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Contraversive Pushing Scale Validation

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ClinicalTrials.gov Identifier: NCT03674268
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
Universidad Francisco de Vitoria
Information provided by (Responsible Party):
J. Nicolas Cuenca Zaldivar, Guadarrama Hospital

Brief Summary:
Transcultural validation of a scale.

Condition or disease Intervention/treatment
Balance Functionality Diagnostic Test: Management of the Contraversive Pushing Scale

Detailed Description:

Prior to the start of the study, we will proceed to the transcultural adaptation of the Contraversive Pushing Scale (CPS) through English-Spanish-English translation. Subsequently, an evaluation survey on the CPS will be administered to 10 physiotherapists who are experts in neurorehabilitation, in order to evaluate the validity of the content of the scale. 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
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Spanish Validation of the Contraversive Pushing Scale
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Intervention Details:
  • Diagnostic Test: Management of the Contraversive Pushing Scale
    Scale of evaluation of trunk control and pushing behavior in patients with stroke.


Primary Outcome Measures :
  1. Contraversive Pushing Scale score [ Time Frame: 4 weeks ]
    Scale of evaluation of trunk control and pushing behavior in patients with stroke.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674268


Contacts
Contact: J. Nicolas Cuenca Zaldivar (+34) 91 856 20 56 nicolas.cuenca@salud.madrid.org

Locations
Spain
J.Nicolas Cuenca Zaldivar Recruiting
Guadarrama, Madrid, Spain, 28440
Contact: J. Nicolas Cuenca zaldivar       nicolas.cuenca@salud.madrid.org   
Sponsors and Collaborators
Guadarrama Hospital
Universidad Francisco de Vitoria
Investigators
Principal Investigator: J.Nicolas Cuenca Zaldivar Guadarrama Hospital

Responsible Party: J. Nicolas Cuenca Zaldivar, Rehabilitation Service Principal Investigator, Guadarrama Hospital
ClinicalTrials.gov Identifier: NCT03674268     History of Changes
Other Study ID Numbers: 4.0
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No