NCT03674268

Brief Summary

Psycometric properties of a scale

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

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

September 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

September 19, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

February 12, 2020

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

September 14, 2018

Last Update Submit

February 11, 2020

Conditions

BalanceFunctionality

Outcome Measures

Primary Outcomes (1)

  • Contraversive Pushing Scale score

    Scale of evaluation of trunk control and pushing behavior in patients with stroke.

    4 weeks

Interventions

Management of the Contraversive Pushing ScaleDIAGNOSTIC_TEST

Scale of evaluation of trunk control and pushing behavior in patients with stroke.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rehabilitation Service Principal Investigator

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 17, 2018

Study Start

September 19, 2018

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

February 12, 2020

Record last verified: 2019-10

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
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.

Locations

ES(1)