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Importance of Core Stability for Coordinated Movement of the Human Body in Stroke Rehabilitation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
core stability in a sitting position and while walking in one place
Sponsored by
Anna Olczak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, core stability, muscle tone, motor coordination

Eligibility Criteria

22 Years - 83 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Anna Olczak

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

The trunk movement coordinated and legs coordination during walking in place.

The coordinated movement of the trunk and legs during fast walking in place.

Arm Description

The intervention (active tension of the muscles stabilizing the core) was tested in post-stroke patients (study group).

The intervention (active tension of the muscles stabilizing the core) was tested in patients with back pain syndrome, but without neurological deficits (control group).

Outcomes

Primary Outcome Measures

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).
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).
The duration of the march-in-place
Time measured for 20 steps using the stopwatch
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).
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]).

Secondary Outcome Measures

Full Information

First Posted
May 10, 2021
Last Updated
May 13, 2021
Sponsor
Anna Olczak
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1. Study Identification

Unique Protocol Identification Number
NCT04886466
Brief Title
Importance of Core Stability for Coordinated Movement of the Human Body in Stroke Rehabilitation
Official Title
Importance of Core Stability for Coordinated Movement of the Human Body in Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2019 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Olczak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, core stability, muscle tone, motor coordination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The trunk movement coordinated and legs coordination during walking in place.
Arm Type
Experimental
Arm Description
The intervention (active tension of the muscles stabilizing the core) was tested in post-stroke patients (study group).
Arm Title
The coordinated movement of the trunk and legs during fast walking in place.
Arm Type
Experimental
Arm Description
The intervention (active tension of the muscles stabilizing the core) was tested in patients with back pain syndrome, but without neurological deficits (control group).
Intervention Type
Procedure
Intervention Name(s)
core stability in a sitting position and while walking in one place
Intervention Description
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.
Primary Outcome Measure Information:
Title
Range of active movement of the trunk in frontal plane.
Description
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).
Time Frame
up to 1 week
Title
Range of active movement of the trunk in sagittal plane.
Description
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).
Time Frame
up to 1 week
Title
The duration of the march-in-place
Description
Time measured for 20 steps using the stopwatch
Time Frame
up to 1 week
Title
Elevation of the feet
Description
The elevation of the feet were measured using the laser pointer, rangefinder (measurement/angle of inclination accuracy of ± 1.5 mm).
Time Frame
up to 1 week
Title
The reaction of the multifidus, transverse abdominal, and supraspinatus muscles.
Description
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]).
Time Frame
up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
83 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Olczak, PhD
Organizational Affiliation
Rehabilitation Clinic, Military Institute of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anna Olczak
City
Warsaw
State/Province
Masovian District
ZIP/Postal Code
04-141
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35040753
Citation
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.
Results Reference
derived

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Importance of Core Stability for Coordinated Movement of the Human Body in Stroke Rehabilitation

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