- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03315273
Measuring Motor Imagery Ability in Patients With Traumatic Brain Injury.
- Validation of translated Motor Imagery ability questionnaire MIQ-RS
- Investigating the Motor Imagery ability in patients with traumatic brain injury
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ghent, Belgium, 9000
- Ghent University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Traumatic brain injury
Patients who have suffered a traumatic brain injury will be assessed with a test battery including
|
Participants will perform 3 different tests to measure the motor imagery ability
|
|
ACTIVE_COMPARATOR: Control
Healthy volunteers matched for age, sex and educational level will be assessed with the same test battery including
|
Participants will perform 3 different tests to measure the motor imagery ability
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor imagery ability
Time Frame: 2 assessments with an interval of 2 weeks
|
Results of test battery assessing motor imagery ability
|
2 assessments with an interval of 2 weeks
|
|
Validity translated MIQ-RS
Time Frame: 2 assessments with an interval of 2 weeks
|
Validity of the translated MIQ-RS in patients with traumatic brain injury and healthy volunteers
|
2 assessments with an interval of 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test-retest reliability
Time Frame: 2 assessments with an interval of 2 weeks
|
Test- retest reliability of the motor imagery ability test battery
|
2 assessments with an interval of 2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristine Oostra, MD, University Hospital, Ghent
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/2017/0826
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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