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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03674268
Other study ID # 4.0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 19, 2018
Est. completion date January 15, 2020

Study information

Verified date October 2019
Source Guadarrama Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Psycometric properties of a scale


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date January 15, 2020
Est. primary completion date January 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain J.Nicolas Cuenca Zaldivar Guadarrama Madrid

Sponsors (2)

Lead Sponsor Collaborator
Guadarrama Hospital Universidad Francisco de Vitoria

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Contraversive Pushing Scale score Scale of evaluation of trunk control and pushing behavior in patients with stroke. 4 weeks
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