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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03661073
Other study ID # 69HCL18_0059
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 17, 2018
Est. completion date January 17, 2022

Study information

Verified date March 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 17, 2022
Est. primary completion date January 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
France Hôpital Henry Gabrielle Saint-Genis-Laval

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 1
Secondary 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. Day 1
Secondary 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. Day 1
Secondary 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. Day 1
Secondary 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. Day 1
Secondary 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. Day 3
Secondary 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. Day 3
Secondary 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. Day 3
Secondary 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. Day 3
Secondary 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. Day 3
Secondary 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. Day 5
Secondary 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. Day 5
Secondary 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. Day 5
Secondary 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. Day 5
Secondary 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. Day 5
Secondary 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. Day 5
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