NCT03315273

Brief Summary

  1. 1.Validation of translated Motor Imagery ability questionnaire MIQ-RS
  2. 2.Investigating the Motor Imagery ability in patients with traumatic brain injury

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

November 7, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

12 months

First QC Date

October 3, 2017

Last Update Submit

May 6, 2019

Conditions

Keywords

Traumatic brain injury, motor imagery ability, validation

Outcome Measures

Primary Outcomes (2)

  • Motor imagery ability

    Results of test battery assessing motor imagery ability

    2 assessments with an interval of 2 weeks

  • Validity translated MIQ-RS

    Validity of the translated MIQ-RS in patients with traumatic brain injury and healthy volunteers

    2 assessments with an interval of 2 weeks

Secondary Outcomes (1)

  • Test-retest reliability

    2 assessments with an interval of 2 weeks

Study Arms (2)

Traumatic brain injury

EXPERIMENTAL

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)

Other: Test battery to measure the motor imagery ability

Control

ACTIVE COMPARATOR

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)

Other: Test battery to measure the motor imagery ability

Interventions

Participants will perform 3 different tests to measure the motor imagery ability

ControlTraumatic brain injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • TBI minimum 3 months ago and maximal 1 year ago

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Kristine Oostra, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 20, 2017

Study Start

November 7, 2017

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations