NCT04886466

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable stroke

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

Study Start

First participant enrolled

August 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

May 10, 2021

Last Update Submit

May 13, 2021

Conditions

Stroke

Keywords

strokecore stabilitymuscle tonemotor coordination

Outcome Measures

Primary Outcomes (5)

  • 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).

    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).

    up to 1 week

  • The duration of the march-in-place

    Time measured for 20 steps using the stopwatch

    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).

    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 \[-1-+1V+/-1mV\]).

    up to 1 week

Study Arms (2)

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).

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).

Procedure: core stability in a sitting position and while walking in one place

Interventions

core stability in a sitting position and while walking in one placePROCEDURE

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.

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

Eligibility Criteria

Age22 Years - 83 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anna Olczak

Warsaw, Masovian District, 04-141, Poland

Location

Related Publications (1)

  • 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.

    PMID: 35040753DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Core Stability

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Postural BalanceProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Study Officials

  • Anna Olczak, PhD

    Rehabilitation Clinic, Military Institute of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D.; senior specjalit of the Rehabilitation Clinc

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 14, 2021

Study Start

August 10, 2019

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

May 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)