The Effects of Cognitive Functioning on Gait Rehabilitation

August 12, 2018 updated by: Istituto Ortopedico Galeazzi

The Effects of Cognitive and Behavioral Functioning on Gait Rehabilitation in Orthopedic Patients Submitted to Total Hip Arthroplasty

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italia
      • Milano, Italia, Italy, 20161
        • Recruiting
        • IRCCS Galeazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: THA Patients
Orthopedic patients submitted to elective surgery (THA - Total Hip Arthroplasty)
Other: Cognitive and physiatric testing
Neuropsychological test battery and physiatric tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between the cognitive functioning and gait rehabilitation
Time Frame: The first measures will be taken at the enrollment, at 7 days after the enrollment and at 15 days after the enrollment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 3, 2018

Primary Completion (ANTICIPATED)

April 2, 2020

Study Completion (ANTICIPATED)

April 2, 2020

Study Registration Dates

First Submitted

May 23, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (ACTUAL)

August 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 12, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • L3031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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