- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04886466
Importance of Core Stability for Coordinated Movement of the Human Body in Stroke Rehabilitation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Surface electrodes (single-use 55 and 40 mm; ECG Electrodes; Sorimex, Poland) were glued to the subject's body according to the SENIAM (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) procedure for the transverse abdominal, multifidus, and supraspinal muscles, and a laser rangefinder was attached to the dorsal side at chest height. Before each exercise, the subject was instructed on how the exercise should be done.
The examination involved two motor exercises. In the first one, the subject was seated on the therapeutic table (with their upper extremities crossed over their chest) and instructed to lean forward as far as possible (ideally to place their torso on their thighs) and then quickly return to their starting position. The movement was repeated three times. Then the subject performed three more repetitions of the movement with their core engaged (i.e., their abdominal muscles contracted or "stabilized"). The range of trunk inclination in the sagittal plane (mm) and in the frontal plane (m), and the reaction of the multifidus, transverse abdominal, and supraspinatus muscles (tension values reported in microvolts [µV]) were measured using a millimeter board, laser pointer, rangefinder (measurement/angle of inclination accuracy of ± 1.5 mm), electrode, and a device for measuring the voltage of selected muscle groups, Luna EMG (accuracy of measurement [-1-+1V+/-1mV]).
The second exercise was a march-in-place with a high elevation of the knees. This exercise was also done as quickly as possible (time measured for 20 steps in place in seconds [s]). The exercise was done in duplicate. On the second occasion, subjects were instructed to do the exercise with their core engaged (i.e., their abdominal muscles contracted or "stabilized"). The exercise was performed in duplicate. The duration of the march and the elevation of the feet were measured, as well as the activity of the multifidus, transverse abdominal, and supraspinatus muscles.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Masovian District
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Warsaw, Masovian District, Poland, 04-141
- Anna Olczak
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Main criteria for stroke group inclusion: 1) patients with ischemic stroke; 2) patients with hemiparesis after 5 to 7 week after stroke; 3) subjects with stable trunk (the Trunk Control Test 70-100 points); 4) subjects who were in a functional state allowing walking (Rankin Scale ≤ 3); 5) no severe deficits in communication, memory, or understanding what can impede proper measurement performance; 6) at least 22 years of age; maximum 83 years of age.
Main criteria for stroke group exclusion: 1) stroke up to five weeks after the episode, 2) epilepsy, 3) lack of trunk stability, 4) lack of independent walking, 5) high or very low blood pressure, dizziness, malaise.
Main criteria for control group inclusion: 1) the control group consisted of subjects with stable trunk (TCT 100 points); correct muscle tension (MAS 0), independent walking; 2) at least 22 years of age; maximum 83 years of age.
Criteria for control group exclusion: 1) a history of neurologic or musculoskeletal disorders such as stroke or brain injury or other conditions that could affect their ability to active movement the trunk and the legs; 2) back pain; 3) no severe deficits in communication, memory, or understanding what can impede proper measurement performance; 4) high or very low blood pressure, dizziness, malaise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: The trunk movement coordinated and legs coordination during walking in place.
The intervention (active tension of the muscles stabilizing the core) was tested in post-stroke patients (study group).
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The intervention consisted of checking how the active tension of the multisection and transverse abdominal muscles affects the pattern of the trunk movement (in the sitting position) and the work of the lower limbs and the speed of movement while walking in a place.
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Experimental: The coordinated movement of the trunk and legs during fast walking in place.
The intervention (active tension of the muscles stabilizing the core) was tested in patients with back pain syndrome, but without neurological deficits (control group).
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The intervention consisted of checking how the active tension of the multisection and transverse abdominal muscles affects the pattern of the trunk movement (in the sitting position) and the work of the lower limbs and the speed of movement while walking in a place.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of active movement of the trunk in frontal plane.
Time Frame: up to 1 week
|
The range of trunk inclination in the frontal plane (m) was measured using a millimeter board, laser pointer, rangefinder (measurement/angle of inclination accuracy of ± 1.5 mm).
|
up to 1 week
|
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Range of active movement of the trunk in sagittal plane.
Time Frame: up to 1 week
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The range of trunk inclination in the sagittal plane (mm) was measured using a millimeter board, laser pointer, rangefinder (measurement/angle of inclination accuracy of ± 1.5 mm).
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up to 1 week
|
|
The duration of the march-in-place
Time Frame: up to 1 week
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Time measured for 20 steps using the stopwatch
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up to 1 week
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Elevation of the feet
Time Frame: up to 1 week
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The elevation of the feet were measured using the laser pointer, rangefinder (measurement/angle of inclination accuracy of ± 1.5 mm).
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up to 1 week
|
|
The reaction of the multifidus, transverse abdominal, and supraspinatus muscles.
Time Frame: up to 1 week
|
The reaction of muscles (tension values reported in microvolts [µV]) was measured using an electrode, and a device for measuring the voltage of selected muscle groups, Luna EMG (accuracy of measurement [-1-+1V+/-1mV]).
|
up to 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Olczak, PhD, Rehabilitation Clinic, Military Institute of Medicine
Publications and helpful links
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
- 1/KRN/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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