NCT03624998

Brief Summary

The present study is designed to investigate whether the behavioral and cognitive functioning might predict the outcome of the rehabilitation of gait related abilities in orthopedic patients submitted to elective surgery (total hip arthroplasty). The evaluation of gait related abilities will be performed with specific physiatric tests, while cognitive functioning will be studied by means of an extended neuropsychological battery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 3, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

May 23, 2018

Last Update Submit

August 12, 2018

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Relationship between the cognitive functioning and gait rehabilitation

    We will measure the patients' cognitive functioning, investigated by means of a extensive neuropsychological and behavioral battery and the outcome of gait rehabilitation, measured at the enrollment, at 7 days after the enrollment and at 15 days after the enrollment.

    The first measures will be taken at the enrollment, at 7 days after the enrollment and at 15 days after the enrollment.

Study Arms (1)

THA Patients

EXPERIMENTAL

Orthopedic patients submitted to elective surgery (THA - Total Hip Arthroplasty)

Other: Cognitive and physiatric testing

Interventions

Cognitive and physiatric testingOTHER

Neuropsychological test battery and physiatric tests

THA Patients

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age comprised between 50 and 80 years
  • Submission to total hip arthroplasty
  • Admission to the local rehabilitation program
  • Signature of the informed consent

You may not qualify if:

  • Major medical issues (e.g. neurologial or neurodegenerative diseases)
  • Assumption of psychiatric drugs
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Galeazzi

Milan, Italia, 20161, Italy

RECRUITING

Related Publications (1)

  • Negrini F, Preti M, Zirone E, Mazziotti D, Biffi M, Pelosi C, Banfi G, Zapparoli L. The Importance of Cognitive Executive Functions in Gait Recovery After Total Hip Arthroplasty. Arch Phys Med Rehabil. 2020 Apr;101(4):579-586. doi: 10.1016/j.apmr.2019.12.004. Epub 2020 Jan 7.

    PMID: 31917194DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2018

First Posted

August 10, 2018

Study Start

April 3, 2018

Primary Completion

April 2, 2020

Study Completion

April 2, 2020

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

IT(1)