NCT03635502

Brief Summary

Motor imagery (MI) might be described as a dynamic process in which an individual mentally stimulates an action without any overt movement. After stroke, motor imagery ability is impaired and also due to structure of MI, not every stroke patients is able to perform MI. Therefore, the aim of the study is a) to compare both explicit and implicit motor imagery ability (MIA) between patients with stroke and healthy subjects, b) to examine predictive effects of clinical characteristics for MIA after stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

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

August 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 17, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

December 27, 2019

Status Verified

December 1, 2019

Enrollment Period

1 month

First QC Date

August 14, 2018

Last Update Submit

December 24, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Movement Imagery Questionnaire-3 (MIQ-3)

    MIQ-3 evaluates an individual's motor imagery ability in 3 subscales: 1. internal imagery, 2. external imagery, 3. kinesthetic imagery. Each of these scales ranges from 1 to 7 where 1 indicates very hard to see/feel (image) and 7 indicates very easy to see/feel. 12 items are included in the MIQ-3 and every item is scored according to the scales. The higher the score in subscales, the better the results are.

    15 min

  • Chaotic Motor Imagery Assessment- Hand Rotation

    Hand Rotation is the first component of Chaotic Motor Imagery Assessment. In this measure, 96 drawings of each hand (left and right) from 4 different plane and at 12 different angle are presented to the individuals and then, it is asked to decide whether it is left or right hand. Total test time, total accuracy, total wrong answers, right accuracy, left accuracy, impaired hand and non-impaired hand accuracy is recorded as outcome scores.

    20 min

  • Box and Block Test

    Box and Block Test is used to calculate mental chronometry (MC) ratio. During the test, patients are asked to carry 15 blocks first physically and then mentally from one box to another. As outcome scores, the time required to carry 15 blocks physically (MET) and mentally (MIT) are recorded. Then MC ratio is calculated with the formula: (MET-MIT)/ MET.

    5 min

  • Fugl-Meyer Assessment- Upper Extremity

    Upper extremity part of Fugl Meyer Assessment (FMAUE) is used to evaluate patients' motor impairment level. Total motor and sensory scores are recorded. Then, patients are divided into 4 different categories according to their motor impairment level: 1. 23-31 points: poor upper extremity function, 2. 32-47 points: limited function, 3. 48-52 points: notable function, 4.53-66 points: full function.

    10 min

Secondary Outcomes (1)

  • Motor Activity Log-28

    5 min

Study Arms (2)

Stroke Group

Healthy Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke patients and age, sex, education matched healthy volunteers who meet the inclusion criteria

You may qualify if:

  • Being between the ages of 18-80,
  • Having a unilateral stroke for the first time and 0-6 months since stroke onset
  • points and above in Mini Mental State Examination (MMDM)
  • Not having a disease that may interfere with the study such as cardiac diseases, orthopedic conditions,etc.

You may not qualify if:

  • Multiple strokes
  • Sever cognitive dysfunction (\<24 points in MMDM)
  • Unilateral neglect
  • Upper extremity pain that interferes with the study or aggravated with movement
  • Visual problems, aphasia or another sequel that might limit the assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34394, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 17, 2018

Study Start

August 17, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

December 27, 2019

Record last verified: 2019-12

Locations