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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Saint-Genis-Laval, France, 69230
        • Hôpital Henry Gabrielle

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stroke
The investigator will include patients with stroke (either hemorrhagic or ischemic) with or without neglect in the experimental group.
Behavioral: Assessment of motor imagery ability
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.
Behavioral: Assessment of motor imagery ability of healthy subject
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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