NCT03509337

Brief Summary

A single-center, observational, prospective, single cohort study with before-after design. Evaluation by shear-wave elastography, measured in kilopascals (KPa), of the muscle, tendon and cubital nerve, before and after the maneuver of putting in tension of the ulnar nerve.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

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

April 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

April 17, 2018

Last Update Submit

August 31, 2018

Conditions

Keywords

Elastography, Nervous tissue, Muscle tonus

Outcome Measures

Primary Outcomes (1)

  • elastographic soft tissue tension (KPa)

    Tension (KPa) in the nerve, muscle and ulnar tendon measured by elastography shear-wave before and after putting the ulnar nerve in tension

    1 day

Interventions

Measurement by shear-wave elastography of the nerve, muscle and ulnar tendon before and after the tension of the ulnar nerve

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers recruited among the students of the Francisco de Vitoria University.

You may qualify if:

  • Francisco de Vitoria University student.
  • Age between 18 and 26 years old.

You may not qualify if:

  • History of neuropathies in upper limbs.
  • Slight neck pain in the last 6 months of traumatic origin.
  • Neck pain in the last 3 months.
  • episodes of moderate / severe neck pain in the last year.
  • History of fracture or dislocation in the upper extremity.
  • Surgical history in the upper extremity.
  • Cervical symptomatology or upper limb at the present time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

J.Nicolas Cuenca Zaldivar

Guadarrama, Madrid, 28440, Spain

Location

Study Officials

  • J. Nicolas Cuenca Zaldivar

    Guadarrama Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rehabilitation Service Principal Investigator

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 26, 2018

Study Start

May 1, 2018

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

September 4, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

The statistical analysis plan and the analytical code will be available in .html and .rmd format as well as the file with the raw data.

Shared Documents
SAP, ANALYTIC CODE
Time Frame
The data will be available permanently once the statistical analysis is complete.
Access Criteria
The data will be available freely and publicly.
More information

Locations