NCT03661073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2022

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

3.5 years

First QC Date

June 1, 2018

Last Update Submit

March 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • Temporal equivalence measured during KVIQ-20

    Day 1

  • Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during KVIQ-20.

    Day 1

  • Score of vividness measured during VMIQ -2

    Day 1

  • Amplitude of electrodermal responses that will be measured during imagined movement with reference to actual movements measured during VMIQ -2.

    Day 1

  • Score of vividness measured during MIQ-RS.

    Day 3

  • +10 more secondary outcomes

Study Arms (2)

Stroke

EXPERIMENTAL

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

Healthy subjects

SHAM COMPARATOR

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

Interventions

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.

Stroke

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.

Healthy subjects

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • For patients:
  • sign of cognitive decline (MMSE score under 27/30)
  • evolutionary pathology associated
  • For healthy subjects:
  • \- neurological or orthopaedical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Henry Gabrielle

Saint-Genis-Laval, 69230, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2018

First Posted

September 7, 2018

Study Start

July 17, 2018

Primary Completion

January 17, 2022

Study Completion

January 17, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations