NCT02931916

Brief Summary

The purpose of this study is to evaluate the reliability and validity of smart-phone based system in postural control ability assessment on subjects with chronic ankle instability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

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

September 29, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

September 29, 2016

Last Update Submit

October 24, 2018

Conditions

Other Instability, Ankle and Foot

Keywords

smart-phoneassessmentchronic ankle instability

Outcome Measures

Primary Outcomes (2)

  • physiological parameter: acceleration data from built-in sensor with unit: m/s^2

    Using the built-in sensor to record the acceleration data during each seconds trial. Both x, y and z axialis will be recorded

    40 seconds

  • physiological parameter: orientation data from built-in sensor with unit: degree

    Using the built-in sensor to record the acceleration data during each seconds trials. Both x, y and z axialis will be recorded

    40 seconds

Study Arms (2)

healthy group

recruited for evaluation of system reliability

Chronic Ankle Instability group

recruited for evaluation of system validity

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

chronic ankle instability group

You may qualify if:

  • clinical diagnosis of ankle functional instability

You may not qualify if:

  • any other condition would affect postural control performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yang Ming university

Taipei, Taiwan

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 13, 2016

Study Start

November 1, 2016

Primary Completion

March 30, 2018

Study Completion

August 31, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

TW(1)