NCT06420869

Brief Summary

Although the negative effect of increased thoracic kyphosis in elderly individuals has been reported in the literature, the effect of the thoracic kyphosis angle on trunk and foot proprioception in young individuals has not been investigated. The aim of this study was to investigate the effect of the thoracic kyphosis on posture, proprioception and perception of postural appearance in young individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

May 16, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2024

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

May 15, 2024

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proprioception evaluation; Evaluation of Trunk Joint Position Sensation

    The BASELINE brand digital goniometer (Baseline 10044E Digital Absolute + Axis Goniometer 10044E SKU: CM10044E) can be employed for the measurement of joint position sense. Prior to commencing the measurement, participants are instructed to assume four different positions in a comfortable standing position. The participants are required to perform 30° flexion, 15° extension, 15° right and left lateral flexion for an active proprioceptive positioning test with their eyes closed. Following each position, the participants are instructed to wait for three seconds and to feel the position. They then return to the upright position and are asked to return to the position they felt and measured in that position. The deviation degrees of the participants are recorded. This process is repeated three times, with the resulting degrees of deviation averaged. During the measurement, it is essential to ensure that flexion in the knees is avoided.

    10 minute

Secondary Outcomes (6)

  • The Body Sensation Assessment

    10 minute

  • The evaluation of foot sensation

    10 min

  • Ankle Joint Position Sensation Evaluation

    10 min

  • Cervical Joint Position Sense Assessment

    10 min

  • Postural Assessment

    5 min

  • +1 more secondary outcomes

Study Arms (2)

Group 1

The study group 1, comprised 23 subjects, comprising both males and females, with an age range of between 18 and 25 years. The subjects exhibited a thoracic kyphosis angle of ≥40° and had not undergone treatment for kyphosis in the previous six months.

Diagnostic Test: Assessment

Group 2

The study group 2, comprised 23 subjects, comprising both males and females, with an age range of between 18 and 25 years.The subjects were selected based on the criteria that their thoracic kyphosis angle was less than 40° and that they did not exhibit any spinal deformities.

Diagnostic Test: Assessment

Interventions

AssessmentDIAGNOSTIC_TEST

A postural evaluation will be conducted, including the measurement of the thoracic kyphosis angle and the assessment of sagittal head posture.A proprioception evaluation will be conducted, whereby the cervical region, trunk and ankle joint position sense and trunk and foot sensation will be evaluated for the purpose of assessing the proprioception of the spine.Turkish adaptation of the Kyphosis Specific Spine Appearance Questionnaire (KSAQ) will be employed to assess postural appearance perception. The KSAQ is a reliable and valid patient-reported outcome tool for assessing individual perception of various aspects of kyphotic deformity and appearance in young patients with kyphosis. KSAQ is a 10-item questionnaire based on a five-point Likert scale, with responses ranging from 1 to 5. The mean of the responses is used to obtain a total score for the KSAQ. The questionnaire is related to patients' perception of appearance, with higher scores indicating a worsening of the deformity.

Group 1Group 2

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe age range of the participants was between 18 and 25 years old.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study will include healthy individuals aged 18 to 25 years. A power analysis was conducted to determine the number of individuals to be included in the study. A sample size of 46 individuals was determined, with 23 individuals per group. The power of the test was calculated using the G\*Power 3.1 program. A similar study in the relevant literature by Fatemeh et al. (2022) calculated the effect size to be 0.991. In order to exceed the 95% value in determining the power of the study, 46 people must be included, including 23 people in groups with a significance level of 5% and an effect size of 0.991 (df=44; t=1.711). All participants will be provided with and required to sign an informed consent form, which will be based on the principle of voluntariness.

You may qualify if:

  • Between 18 and 25 years of age
  • Not being treated for kyphosis in the last 6 months

You may not qualify if:

  • Those diagnosed with scoliosis and/or structural spinal deformity
  • Those with any neurological deficit
  • Those with concomitant disorders such as Scheuermann's disease, genetic diseases such as Beckwith-Wiedemann Syndrome or metabolic diseases that may affect body axis disorders
  • Those with lower limb deformities
  • Those with a history of spinal fracture and/or surgery and/or shoulder joint injury
  • Those with mental disorders and intellectual disabilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kyphosis

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • SENA ÖZDEMİR GÖRGÜ, PhD,PT

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 20, 2024

Study Start

May 16, 2024

Primary Completion

August 16, 2024

Study Completion

December 27, 2024

Last Updated

May 23, 2025

Record last verified: 2024-05

Locations