to keep the center of mass within the boundaries of the support base. Moving the center of mass beyond the boundaries of the support base may cause postural instability and loss of balance. There are studies showing that kyphotic posture affects the center of gravity and affects fall in the elderly, but there are limited studies on the effect of balance in young individuals.
The Aim of This Study Is:
To study the correlation between the balance and severity of thoracic kyphosis will be investigated
- Conditions
- Kyphosis, Balance; Distorted, Postural Kyphosis, Spine Disease, Balance
- Being tested
- FlexiCurve ruler method to assess thoracic kyphosis angle
- Medical subject headings
- Kyphosis, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlexiCurve ruler method to assess thoracic kyphosis angleOther
Also called NeuroCom Balance Manager System ® static posturography device to assess static balance
The determination that the effect of thoracic kyphosis posture on trunk biomechanical alignment may be related to balance may contribute to new treatment recommendations in this area. The aim of this study is to investigate whether the thoracic kyphosis posture has an effect on static balance.
| Study group | Role | What they receive |
|---|---|---|
| Kyphotic Group | Participants with kyphosis angle ≥ 40 degrees joined the kyphosis group. FlexiCurve ruler method was used, which is a reliable tool for measuring kyphosis height and kyphosis index. In addition, it is non-invasive, inexpensive, and easy to use in a clinical setting.
Static balance Assessment:
Objective evaluation of the static balance evaluated by the NeuroCom Balance Manager System ® static posturography device (45 × 45 cm NeuroCom® System Version 8.1 Balance Manager International, Clackamas, Oregon, USA) Receives: Other: FlexiCurve ruler method to assess thoracic kyphosis angle | |
| Control Group | Participants with kyphosis angle < 40 degrees for the control group. FlexiCurve ruler method was used, which is a reliable tool for measuring kyphosis height and kyphosis index. In addition, it is non-invasive, inexpensive, and easy to use in a clinical setting.
Static balance Assessment:
Objective evaluation of the static balance evaluated by the NeuroCom Balance Manager System ® static posturography device (45 × 45 cm NeuroCom® System Version 8.1 Balance Manager International, Clackamas, Oregon, USA) Receives: Other: FlexiCurve ruler method to assess thoracic kyphosis angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kyphosis Angle
Kyphosis angle will be measured by felxicurve ruler, normally kyphosis angle below 40 degrees recognized as normal. For participants with kyphosis angle above 40 degrees recognized as hyperkyphotic posture. FlexiCurve ruler method is valid and reliable to the gold standard.
Measured: 2 Months
Static Balance Measures
NeuroCom Balance Manager System ® static posturography device to assess static balance, which is objective evaluating system. The system compare the values reported for participants assessment then compare them to pre-recorded data base. The values of the test is assessed according to the percentage to the normal (average) values matched with the age group and gender. Above 80% determined as normal, and below this value determine balance disturbance.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start13 Oct 2020
- Primary completion30 Dec 2020
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KyphosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AYSEL yildiz, Ass. Prof., Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834141
- Sponsor's protocol ID
- 09.2020.897
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Thoracic Kyphosis Posture and Static Balance
- ClinicalTrials.gov ID
- NCT04834141
- Acronym / sponsor ID
- 09.2020.897
- Conditions
- Kyphosis, Balance; Distorted, Postural Kyphosis, Spine Disease, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of balanced posture and postural changes have been evaluated in specific populations with different factors that can affect body postures and balance, such as age, musculoskeletal system, and other metabolic diseases. Studies on postural kyphosis and balance involvement are very few in the literature especially in the health population. Of the few studies that have evaluated kyphosis and balance, most are limited by small sample size and the exclusion of men. Many have focused primarily on the geriatric population. The determination that the effect of thoracic kyphosis posture on trunk biomechanical alignment may be related to balance may contribute to new treatment recommendations in this area. The aim of this study is to investigate whether the thoracic kyphosis posture has an effect on static balance.
Detailed description
Background:
Kyphosis is roughly a slight forward curvature of the spine. A slight kyphosis or posterior curvature is normal throughout the human body and is present in every individual. Hyperkyphotic is a kyphotic angle greater than 40° commonly measured on a lateral X-ray measured by the Cobb method between C7 and T12. Postural stability or balance is the ability to keep the center of mass within the boundaries of the support base. Moving the center of mass beyond the boundaries of the support base may cause postural instability and loss of balance. There are studies showing that kyphotic posture affects the center of gravity and affects fall in the elderly, but there are limited studies on the effect of balance in young individuals.
The Aim of This Study Is:
To study the correlation between the balance and severity of thoracic kyphosis will be investigated
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kyphotic Group | – | Other: FlexiCurve ruler method to assess thoracic kyphosis angleParticipants with kyphosis angle ≥ 40 degrees joined the kyphosis group. FlexiCurve ruler method was used, which is a reliable tool for measuring kyphosis height and kyphosis index. In addition, it is non-invasive, inexpensive, and easy to use in a clinical setting. Static balance Assessment: Objective evaluation of the static balance evaluated by the NeuroCom Balance Manager System ® static posturography device (45 × 45 cm NeuroCom® System Version 8.1 Balance Manager International, Clackamas, Oregon, USA) |
| Control Group | – | Other: FlexiCurve ruler method to assess thoracic kyphosis angleParticipants with kyphosis angle < 40 degrees for the control group. FlexiCurve ruler method was used, which is a reliable tool for measuring kyphosis height and kyphosis index. In addition, it is non-invasive, inexpensive, and easy to use in a clinical setting. Static balance Assessment: Objective evaluation of the static balance evaluated by the NeuroCom Balance Manager System ® static posturography device (45 × 45 cm NeuroCom® System Version 8.1 Balance Manager International, Clackamas, Oregon, USA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Fourty-six subjects who joined the study were healthy without any disease might affect balance, body posture, and denied a past history of vestibular disorders, syncope, seizures, or neurological disorders such as stroke or Parkinson's disease. The study take place in Marmara university, Başıbüyük campus, between the period September 2020 to December 2020. Participants were recruited through online poster announcement, they directly contacted the primary investigator for booking an appointment. An appointment were made for the participants in the Faculty of Health Sciences, Physiotherapy and Rehabilitation Department, Biomechanics and Performance Analysis Laboratory, Marmara University.
Key inclusion criteria (3 listed)
- Adults aged 18 and over willing to attend the study.
- For those who join the thoracic kyphosis group, individuals with a kyphosis angle ≥ 40 degrees.
- Individuals with a kyphosis angle < 40 degrees for the control group.
Key exclusion criteria (6 listed)
- Spine trauma, surgery, bone pathology, arthritis etc. have a history of illness Kyphotic deformity types are rounded back, Scheuermann's disease, hunched back, flat back and Dowager hump.
- Any spinal deformity, bone abnormality, postural deformity and disc herniation with / without peripheral symptoms.
- Body mass index (BMI), which is an indicator of obesity, is more than > 30.
- Complaining of balance problems, coordination problems, other neurological or vestibular diseases that affect body balance and posture.
- Having any orthopedic or neurological disease that affects the body joints or the integrity of the musculoskeletal system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlexiCurve ruler method to assess thoracic kyphosis angleAlso: NeuroCom Balance Manager System ® static posturography device to assess static balanceThe determination that the effect of thoracic kyphosis posture on trunk biomechanical alignment may be related to balance may contribute to new treatment recommendations in this area. The aim of this study is to investigate whether the thoracic kyphosis posture has an effect on static balance. | Other | Control Group, Kyphotic Group |
Primary outcome
Kyphosis Angle
Time frame: 2 Months
Kyphosis angle will be measured by felxicurve ruler, normally kyphosis angle below 40 degrees recognized as normal. For participants with kyphosis angle above 40 degrees recognized as hyperkyphotic posture. FlexiCurve ruler method is valid and reliable to the gold standard.
Static Balance Measures
Time frame: 2 Months
NeuroCom Balance Manager System ® static posturography device to assess static balance, which is objective evaluating system. The system compare the values reported for participants assessment then compare them to pre-recorded data base. The values of the test is assessed according to the percentage to the normal (average) values matched with the age group and gender. Above 80% determined as normal, and below this value determine balance disturbance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYSEL yildiz, Ass. Prof. principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kyphosis and Balance; Distorted, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kyphosis Angle (time frame: 2 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.