NCT03213015

Brief Summary

The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand) and to verify if there is correlation between the limitation of the ADROM and the PFP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

July 4, 2017

Last Update Submit

July 10, 2017

Conditions

Keywords

confiabilityanklepatellofemoral pain syndrome

Outcome Measures

Primary Outcomes (1)

  • Ankle Dorsiflexion Degrees

    We will evaluate the ankle range of motion (dorsiflexion) with app (iHand) in smartphone. The measurement will be in degree.

    1 day

Study Arms (1)

Experimental

EXPERIMENTAL

Measurement of ankle dorsiflexion ROM (range of motion) with iHand app (smartphone)

Diagnostic Test: Ankle dorsiflexion measurement

Interventions

It was used the test with WB, called Lunge Test, in which each evaluator marked a point 15 cm distal to the anterior tuberosity of the tibia (TAT) with a felt tip pen. After that the smartphone (app iHand) will be placed at this point. Between each measurement, the mark was removed with alcohol 70% The demarcated point served as a guide for positioning the smartphone. In order to standardize the smartphone positioning, BHome (home button on the iPhone), was aligned with the TAT pen mark. To ensure the same distance from the foot to the test, the distance of the hallux to the wall was measured (tape measure), recorded and reused for each test.

Experimental

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • volunteers with a history of patelofemoral pain
  • presence of image (lesion) in cartilage tissue in Nuclear Magnetic Resonance
  • knee dynamic valgus during the single leg squat test and step down test (clinical tests)

You may not qualify if:

  • acute knee lesion
  • acute ankle lesion
  • surgical procedures before six months ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Filipe Abdalla

Campo Grande, Mato Grosso do Sul, 79117504, Brazil

Location

Related Publications (1)

  • Dill KE, Begalle RL, Frank BS, Zinder SM, Padua DA. Altered knee and ankle kinematics during squatting in those with limited weight-bearing-lunge ankle-dorsiflexion range of motion. J Athl Train. 2014 Nov-Dec;49(6):723-32. doi: 10.4085/1062-6050-49.3.29.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator and Clinical Professor

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 11, 2017

Study Start

January 25, 2017

Primary Completion

March 25, 2017

Study Completion

June 30, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations