NCT04834141

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 1, 2021

Last Update Submit

April 2, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 Months

Study Arms (2)

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)

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)

Other: FlexiCurve ruler method to assess thoracic kyphosis angle

Interventions

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.

Also known as: NeuroCom Balance Manager System ® static posturography device to assess static balance
Control GroupKyphotic Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

KyphosisSpinal Diseases

Condition Hierarchy (Ancestors)

Spinal CurvaturesBone DiseasesMusculoskeletal Diseases

Study Officials

  • AYSEL yildiz, Ass. Prof.

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 8, 2021

Study Start

October 13, 2020

Primary Completion

December 30, 2020

Study Completion

February 10, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations