Traumatic Brain InjuryNCT03315273
Measuring Motor Imagery Ability in Patients With Traumatic Brain Injury.
A study testing Test battery to measure the motor imagery ability in people with Traumatic Brain Injury and Healthy, run by University Ghent at 1 site in Belgium.
Trial summary
1. Validation of translated Motor Imagery ability questionnaire MIQ-RS 2. Investigating the Motor Imagery ability in patients with traumatic brain injury Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Healthy
- What is being tested?
- Test battery to measure the motor imagery ability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Nov 2017to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- TBI minimum 3 months ago and maximal 1 year ago
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
- Validation of translated Motor Imagery ability questionnaire MIQ-RS
- Investigating the Motor Imagery ability in patients with traumatic brain injury
Read the 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.
- Conditions
- Traumatic Brain Injury, Healthy
- Being tested
- Test battery to measure the motor imagery ability
- Keywords
- Traumatic brain injury, motor imagery ability, validation
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test battery to measure the motor imagery abilityOther
Participants will perform 3 different tests to measure the motor imagery ability
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Test battery to measure the motor imagery ability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor imagery ability
Results of test battery assessing motor imagery ability
Measured: 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
Measured: 2 assessments with an interval of 2 weeks
Secondary outcomes (1)
Test-retest reliability
Test- retest reliability of the motor imagery ability test battery
Measured: 2 assessments with an interval of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start7 Nov 2017
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Kristine Oostra, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315273
- Sponsor's protocol ID
- EC/2017/0826
- Status last verified
- May 2019
- First submitted
- 3 Oct 2017
- Last updated
- 7 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Motor Imagery Ability in Patients With Traumatic Brain Injury.
- ClinicalTrials.gov ID
- NCT03315273
- Acronym / sponsor ID
- EC/2017/0826
- Conditions
- Traumatic Brain Injury, Healthy
- Keywords
- Traumatic brain injury, motor imagery ability, validation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury | Experimental | Other: Test battery to measure the motor imagery abilityPatients 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) |
| Control | Active comparator | Other: Test battery to measure the motor imagery abilityHealthy 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- TBI minimum 3 months ago and maximal 1 year ago
Key exclusion criteria (5 listed)
- 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
- Matched for age, sex and educational level No neurological disorders present
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test battery to measure the motor imagery abilityParticipants will perform 3 different tests to measure the motor imagery ability | Other | Control, Traumatic brain injury |
Primary outcome
Motor imagery ability
Time frame: 2 assessments with an interval of 2 weeks
Results of test battery assessing motor imagery ability
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
1 secondary outcome
Test-retest reliability
Time frame: 2 assessments with an interval of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Oostra, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test battery to measure the motor imagery ability in people with Traumatic Brain Injury and Healthy, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor imagery ability (time frame: 2 assessments with an interval of 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.