NCT03884088

Brief Summary

There is many subjective balance tests to evaluate static and dynamic balance. But, there is no sufficient information about which balance test is the most sensitive test to evaluate balance. Therefore, the aim of this study is to compare of sensitivity of the subjective balance tests with an objective system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

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

March 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

March 16, 2019

Last Update Submit

March 14, 2022

Conditions

BalancePosture

Keywords

BalanceLimits of StabilityPostural Sway

Outcome Measures

Primary Outcomes (2)

  • Limits of Stability

    Limits of stability test evaluates dynamic balance of participants. Computerized balance system measured limits of stability for forward, backward, right and left side movements. It calculates the maximum distance a person can lean without losing balance. The unit of measure is centimeters. The higher value is indicated the better balance

    15 minutes

  • Postural Sway

    Postural sway in centimeters by computerized balance system

    15 minutes

Secondary Outcomes (7)

  • Timed up and go test

    15 minutes

  • Functional reach test

    15 minutes

  • One-leg stance test

    15 minutes

  • Romberg test

    15 minutes

  • Berg balance scale

    15 minutes

  • +2 more secondary outcomes

Study Arms (2)

Experimental Group: Balance analysis

EXPERIMENTAL

Balance will be assessed by Computerized Balance system and subjective balance tests.

Other: Limits of Stability

Control Group: Balance analysis

ACTIVE COMPARATOR

Balance will be assessed by Computerized Balance system and subjective balance tests.

Other: Limits of Stability

Interventions

Limits of StabilityOTHER

Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.

Also known as: Postural Sway test, Berg Balance Scale, Y Balance Test, Romberg Balance Test, One-Leg Stance Test, Tinetti Balance Test, Timed up an go test, Functional Reach Test
Control Group: Balance analysisExperimental Group: Balance analysis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years,
  • To be a volunteer to participate

You may not qualify if:

  • orthopedic problems affecting gait and stance
  • visual, auditory, orientational problems that could affect study results,
  • Walking with assist device
  • Having a neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozden Ozkal

Ankara, 06100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 16, 2019

First Posted

March 21, 2019

Study Start

April 1, 2019

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)