Psycometric Properties of Pushing Scale

Psychometric Properties of the Spanish Version of the Contraversive Pushing Scale

Psycometric properties of a scale

Study Overview

• Status: Completed
• Conditions: Balance; Functionality
• Intervention / Treatment: Diagnostic test: Management of the Contraversive Pushing Scale

Detailed Description

After a period of training in the administration of the CPS, a pilot will be conducted with 10 patients who meet the inclusion-exclusion criteria and after signing the informed consent document, in which the 4 researchers will administer the CPS during two sessions on consecutive days, with the objective of evaluating the test-retest and intra-observer reliability, minimize the differences of criteria in its application and, if necessary, write an instruction manual.

Once each patient has signed the informed consent document and it has been verified that the inclusion criteria are met, it will be assigned an Identification Number (ID) that will relate it to your Medical Record (IDHC) by simple coding; The custody of the file with the relation of each ID with its HC will be borne by the principal investigator. Likewise, each observer will be assigned an identification number in order to blind the researcher who performs the statistical analysis. The patients included in the study will be evaluated, through the Spanish version of the CPS, by two of the researchers with an interval of 10 minutes between each evaluation, repeating this same procedure the next day. These evaluation sessions will be carried out throughout the treatment period, repeating on days 1, 15 and 28 of the period of admission of the included patients. Two researchers will evaluate the patients treated in the morning shift and the other two those treated in the afternoon shift of the Physiotherapy Service of the Guadarrama Hospital.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Guadarrama, Madrid, Spain, 28440
      • J.Nicolas Cuenca Zaldivar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with the diagnosis of stroke who enter the Guadarrama Hospital, meet the inclusion / exclusion criteria and agree to participate in the study after signing the informed consent.

Description

Inclusion Criteria:

• Must understand and voluntarily sign the corresponding informed consents and information sheet before any evaluation / procedure related to the study is conducted.
• Male or female, ≥18 years of age at the time of consent.
• Have the diagnosis of ischemic or hemorrhagic hemispheric stroke without excluding other causes (surgery, cancer, etc ...).
• Enter for the first time in the Guadarrama Hospital to receive physiotherapy treatment.

Exclusion Criteria:

• A patient can not be recruited in this study if they have severe cognitive impairment, moderate-severe language problems, or severe vision or hearing deficits that prevent compression and active collaboration during evaluation tests.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contraversive Pushing Scale score	Scale of evaluation of trunk control and pushing behavior in patients with stroke.	4 weeks

Collaborators and Investigators

• Sponsor: Guadarrama Hospital
• Collaborators: Universidad Francisco de Vitoria
• Investigators: Principal Investigator: J.Nicolas Cuenca Zaldivar, Guadarrama Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 4.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be available permanently once the statistical analysis is complete.
• IPD Sharing Access Criteria: The data will be available freely and publicly.
• IPD Sharing Supporting Information Type: Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No