Motor Imagery Ability After Stroke (AVCIM)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of motor imagery ability
Assessment of motor imagery ability of healthy subject
Sponsored by

About this trial
This is an interventional basic science trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Hôpital Henry Gabrielle
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Stroke
Healthy subjects
Arm Description
The investigator will include patients with stroke (either hemorrhagic or ischemic) with or without neglect in the experimental group.
The investigator will include healthy subjects aged-matched to participants of the experimental group in the control group.
Outcomes
Primary Outcome Measures
Score of vividness
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.
Secondary Outcome Measures
Temporal equivalence measured during KVIQ-20
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.
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during KVIQ-20.
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.
Score of vividness measured during VMIQ -2
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.
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during VMIQ -2.
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.
Score of vividness measured during MIQ-RS.
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.
Temporal equivalence measured during MIQ-RS.
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.
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during MIQ-RS.
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.
Percentage of correct response to identify the hand laterality during the implicit motor imagery ability assessment
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.
Response time to identify the hand laterality during the implicit motor imagery ability assessment
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.
Score of vividness measured during iTUG.
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.
Temporal equivalence measured during iTUG.
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.
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during iTUG.
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.
Score of vividness measured during iBBT.
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.
Temporal equivalence measured during iBBT.
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.
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during iBBT.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03661073
Brief Title
Motor Imagery Ability After Stroke
Acronym
AVCIM
Official Title
Comprehensive Assessment of Motor Imagery Ability After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
January 17, 2022 (Actual)
Study Completion Date
January 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stroke
Arm Type
Experimental
Arm Description
The investigator will include patients with stroke (either hemorrhagic or ischemic) with or without neglect in the experimental group.
Arm Title
Healthy subjects
Arm Type
Sham Comparator
Arm Description
The investigator will include healthy subjects aged-matched to participants of the experimental group in the control group.
Intervention Type
Behavioral
Intervention Name(s)
Assessment of motor imagery ability
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Assessment of motor imagery ability of healthy subject
Intervention Description
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.
Primary Outcome Measure Information:
Title
Score of vividness
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Temporal equivalence measured during KVIQ-20
Description
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.
Time Frame
Day 1
Title
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during KVIQ-20.
Description
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.
Time Frame
Day 1
Title
Score of vividness measured during VMIQ -2
Description
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.
Time Frame
Day 1
Title
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during VMIQ -2.
Description
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.
Time Frame
Day 1
Title
Score of vividness measured during MIQ-RS.
Description
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.
Time Frame
Day 3
Title
Temporal equivalence measured during MIQ-RS.
Description
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.
Time Frame
Day 3
Title
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during MIQ-RS.
Description
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.
Time Frame
Day 3
Title
Percentage of correct response to identify the hand laterality during the implicit motor imagery ability assessment
Description
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.
Time Frame
Day 3
Title
Response time to identify the hand laterality during the implicit motor imagery ability assessment
Description
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.
Time Frame
Day 3
Title
Score of vividness measured during iTUG.
Description
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.
Time Frame
Day 5
Title
Temporal equivalence measured during iTUG.
Description
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.
Time Frame
Day 5
Title
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during iTUG.
Description
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.
Time Frame
Day 5
Title
Score of vividness measured during iBBT.
Description
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.
Time Frame
Day 5
Title
Temporal equivalence measured during iBBT.
Description
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.
Time Frame
Day 5
Title
Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during iBBT.
Description
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.
Time Frame
Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital Henry Gabrielle
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France
12. IPD Sharing Statement
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Motor Imagery Ability After Stroke
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