StrokeNCT04886466
Importance of Core Stability for Coordinated Movement of the Human Body in Stroke Rehabilitation
A study testing core stability in a sitting position and while walking in one place in people with Stroke, run by Anna Olczak at 1 site in Poland.
Trial summary
This is an observational study. Measurements were made during two different motor tasks: trunk tilts without and with the tension of the abdominal muscles in the sitting position and walking in a place with high knee lifting. Read more about this study
- Who is it for?
- Ages 22 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- core stability in a sitting position and while walking in one place
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 sitePoland
- Study dates
- 10 Aug 2019to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study. Measurements were made during two different motor tasks: trunk tilts without and with the tension of the abdominal muscles in the sitting position and walking in a place with high knee lifting. It was checked how the intervention (active tension of the muscles stabilizing the core) changes the parameters of the motor coordination of the trunk and lower limbs.
Read the 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.
- Conditions
- Stroke
- Being tested
- core stability in a sitting position and while walking in one place
- Keywords
- stroke, core stability, muscle tone, motor coordination
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stability in a sitting position and while walking in one placeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| The trunk movement coordinated and legs coordination during walking in place. | Experimental | The intervention (active tension of the muscles stabilizing the core) was tested in post-stroke patients (study group). Receives: Procedure: core stability in a sitting position and while walking in one place |
| The coordinated movement of the trunk and legs during fast walking in place. | Experimental | The intervention (active tension of the muscles stabilizing the core) was tested in patients with back pain syndrome, but without neurological deficits (control group). Receives: Procedure: core stability in a sitting position and while walking in one place |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of active movement of the trunk in frontal plane.
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).
Measured: up to 1 week
Range of active movement of the trunk in sagittal plane.
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).
Measured: up to 1 week
The duration of the march-in-place
Time measured for 20 steps using the stopwatch
Measured: up to 1 week
Elevation of the feet
The elevation of the feet were measured using the laser pointer, rangefinder (measurement/angle of inclination accuracy of ± 1.5 mm).
Measured: up to 1 week
The reaction of the multifidus, transverse abdominal, and supraspinatus muscles.
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]).
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start10 Aug 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Olczak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Olczak, Military Institute od Medicine National Research Institute
- Investigators
- Anna Olczak, PhD, Principal investigator, Rehabilitation Clinic, Military Institute of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886466
- Sponsor's protocol ID
- 1/KRN/2019
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olczak A. Importance of core stability for coordinated movement of the human body in stroke rehabilitation. Neurol Res. 2022 Jan;44(1):7-13. doi: 10.1080/01616412.2021.1950952. Epub 2021 Jul 10.
PubMed 35040753
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Core Stability for Coordinated Movement of the Human Body in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT04886466
- Acronym / sponsor ID
- 1/KRN/2019
- Conditions
- Stroke
- Keywords
- stroke, core stability, muscle tone, motor coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Anna OlczakUniversity, hospital or other
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study. Measurements were made during two different motor tasks: trunk tilts without and with the tension of the abdominal muscles in the sitting position and walking in a place with high knee lifting. It was checked how the intervention (active tension of the muscles stabilizing the core) changes the parameters of the motor coordination of the trunk and lower limbs.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The trunk movement coordinated and legs coordination during walking in place. | Experimental | Procedure: core stability in a sitting position and while walking in one placeThe intervention (active tension of the muscles stabilizing the core) was tested in post-stroke patients (study group). |
| The coordinated movement of the trunk and legs during fast walking in place. | Experimental | Procedure: core stability in a sitting position and while walking in one placeThe intervention (active tension of the muscles stabilizing the core) was tested in patients with back pain syndrome, but without neurological deficits (control group). |
Who may qualify
- Ages
- 22 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| core stability in a sitting position and while walking in one placeThe 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. | Procedure or surgery | The coordinated movement of the trunk and legs during fast walking in place., The trunk movement coordinated and legs coordination during walking in place. |
Primary outcome
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).
Range of active movement of the trunk in sagittal plane.
Time frame: up to 1 week
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).
The duration of the march-in-place
Time frame: up to 1 week
Time measured for 20 steps using the stopwatch
Elevation of the feet
Time frame: up to 1 week
The elevation of the feet were measured using the laser pointer, rangefinder (measurement/angle of inclination accuracy of ± 1.5 mm).
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]).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Derived from this study: PubMed 35040753Olczak A. Importance of core stability for coordinated movement of the human body in stroke rehabilitation. Neurol Res. 2022 Jan;44(1):7-13. doi: 10.1080/01616412.2021.1950952. Epub 2021 Jul 10.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Olczak, PhD principal investigator
Rehabilitation Clinic, Military Institute of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core stability in a sitting position and while walking in one place in people with Stroke, run by Anna Olczak at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of active movement of the trunk in frontal plane. (time frame: up to 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04886466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.