- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07347756
The Effect of Gait Imagery on the Muscular Activity of Lower Limbs and Lower Body Kinematics in Stroke Survivors
The Effect of Gait Imagery on the Muscular Activity of Lower Limbs and Lower Body Kinematics in Subacute Stroke Survivors
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Olomouc, Czechia, 77900
- University Hospital Olomouc
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Olomouc, Czechia, 77111
- Palacky University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subacute stage (1 week - 2 months after the onset of the attack) after primary attack of stroke
- Ischemic origin of stroke
- Good cognitive level to understand the study
- Minimum age of 18 years
- Clinically manifested hemiparetic gait with ability to perform independent walking for at least five minutes
- Mild motor deficit with ability to maintain standing without any support
- Ability to walk independently without any manual assistance of another person (≥ 3/5 points according to the Functional Ambulation Categories)
- Good level (≥ 4/7 points) of kinesthetic and visual MI according to the Czech version of the MIQ-RS questionnaire
Exclusion Criteria:
- Present impairments in communication and cognition
- An additional neurological, internal, psychological or psychiatric disorder or severe musculoskeletal disorder that may affect the ambulation
- Previous experience with MI
- Pain during the measurement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention
All individuals will be instructed to realize normal gait imagery (NGI) and gait on the line imagery (GLI) modalities in a single experimental session. The order of imagining these two gait modalities was randomized and both modalities consisted of these tasks: rest (non-imagery task), NGI/GLI before and after the real execution of normal gait/tandem gait on the line. The order of the tasks was not randomized. Individuals are also asked about the ease/difficulty of imagining both NGI/GLI before and after the real execution of gait tasks using a five-point scale. Each task is measured once for 30 s with respect to sustained attention and possible onset of fatigue. |
The initial position, which is identical for all measured tasks, consisted of an upright bipedal stance in front of an unobtrusive white screen with feet at pelvic width, upper limbs held loosely along the body, eyes open and facing forward. During the rest task, non-motor imagery task, participants are instructed to sing the song "Happy Birthday" in their minds. NGI before the real execution of normal gait and GLI before the real execution of gait on the line are tasks associated with the imagery of normal gait or tandem gait on the line. Participants first observed a 5 m section of the corridor for NGI, or a line located in the middle of the same corridor for GLI. The last tasks, NGI after the real execution of normal gait and GLI after the real execution of gait on the line, differed from above mentioned tasks in the immediate real experience of normal gait or gait on the line. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective measurement of muscle activity
Time Frame: Day 1
|
Muscle activity [V] will be measured by surface electromyography during all tasks (rest and gait imagery before/after real gait execution) across both gait imagery modalities (normal gait imagery and gait on the line imagery).
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Day 1
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Objective measurement of lower body kinematics 1
Time Frame: Day 1
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Lower body kinematics will be measured by gyroscope [deg/s] during all tasks (rest and gait imagery before/after real gait execution) across both gait imagery modalities (normal gait imagery and gait on the line imagery).
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Day 1
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Objective measurement of lower body kinematics 2
Time Frame: Day 1
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Lower body kinematics will also be measured by accelerometer [g] during all tasks (rest and gait imagery before/after real gait execution) across both gait imagery modalities (normal gait imagery and gait on the line imagery).
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire - Evaluation of gait imagery
Time Frame: Day 1
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Individuals will be asked about ease/difficulty of imagining both normaI gait imagery/gait on the line imagery before and after the real execution of gait tasks using a five-point scale (maximum value - 5 points [easy] to minimum value - 1 point [difficult]).
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Day 1
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Haltmar H., Janura M., Haltmar M., & Elfmark M. (2024).The effect of gait imagery and its more demanding variant on muscle activity in stroke survivors. Rehabilitace a fyzikální lékařství, 31(3), 116-125. doi: 10.48095/ccrhfl2024116.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IGA_FTK_2021_014
- 13/2021 (Other Identifier: Faculty of Physical Culture Palacky University Olomouc)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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