NCT03861312

Brief Summary

Chronic neck pain is one of the most common causes of pain, affecting 15% of the adult population, and the fourth leading cause of disability. The recognition of laterality is the ability to recognize a part of the body that belongs to the left or right which is used as a tool to create a normal process of motor planning.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

December 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
Last Updated

March 4, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

February 26, 2019

Last Update Submit

March 1, 2019

Conditions

Keywords

Laterality task, neck pain

Outcome Measures

Primary Outcomes (4)

  • Response time

    Changes in the time response. Time response is defined as the time between the image appearance and the subject response.

    Immediately post-intervention

  • Accuracy

    Changes in the accuracy at the end of the intervention. Accuracy must be taken as the precision of the response when a subject say wether the image is right or left. It is measured by percentage of success.

    Immediately post-intervention

  • Joint Position Error

    Changes in the joint position error at the end of the intervention. It is measured on centimeters.

    Immediately post-intervention

  • Cervical Active Range of Motion

    Changes the cervical active range of motion at the end of the intervention. It is measured on centimeters.

    immediately post-intervention

Study Arms (2)

Neck Laterality

EXPERIMENTAL

It was done with 20 images of necks and 4 seconds for each image in the Vanilla program of the tablet application.

Behavioral: Neck Laterality

Foot Laterality

EXPERIMENTAL

It was done with 20 images of feet and 4 seconds for each image in the Vanilla program of the tablet application.

Behavioral: Foot Laterality

Interventions

Neck LateralityBEHAVIORAL

Patients who belonged to the neck group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the "Vanilla" program

Neck Laterality
Foot LateralityBEHAVIORAL

Patients who belonged to the foot group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the "Vanilla" program

Foot Laterality

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Marcos Lorenzo, Msc

    d.marcosl20@gmail.com

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 4, 2019

Study Start

December 1, 2016

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

March 4, 2019

Record last verified: 2019-03