NCT05595902

Brief Summary

The aim of this study is to determine the normative values of navicular height and navicular drop in individuals over 65 years of age. The secondary aim is to investigate the effects of age, gender, and body mass index on these normative values.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
445

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

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

October 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

October 24, 2022

Last Update Submit

March 1, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Navicular Drop Test

    The navicular height and the amount of navicular drop will be made separately for each foot. The navicular prominence is found by palpation and marked with a marker pen when the individual is in a sitting position with the hips and knees flexed to 90 degrees and the subtalar joint in neutral position (the subtalar joint is palpated and the talus is in a neutral position). The height of the navicular protrusion from the ground is measured with a rigid ruler. Then, while the person stands on both feet equally, the height of the navicular protrusion from the ground is also measured with a ruler. The difference between the two measurements is noted as the amount of "navicular drop" (NDT).

    10 minutes

Secondary Outcomes (4)

  • Age

    1 minute

  • Gender

    1 minute

  • Body-Mass index

    3 minutes

  • Foot Posture Index

    15 minutes

Study Arms (3)

Young older adults

≥65-\<75 years of age

Older adults

≥75-\<90 years of age

≥90 years old

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy older adults

You may qualify if:

  • Being 65 years or older
  • Having a body mass index between 18.5 and 29.0 kg/m2

You may not qualify if:

  • Having chronic diseases that affect the foot structure and connective tissue (such as diabetes mellitus, rheumatoid arthritis, gout, etc.).
  • Have had foot or ankle surgery in the last 6 months
  • Having orthopedic or neurological deformities (related to stroke, Parkinson's, multiple sclerosis, spinal cord injury, etc.) that will affect the foot structure and mobility.
  • Dependence on standing and ambulation (except independence gained through the use of assistive devices)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD., Asisst. Prof.

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 27, 2022

Study Start

April 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 20, 2023

Last Updated

March 2, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share