NCT04173702

Brief Summary

This study will evaluate how age, visual sensation and different ground properties affect of postural sways and stability limits at different support surface widths. 60 individuals will be included in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable healthy

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

First Submitted

Initial submission to the registry

May 6, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

May 6, 2019

Last Update Submit

December 4, 2023

Conditions

Keywords

BalanceStance widthPostural swayLimits of stability

Outcome Measures

Primary Outcomes (1)

  • Postural Sway

    Postural sways were used to evaluate dynamic balance. Postural sway, in terms of human sense of balance, refers to horizontal movement around the center of gravity. Postural sway was assessed during quite standing with open/closed eyes on a hard/soft floor with the Bertec Balance System on 4 different support surfaces: adjacent feet, width of the bitrochanteric diameter, increased by 50% width of the bitrochanteric diameter and reduced by 50% of the width of the bitrochanteric diameter randomly.

    1 week

Secondary Outcomes (1)

  • The Limits of Stability

    1 week

Study Arms (1)

Healthy Group

EXPERIMENTAL

Postural sway and stability limits in assessment of healthy individuals

Diagnostic Test: balance analysis

Interventions

balance analysisDIAGNOSTIC_TEST

Computerized balance analysis system will use to evaluate postural sway and limits of stability at four different support surfaces.

Healthy Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals aged between 18-50
  • Without any diagnosed disease
  • Individuals who voluntarily agree to participate in this research

You may not qualify if:

  • The presence of previous lower extremity surgery
  • Pain during evaluation
  • Foot ankle instability
  • Important and irreversible visual deficits
  • Body mass index (BMI) greater than\> 40 kg / m²
  • Limitation of ankle, knee and hip joint in lower extremity
  • Muscle strength of the lower extremity (dorsiflexors, plantar flexors, quadriceps, hamstring, gluteus maximus, gluteus medius) and the trunk (rectus abdominous, internal and external oblique abdominals, back extensor) below 5.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related Publications (1)

  • Goodworth AD, Mellodge P, Peterka RJ. Stance width changes how sensory feedback is used for multisegmental balance control. J Neurophysiol. 2014 Aug 1;112(3):525-42. doi: 10.1152/jn.00490.2013. Epub 2014 Apr 23.

    PMID: 24760788BACKGROUND

Study Officials

  • Melek M. ERDEM

    Tayyip Erdogan University Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Semra TOPUZ, Assoc. Prof.

    Hacettepe University

    STUDY DIRECTOR
  • Ozden OZKAL, PT, PhD

    Hacettepe University

    STUDY CHAIR
  • Ali I. Yalcin, PT, M.Sc.

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Clinical trials with a single arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 6, 2019

First Posted

November 22, 2019

Study Start

January 17, 2022

Primary Completion

June 15, 2023

Study Completion

October 16, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Data will be available within 6 months with completion of the result report.
Access Criteria
Requestors will be required to sign a Data Access Agreement.
More information

Locations