search
Back to results

Measuring Motor Imagery Ability in Patients With Traumatic Brain Injury.

Primary Purpose

Traumatic Brain Injury, Healthy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Test battery to measure the motor imagery ability
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic brain injury, motor imagery ability, validation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • TBI minimum 3 months ago and maximal 1 year ago

Exclusion Criteria:

  • Other neurological disorders
  • Severe cognitive deficits, unable to understand the study protocol
  • Severe motor impairment, unable to perform the TDMI (Time Dependent Motor Imagery) screening test

Control group:

Matched for age, sex and educational level No neurological disorders present

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Traumatic brain injury

Control

Arm Description

Patients who have suffered a traumatic brain injury will be assessed with a test battery including a motor imagery ability questionnaire (MIQ-rs) a mental rotation test a chronometry test (TDMI)

Healthy volunteers matched for age, sex and educational level will be assessed with the same test battery including a motor imagery ability questionnaire (MIQ-RS) a mental rotation test a chronometry test (TDMI)

Outcomes

Primary Outcome Measures

Motor imagery ability
Results of test battery assessing motor imagery ability
Validity translated MIQ-RS
Validity of the translated MIQ-RS in patients with traumatic brain injury and healthy volunteers

Secondary Outcome Measures

Test-retest reliability
Test- retest reliability of the motor imagery ability test battery

Full Information

First Posted
October 3, 2017
Last Updated
May 6, 2019
Sponsor
University Ghent
Collaborators
University Hospital, Ghent
search

1. Study Identification

Unique Protocol Identification Number
NCT03315273
Brief Title
Measuring Motor Imagery Ability in Patients With Traumatic Brain Injury.
Official Title
Measuring Motor Imagery Ability in Patients With Traumatic Brain Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
University Hospital, Ghent

4. Oversight

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

5. Study Description

Brief Summary
Validation of translated Motor Imagery ability questionnaire MIQ-RS Investigating the Motor Imagery ability in patients with traumatic brain injury
Detailed Description
Translation of the MIQ-RS following the WHO guidelines. Followed by a validation of this translated questionnaire in patients with traumatic brain injury and in healthy volunteers. Investigating the motor imagery ability using 3 different test MIQ-RS (movement imagery questionnaire) TDMI (time dependent motor imagery) mental chronometry test Patients and controls will perform all 3 test twice with an interval of 2 weeks to measure the test-retest reliability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Healthy
Keywords
Traumatic brain injury, motor imagery ability, validation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of 2 groups: one existing of patients with traumatic brain injury and one control group of healthy volunteers matched for age, sex and educational level
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traumatic brain injury
Arm Type
Experimental
Arm Description
Patients who have suffered a traumatic brain injury will be assessed with a test battery including a motor imagery ability questionnaire (MIQ-rs) a mental rotation test a chronometry test (TDMI)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Healthy volunteers matched for age, sex and educational level will be assessed with the same test battery including a motor imagery ability questionnaire (MIQ-RS) a mental rotation test a chronometry test (TDMI)
Intervention Type
Other
Intervention Name(s)
Test battery to measure the motor imagery ability
Intervention Description
Participants will perform 3 different tests to measure the motor imagery ability
Primary Outcome Measure Information:
Title
Motor imagery ability
Description
Results of test battery assessing motor imagery ability
Time Frame
2 assessments with an interval of 2 weeks
Title
Validity translated MIQ-RS
Description
Validity of the translated MIQ-RS in patients with traumatic brain injury and healthy volunteers
Time Frame
2 assessments with an interval of 2 weeks
Secondary Outcome Measure Information:
Title
Test-retest reliability
Description
Test- retest reliability of the motor imagery ability test battery
Time Frame
2 assessments with an interval of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: TBI minimum 3 months ago and maximal 1 year ago Exclusion Criteria: Other neurological disorders Severe cognitive deficits, unable to understand the study protocol Severe motor impairment, unable to perform the TDMI (Time Dependent Motor Imagery) screening test Control group: Matched for age, sex and educational level No neurological disorders present
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Oostra, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Measuring Motor Imagery Ability in Patients With Traumatic Brain Injury.

We'll reach out to this number within 24 hrs