- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03661073
Motor Imagery Ability After Stroke (AVCIM)
March 13, 2023 updated by: Hospices Civils de Lyon
Comprehensive Assessment of Motor Imagery Ability After Stroke
Individuals with stroke may experience sensory-motor deficit and/or neglect, with possible reduction in motor imagery ability (MI).
To our knowledge, no study completely investigated MI ability in one individual whereas MI practice can be performed using visual or kinesthetic modalities (respectively visualizing with mind's eyes or imagining movement using sensation) and internal or external perspectives (performing action as spectator or as actor).
This study aims to investigate MI ability in patients with stroke as compared to aged-matched healthy individuals.
The investigators will assess explicit MI ability using 3 questionnaires (Movement Imagery Questionnaire-RS - MIQ-RS, Kinesthetic and Visual Imagery Questionnaire-20 - KVIQ-20, Vividness of Movement Imagery Questionnaire-2 - VMIQ-2) and 2 tests (imagined Time Up and Go - iTUG, imagined Box and Block test - iBBT).
Outcome parameters will be i) the composite score of vividness measured for all tests using Likert scales, ii) the temporal equivalence between MI and Physical practice (PP - where MI/PP ratio equal to 1 indicate good MI ability and respect of temporal equivalence between MI and PP) and iii) the amplitude of electrodermal activity.
The investigators will also study implicit MI ability using a hand laterality judgment task.
Outcomes parameters will be response time (i.e. the duration to identify the hand laterality) and the percentage of correct responses.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
50
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 Contact
- Name: Sebastien MATEO, PhD
- Phone Number: +33 (0) 478 865 066
- Email: sebastien.mateo@chu-lyon.fr
Study Contact Backup
- Name: Gilles RODE, MD
- Phone Number: +33 (0) 478 865 066
- Email: gilles.rode@chu-lyon.fr
Study Locations
-
-
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Saint-Genis-Laval, France, 69230
- Hôpital Henry Gabrielle
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-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
For both groups:
- be more than 18 years old
- be less than 75 years old
- benefit from social security
For experimental group:
- patient admitted in Henry Gabrielle hospital for rehabilitation
- patient with one single episode of stroke
Exclusion Criteria:
For patients:
- sign of cognitive decline (MMSE score under 27/30)
- evolutionary pathology associated
For healthy subjects:
- neurological or orthopaedical history
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: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stroke
The investigator will include patients with stroke (either hemorrhagic or ischemic) with or without neglect in the experimental group.
|
The intervention will last 3 hours ± 45 minutes, the assessment will be spread over 3 sessions of 1 hour ± 15 minutes on one week.
The time between two sessions will depend on patient fatigability and availability.
The VMIQ-2 and the KVIQ-20 will be realized during the first session.
In the second session, patients will perform the hand laterality judgment task and the MIQ-RS.
During the last session the Timed up and go and the box and block test will be realized.
|
Sham Comparator: Healthy subjects
The investigator will include healthy subjects aged-matched to participants of the experimental group in the control group.
|
The intervention will last 2 hours ± 15 minutes.
All the tests will be spread over 1 session.
Assessment order will be VMIQ-2, KVIQ-20, the hand laterality judgment task, the after a break MIQ-RS, iTUG and iBBT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score of vividness
Time Frame: Day 1
|
Participants will self-report vividness that describe the success in imagining movements using a 5-points Likert scale (1=no image or no sensation to 5=image as clear as PP or sensation as intense as PP) for the KVIQ-20.
The investigators will average the vividness for each items of the questionnaire.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Temporal equivalence measured during KVIQ-20
Time Frame: Day 1
|
The investigators will time the duration of physical practice (PP) and motor imagery (MI) movements, and then compute a ratio MI/PP for each item and average these ratios to get a measure of temporal equivalence for the KVIQ-20.
|
Day 1
|
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during KVIQ-20.
Time Frame: Day 1
|
The investigators will measure amplitude of electrodermal response during actual and imagined movement.
The investigators will average the amplitude of response and compute the ratio imagined/actual expressed in percent for the KVIQ-20.
|
Day 1
|
Score of vividness measured during VMIQ -2
Time Frame: Day 1
|
Participants will self-report vividness that describe the success in imagining movements using a 5-points Likert scale (1=no image or no sensation to 5=image as clear as PP or sensation as intense as PP) for the VMIQ -2.
The investigators will average the vividness for each items of the questionnaire.
|
Day 1
|
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during VMIQ -2.
Time Frame: Day 1
|
The investigators will measure amplitude of electrodermal response during actual and imagined movement.
The investigators will average the amplitude of response and compute the ratio imagined/actual expressed in percent for the VMIQ -2.
|
Day 1
|
Score of vividness measured during MIQ-RS.
Time Frame: Day 3
|
Participants will self-report vividness that describe the success in imagining movements using a 7-points Likert scale a 7-points Likert scale for MIQ (1=very difficult to imagine to 7=very easy to imagine) for the VMIQ -2.
The investigators will average the vividness for each items of the questionnaire.
|
Day 3
|
Temporal equivalence measured during MIQ-RS.
Time Frame: Day 3
|
The investigators will time the duration of physical practice (PP) and motor imagery (MI) movements.
Then the investigators will compute a ratio MI/PP for each item and average these ratios to get a measure of temporal equivalence for the MIQ-RS.
|
Day 3
|
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during MIQ-RS.
Time Frame: Day 3
|
The investigators will measure amplitude of electrodermal response during actual and imagined movement.
The investigators will average the amplitude of response and compute the ratio imagined/actual expressed in percent for the MIQ-RS.
|
Day 3
|
Percentage of correct response to identify the hand laterality during the implicit motor imagery ability assessment
Time Frame: Day 3
|
Participant will have to identify the hand laterality of the 196 hand pictures successively displayed on a computer screen with different rotation and orientation (namely palm, back, thumb, pinky).
The investigators will record the response and compute the averaged percentage of correct response.
|
Day 3
|
Response time to identify the hand laterality during the implicit motor imagery ability assessment
Time Frame: Day 3
|
Participant will have to identify the hand laterality of the 196 hand pictures successively displayed on a computer screen with different rotation and orientation (namely palm, back, thumb, pinky).
The investigators will time the duration to indicate the response and compute the averaged the response time for identification.
|
Day 3
|
Score of vividness measured during iTUG.
Time Frame: Day 5
|
Participants will self-report vividness that describe the success in imagining movements using a 5-points Likert scale (1=no image or no sensation to 5=image as clear as PP or sensation as intense as PP) for the iTUG.
The investigators will average the vividness for each items of the questionnaire.
|
Day 5
|
Temporal equivalence measured during iTUG.
Time Frame: Day 5
|
The investigators will time the duration of physical practice and motor imagery movements three consecutive times.
Then the investigators will compute a ratio MI/PP for time and average these ratios to get a measure of temporal equivalence for the iTUG.
|
Day 5
|
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during iTUG.
Time Frame: Day 5
|
The investigators will measure amplitude of electrodermal response during actual and imagined movement.
The investigators will average the amplitude of response and compute the ratio imagined/actual expressed in percent for the iTUG.
|
Day 5
|
Score of vividness measured during iBBT.
Time Frame: Day 5
|
Participants will self-report vividness that describe the success in imagining movements using a 5-points Likert scale (1=no image or no sensation to 5=image as clear as PP or sensation as intense as PP) for the iBBT.
The investigators will average the vividness for each items of the questionnaire.
|
Day 5
|
Temporal equivalence measured during iBBT.
Time Frame: Day 5
|
The investigators will time the duration of physical practice and motor imagery movements three consecutive times.
Then the investigators will compute a ratio MI/PP for time and average these ratios to get a measure of temporal equivalence for the iBBT.
|
Day 5
|
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during iBBT.
Time Frame: Day 5
|
The investigators will measure amplitude of electrodermal response during actual and imagined movement.
The investigators will average the amplitude of response and compute the ratio imagined/actual expressed in percent for the iBBT.
|
Day 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 17, 2018
Primary Completion (Actual)
January 17, 2022
Study Completion (Actual)
January 17, 2022
Study Registration Dates
First Submitted
June 1, 2018
First Submitted That Met QC Criteria
September 4, 2018
First Posted (Actual)
September 7, 2018
Study Record Updates
Last Update Posted (Actual)
March 14, 2023
Last Update Submitted That Met QC Criteria
March 13, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL18_0059
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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